How To Ensure That A Drug Is Authorized In France?


In order to guarantee better health safety, the marketing of drugs requires certain rules to be respected. In addition, French legislation is very strict regarding medicines. In this case, you must make sure that the ones you buy from the pharmacy are authorized. To do so, read this article.

What is an AMM?


As the marketing of drugs is strictly regulated, a pharmaceutical company must, before any sale of a new drug or medical device, file a marketing authorization file with the competent authorities. Indeed, the latter is obliged to evaluate the quality, safety, and efficacy of medicines. For the evaluation, the authorities focus on all relevant scientific data obtained on the drug, such as results of toxicological, pharmacological, and clinical studies, scientific literature, etc.

Once the quality, safety, and efficacy of the drug are deemed satisfactory, it is authorized to be sold on the market by an authorized pharmacy. It should be noted that the MA is issued either by the ANSM (Agence Française de Sécurité du Médicament et des Produits de Santé) or by the EMA (European Medicines Agency), depending on the procedure. It is accompanied by the summary of product characteristics (SPC), the package insert, and the labeling. Subsequently, every authorized drug receives a marketing authorization number.

What happens to drugs after they have been granted marketing authorization?

Generally, the MA is issued for a period of 5 years. Thereafter, it may be renewed for an indefinite period. However, the ANSM may renew it for an additional 5 years for reasons of vigilance regarding the quality, safety, and efficacy of the drug. In addition, the MA can be modified at the initiative of the laboratory or by the imposition of the competent health authorities.

These modifications require authorization before being implemented. The decision whether or not to market the drug rests solely with the laboratory or the pharmacy once the MA has been obtained. It should be noted that if the laboratory does not market the drug within 3 years following the year in which the MA was obtained, the latter will become null and void.

Once on the market, the proper use of the drug is governed by systematic measures that you can see in the summary of product characteristics, in the package insert, or the conditions of prescription and delivery.

What are the other authorizations?

Temporary authorization for use or ATU


The ANSM issues temporary authorization for the use of drugs that do not yet have marketing authorization. Generally, it is intended for drugs for patients with serious or even rare diseases for which other treatments are neither appropriate nor available. In this case, their quality, safety, and efficacy are only presumed on the basis of current scientific knowledge. And this authorization is issued for a specific period.

Temporary recommendation for use or RTU

This recommendation concerns drugs that already have marketing authorization. It is used as authorization for another therapeutic use. It is issued by the ANSM as an “off-label” recommendation for a period not exceeding 3 years.

How to be sure that it is an authorized drug?

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To ensure that a drug is actually authorized, consider buying your drugs and medical devices through a legal channel. In other words, the medication must:

    • Be sold by a pharmacist, who is the only one authorized to sell drugs.
    • Have a marketing authorization number or MA
    • If the drug is not subject to medical prescription, or if you buy it via the website of a pharmacy, make sure that the Order of Pharmacists authorizes the pharmacy.

If you buy your medicines outside the legal circuit, you run the risk of having counterfeit products or products whose use could be inappropriate. In this case, their quality, safety, and efficacy are not guaranteed, as the competent health authorities do not control these drugs.

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