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Definition and meaning of the term "drug"

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Article L 5111-1 of the Public Health Code defines a drug as "any substance or combination for treating or preventing disease in human beings or animals and any product that can be administered to man or animals to establish a medical diagnosis or to restoring, correcting or modifying organic functions."

Medicines Control is provided in France by the French Agency for the Safety of Health Products (AFSSAPS). This public state issues licenses for placing drugs on the market (AMM). The AMM is issued after an evaluation of the product is made. The evaluation takes into account:
- pharmaceutical quality (chemical quality)
- The side effects
- efficacy

All health professionals (approximately 300 000 persons) are responsible for pharmacovigilance. They are required to report adverse reactions to the regional pharmacovigilance centers or directly to manufacturers.

AFSSAPS has animal health powers that allows it to take the necessary measures to punish offenders. These steps could be AMM, suspension, withdrawal of a product etc.

Tags - AMM, drug, pharmacovigilance, Public Health Code

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