Request for scientific opinions to Afssaps

Industry can make requests for scientific opinions to Afssaps. Requests are optional and can be made for the following reasons:

  • During the development of a medicinal product (it should be done preferably when efficacy data is already available);
  • Before submission of a Marketing Authorization (MA) request(to verify that the MA dossier is complete);
  • After obtaining the Marketing Authorization (to discuss, for instance, specific commitments with the authorities).

The scientific opinion is given during a meeting with Afssaps (1 hour long), during which the company presents its request and questions (10 questions at most).

Normally, the meeting takes place within two months from the company’s request submission.

Source: Afssaps.