Focus on the French Health Products Safety Agency
The French Health Products Safety Agency (Afssaps) was created by the law of 1 July 1998, passed to strengthen existing monitoring and health
safety systems, in order to provide an improved response to the increasing diversity and interaction of health safety issues relating to healthcare products. The Afssaps was set up in 1999, and benefited not only from the skills of its forerunner, the Medicinal Products Agency, but also from the fact that its scope of activity was extended to cover the whole range of healthcare products.
It serves the interests of public health thanks to the high level of expertise it can call upon, both internally and externally. It is thus able to produce not only scientific analyses and recommendations, but also tens of thousands of decisions a year, taken on behalf of the State by the Agency’s Director General.
What is the role of the NWG?
We examine the proposed name -called « invented name »- within the marketing authorisation (AMM) procedure. The Group checks whether there is no possible confusion with a previous AMM or with an INN (International Non proprietary Name).
What are the criteria?
We have internal guidelines knowing that pharmaceutical professionals are bound by the provisions of French Law (Editor’s note: the invented name should be chosen so as to prevent any confusion with other pharmaceuticals and must not be misleading on the qualities or characteristics of the speciality). The most important criterion is the risk to public health. In theory, if the proposed name is close to a previous AMM but with an identical active substance, the authorisation could be given (Editor’s note: this is balanced with the comparison principles between trademarks). However, the NWG also takes into account the general environment and would be reluctant to give the authorisation in particular if the previous name is known on the market.
What is the procedure before the issuance of a final decision on the denomination?
Within 2 months of the AMM request, the AFSSAPS issues a first opinion. The applicant is allowed to answer within 30 days. The decision is rendered within the following 30 days. An appeal can be filed before the AFSSAPS – and the case is re-examined by the NWG – and then before the French administrative Tribunal. The decisions refusing an AMM are not published, the only available decisions are the rare ones issued by the Tribunal.
Are you influenced by case law on trademarks?
No. We do not have any obligation to rule in the same way, and we do not apply the same criteria. However, the applicants may invoke decisions issued from case law in order to support their arguments.
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