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Medicines prescribed without marketing authorization. controlled freedom

Alain Saint-Pierre is a Doctor of Pharmacology and a member of the National Academy of Pharmacy. The author states that he has no interest in the topic.


After a long and careful process aimed especially at evaluating the benefit-risk ratio, the marketing authorization (AMM) of the health product is a guarantee of efficacy and safety for the prescriber. It is always given for one (or several) clinical situations, and the fact that the drug has a marketing authorization does not allow its use in pathologies that this marketing authorization does not mean. Some clinical situations may require the use of drugs that do not have a marketing authorization for the intended indications, but even in these situations the freedom of prescription is not complete; more recently, diversion procedures have been implemented to replace previously considered complex procedures.

• Early Access Authorization Procedure (AAP)

AAP is designed to enable…

Source: Le Figaro

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