ANSM opens public consultation with respect to its draft recommendations on medicinal product names
26 September 2016
Today, the National Agency for Medicines and Health Products Safety (ANSM) published its draft recommendations on the choice of medicinal product names (the Recommendations) for public consultation. The consultation will be open for two months: interested parties can submit comments until 30 November via the ANSM website here.
The Recommendations aim at preventing public health risks related to medicinal product names, for example when such names lead to confusion or induce errors with respect to their composition, indication, intended uses, or target population. The Recommendations provide guidelines on the choice of both fantasy names and International Non-Proprietary Names (INN), and include in particular:
- A stricter framework for so-called “umbrella brands” in order to avoid confusion amongst patients and errors with respect to the use of such products:
- When the umbrella brand refers only to medicinal products: the same fantasy name should only be used with respect to medicinal products subject to optional prescription and if certain conditions are met;
- When the umbrella brand refers to both medicinal products and other products (e.g. cosmetics): the use of (part of) the name of a non-medicinal product for a medicinal product name will be refused by the ANSM;
- It is also reminded that the external packaging of umbrella brand products (both medicines and other products) must differ in order not to create confusion amongst patients.
- Stricter rules with respect to the mentioning of an aroma in the fantasy name (which will only be allowed exceptionally in order to improve treatment observance); and
- A recommendation to express the name of generic medicinal products by means of their INN accompanied by a trademark or the name of the marketing authorisation holder.
Importantly, the Recommendations also recall that approval of a name by the ANSM does not exonerate pharmaceutical companies from liability in case of adverse events linked to the medicinal product name.
The ANSM, which is responsible for examining medicinal product names proposed by pharmaceutical companies in the context of national and DCP/MRP marketing authorisation and variation applications, has developed these Recommendations in line with those established by the European Medicines Agency (EMA) for centralised marketing authorisation applications (see EMA guidelines here). Pharmaceutical companies should refer to the EMA guidelines with respect to the two other components of a medicinal product denomination (in addition to the name of the product) that are not covered by the ANSM Recommendations, i.e., dosage and pharmaceutical form.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2016 Issue (Thomson Reuters).