2023-10-16 07:00:08
EXPERT OPINION – The new exemption procedures represent progress. Unfortunately, it still remains limited by the low number of indications and patients concerned.
Alain Saint-Pierre is a doctor of pharmacy and a member of the National Academy of Pharmacy. The author indicates that he has no links of interest related to the subject.
Granted after a long and careful process, which aims to evaluate in particular the benefit-risk ratio, themarketing authorization (MA) of a health product is a guarantee of effectiveness and safety for the prescriber. It is always issued for one (or more) clinical situations, and the fact that a medicine has a marketing authorization does not authorize its use in pathologies that this marketing authorization does not designate. Certain clinical situations may require the use of medicines which do not have marketing authorization for the intended indication, but even in these situations, freedom of prescription is not total: derogation procedures have recently been implemented, which replace previous procedures considered complicated.
• The early access authorization procedure (AAP)
The AAP is intended to enable…
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