What’s new

Transfer to Valvira of functions related to medical devices 1.11.2009

Thu, 17 Sep 2009 12:55:00 GMT

Transfer to Valvira of functions related to medical devices 1.11.2009

The Medical Devices Department of the National Agency for Medicines monitors the manufacture and marketing of medical devices and promotes their safe use. The functions relating to medical devices will become part of the National Supervisory Authority for Welfare and Health as from 1 November 2009.

The National Product Control Agency for Welfare and Health (STTV) and the National Authority for Medicolegal Affairs (TEO) merged on 1 January 2009 creating a new central office of the administrative sector of the Ministry of Social Affairs and Health known as the National Supervisory Authority for Welfare and Health (Valvira). Through guidance and supervision, Valvira improves the management of health risks in the environment as well as legal protection and the quality of services in social welfare and health care.

The new contact information of the Medical Devices entity as from 1 November 2009:

Valvira (National Supervisory Authority for Welfare and Health)
Lintulahdenkuja 4
P.O. Box 210
FI-00531 Helsinki
FINLAND

Tel. + 358 9 772 920
Fax + 358 9 772 2138
Email: firstname.lastname@valvira.fi
Registry office: kirjaamo@valvira.fi
www.valvira.fi

For further information:

Jussi Holmalahti, director, Licensing, Valvira, tel. +358 9 7729 2157

Marja-Liisa Partanen appointed as the new Director General for Valvira

Fri, 28 Aug 2009 11:46:00 GMT

Marja-Liisa Partanen appointed as the new Director General for Valvira

The Government has appointed LL.M. Marja-Liisa Partanen as the Director General of the National Supervisory Authority for Welfare and Health (Valvira) as of 1 November 2009.

Read more: Ministry of Social Affairs and Health, Press release (in finnish)

The Government proposes establishing a new national Medicines Agency

Tue, 19 May 2009 07:34:00 GMT

The Government proposes establishing a new national Medicines Agency

The Government has decided on the content of the government bill regarding the Agency on 13 May. The President of the Republic submitted the bill to Parliament on Friday 15 May. According to it, the Finnish Medicines Agency will start work on 1 November 2009 in Kuopio.

The main duties of the Finnish Medicines Agency that is to be established are proposed authorisation and supervision tasks in the pharmaceuticals field, research and development, and production and dissemination of information on medicinal products with a view to improve the effectiveness of pharmaceutical service and pharmacotherapy.

The tasks of the new Agency include the present tasks of the National Agency for Medicines associated with medicinal products. The National Agency for Medicines has actively contributed to the supervision of medicinal products within the EU. The Government bill wants to stress and expand the EU level and international cooperation of the new Agency.

The Ministry of Social Affairs and Health and the National Agency for Medicines have prepared a plan to ensure the optimal functioning of operations during the transition. The regionalisation will be carried out during a transition period of five years. The most important tasks of the present National Agency for Medicines, EU level and other international commitments included, will be prioritised. The Agency has also undertaken measures to retain skills and expertise. Electronic official communication and automated case management are being developed, processing of marketing authorisations included.

Read more:
The Ministry of Social Affairs and Health www.stm.fi/en/
Press release 183/2009 13.05.2009 The Government proposes establishing a new national Medicines Agency

For further information contact:
Marja-Liisa Partanen, Director General, National Agency for Medicines, tel. +358 9 4733 4200
Vesa Jormanainen, Project Manager, tel. +358 50 430 1732

Ministry of Social Affairs and Health:
Päivi Sillanaukee, Director-General, tel. +358 9 160 73313
Anne Koskela, Ministerial Counsellor, Legal Affairs, tel. +358 9 160 74340, +358 50 5011908
Ulla Närhi, Ministerial Adviser, tel. +358 9 160 74 146

Ms. Marja-Leena Partanen appointed as Director General of the NAM

Fri, 15 May 2009 08:29:00 GMT

Ms. Marja-Leena Partanen appointed as Director General of the NAM

Ms. Marja-Liisa Partanen, Deputy Director General at the Ministry of Social Affairs and Health has been appointed as Director General of the National Agency for Medicines as of 13 February. She is the successor of professor Hannes Wahlroos whohad given his resignation earlier this year.

Ms Liisa Hyssälä, Minister of Social Affairs and Health has launched a project to reorganise the tasks of agencies under the Ministry of Social Affairs and Health pertaining to pharmaceutical supply through the establishment of a new pharmaceutical centre. The aim of the reorganisation is to consolidate pharmaceutical supply resources and to streamline operations.

The responsibility for preparing for the new pharmaceutical centre has been transferred by the Ministry of Social Affairs and Health to Director General Partanen. The Ministry will continue the preparations for establishing the new pharmaceutical centre and the reorganisation of pharmaceutical supply.

The project steering group will be leading the process, defining the strategy, organisation and management system for the centre and determining the tasks to be relocated. The project group will guide and coordinate the reform under the steering group and answers for, inter alia, the preparations for strategy, organisation and management system for the new centre.

The new pharmaceutical centre will start with R & D operations in Kuopio on 1 November 2009. Special attention will be paid to securing the continuity of operations even during the decentralisation process up to 2014.

Read more:
the Ministry of Social Affairs and Health
Press release 19.1.2009 New Pharmaceutical Centre will be established in Kuopio
Press release 10.9.2008 Pharmaceutical expertise to be consolidated into new centre in Finland

Director General, professor Hannes Wahlroos resigned

Wed, 14 Jan 2009 08:46:00 GMT

Director General, professor Hannes Wahlroos resigned

Professor Hannes Wahlroos has resigned from his position as Director General of the National Agency for Medicines (NAM). He left his official note today to the Ministry of Social Affairs and Health.

“After serving the Finnish Government for 30 years in this sector and acting as the Head of the NAM for 16 years this is the right moment to transfer the responsibility. The Finnish Ministry of Social Affairs and Health will execute plans to reorganise and relocate the pharmaceutical administration in Finland.”

“During these years I have experienced a lot in the EU, EMEA and HMA circles. I am sure the future pharmaceutical regulatory framework in Europe will be even stronger and operate for the benefit of European citizens and stakeholders. The new Finnish pharmaceutical administration will also meet the national and European challenges with new goals and strengths.”

“I face the future with an open mind and will now be available for new tasks and challenges.”

National Agency for Medicines launches new online search tool

Tue, 02 Dec 2008 11:03:00 GMT

National Agency for Medicines launches new online search tool

Finland’s National Agency for Medicines (NAM) has launched a new online search facility. Titled “Is this a medicinal substance or a medicinal product?”, the new facility allows consumers and importers to ascertain whether a substance is classed as a medicine or whether a given product has previously been classed as a medicine.

The search facility comprises information found in the annexes to NAM’s decision on medicinal products list as well as information on classification decisions taken by NAM dating back to 2001. It is designed to make it easier for importers and the public to access information on the classification of medicinal products. With the launch of the new search facility, more information on classification decisions taken by NAM, including the grounds on which the decisions are based, is now going to be made publicly available.

The distinction between medicines and other products is not always clear. Where there is uncertainty as to whether a product should be classed as a medicine or, for example, as a nutritional supplement, a cosmetic product or a biocide, an application for classification should be submitted to the National Agency of Medicines. The Agency will assess the product’s composition, the mechanism by which its effect is obtained, any marketing claims made and the dosage. Applying for classification is important as it is the product’s classification that determines the legislative acts governing its import, distribution channels, sale and marketing. In addition, products fall with the remit of different supervisory authorities depending on their classification.

Searches can be carried out using the product’s composition or name or a company name. Other search options include the date of the classification decision or the grounds on which the decision was taken. You can also search for products under relevant words such as caffeine, ginseng* or a company name. Searches under the active substance can be carried out in Finnish, Swedish, English or Latin. The most extensive search results are available in Finnish.

The search result may be displayed as a reference to Annex 1, 2 or 3 of NAM’s List of Medicines and/or a list of earlier classification decisions. The grounds for the decision and product composition information relevant to the decision are available separately.

Summaries of product characteristics (SPCs) and package leaflets (PLs) for medicinal products with marketing authorisation continue to be available through the NamWeb search tool.

Further resources:
“Is this a medicinal substance or a medicinal product?” search tool
NamWeb (information on medicinal products authorised for marketing)
List of Medicines
Classification

Further information:
Kristiina Pellas, Senior Pharmaceutical Officer, tel: +358 (0)9 4733 4336
Tuula Nousu, Legal Officer, tel: +358 (0)9 4733 4219

firstname.lastname@laakelaitos.fi

Substitutable medicinal products for January–March 2009

Wed, 26 Nov 2008 12:29:00 GMT

Substitutable medicinal products for January–March 2009

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period 1.1.–31.3.2009.

List in Finnish (pdf, 673 kb)

More about substitutable medicinal products

Further information:
Pekka Kurki, Head of Department, professor, tel. +358 9 4733 4225
Marjo-Riitta Helle, Head of Section, tel. +358 9 4733 4239
Risto Salmi, Legal Officer, tel. +358 9 4733 4220

firstname.lastname@nam.fi

Initial effects of the Sunset clause

Mon, 24 Nov 2008 07:20:00 GMT

Initial effects of the Sunset clause on the marketing authorisations and registrations of medicinal products

The reform of the European pharmaceutical Directives in 2004 introduced the Sunset clause, under which a marketing authorisation or registration lapses i.e. ceases to be valid if the product has not been placed on the market within three years of the granting of the marketing authorisation or registration, or if the product has been absent from the market for a period of three consecutive years (the Sunset clause has been implemented into section 29 of the Medicines Act (395/87). The aim and intention of enacting the Sunset clause was to ensure that medicinal products with marketing authorisation or registration are placed on the market in the authorising Member State and thus become available to patients.

The legal effects of the Act commenced on 7 November 2008, on which date 250 marketing authorisations lapsed. Another 441 marketing authorisations at risk of lapsing were withdrawn by the relevant marketing authorisation holder before 7 November 2008. Most of the lapsed and withdrawn marketing authorisations concerned generic medicinal products, while of the 261 registrations of homeopathic preparations at risk of lapsing, 173 came to lapse. The lapsing of the aforementioned marketing authorisations and registrations will have no effect on medical or veterinary care in Finland, as the products concerned were not available on the Finnish market.

Section 29 of the Medicines Act will in future ensure that the administration of marketing authorisations and registrations targets precisely those medicinal products intended for the Finnish market and Finnish patients. The National Agency for Medicines will publish a monthly bulletin on the marketing authorisations and registrations that have lapsed.

Read more:
List of lapsed marketing authorisations and registrations (pdf)
Lapsing of marketing authorisations and registrations (Sunset clause)

For further information, please contact:
Professor Pekka Kurki, Head of Section, tel. +358 (0)9 4733 4225
Consulting Legal Advisor Risto Salmi, tel. +358 (0)9 4733 4220

firstname.lastname@laakelaitos.fi

Regulation 1/2007 on clinical trials published in English

Tue, 18 Nov 2008 10:30:00 GMT

Regulation 1/2007 on clinical trials published in English

Administrative regulation 1/2007 (Clinical trials on medicinal products in human subjects) has been translated into English. The unofficial translation has been published on the National Agency for Medicines website.

The regulation nationally implements Directive 2001/20/EC of the European Parliament and of the Council on the conduct of clinical trials on medicinal products for human use and, concerning its application, Commission Directives 2003/94/EC on good manufacturing practice and 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. The Regulation does not concern Article 6 of Commission Directive 2005/28/EC.

Read more:
Clinical trials on medicinal products in human subjects (Regulation 1/2007)

New medical devices legislation proposed to improve patient safety

Mon, 06 Oct 2008 10:59:00 GMT

New medical devices legislation proposed to improve patient safety

News from the Ministry of Social Affairs and Health and the National Agency for Medicines

A Finnish Government proposal has been drafted to clarify the liability of authorities, businesses and professional users of medical devices, with the aim of improving patient and occupational safety and promoting the safety of medical devices. Initiated by the Ministry of Social Affairs and Health, the proposal was prepared by the National Agency for Medicines.

The suggested clarifications to the liability of device manufacturers, distributors and professional users as well as the duties of supervisory authorities will make the situation clearer from the perspective of all those operating in the sector. They will also help realise the ultimate purpose of the legislation – ensuring device safety. Another aim of the proposal is to amend Finnish legislation so it will clearly present the system of supervision concerning medical devices and the relationship of national provisions to EU provisions. This will be particularly beneficial for Finnish device manufacturers planning to launch their products in the European single market.

The proposal clarifies the division of liability, with provisions suggested including the obligation of the distribution chain and professional users to comply with the manufacturer's instructions. Also proposed is an obligation for professional users to maintain a performance monitoring system regarding compliance with obligations laid down in the Medical Devices Act. Organisations and teachers using medical devices for educational purposes are also to be assigned professional user’s liability regarding the use of such devices. The proposal also specifies the requirements that health care units must meet in their own device production.

Current Finnish legislation does not enable comprehensive and efficient supervision of product safety. Devices are becoming more complex and their number in the market is increasing. This calls for legislation to ensure that there are sufficient supervision measures available to authorities. Efficient supervision is also beneficial to businesses as it guarantees equal competition conditions.

If adopted, the revised Medical Devices Act will replace the current Medical Devices Act (1505/1994) and implement Directive 2007/47/EC.

The drafting process has involved consultation by the National Agency for Medicines with several actors in the field of devices and supplies as well as professionals using them. The closing date set by the Ministry of Social Affairs and Health for opinions on the proposal is 10 November 2008.

You can read more about the proposal on the National Agency for Medicines website (in Finnish).

Further information:
Marja-Liisa Partanen, Deputy Director-General, Ministry of Social Affairs and Health, tel. +358 (0)9 160 73804, +358 (0)50 559 9169

Professor Tomi Kauppinen, Head of Department, National Agency for Medicines, tel. +358 (0)9 4733 4241
Ilona Rintanen, Legal Officer, tel. +359 (0)9 4733 4479

New application form for variation to a marketing authorisation for medicinal products

Wed, 17 Sep 2008 09:17:00 GMT

New application form for variation to a marketing authorisation for medicinal products

The National Agency for Medicines wishes to remind all applicants that the application form for variation to a marketing authorisation for medicinal products has been renewed in May 2008. The renewed application form must be used in all new applications for variation to a marketing authorisation for medicinal products.

Changes of pharmaceutical administration being prepared by the Ministry of Social Affairs and Health

Tue, 16 Sep 2008 12:02:00 GMT

Changes of pharmaceutical administration being prepared by the Ministry of Social Affairs and Health

The Ministry of Social Affairs and Health has set up a project to prepare a reform of its central administration related to pharmaceuticals.

The tasks planned for a new pharmaceutical centre include drug research and development, dissemination of best practices, preparation of evaluations of overall and cost effectiveness and, to a certain extent, licensing practices, such as marketing authorisations for medicinal products. The new centre is due to commence its operations in the autumn of 2009. The optional locations for the centre currently being investigated are Kuopio or Oulu in Eastern and Northern Finland.

The organisational reform include the National Agency for Medicines, the Centre for Pharmacotherapy Development ROHTO and, in respect of duties relating to pharmaceutical supply, the National Authority for Medicolegal Affairs, National Product Control Agency for Welfare and Health, the National Public Health Institute, and the National Research and Development Centre for Welfare and Health.

Substitutable medicinal products for October–December 2008

Thu, 28 Aug 2008 10:42:00 GMT

Substitutable medicinal products for October–December 2008

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.10.–31.12.2008.

List in Finnish (pdf, 231 kb)

More about substitutable medicinal products

Further information:
Professor Pekka Kurki, Head of Department, tel. +358 9 4733 4225
Marjo-Riitta Helle, Head of Section, tel. +358 9 4733 4239
Risto Salmi, Legal Officer, tel. +358 9 4733 4220

firstname.lastname@nam.fi

List published of marketing authorisations and registrations at risk of lapsing

Fri, 15 Aug 2008 09:27:00 GMT

List published of marketing authorisations and registrations at risk of lapsing

The reform of European pharmaceutical legislation (Directives 2004/27/EC, 2004/28/EC of the European Parliament and of the Council) introduced the “sunset clause” subsequently transposed into the national legislation in section 29(1) of the Medicines Act (395/87).

Under the said provision, a marketing authorisation or registration lapses i.e. ceases to be valid if the product has not been placed on the market within three (3) years of the granting of the marketing authorisation or registration, or if the product has been absent from the market for a period of three (3) consecutive years.

The provision entered into force on 7 November 2005 and it will have legal effect on the marketing authorisations and registrations of medicinal products as of 7 November 2008. The provisions on the waiver procedure to prevent a marketing authorisation or registration from lapsing are laid down in section 29(3) of the Medicines Act.

By its letter dated 20 December 2007 to holders of marketing authorisations and registrations and on its website, the National Agency for Medicines has announced that it will publish on 15 August 2008 a list of the marketing authorisations and registrations at risk of lapsing on 7 November 2008. The said list has been published on this date and may be accessed from the link below.

No corresponding list of marketing authorisations and registrations lapsing after 7 November 2008 will be published; ensuring the validity of marketing authorisations and registrations is the duty of the relevant holders. Holders will be notified in writing once their marketing authorisation or registration has lapsed. In addition, the National Agency for Medicines will maintain on its website lists on those marketing authorisations and registrations which have lapsed.

The final list of marketing authorisations and registrations which lapsed on 7 November 2008 will be published on the National Agency for Medicines website on 14 November 2008. The holders of the marketing authorisations and registrations will also be provided written notification of the lapsing.

Read more:
List of marketing authorisations and registrations at risk of lapsing (pdf)
Lapsing of marketing authorisations and registrations (Sunset clause)

Further information:
Risto Salmi, Consulting Legal Advisor, tel. +358 (0)9 4733 4220

firstname.lastname@nam.fi

Lapsing of marketing authorisations and registrations 8.11.2008

Mon, 16 Jun 2008 09:10:00 GMT

Lapsing of marketing authorisations and registrations 8.11.2008

National Agency for Medicines has sent a letter concerning lapsing of marketing authorisations and registrations in Finland and the reference member state duties of the National Agency for Medicines to holders of marketing authorisations and registrations on June 13th 2008.

Further information:
Risto Salmi, Consulting Legal Advisor, tel. +358 9 4733 4220

firstname.lastname@nam.fi

Substitutable medicinal products for July–September 2008

Wed, 28 May 2008 12:36:00 GMT

Substitutable medicinal products for July–September 2008

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.7.–30.9.2008.

List in Finnish (pdf)

firstname.lastname@nam.fi

Changes in NAM’s URL addresses

Mon, 26 May 2008 12:42:00 GMT

Changes in NAM's URL addresses

Because of the change in National Agency for Medicine’s Internet Service Provider there will be changes in some of NAM’s URL addresses on May 26th 2008.

We kindly ask our partners and interest groups to check up possible links to NAM’s website. Should there be any problems, please contact the National Agency for Medicines.

Further information:
Anna Karjalainen, Web Editor, tel. +358 9 4733 4386

firstname.lastname@nam.fi

Drug counterfeiting must be tackled through legislation

Tue, 13 May 2008 13:10:00 GMT

Drug counterfeiting must be tackled through legislation

Issues of drug counterfeiting and pharmaceutical crime must tackled through EU legislation. At the moment counterfeits and pharmaceutical crime are not defined in EU legislation which makes it more difficult for authorities to protect consumers from problems related to drug counterfeiting. It is the opinion of the National Agency for Medicines that there is a real need for legislative definitions for these issues. There is also a need for European-level coordinating body with clear definition of role and responsibility in the area of anti-counterfeiting of drugs.

Read more:
NAM's statement on EU consultation "Key ideas for better protection of patients against the risk of counterfeit medicines" (pdf)

Further information:
Professor Jussi Holmalahti, Head of the Department of Enforcement & Inspection, tel. +358 9 4733 4221

firstname.lastname@nam.fi

Change in Sampo bank's swift code

Mon, 14 Apr 2008 10:35:42 GMT

Change in Sampo bank's swift code

The swift code of Sampo bank has changed. The new swift code is DABAFIHH.

Further information:
Fees

Supplement 6.1 of the European Pharmacopoeia has been published

Tue, 01 Apr 2008 09:25:17 GMT

Supplement 6.1 of the European Pharmacopoeia has been published

The first supplement of the sixth edition (Supplement 6.1), as well as the updated cumulative Internet- and CD-ROM version, of the European Pharmacopoeia have been published. The supplement alongside its versions will be implemented on April 1, 2008. The National pharmacopoeia documents have been updated according to the Supplement 6.1.

Further information:
European Pharmacopoeia
National Pharmacopoeia documents

For further information please contact:
Professor Jussi Holmalahti, Head of the Department of Enforcement & Inspection, tel. +358 9 4733 4221
Kaarina Sinivuo, Senior Researcher, tel. +358 9 4733 4307

firstname.lastname@nam.fi

NAM’s Strategic Targets 2008 – 2012

Wed, 27 Feb 2008 08:43:51 GMT

NAM’s Strategic Targets 2008 – 2012

The NAM has updated its strategic targets 2008 – 2012.

More about strategy

Further information:
Hannes Wahlroos, Director General, Prof., tel. +358 9 4733 4200

Substitutable medicinal products for April–June 2008

Fri, 15 Feb 2008 11:22:39 GMT

Substitutable medicinal products for April–June 2008

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.4.–30.6.2008.

List in Finnish (pdf, 1 488 kb)

More about substitutable medicinal products

Further information:
Professor Pekka Kurki, Head of Department, tel. +358 9 4733 4225
Marjo-Riitta Helle, Head of Section, tel. +358 9 4733 4239
Risto Salmi, Legal Officer, tel.+358 9 4733 4220

firstname.lastname@nam.fi

The Finnish National Agency for Medicines enables electronic official communication and adopts automated case management

Mon, 04 Feb 2008 22:00:00 GMT

The Finnish National Agency for Medicines enables electronic official communication and adopts automated case management

Capgemini to deliver a case management system for the Finnish National Agency for Medicines

Helsinki, February 1 2008 –The Finnish National Agency for Medicines (NAM) has signed an agreement with Capgemini, one of the world's foremost providers of consulting, technology and outsourcing services, to provide an automated case management system.Overthe next two years, all of NAM’s functions will be prepared for automated communication.The project has been divided into several subprojects.The first of these will be the automation of the marketing authorisation process. According to the target schedule, electronic marketing authorisation processes will be implemented and in use during the first half of the year 2009.

NAM’s case management system is based on the Microsoft MOSS 2007 platform, which provides versatile shrink-wrap features and a flexible way for implementing the special case management requirements.Furthermore, the system will comprise a Microsoft SQL Server database and BizTalk integration solution.

The development work will take into consideration those EU standards and directives that pertain to electronic official communication.The implementation of the system will be compliant also with the Finnish SÄHKE provisions that regulate the permanent storage of electronic public administration records.

The agreement between Capgemini and NAM includes the delivery and deployment of the case management system as well as the development of NAM’s electronic procedures.

“From NAM’s perspective, this is a strategic development leap into a new operation model in which customer relationships and processes steer the operations.The development starts with priority given to the processing of marketing authorisation applications by the pharmaceutical industry. Gradually, we will move on to the rest of NAM’s core processes”, comments Professor Hannes Wahlroos, Director General of the National Agency for Medicines.“Similar projects exist in the medicines agencies of several other EU member states.With this development investment, NAM strives toward smoother customer service and operational efficiency.”

“A public bidding was arranged for the project.Capgemini was the winner because it was deemed to be the most compatible with the business requirements of NAM and it was considered to have a good overall view of the architecture, modern and flexible technology solutions, success in reference queries and competence of its experts”, comments Maarit Waskilampi-Kuikka,Head of Data Resource Management of the National Agency for Medicines.

”The now agreed collaboration with NAM is asignificant project for Capgemini Finland. Case management and automated official communication are key areas for our business with public sector clients in Finland and globally. A year ago we started together with Microsoft a business unit that has strengthened our position in delivering large-scale case management solutions”, says Elja Kirjavainen, Sales Director for Capgemini Finland. “The collaboration with NAM is not only implementing a system but a change project for the agency’s whole operation model, and Capgemini’s wide expertise in building the system and in managing the change will be utilised. Strong experience in public sector and knowing the agency’s operation are the success factors for the project.”

In the case management system delivery, Capgemini utilises a distributed delivery model with experts from several countries participating.The agreement now concluded on the case management system and collaboration with Capgemini will continue for five years.

For further information please contact:
Hannes Wahlroos, Director General, Professor, National Agency for Medicines, tel. +358 (9) 4733 4200, hannes.wahlroos@nam.fi
Maarit Waskilampi-Kuikka, Head of Data Resource Management, National Agency for Medicines, tel. +358 (9) 4733 4500, maarit.waskilampi-kuikka@nam.fi
Elja Kirjavainen, Sales Director, Capgemini, tel. +358 400 487 657, elja.kirjavainen@capgemini.com
Marja Jokinen, Communications, Capgemini, tel. +358 50 5810 264, marja.jokinen@capgemini.com

About Capgemini
Capgemini, one of the world's foremost providers of consulting, technology and outsourcing services, enables its clients to transform and perform through technologies. Capgemini provides its clients with insights and capabilities that boost their freedom to achieve superior results through a unique way of working – the Collaborative Business Experience – and through a global delivery model called Rightshore®, which aims to offer the right resources in the right location at competitive cost. Present in 35 countries, Capgemini reported 2006 global revenues of EUR 7.7 billion and employs over 83,000 people worldwide. More information is available at www.capgemini.com.

About National Agency for Medicines
The National Agency for Medicines promotes the health and safety of the citizens by regulatory control of medicinal products, medical devices and blood products.More information:www.nam.fi.

New Decree on Fees for Services

Fri, 04 Jan 2008 09:30:31 GMT

New Decree on Fees for Services

The Ministry of Social Affairs and Health has issued a new decree on the service fees charged by the National Agency for Medicines. The decree takes effect from 1 January 2008 and will remain in force until the end of 2009.

Key changes introduced by the decree include increases to marketing authorisation application fees, type II variation fees and the annual fee as well as certain changes to licensing and inspection fees.

Further information
Decree on Fees

For further information, please contact
Marja-Liisa Hurme, Finance Manager, tel: +358 (0)9 4733 4216

Further development of the management of marketing authorisation issues

Thu, 20 Dec 2007 11:06:14 GMT

Further development of the management of marketing authorisation issues

Innovative new medicinal products in the European Union are assessed according to the centralised procedure coordinated by the European Medicines Agency, EMEA. Marketing authorisation applications for other medicines are mainly managed in the decentralised and mutual recognition procedures which are based on the mutual collaboration of the national agencies.

The future of the European Regulatory Medicines Network is dependent on whether the member states wish to contribute to the mutual collaboration by offering their best expertise for tasks which involve other member states of the EU. Common decisions sometimes require harmonisation of national regulatory principles and even of treatment practices, while the member states generally show great reluctance to accept this. Due to the increased number of applications and regulatory principles the mutual responsibilities are shared by too few medicines agencies.

Among others the NAM has also been immersed in a backlog of applications. Analysis of the situation is followed by conclusions to help solve the situation so that marketing authorisation procedures are able to respect the due dates without jeopardising the safety of medicines or NAM’s strategic aims.

Above mentioned issues were also informed and discussed in a meeting which the NAM held for the industry on 19 December 2007.

Read more:
TABU 6/2007 (pdf)
European marketing authorisation procedure scope for further development
Further development of the management of marketing authorisation issues

For further information please contact:
Pekka Kurki, Head of Department, Professor, tel. +358 9 4733 4225
Marjo-Riitta Helle, Head of Section, Generic Medicines, tel. +358 9 4733 4239
Pirjo Laitinen-Parkkonen, Head of Section, Innovative Medicines, tel. +358 9 4733 4411
Irmeli Happonen, Head of Section, Veterinary Medicines, tel. +358 9 4733 4284
Risto Salmi, Consulting legal advisor, tel. +358 9 4733 4220

forname.surename@nam.fi

Amendment of the Medicines Act concerning the lapsing of marketing authorisations and registrations of medicinal products (sunset clause) will have legal effect as of 7 November 2008

Fri, 14 Dec 2007 05:32:40 GMT

Amendment of the Medicines Act concerning the lapsing of marketing authorisations and registrations of medicinal products (sunset clause) will have legal effect as of 7 November 2008

Lapsing of marketing authorisations and registrations

The reform of European pharmaceutical legislation (Directives 2004/27/EC and 2004/28/EC of the European Parliament and of the Council) introduced the “sunset clause”, which has been transposed into national legislation in section 29, subsection 3, paragraph 1 of the Medicines Act (395/87). Under the sunset clause, a marketing authorisation or registration shall cease to be valid if the authorised or registered product has not been placed on the market within three years of the granting of the registration or authorisation or if an authorised or registered product has been absent from the market for a period of three consecutive years.

The amended section 29 of the Medicines Act (395/87) entered into force on 7 November 2005. The provision will have legal effect on marketing authorisations and registrations of medicinal products as of 7 November 2008.

List of marketing authorisations and registrations at risk of lapsing

The National Agency for Medicines will publish on its website on 15 August 2008 a list of those marketing authorisations and registrations that will cease to be valid pursuant to section 29(1)(3) and for which no waiver has been sought by the deadline. If the holder wishes to retain the marketing authorisation or registration of a product appearing on this list, the said product must be placed on the market by 7 November 2008.

For reasons relating to the health of humans or animals or for other particular reasons, the National Agency for Medicines may upon application from the holder of the marketing authorisation or registration decide that the marketing authorisation or registration shall not cease to be valid pursuant to subsection 1, paragraph 3. Application to continue the validity of a marketing authorisation or registration shall be submitted to the National Agency for Medicines no later than three (3) months prior to the expiry of the three-year time limit (section 29, Medicines Act 395/87). Waiver applications must thus be submitted to the National Agency for Medicines by 7 August 2008 at the latest.

If the holder of a marketing authorisation or registration has not applied for a waiver to extend validity and the medicinal product has not been placed on the market by 7 November 2008, the marketing authorisation or registration is deemed to have ceased to be valid. A list of marketing authorisations and registrations that have ceased to be valid will be published on the National Agency for Medicines website on 15 November 2008.

During December 2007, the National Agency for Medicines will dispatch to all holders of marketing authorisations and registrations a letter addressing the lapsing of marketing authorisations and registrations.

For further information, please contact:
Consulting Legal Advisor Risto Salmi, tel. +358 9 4733 4220
Original medicinal products: Procedure Manager Marja Helenius, tel. +358 9 4733 4235
Generic medicinal products: Procedure Manager Hanna Saari (until 31 Dec 2007), tel. +358 9 4733 4231; Project Manager Anna Tirri (as of 1 Jan 2008), tel. +358 9 4733 4352
Veterinary medicinal products: Procedure Manager Paula Kajaste, tel. +358 9 4733 4286
firstnam.lastname@nam.fi

Notification of the results of paediatric studies to the Authorities

Tue, 04 Dec 2007 11:42:18 GMT

Notification of the results of paediatric studies to the Authorities

Under article 45 of the paediatric regulation, any paediatric studies already completed by January 26, 2007, shall by 26 January 2008 be submitted by the marketing authorisation holder for assessment to the competent Authority where the medicinal product is authorised.

Each MAH is required to fill in the information on the medicinal products for their national approved MAs, using the templates available via the following link of the CMD(h).
The information is collected for all medicinal products, irrespective of the route of authorisation and irrespective of whether it is a medicinal product containing a new active substance or a generic medicinal product.

The filled-in template should be sent to the competent Authority of each Member States where the medicinal product is authorised.
Documents to be submitted to the National Agency for Medicines should be sent to paed@nam.fi, additionally a copy of the documents should be sent to EMEA at paedstudies@emea.europa.eu.

The assessment of the paediatric data will be done within the Paediatric Worksharing process coordinated by EMEA and CMD(h).
The assessment may result in the competent Authority requesting the summary of products characteristics and package leaflet to be updated.

Further instructions and the templates are available on the website of the CMD(h).

For further information please contact:

Merete Broms, Coordinator for Paediatric Medicines, tel. +358-9-4733 4397
Maria Virkki, MD, PhD, Senior Medical Officer, tel. +358-9-4733 4329
Jaana Joensuu, MD, PhD, Senior Medical Officer, tel. +358-9-4733 4268
Pirjo Laitinen-Parkkonen, MD, PhD, Head of Section, tel. +358-9-4733 4411

Substitutable medicinal products for January–March 2008

Mon, 26 Nov 2007 12:59:20 GMT

Substitutable medicinal products for January–March 2008

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.1.–31.3.2008.

List in Finnish (pdf, 235 kt)

More about substitutable medicinal products

Further information:
Professor Pekka Kurki, Head of Department, tel. +358 9 4733 4225
Marjo-Riitta Helle, Head of Section, tel. +358 9 4733 4239
Risto Salmi, Legal Officer, tel.+358 9 4733 4220
firstname.lastname@nam.fi

New Checklist to Help Consumers Evaluate Information on Medicines

Mon, 15 Oct 2007 07:43:07 GMT

New Checklist to Help Consumers Evaluate Information on Medicines

The internet is gaining popularity as a source of drug information, and numerous websites now compete for consumer attention. The quality of the information on offer can vary greatly, however, and it is becoming increasingly important that consumers are able to evaluate information independently.

To address the situation, the National Agency for Medicines in Finland has launched an evaluation checklist on its website. It is also intended to remind consumers of the importance of information quality assessments more generally. The DARTS checklist draws the consumers’ attention to details such as the Date, Author, References, Type and Sponsor of the information offered. By responding to the checklist questionnaire, users will be able to assess the reliability of the information more easily.

The DARTS checklist has been drawn up by the National Agency for Medicines as part of its work on the European Commission Pharmaceutical Forum Working Group on Information to Patients. It is based on existing quality criteria aimed at both consumers and information providers. The aim has been to create an evaluation tool that is quick, straightforward and easy to use. Originally produced in English, the checklist is now also available in Finnish (KATSE) and Swedish (DARTS).

National Agency for Medicines Staff Training Day 9 - 10 October 2007

Fri, 05 Oct 2007 07:15:10 GMT

National Agency for Medicines Staff Training Day 9 - 10 October 2007

Staff at the National Agency for Medicines will attend training on 9 and 10 October 2007.

During this time, all calls will be answered by The National Agency for Medicines switchboard. If the matter is urgent, on-call staff will be available

Our reception on the 4^th floor of Mannerheimintie 103b will be open as normal. The registry will be closed.

Switchboard tel: +358 (0)9 473 341
Fax: +358 (0)9 714 469
kirjaamo@laakelaitos.fi

The eighth supplement of the fifth edition of the European Pharmacopoeia into effect July 1, 2007

Fri, 29 Jun 2007 10:33:27 GMT

The eighth supplement of the fifth edition of the European Pharmacopoeia into effect July 1, 2007

The eighth supplement of the fifth edition (Supplement 5.8), as well as the updated cumulative Internet- and CD-ROM version of the European Pharmacopoeia will be implemented on July 1, 2007.

The national pharmacopoeia documents have been updated according to the Supplement 5.8.

NAM launched a project to normalise application processing times

Wed, 30 May 2007 06:04:39 GMT

NAM launched a project to normalise application processing times

Statutory international processes tied to fixed time periods have caused a backlog in new applications entering the national process at the same time.

The NAM has taken steps to normalise this situation with a separate project. The backlog will be handled by June 2009.

In order to avoid creating a new backlog for new applications, the authorising process is simplified while the follow-up and reporting procedures will be further developed.

Additional information:
professor Olavi Tokola, Head of Department, Marketing authorisations, t. +358 9 4733 4227
Marjo-Riitta Helle, Head of Section, Marketing authorisations, t. +358 9 4733 4239

New instructions for applying for Export and GMP Certificates

Mon, 30 Apr 2007 07:20:46 GMT

New instructions for applying for Export and GMP Certificates

The practises for applying Export (CPP,Certificate of a Pharmaceutical Product) and GMP (Good Manufacturing Practise) Certificates have been changed in order to get the handling process more efficient and also to follow the new guidelines of EU concerning the structure of GMP Certificate.

The CPP and GMP Certificates can not be applied with the shared form after 31.5.2007. The new instructions and the new form for the CPP Certificate are available on the website.

Further information:

Export Cerficates: Minna Turunen, Secretary for Marketing Authorisations, tel. +358 9 4733 4234

GMP Certificates:
Päivi Nevalampi, Pharmaceutical Officer, tel. +358 9 4733 4282
Paula Köysti, Pharmaceutical Officer, tel. +358 9 4733 4217

Annual Report 2006

Tue, 17 Apr 2007 10:09:11 GMT

Annual Report 2006

Annual Report 2006 (pdf)

Orders of printed copies: viestinta@nam.fi

Annual Reports

The seventh supplement of the fifth edition of the European Pharmacopoeia into effect April 1, 2007

Fri, 30 Mar 2007 09:20:09 GMT

The seventh supplement of the fifth edition of the European Pharmacopoeia into effect April 1, 2007

The seventh supplement of the fifth edition (Supplement 5.7), as well as, the updated cumulative Internet- and CD-ROM version of the European Pharmacopoeia will be implemented on April 1, 2007. The National pharmacopoeia documents have been updated according to the Supplement 5.7.

European Pharmacopoeia and national pharmacopoeia documents

New organizational structure for marketing authorisation

Wed, 14 Mar 2007 10:09:37 GMT

New organizational structure for marketing authorisation

The Department of Marketing Authorisation has been reorganized. Instead of five sections the department is now divided into three sections that are Sections for Innovative Medicines, Generic Medicines and Veterinary Medicines. Additionally a Support and Development Group reporting for the Head of Department was set up.

The main purpose of the reorganization is to ensure more balanced use of resources between various processes to meet all requirements and strategic goals.

For more information, please, contact:
Professor Olavi Tokola, Head of Dept., t. +358 9 4733 4227.

The Department of Marketing authorisation, 12.2.2007 (pdf)

Strenghening medicines safety monitoring

Mon, 26 Feb 2007 11:00:01 GMT

Strenghening medicines safety monitoring

Commission Vice-President Günter Verheugen announced today a strenghening of the EU pharmacovigilance system. By making clear the roles and responsibilities for pharmacovigilance, by simplifying reporting rules and by ensuring that robust safety studies are performed to support rapid EU decision-making, the planned reform will better protect public health and support the safe use of new and innovative medicines.

For more information on:

the strategy to strenghen and rationalise the EU system of pharmacovigilance,
the results of the public consultation,
the independent study, and
the current EU pharmacovigilance rules,

see:
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacovigilance_acs/index.htm

Further information:
Erkki Palva, Head of Dept., Prof., tel. +358 9 4733 4288
Marja-Leena Nurminen, Senior Medical Officer, tel. +358 9 4733 4294

Emails: firstname.lastname@nam.fi

Substitutable medicinal products for April-June 2007

Fri, 23 Feb 2007 13:19:35 GMT

Substitutable medicinal products for April-June 2007

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.4.-30.6.2007.

List in Finnish (pdf, 225kt)

More about substitutable medicinal products

Further information:
Professor Olavi Tokola, Head of Department, tel. +358 9 4733 4227

Marjo-Riitta Helle, Head of Section, tel. +358 9 4733 4239

Risto Salmi, Legal Officer, tel. +358 9 4733 4220

Emails: firstname.lastname@nam.fi

Recommendation for quality criteria for sales promotions of medicines

Mon, 19 Feb 2007 11:52:22 GMT

Recommendation for quality criteria for sales promotions of medicines

The work of pharmaceutical sales representatives is marketing, which is aimed at promoting the use of medicines.

A sales promotion event at its best provides up-to-date and good quality information about medicines and their use to practising doctors and pharmacists. In line with the rest of the pharmaceutical marketing, Finnish Medicines Agency (FIMEA) in Finland also monitors compliance with all parts of the pharmaceutical legislation at sales promotions. FIMEA has established quality criteria for these sales promotion events based on the points in the Medicines Act and Decree important with respect to the communication of appropriate information about medicines which promotes their correct and safe use.

The quality criteria comprise a recommendation which FIMEA hopes that the pharmaceutical companies will follow in their marketing. To the professional attending a sales promotion event the recommadation will give a perception of what can be expected of the information content of the presentation. Throughout the current year FIMEA will monitor the extent to which the criteria are followed at these events.

FIMEA (former NAM) has also published the recommendations for quality criteria for sales promotions of medicines in TABU 1/2007.

Additional information:
Kristiina Pellas, Senior Pharmaceutical Inspector, t. +358 9 4733 4336
Kirsti Villikka, Head of Unit, t.+358 9 4733 4321
Erkki Palva, Director, t. +358 9 4733 4288

Updated 17.2.2010

Update of product information of non-steroidal anti-inflammatory drugs (NSAID's)

Wed, 07 Feb 2007 11:37:11 GMT

Update of product information of non-steroidal anti-inflammatory drugs (NSAID's)

The Pharmacovigilance Working Party (PhVWP) of CHMP has agreed on SPC and PL recommendations on cardiovascular safety of non-steroidal anti-inflammatory drugs. In addition, recommendations for wordings regarding gastrointestinal safety and skin reactions, as agreed by the CHMP on October 2005 and May 2006, have been prepared. National translations are provided by the NAM.

In Finland, the recommendations concern the following products:

Indometacinum (M01AB01, M01AB51)
Diclofenacum (M01AB05, M01AB55)
Etodolacum (M01AB08)
Ketorolacum trometamolum (M01AB15)
Aceclofenacum (M01AB16)
Tenoxicamum (M01AC02)
Meloxicamum (M01AC06)
Ibuprofenum (M01AE01, M01AE51)
Naproxenum (M01AE02)
Ketoprofenum (M01AE03)
Acidum tiaprofenicum (M01AE11)
Dexibuprofenum (M01AE14)
Acidum mefenamicum (M01AG01)
Acidum tolfenamicum (M01AG02)
Nabumetonum (M01AX01)

National Agency for Medicines has submitted a request to the Marketing Authorisation Holders to submit type II variation applications to update the SPCs (sections 4.2, 4.3, 4.4 and 4.8 accordingly) and PLs according to the PhVWP recommendations before 28 February 2007. Wordings are requested to be implemented as such. In case of double information, the old wordings, which differ from those proposed, are to be deleted.

With regard to PL wordings, consultation with patient groups has been organised via the EMEA, and further user-testing by individual MA holders will not be expected on this occasion. Please note that the agreed wordings to the PL are provided only for the cardiovascular system. The Applicant should check and amend the PL, if necessary, so that it will also be in accordance with the new gastrointestinal and dermatological information in the SPC.

Incorporating updated PLs into new production batches will be required to start within a 3-6 month timeframe, but no later than 31 August 2007.

Variation applications are to be submitted to the Marketing Authorisation Department at the National Agency for Medicines.

For further information:
Tuomo Lapveteläinen, Senior Medical Officer, Marketing Authorisation, t. +358 9 473 341
Taina Methuen, Senior Medical Officer, Marketing Authorisation, t. +358 9 4733 4412
Kirsti Villikka, Senior Medical Officer, CMDh member, Marketing Authorisation, t. +358 9 4733 4404
Hanna Saari, Project Manager, Marketing Authorisation, t. +358 9 4733 4231

European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs, EMEA Press Release 24.10.2006. See also: Questions and Answers on the review of non-selective NSAIDs

Liitteet:

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Diclofenac
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Ibuprofen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (OTC products) / Ibuprofen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Ketoprofen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (OTC products) / Ketoprofen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Ketorolac
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Naproxen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Other NSAID’s
word /pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (OTC products) / Other NSAID’s
word / pdf

The second HMA meeting in Helsinki: benchmarking moves forward

Wed, 29 Nov 2006 13:44:27 GMT

The second HMA meeting in Helsinki: benchmarking moves forward

The European Heads of Medicines Agencies met in Helsinki for the second time during Finland’s EU Presidency on 29-30 November 2006. During the two-day meeting the delegates discussed among others the benchmarking of the Agencies, the need to reform the Community system of pharmacovigilance and the availability of veterinary medicines.

Nearly 70 delegates participated from the current EU Member States and acceding countries, the European Economic Area, the Comission and the European Medicines Agency.

The next HMA meeting will be held in Dresden from 7-9 February 2007 under the German EU Presidency.

The press release will be published in English on the HMA website in the upcoming days.

Additional information:
Prof. Hannes Wahlroos, Director General, National Agency for Medicines, Finland, tel. +358 9 4733 4200, hannes.wahlroos@nam.fi

The Heads of Medicines Agencies (HMA) is a network of both human and veterinarymedicines agencies of the EEA. This network provides a forum for the co-ordination and theexchange of views and proposals on issues concerning the European System of MedicinesRegulations and the role of the HMA within that system. The Agencies usually meet fourtimes a year under the chairmanship of the Member State that holds the Presidency of the EU.

The HMA meet again in Finland on 29-30 November 2006

Tue, 28 Nov 2006 14:45:40 GMT

The HMA meet again in Finland on 29-30 November 2006

The Heads of Medicines Agencies (HMA) hold their second meeting under Finland’s EU Presidency in Helsinki on 29-30 November, 2006.

The first meeting in Finland took place on 6-7 September 2006. Read more

NAM continues to campaign for the safe and correct use of analgesics

Thu, 09 Nov 2006 10:47:31 GMT

NAM continues to campaign for the safe and correct use of analgesics

National Agency for Medicines continues its public campaign called "Enough is enough - also in medicines" to promote the safe and correct use of analgesics. The aim is to decrease the customary use of analgesics and to raise awareness on their differences and adverse effects. It has been estimated that 100-200 people in Finland die each year of the bleeding of digestive track.

A study carried out at the University of Kuopio on the frequent analgesics use at population level (Pain; 2005 June; 115(3):374-81) confirms the customary use of the adult population. The campaign is especially targeted to middle-aged and elderly women who are known to use both over-the-counter and prescription drugs more than the average population.

Campaign will be seen between November and February on TV, in magazines and on a website www.liikaonliikaa.fi
(Finnish and Swedish) where everyone can test whether he or she uses analgesics in a correct way. In addition, consumers are encouraged to turn to their physician or pharmacist for advise, and to carefully read the package leaflet.

Additional information:
Prof. Erkki Palva, Head of Department, +358 9 4733 4288, erkki.palva@nam.fi
Pirkko Paakkari, Senior Medical Officer, +358 9 4733 4292, pirkko.paakkari@nam.fi
Mari Saarteinen, Communications Adviser, +358 9 4733 4371, communications@nam.fi (till Nov. 2006)
Katja Lindgren-Äimänen, Information Officer, +358 9 4733 4209, communications@nam.fi

The European Medicines Agency’s (EMEA) Opinion on Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Tue, 24 Oct 2006 09:00:00 GMT

The European Medicines Agency’s (EMEA) Opinion on Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

The EMEA, in its scientific committee CHMP, has evaluated newly available data on the cardiovascular safety of non-selective NSAIDs, which signalled a potentially increased thrombotic risk (such as heart attack or stroke) for some of these NSAIDs especially when used at high doses and in long-term treatment. The CHMP concludes that:

Non-selective NSAIDs are important treatments for arthritis and other painful conditions.
Some non-selective NSAIDs may be associated with a small increased risk for thrombotic events when used at high doses for long-term treatment.
The overall benefit/risk balance for non-selective NSAIDs remains favourable when used in accordance with the product information, namely on the basis of the overall safety profile of the respective non-selective NSAID, and taking into account a patient’s individual risk factors (e.g. gastrointestinal, cardiovascular and renal).

General prescribing advice remains as follows:

Prescribers and patients should use non-selective NSAIDs as necessary at the lowest effective dose for the shortest possible duration to control symptoms
Prescribers should continue to select any NSAID on the basis of the overall safety profile of the product, as set out in the product information, and a patient’s individual risk factors.
Prescribers should not switch between NSAIDs without careful consideration of the overall safety profile of the products and the patient’s individual risk factors, as well as patient’s preferences.

The summaries of product characteristics will be updated respectively. These conclusions have no prejudice to the outcome of the ongoing re-evaluation of piroxicam, in which the benefit risk balance is currently being assessed.

Please, see also EMEA’s pages http://www.emea.europa.eu/

Further information:
Professor Erkki Palva, Head of Department, tel. +358 9 4733 4288
Marja-Leena Nurminen, Senior Medical Officer, tel. +358 9 4733 4294

Wahlroos: Pharmacies as part of health policies

Fri, 20 Oct 2006 12:22:42 GMT

Wahlroos: Pharmacies as part of health policies

Director General Hannes Wahlroos comments in his editorial in TABU 5/2006 on the recent elements of marketing and competition in some larger-than-medium sized pharmacies.

Wahlroos says that the government programme after the elections next spring ought to contain clear principles and guidelines for the development of pharmacy operations.

- If the present principles, with their emphases on health policies, nationwide distribution of medicinal products, cost-effectiveness, pharmaceutical information and professional pharmaceutical services, are to be followed in the end, the result should be that pharmacies maintain their status as pharmacies. Otherwise, the markets will rule, and control of the increase in the sales and consumption of medicinal products will become even more difficult than before.

Finnish Statistics on Medicines 2005 now

Fri, 20 Oct 2006 10:11:38 GMT

Finnish Statistics on Medicines 2005 now

According to the Finnish Statistics on Medicines 2005, published jointly by the National Agency for Medicines and the Social Insurance Institution of Finland (Kela), the sales value of medicines grew from EUR 2.3 billion to EUR 2.4 billion. Most of the costs of medicines (72%) were attributable to prescription-only medicines used in outpatient care. Reimbursements for medicines used in outpatient care totalling EUR 1.1 billion were made to 3.3 million individuals, representing an increase of 6.1% on the previous year.

There was continued growth in the use of medicines e.g. in the group of drugs used to treat gastric hyperacidity (9%), in the group of cardiovascular drugs (8%), and in the groups of antimicrobial (5%), antidiabetic (4%), and antipsychotic drugs (4%).

Generic substitution and price competition between pharmaceutical companies were factors in the relatively modest increase in the costs of medicines. Operating under the Ministry of Social Affairs and Health, the Pharmaceuticals Pricing Board lowered the wholesale prices of certain groups of medicinal products. For example, despite the increase (8%) in the consumption of cardiovascular drugs, the wholesale value of this group of drugs decreased by two per cent.

Thevalue of sales of self-medication products (at retail prices inclusive of tax)was EUR 319 million. The self-medication product groups with the highest costs were analgesics (EUR 64m),drugs for the treatment of digestive tract disturbances (EUR 44m), and vitamins and trace elements classified as medicines (EUR 42m).

Further reading:
Finnish Statistics on Medicines 2005

More up-to-date information on drug consumption in the current year (2006) is available on the National Agency for Medicines website at www.nam.fi.
Drug Consumption Reports

For further details, please contact:
Tinna Voipio, Researcher, tel. +358 9 4733 4296
Pirkko Paakkari, Senior Medical Officer, tel. +358 9 4733 4292
firstname.surname@nam.fi

EMEA's Scientific Committees searched for mutual views in Helsinki

Wed, 11 Oct 2006 15:25:46 GMT

EMEA's Scientific Committees searched for mutual views in Helsinki

Under Finland's EU Presidency, the National Agency for Medicines hosted an informal meeting of the Committees of the European Medicines Agency CHMP, CMD(h) and COMP on 10 and 11 October, 2006.

During the two days, the Committees aimed at finding methods to resolve divergent views on issues related to marketing authorisation applications. In addition, the members looked into ways of increasing transparency in the committee work. 90 participants arrived in Helsinki from the EU and EEA countries, Commission and the EMEA.

Press Release 11 October 2006

Read more about the EU-meetings organised by NAM

EMEA's scientific committees meet in Helsinki on 10-11 October 2006

Tue, 10 Oct 2006 14:01:22 GMT

EMEA's scientific committees meet in Helsinki on 10-11 October 2006

Under Finland's EU Presidency, the National Agency for Medicines hosts an informal meeting of the Committees of the European Medicines Agency CHMP, CMD(h) and COMP on 10 and 11 October, 2006.

Read the news

EMEA update on review of non-selective NSAIDs

Tue, 26 Sep 2006 11:51:24 GMT

EMEA update on review of non-selective NSAIDs

EMEA’s Committee for Medicinal Products for Human Use (CHMP) is to look again at the cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs.

The Committee has begun reviewing available safety data from clinical and epidemiological studies. It will give a scientific opinion on the cardiovascular safety of non‑selective NSAIDs during its next meeting of 16-19 October 2006, including recommendations on how to address any safety concerns that may be identified.

There are many different types of NSAIDs, but this review is only looking at a group of compounds called non‑selective NSAIDs. The non-selective NSAIDs being looked at arediclofenac, etodolac, ibuprofen, indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen, nimesulide and piroxicam.Non-selective NSAIDs are so‑called because they act on all types of the cyclo‑oxygenase enzyme, including one type that is involved in the inflammation process.

Following its review of NSAIDs in 2005, the EMEA has been monitoring closely this class of compounds. CHMP has become aware of new safety data concerning non‑selective NSAIDs, especially in long-term use, that signal a potential risk of heart attack or stroke. This review is initiated to evaluate the cardiovascular safety of non-selective NSAIDs as a group in the context of their overall benefit-risk profile.

Advice for patients and prescribers:

Patients and prescribers should continue to use non‑selective NSAIDs as currently recommended.
Doctors and patients should always use the lowest effective dose for the shortest possible durationto control symptoms.
Doctors should continue to prescribe NSAIDs on the basis of the overall safety profiles of the medicines as set out in the product information, and individual risk factors.
Patients who have concerns or questions should talk to their doctor or pharmacist.

Press Release 26/9/2006 at EMEA's website

Additional information:
Prof. Erkki Palva, Head of Department,
tel. +358 9 4733 4288
Marja-Leena Nurminen, Senior Medical Officer,
tel. +358 9 4733 4294

Heads of Medicines Agencies developed the regulatory network in Helsinki

Thu, 07 Sep 2006 12:33:30 GMT

Heads of Medicines Agencies developed the regulatory network in Helsinki

The Heads of Medicines Agencies (HMA) held their first meeting under Finland’s EU Presidency in Helsinki on 6-7 September, 2006. During the two-day meeting the delegates discussed among others the development and strategy of the European regulatory network, and the implementation of the new pharmaceutical EU-legislation.

Over 70 representatives from the EU Member States and Acceding countries, EEA-countries, the Commission, and the European Medicines Agency participated in the meeting.

The next HMA-meeting will be held in Helsinki on 29-30 November, 2006.

The press release is published on the website of HMA.

Additional information:
Prof. Hannes Wahlroos, Director General, National Agency for Medicines, tel. +358 9 4733 4200, hannes.wahlroos@nam.fi

The HMA convene in Helsinki 6-7 September 2006

Wed, 06 Sep 2006 13:51:23 GMT

The HMA convene in Helsinki 6-7 September 2006

The European Heads of Medicines Agencies meet in Helsinki for the first time under Finland's EU Presidency.

Read the news

EU Regulatory Authorities for Veterinary Medicines met in Helsinki

Tue, 05 Sep 2006 12:41:44 GMT

EU Regulatory Authorities for Veterinary Medicines met in Helsinki

The representatives of the regulatory authorities for veterinary medicinal products held an informal meeting 4-5 September in Helsinki under Finland's EU Presidency. More than 50 participants from the Member States attended the meeting hosted by the National Agency for Medicines.

Enhanced service of basic information on medicines is now available

Thu, 31 Aug 2006 07:07:11 GMT

Enhanced service of basic information on medicines is now available

The renewed service containing basic information on medicines, i.e. Summaries of Product Characteristics (SPC) and Package Leaflets (PL) is published on the web site.

The service has now more efficient search functions, better usability and more up to date information thanks to the renewed publishing process.

The renewed service provides over 4000 summaries of product characteristics and over 3000 package leaflets as well as information on veterinary medicinal products and herbal medicinal products with marketing authorisation.

Index Information Technologies Ltd. has implemented the renewed technology of the service.

Summaries of Product Characteristics (SPC) and Package Leaflets

Additional information:
Leila Peura, System Specialist,
leila.peura@nam.fi

Substitutable medicinal products for October-December 2006

Thu, 31 Aug 2006 05:28:58 GMT

Substitutable medicinal products for October-December 2006

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.10.-31.12.2006.

List in Finnish (pdf)

More about substitutable medicinal products

Further information:
Professor Olavi Tokola, Head of Department, tel. +358 9 4733 4227

Marjo-Riitta Helle, Head of Section, tel. +358 9 4733 4239

Risto Salmi, Legal Officer, tel. +358 9 4733 4220

Emails: firstname.lastname@nam.fi

Adverse reaction related to phacoemulsification cataract surgery and the use of tamsulosin

Fri, 18 Aug 2006 12:09:40 GMT

Adverse reaction related to phacoemulsification cataract surgery and the use of tamsulosin

A known surgical condition recently named “Intraoperative Floppy Iris Syndrome” (IFIS) has been observed during phacoemulsification cataract surgery in some patients currently or previously treated with tamsulosin. Tamsulosin is used for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia.The summary of product characteristics will be up-dated due to this adverse reaction.

This variant of small pupil syndrome is characterised by
- the combination of a flaccid iris that billows in response to intraoperative irrigation currents
- progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs and
- potential prolapse of the iris toward the phacoemulsification incisions.

At present, the drug most commonly associated with IFIS has been tamsulosin, but IFIS reports associated with other alpha₁ adrenoceptor antagonists have been received. It is still not known whether there is a class effect for this group of drugs.

Discontinuing tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping of therapy prior to cataract surgery has not yet been established. The initiation of therapy with tamsulosin in patients for whom cataract surgery is scheduled is not recommended.

See the article of Senior Lecturer Olavi Pärssinen in TABU 6/2005 “Tamsulosin-induced iris complications associatedwith cataract operations”on pages 53-54.

Additional information:
Marja-Leena Nurminen, Senior Medical Officer,
tel. +358 9 4733 4294
Annikka Kalliokoski, Senior Medical Officer,
tel. +358 9 4733 4375
Prof. Erkki Palva, Head of Department,
tel. +358 9 4733 4288

Phosphoral oral solution can cause serious electrolyte and kidney disorders

Mon, 14 Aug 2006 11:30:33 GMT

Phosphoral oral solution can cause serious electrolyte and kidney disorders

The summary of product characteristics of Phosphoral oral solution has been updated due to the safety concerns that have arisen, namely electrolyte and kidney disorders. Phosphoral is used as a bowel cleanser prior to colonoscopy, x-ray or colon surgery. The oral solution contains sodium phosphate.

Some of the elderly patients have suffered from electrolyte disorders of which some have been fatal. The product should be used with care in at-risk populations:
-elderly or debilated patients,
-patients with increased risk for underlying renal impairment,
- patients with heart desease, acute myocardial infraction or unstable angina,
- patients with an increased risk for electrolyte disturbances.

These patients should be adequately hydrated and baseline and post-treatment electrolyte levels should be taken into account.

Furthermore, nephrocalcinosis (precipitation of calcium salts in the renal tissue) associated with transient renal insufficiency and renal failure has been reported in patients using sodium phosphates for bowel cleansing. The majority of these patients were elderly females taking drugs that may result in dehydration or those taking medications which may decrease kidney function.

The adverse drug reaction register of NAM in Finland has received two reports of similar adverse reactions in association with Phosphoral use within a time period of 10 years. In 2005, a total of 33 000 packages (one package is needed for one treatment) of Phosphoral were sold in Finland.

Additional information
Annikka Kalliokoski, Senior Medical Officer,
tel. +358 9 4733 4375
Prof. Erkki Palva, Head of Department,
tel. +358 9 4733 4288

Enhanced service of basic information on medicines

Wed, 02 Aug 2006 07:11:50 GMT

Enhanced service of basic information on medicines

The service containing basic information on medicines, i.e. summaries of product characteristics and product information leaflets will be technically renewed in August. The service will be enhanced with faster and more reliable functions. The user are advised to check that the links made to the service are updated in September.

Additional information:
Leila Peura, System Specialist,
tel. +358 9 4733 4265, leila.peura@nam.fi

Case reports on liver injuries from Black Cohosh

Tue, 18 Jul 2006 07:03:30 GMT

Case reports on liver injuries from Black Cohosh

The European Medicines Agency (EMEA) and the Committee on Herbal Medicinal Products (HMPC) have been made aware of the number of case reports on liver injuries in patients using Cimicifugae racemosae rhizoma,Black Cohosh, root.

Read EMEA's Public Statement 18 July, 2006

Competent Authorities for Medical Devices met in Tampere

Mon, 10 Jul 2006 07:20:41 GMT

Competent Authorities for Medical Devices met in Tampere

European Competent Authorities for Medical Devices and the representatives of the European Commission convened in a meeting 6-7 July 2006 in Tampere under Finland’s EU Presidency.

The CA Meeting provides a forum for senior regulators within the Competent Authorities for Medical Devices to discuss issues of mutual concern with regard to the implementation of the medical devices legislation, ensuring the effective use of national resources at a European level and dealing effectively with issues which are strategic in nature. The CA Meeting is composed of the senior regulators of the EU and European Economic Area Member States. Other representatives are from the acceding countries and the European Commission. The meeting was attended by 55 participants.

Additional information:
Petri Pommelin, Head of Department, tel. +358 9 4733 4241, petri.pommelin@nam.fi

Press Release 7 July 2006

Competent Authorities Meeting 6-7 July, Tampere

Wed, 05 Jul 2006 07:54:35 GMT

Competent Authorities Meeting 6-7 July, Tampere

National Agency for Medicines hosts a meeting of the Competent Authorities for Medical Devices in Tampere during Finland's EU Presidency 2006

Substitutable medicinal products for July-September 2006

Wed, 31 May 2006 05:38:10 GMT

Substitutable medicinal products for July-September 2006

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.7.-30.9.2006.
List in Finnish (pdf)

More about substitutable medicinal products

Further information:
Professor Olavi Tokola, Head of Department, tel. +358 9 4733 4227
Jussi Holmalahti, Head of Section, tel. +358 9 4733 4239

Emails: firstname.lastname@nam.fi

Quality control meetings 2006

Sun, 21 May 2006 21:00:00 GMT

Quality control meetings 2006

For the information of applicants for marketing authorisations:

Applications that reach the marketing authorisation decision stage are dealt with at quality control meetings (KOLA) where the documentation on consideration, conclusions and quality control measures required for marketing authorisation decisions is approved.

The meetings for the period January 1 to June 30, 2006 will be held in the following weeks:
2, 4, 6, 9, 11, 13, 14, 16, 18, 20, 22, 24 ja 26.

The meetings for the period July 1 to December 31, 2006 will be held in weeks:
28, 30, 32, 34, 37, 39, 41, 43, 45, 47, 49, 51 ja 52.

Updated: 22.5.2006

NAM renewed its strategy

Mon, 15 May 2006 13:14:32 GMT

NAM renewed its strategy

The National Agency for Medicines has published its strategy for 2006-2012.

Strategic planning at NAM has a tradition spanning more than a decade. The strategy helps to define targets and allocate resources to the areas of influence.

The strategy for 2006-2012 is structured in a traditional way. It contains the mission statement and values, defines our clients and describes the operational environment. The vision and strategic targets guide our operations in the years to come.

With its updated strategy NAM continues to develop its influential role in the Finnish health care system as a promoter of safety in medicines and medical devices.

To order a copy, contact communications@nam.fi

Strategy 2006-2012

NAM publishes its Annual Report 2005

Tue, 11 Apr 2006 06:20:39 GMT

NAM publishes its Annual Report 2005

The Annual Report of the National Agency for Medicines is published in Finnish and English. It is available on the website in pdf-format. A printed report will be sent to the stakeholders in the near future.

The Annual Report can be ordered at communications@nam.fi

Annual Report 2005

Annual Reports

Jussi Holmalahti PhD (Pharm) appointed head of Enforcement and Inspection Department

Wed, 05 Apr 2006 11:51:05 GMT

Jussi Holmalahti PhD (Pharm) appointed head of Enforcement and Inspection Department

The National Agency for Medicines has appointed Jussi Holmalahti as head of the Enforcement and Inspection Department with effect from 1 August 2006. Holmalahti has served the National Agency for Medicines in various posts since 1997.

The position became vacant on the retirement of the present incumbent, Professor Liisa Turakka.

The Enforcement and Inspection Department is responsible for licences for the pharmaceutical industry, wholesalers and pharmacies, as well as for the supervision and inspection of their operations. The Department’s remit also includes laboratory services and the supervision of clinical trials.

Glove study 2005: increase in allergen content

Mon, 03 Apr 2006 09:55:46 GMT

Glove study 2005: increase in allergen content

National Agency of Medicines has published a new study on the allergen content of medical latex gloves

The glove study examined the allergen content of medical latex gloves that were on the Finnish market in spring 2005. The study material consisted of samples of glove batches from a total of 20 manufacturers and 84 glove types/brands. The gloves were grouped into five categories on the basis of their allergen content.

Six earlier studies showed that the average allergen content of natural rubber gloves on the Finnish market has been decreasing continuously since 1995. However, the results of a study in 2003 indicated that this decrease has slowed down more recently.

This study, as all the previous ones, was conducted jointly by the National Agency for Medicines, the Finnish National Public Health Institute and the Tampere University Central Hospital. The researchers in charge were Professor Emeritus Timo Palosuo, and Docent Kristiina Turjanmaa..

Further information:
Timo Palosuo, Professor Emeritus, tel. + 358 9 47 441
timo.palosuo@ktl.fi

Kristiina Turjanmaa, Docent, tel. + 358 3 3116 5170
kristiina.turjanmaa@pshp.fi

Hely Reinikka-Railo, Senior Officer, tel. + 358 9 4733 41
hely.reinikka-railo@nam.fi

Ritva Raunio, Department Secretary, tel. + 358 9 4733 41
ritva.raunio@nam.fi

TLT-info 1/2006
Glove Study 2005

List of substitutable medicinal products 1.4.-30.6.2006

Tue, 28 Feb 2006 10:36:05 GMT

List of substitutable medicinal products 1.4.-30.6.2006

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.4.-30.6.2006.

List of substitutable medicinal products (in Finnish)

Further information:
Head of Section Jussi Holmalahti, jussi.holmalahti@nam.fi,
tel. +358 9 4733 4239

Drug information for consumers and patients – a review of the research

Fri, 17 Feb 2006 07:12:37 GMT

Drug information for consumers and patients – a review of the research

Patients and consumers want more and more information about drugs. Patients need drug information in order to be able to participate in decision-making about their treatment. Consumers also need information that enables them to choose between self-treatment of symptoms and requesting evaluation from a doctor. Drug information must be valid and understandable.

‘Drug information for consumers and patients – a review of the research’ summarises recent research on drug information. Recommendations are also given. The report focuses on sources and tools of drug information, as well as on its special needs and future challenges.

The improvement of the quality and availability of drug information is one of the goals of the European Union. ‘Drug information for consumers and patients – a review of the research’ is aimed at contributing to the discussion and development concerning drug information both in Finland and on the EU level.

For more information, please contact:
Planning for Pharmaceutical Policies
Senior Researcher Ulla Närhi,
tel. +358 9 4733 4385, ulla.narhi@nam.fi
Research Secretary Anna Karjalainen,
tel. +358 9 4733 4386, anna.karjalainen@nam.fi

Publication of National Agency for Medicines
Drug Information for consumers and patients - a review of the research

Decree on fees 2005-2007

Tue, 10 Jan 2006 09:46:21 GMT

Decree on fees 2005-2007

Decree of the Ministry of Social Affairs and Health concerning activities of the National Agency for Medicines subject to fees 870/2005 is effective from 15 November, 2005. The degree has been revised according to the changes in the Medicines Act and Decree (HE 108/2005) entered into force 4 November, 2005. Only minor changes have been made to the fees.

Further information:
Project Manager Outi Hemmo, tel: +358 9 4733 4231,outi.hemmo@nam.fi
Head of Finance Marja-Liisa Hurme, tel. +358 9 4733 4216,marja-liisa.hurme@nam.fi

List of substitutable medicinal products 1.1.-31.3.2006

Wed, 23 Nov 2005 11:05:50 GMT

List of substitutable medicinal products 1.1.-31.3.2006

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.1.-31.3.2006.

Read more List of substitutable medicinal products

Further information:
Professor Olavi Tokola, Head of Department, tel. +358 9 4733 4227, olavi.tokola@nam.fi
Jussi Holmalahti, Head of Section, tel. +358 9 4733 4239, jussi.holmalahti@nam.fi

Criteria for compiling the list of substitutable medicinal products 1.1.2006

Updated principles for compiling the list of substitutable medicinal products

Wed, 23 Nov 2005 10:09:37 GMT

Updated principles for compiling the list of substitutable medicinal products

The National Agency for Medicines is compiling a list of products that contain the same quantity of the same active agent and are biologically equivalent. The reform of the Medicines Act and the experience gained during three years of medicinal product substitution have been taken into account in updating the principles for compiling the list of substitutable medicinal products.

Wider definition of active agent
According to the new definition of active agent, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of the same agent may, on certain conditions, be considered as the same active agent and thus mutually substitutable, provided they otherwise meet the criteria for substitutability.

New pharmaceutical forms accepted as substitutable
In applications for marketing authorisation, different pharmaceutical forms releasing the medicinal substance immediately (i.e. different forms of tablets and capsules) have been considered equivalent for several years. This principle will now also be applied to medicinal product substitution. New substitutable pharmaceutical forms have been included: modified-release tablets, modified-release capsules, ointments and shampoos. Modified-release tablets and capsules may be mutually substitutable, as may gastro-resistant tablets and capsules, provided they otherwise meet the criteria for equivalence.

Antipsychotics and medication used to treat dementia are now also considered to be substitutable. Parallel distribution of centrally authorised products, corresponding to parallel import, has been added to the terminology.

For further details, see
Criteria for compiling the list of substitutable medicinal products

More information:
Professor Olavi Tokola, Head of Department, tel. +358 9 4733 4227, olavi.tokola@nam.fi
Jussi Holmalahti, Head of Section, tel. +358 9 4733 4239, jussi.holmalahti@nam.fi

Change to reporting of non-EU spontaneous adverse reactions

Tue, 15 Nov 2005 09:42:22 GMT

Change to reporting of non-EU spontaneous adverse reactions

According to the Pharmacovigilance Regulation 1/2005 implemented on November 7th, 2005, adverse reactions originating from a non-EU country should be reported to the attention of the EMEA and the National Agency for Medicines.

Regulatory authorities have access to the Eudravigilance database. Therefore, spontaneous adverse reactions occurring in a non-EU country should only be reported electronically to EMEA's Eudravigilance database.

Further information:
Senior Medical Officer Tapani Vuola, tel. +358 9 4733 4410, tapani.vuola@nam.fi
Researcher Tiina Kostiainen, tel. +358 9 4733 4336, tiina.kostiainen@nam.fi

Clinical trial cases (SUSAR) originating in Finland should be reported in hard copy by mail until otherwise informed. Foreign SUSARs can be reported electronically to the National Agency for Medicines.

Further information:
Coordinator Suvi Mantere, tel. +358 9 47334 328, suvi.mantere@nam.fi

Finnish Statistics on Medicines 2004

Fri, 09 Sep 2005 10:07:38 GMT

Finnish Statistics on Medicines 2004

In 2004, sales of medicines in Finland totalled approximately EUR 2.3 billion, which is an increase of 7.1 % on 2003; the increase was greater than during the previous year (6.4 %). In monetary terms, however, generic substitution and subsequent price competition, as well as the re-evaluation of fixed-term prices by the Pharmaceuticals Pricing Board, continued to control the growth of sales of prescription-only medicines.

Finnish Statistics on Medicines is published annually by the National Agency for Medicines and the Social Insurance Institution.

Further information:
Senior Medical Officer Pirkko Paakkari, pirkko.paakkari@nam.fi
Researcher Tinna Voipio, tinna.voipio@nam.fi

List of substitutable medicinal products 1.10.-31.12.2005

Tue, 30 Aug 2005 05:37:15 GMT

List of substitutable medicinal products 1.10.-31.12.2005

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.10.-31.12.2005.

Further information: Head of Department, Prof. Olavi Tokola, olavi.tokola@nam.fi

List of substitutable medicinal products 1.7.-30.9.2005

Fri, 27 May 2005 10:14:48 GMT

List of substitutable medicinal products 1.7.-30.9.2005

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.7.-30.9.2005.

Further information: Head of Department, Prof. Olavi Tokola, olavi.tokola@nam.fi

Annual Report 2004

Fri, 22 Apr 2005 12:46:15 GMT

Annual Report 2004

Annual report 2004 (pdf, size 1,14 MB)

The National Agency for Medicines sends its annual report to the representatives of its key stakeholders.

Orders of printed copies: viestinta@nam.fi

New functional measures and guidance for generic applications in Finland

Mon, 18 Apr 2005 07:00:00 GMT

New functional measures and guidance for generic applications in Finland

The EU-wide regulatory framework within mutual recognition procedures (MRP) is based on the co-operation and sharing of the regulatory workload between 25 EU Member States and 3 EEA countries. The National Agency for Medicines (NAM) is willing to handle its share of the common regulatory workload. However, every national competent authority, as NAM, has limitations to accommodate large and unexpected fluctuations in the number of Marketing Authorisation Applications (MAAs).

During 2003 and 2004 NAM has granted app. 500 national marketing authorisations per year. In 2004, the number of MRP procedures with Finland as reference member state (RMS) has been expanded to over 150 procedures (30 % of all MRP procedures in the EU). Due to the large number of MAAs for generic products during recent months the NAM has currently over 800 pending applications for marketing authorisation. Most applicants are planning a Mutual Recognition Procedure after national authorisation in Finland. A considerable amount of these products are not planned to be marketed in Finland.

There is a serious concern that this extremely heavy workload will definitely lead to delays and longer processing times for all marketing authorisation procedures in Finland. Therefore, NAM is obliged to adjust its functions to cope with the unexpected workload due to MAAs of generic products intended for other markets. According to NAM’s opinion the applicants should submit their future MAAs for generic products primarily to those Member States to which their products are de facto targeted.

As a part of these new functional measures and guidance:

1. The applicants are asked to provide a list of planned national or decentralised submissions during 2005 to the national marketing authorisation procedure in Finland. The following information should be included to the list if possible:

Drug substance, strengths and pharmaceutical forms
Number of Trade names (duplicates)
Plans for MRP or decentralised procedures (DCP) incl. concerned member states (CMSs) and draft time schedule.

When the NAM is planned to act as the RMS, the applicant should contact prior to the national or decentralised submission in order to draw up a time plan. The contact person is Dr. Jussi Holmalahti, Head of Section to whom further information would be addressed in a written form or by e-mail (jussi.holmalahti@nam.fi).

2. The applicants are asked to provide information concerning the schedule for marketing introduction in Finland for each individual MA (pending MAAs as well as planned submissions). The information is extremely important for NAM to prioritize assessment duties. This information will be also taken account to analyse the consequences of the new so-called “Sunset Clause”[1]coming to operation since 30 October 2005. In the future this may risk the validity of Finnish marketing authorisations and consequently the grounds for Finland to act as RMS for those medicinal products.

3. The NAM will concentrate to keep the processing time of each individual national authorisation in 210 days. To get more resources for processing of applications in the order of submission, so-called clones or duplexes are not any more processed by fast track. The applicants are asked to take account the chance in the procedure of the NAM in the future submissions.

4. The applicant can help to cut processing times by submitting complete and well-compiled applications. However, to make the discussions more efficient between the NAM and the applicant, especially in clinical and pharmaceutical issues concerning SPC and PIL, the applicants are asked to provide a contact point of the Finnish/Swedish speaking person authorised for communication with the NAM.

The National Agency for Medicines is committed to contribute and to co-operate in the national and European marketing authorisation procedures in the best possible ways and according to the legislative frameworks. However, the new functional and practical measures and guidance above are regarded necessary for the purpose of keeping the regulatory processes in control and in rational management.

Director General, professor Hannes Wahlroos

Head of Department, professor Olavi Tokola

[1]Marketing authorisation ceased to be valid if product is not marketed within three years or for three consecutive years.

pdf

The antipsychotic risperidone and nicotine replacement preparations were in euro terms among the 10 biggest selling medicines of 2004

Thu, 14 Apr 2005 10:47:55 GMT

The antipsychotic risperidone and nicotine replacement preparations were in euro terms among the 10 biggest selling medicines of 2004

In 2004, the total pharmaceutical sales (retail prices for pharmacy sales, and wholesale prices for institutional sales) amounted to EUR 2.29 billion. The turnover increased by 7% compared to the previous year and was slightly more than in 2003 (6.4%).

The therapeutic group with the highest sales, EUR 307 million in wholesale prices, was that of medicinal agents affecting the nervous system (ATC class N). The sales in the second largest group, cardiovascular medicines (ATC class C), amounted to EUR 269 million.

Calculated as units per day, the medicine that was used the most was acetylsalicylic acid in the indication of arterial occlusion prophylaxis. In addition to olanzapine, which has been on the top 10 list before, the antipsychotic risperidone made it to the list as well. Nicotine replacement preparations also made it to the list of medicines with the highest sales. In the other Nordic countries, these preparations have been on the list before.

In the group of medicines affecting the nervous system, consumption measured in daily units grew only by 3%, but the sales in euros increased, particularly due to new antipsychotics (18%) and anti-Alzheimer medicines (29%). Many antidepressants are subject to generic substitution, and as a result, the sales value fell by 2% in this group even though consumption increased by 6%.

The consumption of antimicrobials fell by 8%. Special attention has been paid to the excessive use of macrolides, and in this group consumption fell by 27%.

The sales of antiasthmatic medicines increased, especially due to combination products used in the treatment of asthma. The consumption and sales of these medicines increased by 15%.

The 10 most used medicinal agents in 2004 as DDD/1000 residents/day.

ATC code			TMH x 1 000 €	change-%	DDD/1 000 residents/day	change %
B01AC06	Asetyl- salicylic acid	arterial occlusion prophylaxis	7776	18.0	96.17	5.3
C09AA05	Rami- priili	cardio- vascular medicine	11075	-5.5	36.62	29.1
M01AE01	Ibupro- fen	anti- inflammatory analgesic	20331	2.4	33.92	2.9
C03CA01	Furose- mide	cardiac medicine	4668	4.3	32.07	3.7
C10AA01	Simva- statin	cholesterol- lowering medicine	15784	-37.6	30.89	20.0
C10AA05	Atorva- statin	cholesterol- lowering medicine	37280	14.4	29.02	15.5
N05CF01	zopi- clone	hypnotic	5132	-14.4	27.06	-2.7
C09AA02	Enala- pril	cardio- vascular medicine	4190	-43.0	26.50	-1.3
C08CA01	Amlodi- pine	cardio- vascular medicine	18017	11.1	20.95	12.5
G03CA03	Oestra- diol	hormone	11103	5.9	20.89	-6.7

The 10 most used medicinal agents in 2004 (in thousands of euros) calculated on the basis of wholesale prices.

ATC code			TMH x 1 000 €	change-%	DDD/1 000 residents/day	change %
C10AA05	Atorva- statin	cholesterol- lowering medicine	37280	14.4	29.02	15.5
N05AH03	Olantza- pine	anti- psychotic	27355	15.3	3.83	16.6
R03AK06	Salmeterol and fluticasone	anti- asthmatic	23869	13.1	7.27	12.1
M01AE01	Ibupro- fen	anti- inflammatory analgesic	20331	2.4	33.92	2.9
C08CA01	Amlodi- pine	cardio- vascular medicine	18017	11.1	20.95	12.5
A02BC05	Esome- prazole	antacid	17577	20.0	7.06	18.7
N05AX08	Risperi- done	anti- psychotic	16076	20.6	2.12	6.1
C10AA01	Simva- statin	cholesterol- lowering medicine	15784	-37.6	30.89	20.0
N07BA01	Nico- tine	nicotine replacement therapy	15497	9.2	4.79	6.9
C07AB02	Meto- prolol	cardio- vascular medicine	14647	-2.2	18.62	0.1

Medicine consumption statistics

Further information available from:
Pirkko Paakkari, Senior Medical Officer, tel. +358 9 4733 4292, pirkko.paakkari@nam.fi
Tinna Voipio, Researcher, tel. +358 9 4733 4296, tinna.voipio@nam.fi

EMEA celebrating 10 years, Statement by prof. Wahlroos

Fri, 11 Mar 2005 12:00:00 GMT

EMEA celebrating 10 years, Statement by prof. Wahlroos

Statement by prof. Hannes Wahlroos, Chairman of the EMEA Management Board (pdf)

List of substitutable medicinal products 1.4. - 30.6.2005

Wed, 23 Feb 2005 10:40:17 GMT

List of substitutable medicinal products 1.4. - 30.6.2005

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.4. - 30.6.2005.

Further information: Head of Department, Prof. Olavi Tokola, olavi.tokola@nam.fi

Self-medication – part of responsible health care

Thu, 17 Feb 2005 07:00:05 GMT

Self-medication – part of responsible health care

The tendency to change the classification for the supply of medicinal products from a prescription only medicine to a self-medication product, appears still to be continuing. An EU regulation will come into effect on October this year and make centralised decisions on self-medication status within the entire EU possible.

An essential constraint on the increased and sensible use of self-medication products is the operation of pharmacies on the professional premises supporting the general health policy, says Director General, Professor Hannes Wahlroos in his editorial on TABU Magazine 1/2005.

For more information, please contact Director General, Professor Hannes Wahlroos, tel. +358 9 4733 4200, +358 50 500 3709.

The fifth edition of the European Pharmacopoeia into effect January 1, 2005

Fri, 07 Jan 2005 06:52:46 GMT

The fifth edition of the European Pharmacopoeia into effect January 1, 2005

The fifth edition of the European Pharmacopoeia replacing the fourth edition and its supplements has been published. The implementation date for the new edition is January 1, 2005

European Pharmacopoeia
National pharmacopoeia documents

DIA: Better Medicines for Children, May 19-20, 2005

Mon, 03 Jan 2005 11:28:46 GMT

DIA: Better Medicines for Children, May 19-20, 2005

Drug Information Association DIA:

Better Medicines for Children - Current Regulatory and Scientific Status and Future Prospects
May 19-20, 2005, Hilton Helsinki Kalastajatorppa, Helsinki, Finland

Please note that the programme is being updated on a regular basis on the DIA Homepage www.diahome.org.

New electronic application forms for parallel import of a medicinal product

Fri, 31 Dec 2004 10:04:42 GMT

New electronic application forms for parallel import of a medicinal product

The National Agency for Medicines will adopt new electronic application forms for parallel import of a medicinal product as of 3 January 2005. The forms are published in word- and pdf-formats.

Application for parallel import of a medicinal product
pdf, word

Adoption of calling times at the Inspectorate

Wed, 29 Dec 2004 06:49:43 GMT

Adoption of calling times at the Inspectorate

The National Agency for Medicines Inspectorate is going to adopt calling times. From 3 January 2005 onwards, advice concerning operating licences for pharmaceutical entrepreneurs, licence applications, and matters associated with general supervision is provided by telephone on a daily basis from 1 p.m. to 2 p.m. only.

Change in the notification of product defects

Wed, 29 Dec 2004 06:46:19 GMT

Change in the notification of product defects

The receipt of notifications of product defects at the National Agency for Medicines will undergo a change in the beginning of 2005. Starting from 3 January 2005, notifications of product defects should be made by telephone at number 050 354 4435 or at the National Agency for Medicines switchboard at (09) 473 341, from where the call will be connected to the on-call number. The fax number at which the written notifications concerning the product defect situation should be submitted remains the same, (09) 4733 4267. Notifications of product defects should not be made by email or by mail.

Regarding notifications of product defects requiring prompt action outside office hours, the contact information of the persons in charge remains the same.

Celecoxib and cardiovascular events

Wed, 22 Dec 2004 08:28:00 GMT

Celecoxib and cardiovascular events

The European Medicines Agency (EMEA) has been informed by Pfizer of a clinical study that shows an increased risk of fatal or major non-fatal cardiovascular events (i.e. acute myocardial infarction and stroke) in patients taking celecoxib compared to patients given placebo. Celecoxib is a member of the class of medicines called COX-2 inhibitors.

Read more:
EMEA statement on celecoxib, Press release 17 December 2004 (www.emea.eu.int)

Information available in finnish:
Selekoksibin (Celebra, Onsenal) sydän- ja verisuonivaikutukset

Further information available from
Erkki Palva, Professor, Head of Department,
telephone +358 9 4733 4288,
Pirkko Paakkari, Senior Medical Officer,
telephone +358 9 4733 4292,
Pekka Kurki, Head of Section,
telephone +358 9 4733 4225.

Medicines Act (395/87) and decree (693/87) in English

Fri, 10 Dec 2004 13:27:25 GMT

Medicines Act (395/87) and decree (693/87) in English

The National Agency for medicines has published on it’s website unofficial translations of Medicines Act and decree.

Read more: Medicines Act and Decree (395/1987; admentments up to 296/2004 included and 693/1987; admentments up to 312/2004 included) , unofficial translation
(pdf, 554 KB)

More information: viestinta@nam.fi

CHMP meeting on Paroxetine and other SSRIs

Thu, 09 Dec 2004 14:02:31 GMT

CHMP meeting on Paroxetine and other SSRIs

The European Medicines Agency scientific committee, the Committee for Medicinal Products for Human Use (CHMP), held an extraordinary meeting in London on 8 December 2004.

During the course of this meeting, the CHMP re-examined its 22 April 2004 paroxetine opinion, at the request of the European Commission, in the light of additional information arising from newly available observational studies.

The CHMP, following the assessment of this additional information, confirmed its initial conclusion that the benefit/risk balance of paroxetine remains positive in the treatment of adults. The Committee also reaffirmed its previous conclusion that changes to the product information should be introduced, especially with regard to warnings of suicide-related behaviour in children and adolescents.

Read more: CHMP meeting on Paroxetine and other SSRIs, EMEA Press release 9 December 2004, 14:00 UK time (www.emea.eu.int)

The National Agency for Medicines has confirmed its previous conclusion on the use of SSRIs on medical treatment of children and adolescents (available in finnish: Masennuslääkkeiden käyttö lasten ja nuorten hoidossa).

Further information available from
Erkki Palva, Professor, Research Director,
telephone +358 9 4733 4288,
Tapani Vuola, Senior Medical Officer,
telephone +358 9 4733 4209,
Sari Ekholm, Senior Medical Officer,
telephone +358 9 4733 4321,
Marja-Leena Nurminen, Senior Medical Officer,
telephone +358 9 4733 4294,
Jyrki Vanakoski, Senior Medical Officer,
telephone +358 9 4733 4375.

List of substitutable medicinal products 1.1. - 31.3.2005

Wed, 24 Nov 2004 14:34:21 GMT

List of substitutable medicinal products 1.1. - 31.3.2005

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.1. - 31.3.2005.

Further information: Head of Department, Prof. Olavi Tokola, olavi.tokola@nam.fi

List of substitutable medicinal products 1.7. - 30.9.2004

Tue, 25 May 2004 13:00:09 GMT

List of substitutable medicinal products 1.7. - 30.9.2004

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.7. - 30.9.2004.

Further information: Head of Department, Prof. Olavi Tokola, olavi.tokola@nam.fi

Director General, Prof. Hannes Wahlroos elected to the Chairman of the EMEA Management Board

Tue, 25 May 2004 11:35:37 GMT

Director General, Prof. Hannes Wahlroos elected to the Chairman of the EMEA Management Board

Director General, Prof. Hannes Wahlroos (51) was elected to the Chairman of the Management Board of the European Medicines Agency (EMEA) on 24th May, 2004. The term lasts three years.

For further inquiries, please, contact Director General, Prof. Hannes Wahlroos, te. +358 9 4733 4200, +358 50 500 3709.

Importers of parallel products are obliged to notify the marketing authorisation holder of the original product marketed in Finland as of 1 May 2004

Wed, 19 May 2004 12:22:38 GMT

Importers of parallel products are obliged to notify the marketing authorisation holder of the original product marketed in Finland as of 1 May 2004

The Act on the implementation of regulations belonging to the area of legislation of the agreement on the accession of Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia to the European Union [no. 1259/2003; implemented on 1 May 2004 (321/2004)] requires that, for the part of parallel import from Latvia, Lithuania, Poland, Slovakia, Slovenia, Czech Republic, Hungary and Estonia, a written certificate of the importer of parallel products having notified the marketing authorisation holder of the original product marketed in Finland about their application in writing one month prior to submitting the application to the National Agency for Medicines.

A copy of this written notification must be annexed to the application.

Further information available from:
Tuula Santala, Coordinator for Marketing Authorisations,
tel. +358- 9-47334 272
Risto Salmi, Legal Officer, tel. +358- 9-47334 220

Clinical drug trials and the Acts amending the Medical Research Act and Medicines Act

Tue, 04 May 2004 06:38:51 GMT

Clinical drug trials and the Acts amending the Medical Research Act and Medicines Act

Parliament gave its approval to the Acts amending the Medical Research Act and Medicines Act on April 23, 2004 and they will come into force on May 1, 2004. Because of the amendments, the National Agency for Medicines has made a draft of the new regulation on clinical drug trials, which is at present being circulated for comment. The present regulation 1/2001 and regulation 4/2003, which extends its period of validity to the end of June 2004, will be in force until the new regulation becomes operative.

Reporting of clinical drug trials once the amendments have come into force

Trials, changes to a research plan and the termination of trials can be notified as before, but the National Agency for Medicines also accepts the common European forms that are available at the website of the European Agency for the Evaluation of Medicinal Products http://eudract.emea.eu.int/. The National Agency for Medicines will give guidelines about filling in these forms on its website in May 2004.

Serious unexpected adverse reactions must be reported to the National Agency for Medicines as before and to the Ethics Committees in accordance with the instructions of the National Advisory Board on Health Care, df. http://www.etene.org/. Adverse reactions that appear in multinational multicentre trials must be reported to the competent authorities in the concerned Member States of the European Union, as prescribed in sections 10 § f and 10 § g of the Medical Reseach Act.

Further information:
New regulation on clinical drug trials on humans
Clinical Trials

New regulation on clinical drug trials on humans

Wed, 21 Apr 2004 10:56:43 GMT

New regulation on clinical drug trials on humans

The National Agency for Medicines has prepared a draft of new regulation on clinical drug trials on humans. The updating was made necessary by new legislation on medical research and updates on Medicinal Act.

The new regulation will come into effect on June 2004.

Further information: Head of Section Ali Bardy, tel +358 9 4733 4324, ali.bardy@nam.fi

National Agency for Medicines chooses its EU areas of focus

Tue, 06 Apr 2004 13:00:00 GMT

National Agency for Medicines chooses its EU areas of focus

In future EU cooperation, the National Agency for Medicines will be focusing particularly on issues connected with biological products and medicinal products for paediatric use. The Agency made the decision under a performance agreement entered into with the Ministry of Social Affairs and Health. The aim is to increase the Agency's influence in the EU and reinforce future strategy on medicines control in a changing and expanding EU.

Biological medicinal products, especially biotech preparations, cell-therapy products and gene-therapy products, plus paediatric (children's) medicines, have been confirmed as the areas in which the Agency wishes to exert influence in the EU.

Director General, prof. Hannes Wahlroos, why is the National Agency for Medicines planning to increase its influence in the EU?

"The Agency is following its basic strategy whereby simply monitoring EU cooperation and participating in it is not enough for Finland. If we are going to be involved, we need to have some influence, too. The only problem is that the agenda for EU medicines regulation is extremely extensive, so we have to concentrate on an area where we expect to be successful and exhibit a high profile. Now these areas of focus have been chosen."

"The National Agency for Medicines will be continuing its activities in promoting Finland's interest in all areas of EU cooperation, but special efforts and special influence will be aimed at biological products and paediatric medicines. The good work that has previously been done in developing modes of cooperation for quality control of medicinal products and control of medical devices will be continued."

Choices call for expertise

Choosing to focus on biological products and paediatric medicines calls for the Agency to apply the latest scientific knowledge in the control of new and emerging medicinal treatments.

Biotechnology is used to produce hormone preparations such as insulin, growth factors and cytokines, and monoclonal antibodies. These preparations are used in the treatment of diabetes, cardiovascular disease, infections, cancer and rheumatoid diseases, for example. Gene therapy is being developed for treating various diseases including cancer and vascular disease. Cell therapy is expected to lead to vaccinations against cancer, help for liver failure and treatment for wounds and osteoarthritis. Biological products also include vaccinations, immunoglobulins and blood-clotting factors.

In the treatment of children's diseases at the moment, we are having to use many medicines for which efficacy and safety studies on different age groups have not been carried out, or for which there are no forms or strengths that have been found suitable for children, but which are mainly being used on the basis of clinical experience. It is the aim of the NAM to become an expert organization in special issues affecting the pharmacotherapy of children and to promote safe and effective medicines for child patients whether dealing with new or familiar drugs.

Choices made after careful preparatory work

When the choices were being considered, many issues had to be taken into account. Should influence-related choices be based on pharmaceutical policy, Agency strategy, or performance agreements? Are our areas of focus credible? Do the choices that we made genuinely affect our status and the overall result? Do the various choices reinforce each other? How can we improve our competitiveness within the EU?

"The choices that have been made are well founded, since they are based on the Agency's operating strategy, its performance agreement and its pharmaceutical strategy. We already have a sound foundation for the chosen areas of focus and consequently we have international credibility, as well. The choices that have been made reinforce each other insofar as many of the traditional diseases that are treated with medicines based on gene and cell therapy already appear in childhood," says prof. Olavi Tokola, Head of the Marketing Authorisation Department.

The choices are also based on the Agency's basic task, i.e. ensuring that medicines are safe. There are always particular risks associated with the use of biological products and these have to be assessed at different stages of medicine control simply because we have a pharmaceutical industry in Finland and we actively carry out clinical research here, too. Risk management is made even more challenging by the fact that the latest products and production processes are mainly based on the application of entirely new scientific knowledge.

The blood and tissue directives and in due course the human tissue engineering directive are all going to increase the Agency's responsibilities in terms of control. The new Good Clinical Practice Directive gives biological products a special status. What is at stake here is a national interest of substantial proportions, which is written into Agency strategy.

The National Agency for Medicines has been working hard and established a foothold in the expert groups within the EMEA. Although the Agency's resources set limits on its functions, small may very well be beautiful when it comes to organizing unhindered cooperation among experts in the biotech, pharmaceutical, toxicological and pharmacological sectors.

Building influence in the period up to 2007

The National Agency for Medicines is starting to build its operations systematically according to its influence targets. The Agency already has considerable competence and expertise in certain sub-sectors of the areas of focus, but training coupled with additional resources or job rotation will help to strengthen the basis for the work.

The choice of areas of focus is not going to endanger the continuity of the Agency's basic tasks. On the other hand, emphasis and important influence in EU cooperation will be aimed particularly at the chosen areas of focus.

NAM experts will have the chance to exert substantial influence in the chosen areas of regulatory issues in different ATC-groups of products, whether it is a matter of scientific evaluation, inspection, teamwork or scientific advice. In future operations in the chosen areas, there is going to be an increasing reliance on Finnish networks and top Finnish expertise.

For further information, please contact:

Professor Hannes Wahlroos, Director General, tel: +358 9 4733 4200, hannes.wahlroos@nam.fi

Professor Olavi Tokola, Head of Department
tel: +358 9 4733 4227, olavi.tokola@nam.fi

Dr Markku Toivonen, Head of Section
tel: +358 9 4733 4226, markku.toivonen@nam.fi

Dr Pekka Kurki, Head of Section
tel: +358 9 4733 4225, pekka.kurki@nam.fi

Annual Report 2003

Mon, 05 Apr 2004 08:21:12 GMT

Annual Report 2003

The annual report 2003 (pdf).

Orders of printed copies: Communications, fax +358 9 4733 4360 or email: viestinta@nam.fi.

Antipsychotic drugs may increase the risk of cerebrovaskular disorders in elderly patients with dementia

Tue, 09 Mar 2004 09:38:00 GMT

Antipsychotic drugs may increase the risk of cerebrovaskular disorders in elderly patients with dementia

According to review by the European Agency for the Evaluation of Medicinal Products (EMEA), the antipsychotic drug olanzapine (ZYPREXA) has been found to increase the risk of cerebrovascular disorders approximately three-fold (olanzapine 1.3%, placebo 0.4%) and increase mortality approximately two-fold (olanzapine 3.5%, placebo 1,5%) in elderly patients with dementia. This information is derived from new clinical trials and assessment by competent authorities.

Also the antipsychotic drug risperidone (RISPERDAL) has been found to increase the risk of cerebrovascular disorders approximately three-fold in elderly patients with dementia (3.3% vs. 1.2%)

The mechanism underlying these adverse reactions is unknown. The risk of cerebrovascular disorders was found to be especially increased in patients who had vascular or mixed type dementia. The safety of other antipsychotic drugs, which have been on the market for longer periods, has not been studied in elderly patients with dementia.

Antipsychotic drugs are also used to treat dementia-related symptoms

Antipsychotic drugs have been used with good results for the treatment of, among others, schizophrenia since the 1950’s. These drugs are also used for the treatment of severe symptoms of dementia, such as agitation and aggression. The extent of their use in the treatment of dementia cannot be evaluated on the basis of available registry data. However, their use is thought to be rather common.

The adverse reactions described herein have not been observed in other patient groups besides elderly patients with dementia. During the past 30 years, only three adverse reactions pertaining to cerebrovascular disorders have been reported to the National Agency for Medicines in association with antipsychotic use.

Use of antipsychotics to treat dementia should be viewed critically

The National Agency for Medicines recommends that antipsychotic drugs are used for the treatment of dementia-related psychosis and behavioural disturbance in elderly patients only if it is absolutely necessary in view of the patient’s condition. Use of antipsychotic drugs in these patients should be reviewed repeatedly at regular intervals.

The Summary of Product Characteristics and Package Leaflet of above-mentioned medicinal products will be updated to reflect this new information and health care professionals will be informed through a Dear Doctor Letter.

EMEA: Public Statement on the Safety of Olanzapine (Zyprexa, Zyprexa Velotab) (9.3.2004)

Further information available from
Erkki Palva, Professor, Research Director,
telephone (09) 4733 4288, erkki.palva@nam.fi
Tapani Vuola, Senior Medical Officer,
telephone (09) 4733 4209, tapani.vuola@nam.fi
Marja-Leena Nurminen, Senior Medical Officer,
telephone (09) 4733 4294, marja-leena.nurminen@nam.fi
Jyrki Vanakoski, Senior Medical Officer,
telephone (09) 4733 4375, jyrki.vanakoski@nam.fi
Sari Ekholm, Senior Medical Officer,
telephone (09) 4733 4321, sari.ekholm@nam.fi

Issuance of Export and GMP Certificates

Thu, 04 Mar 2004 08:43:55 GMT

Issuance of Export and GMP Certificates

The National Agency for Medicines issues certificates concerning pharmaceutical products and active pharmaceutical ingredients and their manufacturer requested by exporting pharmaceutical companies and by the authorities of the importing country.

Changes in the procedures for granting CPP export certificates for pharmaceutical products and GMP certificates concerning pharmaceutical manufacturers by pharmaceutical companies takes effect as of 1.3.2004.

Electronic forms, including instructions for completion, are available on the website of the National Agency for Medicines. The instructions are available in Finnish, Swedish, and English. Priced paper forms are no longer available.

List of substitutable medicinal products 1.4. - 30.6.2004

Tue, 24 Feb 2004 13:43:41 GMT

List of substitutable medicinal products 1.4. - 30.6.2004

The National Agency for Medicines has published the updated list of substitutable medicinal products for the period of 1.4. - 30.6.2004.

Further information: Head of Department, Prof. Olavi Tokola, olavi.tokola@nam.fi

Decree on fees 2004

Wed, 31 Dec 2003 10:35:49 GMT

Decree on fees 2004

Decree of the Ministry of Social Affairs and Health concerning activities of the National Agency for Medicines subject to fees (1064/2003) will be effective from 1 January 2004 until 31 December 2005.

Please, note that:

As of 1 January 2004 scientific advice pertaining to medicinal products for human use is subject to fees. The fee will be collected at the conclusion of the scientific advice procedure.
Marketing authorisations have been rearranged to comply with the current EU regulations. Fees collected for marketing authorisations have also been revised as well as fees for immunological veterinary medicinal products. Revisions are based on cost-accounting.
Annual fees have also undergone revisions together with fees collected for type II variations and notifications on clinical trials.

Read more: Decree on fees 1064/2003 (pdf)

Further information:
Marketing Authorisation Department, Development Manager Elvi Metsäranta, tel. +358 9 4733 4380, elvi.metsaranta@nam.fi

List of substitutable medicinal products 1.1. - 31.3.2004

Thu, 27 Nov 2003 08:27:46 GMT

List of substitutable medicinal products 1.1. - 31.3.2004

The National Agency for Medicines has published the updated list of substitutable medicinal products for the next period 1.1. - 31.3.2004.

Further information: Head of Department, Prof. Olavi Tokola, olavi.tokola@nam.fi

New regulation 2/2003 applying for and maintaining marketing authorisation for a medicinal product

Fri, 07 Nov 2003 08:42:41 GMT

New regulation 2/2003 applying for and maintaining marketing authorisation for a medicinal product

New regulation 2/2003 applying for and maintaining marketing authorisation for a medicinal product has come into a force on the 1 October 2003.

With this Regulation, the National Agency for Medicines brings into effect the requirements for Common technical document, CTD and provides more detailed national regulations concerning changes to medicinal products concerning the national variation applications.

The requirements concerning the content of the national and mutual recognition renewal applications have been harmonised. The new requirements of the national renewal applications will be applied for national renewal applications submitted after 1.4.2004.

In addition the requirement of submitting the electronic versions of the summary of products characteristics and package information leaflets/packages inserts have been given in the regulation.

More information is given by
Project Manager Outi Hemmo,
tel: +358 9 4733 4231, outi.hemmo@nam.fi

More: Regulation 2/2003

NEW: Column for frequently asked questions (FAQ)

Fri, 27 Jun 2003 08:21:11 GMT

NEW: Column for frequently asked questions (FAQ)

National Agency for Medicines has opened a column for frequently asked questions and answers. At the moment questions and answers concerning the regulatory matters of marketing authorisations are published on the column. FAQ column is updated regularly and it is possible to propose new questions for the column.

Questions and answers about other topics will be issued later on.

Common technical document (CTD) – application format mandatory from 1 july 2003 (updated 25.6.2003)

Tue, 17 Jun 2003 09:38:54 GMT

Common technical document (CTD) – application format mandatory from 1 july 2003 (updated 25.6.2003)

The new application format, CTD, will be in use for the applications submitted after 1 July 2003. The format has to be used for all marketing authorisation applications and variation applications concerning human medicinal products. The requirement for CTD-format applies also to the herbal medicinal products and the documentation of the European Drug Master File.

The Member States have to implement the CTD-format to their national legislations by the end of October 2003. Until the national implementation NAM has no legal basis not to accept the application dossiers in the old format. NAM intends to implement the CTD-format to the national legislation by 1 October 2003.

It should be notified that the national implementation in the Member States can be carried out in any time between July and October. Therefore, in order to be assured that the application format is acceptable to the national authorities it is highly recommended that the applicants use only the CTD-format.

However, the marketing authorisation application handled via the mutual recognition procedure can be submitted to the concerned member states in the “old” NtA 2B format until 31.12.2004, if the first application has been submitted to the reference member state (RMS) before 1 July 2003. The NtA 2B format is also applicable for the so-called “clone or dublicate” applications (identical product with different trade name) if the first dossier has been submitted to the NAM or the RMS before 1 July 2003.

Reformatting of the dossiers of the already authorised products into the CTD-format is not needed. However, the marketing authorisation holder may, for example, reformat the quality part of the dossier if this is considered useful. The signed confirmation that the content of the documentation is identical with the already approved old documentation is required. As no changes to the content of the documentation have been done, there is no need to submit the variation application. The updated documentation will be submitted to the NAM as for notification only and no fee is required.

More information relating to the CTD can be found on the Commission website (Questions & Answers).

For further information please contact:

Outi Hemmo, Project Manager, telephone: + 358 9 47334 231
outi.hemmo@nam.fi

Sinikka Lauer, Coordinator for Marketing Authorisations, telephone: +358 9 47334 230
sinikka.lauer@nam.fi

Annual report 2002

Thu, 12 Jun 2003 09:00:55 GMT

Annual report 2002

The annual report 2002 (pdf).

Orders of printed copies: Communications, fax +358 9 4733 4360.

PIC/S Expert Circle on Medicinal Gases

Fri, 06 Jun 2003 08:50:56 GMT

PIC/S Expert Circle on Medicinal Gases

PIC/S Expert Circle on Medicinal Gases will be held in Hämeenlinna, Finland 9. - 11.6.2003.

Inquiries about the seminar: Risto Suominen, Senior Pharmaceutical Inspector, telephone (09) 4733 4203.

Programme of the seminar (pdf).

The finnish representation in international organisations in the field of medicinal products, blood safety and medical devices

Tue, 29 Apr 2003 07:47:28 GMT

The finnish representation in international organisations in the field of medicinal products, blood safety and medical devices

The finnish representation in international organisations in the field of medicinal products, blood safety and medical devices, April 2003 (pdf).

Inquiries: Personal Assistant to DG Ms. Maaret Marttunen, maaret.marttunen@nam.fi.

Drug Consumption Statistics 2001 available

Tue, 23 Jul 2002 09:51:04 GMT

Drug Consumption Statistics 2001 available

Drug consumption statistics contain information about drug sales and reimbursements under the national health insurance scheme. Finnish Statistics on Medicines is published jointly by the National Agency for Medicines and the Social Insurance Institution. The present publication is the fifteenth in the series.

We welcome any feedback on the publication of medicine consumption statistics, and suggestions for improvement. Please send your suggestions by e-mail to: salesstatistics@nam.fi.

Additional information on Finnish Statistics on Medicines and orders of printed copies:
salesstatistics@nam.fi,
telefax +358 9 4733 4297, tel. +358 9 4733 4289.

Drug consumption statistics

Information about reimbursements is available at the website of the Social Insurance Institution:
http://www.kela.fi/tutkimus/laaketil/laakekorvaustilastot.html

Information about drug consumption in Nordic countries:
Danmark: www.dkma.dk
Finland: www.nam.fi
Island: http://brunnur.stjr.is/interpro/htr/htr.nsf/pages/lyfjanotkun-1989-1999
Norge: www.drugconsumption.nmd.no

The sale of Nimed, an anti-inflammatory analgesic, is temporarily suspended due to its adverse liver effects

Thu, 14 Mar 2002 22:00:00 GMT

The sale of Nimed, an anti-inflammatory analgesic, is temporarily suspended due to its adverse liver effects

A decision was made on 15.3.2002 by the National Agency for Medicines in Finland together with Aventis Pharma to suspend the distribution, sale and any other supply for consumption of tablets and granules of Nimed; the suspension will come into force on 18.3.2002. The marketing authorisation of all preparations of Nimed will nevertheless remain in force. The decision is due to the severe undesirable effects on the liver associated with the use of Nimed. A review by the National Agency for Medicines and the marketing authorisation holder Aventis Pharma of the situation is currently under way.

The active substance contained in Nimed is nimesulide of the anti-inflammatory analgesic group. Marketing authorisation for it as a prescription drug was approved in Finland in August 1997 and it was introduced on to the market in January 1998. Nimed is indicated for the treatment of pain associated with arthrosis, various transient pains, dysmenorrhoea and fever.

By 13.3. 2002, the adverse effects register of the National Agency for Medicines had received a total of 109 reports on adverse effects associated with the use of Nimed, 66 of which were on liver effects. The reports most frequently involved symptomfree elevation of liver enzymes, but cases of hepatitis and isolated cases of reactions necessitating a liver transplant were also reported. The first report of a fatal liver effect which is suspected to be associated with the use of Nimed was received by the National Agency for Medicines on 11.3.2002. The patient was also using other drugs and the case is under review at present.

The use of Nimed is not prohibited, but the patients are requested to contact the doctor in charge of their treatment as necessary to ensure that they receive appropriate medication. The patient should also contact his or her doctor if new symptoms possibly indicative of liver dysfunction occur such as general malaise, nausea, lack of appetite, abdominal pain or jaundice.

Further information available from
Erkki Palva, Professor, Research Director, telephone (09) 4733 4288, 050 552 1154 erkki.palva@nam.fi
Marja-Leena Nurminen, Senior Medical Officer, telephone (09) 4733 4294 marja-leena.nurminen@nam.fi
Riitta Tokola, Senior Medical Officer, telephone (09) 4733 4331 riitta.tokola@nam.fi
Hannu Kokki, Senior Medical Officer, telephone (09) 4733 4375 hannu.kokki@nam.fi

Clarification of the regulation concerning imports of medicinal products for personal use

Mon, 17 Dec 2001 12:38:20 GMT

Clarification of the regulation concerning imports of medicinal products for personal use

The National Agency for Medicines has clarified the regulation concerning imports of medicinal products for personal use. The new regulation came into effect on January 1, 2002. Restrictions on medicine imports are part of an overall control system designed to ensure patient safety.

Medicine imports to Finland subject to a number of restrictions.

Travellers entering Finland are allowed to bring in the medicines they need for their own use. The new regulation helps to clarify a number of practical aspects. For example, it incorporates the restrictions on imports of buprenorphine and methadone imposed by the National Agency for Medicines in 2000 and 2001, respectively.

The new regulation (6/2001) replaces the regulation issued in 1996. In future, imports of medicines for personal use will be covered by decrees issued by the Ministry of Social Affairs and Health.

Important restrictions

The regulation limits the amount of medicines anyone entering Finland can bring in, depending on whether such products come under the Finnish classification of self-care medicine, prescription drugs, veterinary drugs or narcotic drugs. The aim is to prevent illegal trading in medicines. Most of the restrictions apply to narcotic drugs, which anyone entering Finland can bring to a maximum amount equivalent to 14 days’ use. Most soporifics and tranquillizers, for example, are categorized as narcotic drugs.

International agreements also limit the amount of medicines that can be brought into Finland. Anyone entering the country from the European Economic Area can bring in an amount equivalent to one year’s need, while those coming from outside the EEA can bring in an amount equivalent to three months’ need.

As those entering Finland can only bring in medicinal products for their own use, prescribed products in their possession must be accompanied by a doctor’s prescription. The amounts allowed in are determined by the size of the daily dose, which is the amount so prescribed or, in the case of self-care medicine, the amount indicated on the package.

Medicines sold by mail

Medicines should only be purchased from authorized retail outlets. Thus, pharmacies in the EU, for example, can send medicinal products to Finland by mail. Medicinal products equivalent to three months’ need can be sent to Finland from any EEA country in this way. However, neither narcotic drugs nor veterinary drugs can be sent by post. Likewise, medicines cannot be supplied to Finland by mail order, or in a courier’s bag, or ordered on the Internet.

What should be remembered when taking medicines into another country?

When travelling from Finland to another country:
- Medicine imports are subject to restrictions in most countries.
- Persons travelling abroad must familiarize themselves with the import restrictions in the country of destination.

When returning to Finland:
- The amount of medicinal products that can be brought in is subject to restrictions.
- When bringing in prescription drugs, you must be able to present the prescription at the customs.
- For more information, contact the National Agency for Medicines (www.nam.fi).
- Under Finnish law, it is illegal to purchase or sell medicinal products on the Internet.
- Medicines can only be sent to Finland by mail from an EEA country.

For more information, contact:
Hanna-Maija Koponen-Piironen, Senior Pharmaceutical Inspector, Inspectorate, Tel. +358 9 4733 4218, e-mail: hanna-maija.koponen@nam.fi
Eija Pelkonen, Head of Inspectorate, Tel. +358 9 4733 4210, e-mail: eija.pelkonen@nam.fi

Regulation 6/2001: Importing medicinal products for personal use

Clarification of the regulation concerning imports of medicinal products for personal use

Mon, 17 Dec 2001 11:48:57 GMT

Clarification of the regulation concerning imports of medicinal products for personal use

The National Agency for Medicines has clarified its regulation concerning imports of medicinal products for personal use. The revised regulation came into effect on January 1, 2002. Restrictions on medicine imports are part of an overall control system designed to ensure patient safety.

For more information, see Press Release of December 17, 2001

Drug consumption statistics available on the website

Mon, 15 Oct 2001 10:47:34 GMT

Drug consumption statistics available on the website

In October, the National Agency for Medicines will start publishing on its Internet pages medicine consumption statistics based on the data in the Register of Medicine Sales. Annual medicine consumption statistics have been published since 1987 jointly by the National Agency for Medicines and the Social Insurance Institution under the title Finnish Statistics on Medicines. The electronic version of consumption figures for the year 2000 will complement the printed volume. Both versions will be published in October.

We would welcome any feedback on the publication of medicine consumption statistics, and suggestions for improvement. Please send your suggestions by e-mail to: salesstatistics@nam.fi.

Drug Consumption Statistics 2000

Liisa Turakka elected second vice-chair of the European Pharmacopoeia Commission

Mon, 25 Jun 2001 11:47:12 GMT

Liisa Turakka elected second vice-chair of the European Pharmacopoeia Commission

Professor Liisa Turakka, Head of the National Agency for Medicines Pharmaceutical Department, was elected second vice-chair of the European Pharmacopoeia Commission at a meeting held in Strasbourg, France on June 21, 2001. The meeting chose D. De Kaste from the Netherlands as the first vice-chair, while H. G. Kristensen from Denmark was elected to chair the Commission. All three have a three-year term of office. This is the first time a Finn has been elected to this position.

The European Pharmacopoeia Commission makes decisions in matters concerning the preparation and approval of quality requirements for medicinal products, which are published in the European Pharmacopoeia. The Commission’s operations are based on the Convention on the Elaboration of a European Pharmacopoeia, which was signed in 1964. Finland joined the Convention in 1982 after attending Commission meetings as an observer since 1975. The Commission has a permanent secretariat in the Strasbourg-based European Directorate for the Quality of Medicines (EDQM).

The members of the European Pharmacopoeia Commission comprise 27 European countries and the European Union. Observers from countries outside Europe, such as Australia and Canada, also attend meetings.

Katja Lindgren-Äimänen, Communications Officer
tel. +358 9 4733 4209, fax +358 9 4733 4360

New regulation on clinical drug trials on humans

Tue, 01 May 2001 10:45:19 GMT

New regulation on clinical drug trials on humans

The National Agency for Medicines has issued a new regulation on clinical drug trials on humans, which came into effect on May 1, 2001. The updating was made necessary by new legislation on medical research introduced in 1999 and also by needs related to practical research work.

The Finnish Act on medical research sets out explicit minimum requirements for the composition and work of Ethics Committees. Consequently, under the new regulation, a notification of clinical drug trials can be made to an Ethics Committee and the National Agency for Medicines at the same time.

Biological information is needed in addition to pharmaceutical, pharmacological and toxicological information so that any harmful effects of prions and viruses, for example, can be dealt with.

The new regulation contains more specific instructions about notification of any harmful effects.

For more information, contact Senior Medical Officer Ali Bardy, National Agency for Medicines Pharmacological Department, tel +358 9 4733 4324, e-mail: ali.bardy@nam.fi