Scientific advice

On written request, the National Agency for Medicines gives scientific advice on documentation of the quality, efficacy and safety of human or veterinary medicinal products at its discretion.

Advice may be sought on planned or completed studies or documentation. The National Agency for Medicines will not provide precedents or estimates on the sufficiency of any documentation that will be or has been produced for marketing authorisation purposes. The advice is not binding on either the National Agency for Medicines or the party seeking advice.

Scientific advice may be sought on the type of questions to which no answers can be found in the national regulations or guidelines or EU authority guidelines (Guideline, Note for Guidance, Points to Consider).

Advice may be sought regardless of any marketing authorisation procedure subsequently initiated by the pharmaceutical industry. However, if scientific advice has already been sought from the European Agency for the Evaluation of Medicinal Products (EMEA), any new subsequent request for advice on the same product should also be submitted to the EMEA. Likewise, a request for advice should be submitted to the EMEA if an application for marketing authorisation for the medicinal product has already been through the centralized procedure.

As a rule, scientific advice is given on the basis of a meeting held at the National Agency for Medicines.