ANSM reviews 33 active ingredients

The National Agency for the Safety of Medicines and Health Products (ANSM) has started evaluating 33 active ingredients that might be removed from the market, according to the association of primary healthcare product manufacturers NéreS and supported by pharmacists' unions. This review includes prescription-only medicines and drugs not sold in France but delisted elsewhere in Europe.

Etofenamate under review

One of the ingredients under consideration is etofenamate, a non-steroidal anti-inflammatory drug used in countries like Germany, Spain, Ireland, and Poland. It is applied topically and is used to treat local pain from acute ankle sprains, strains, or bruises. Patches containing etofenamate may be included in official medical advice, as the ingredient was exempted from toxic substance regulations by the ANSM on October 9.

Two paths for delisting

There are two possible ways to delist a substance. A pharmaceutical company can request the ANSM to change a prescription-only medicine to a non-prescription one, using the medicine’s existing marketing authorization. Alternatively, a company can directly apply for a non-prescription medicine authorization. The ANSM will release a guide next year explaining the procedures for these changes.

ANSM evaluates each request individually

The ANSM reviews each delisting request on a case-by-case basis, with no set schedule. It currently receives few requests after the list was published. A working group with manufacturers must reconvene by year's end to finalize the delisting procedures.

Future expansion under proposed law

If Article 30 of the draft law on the financing of the Social Security (PLFSS) for 2027 is adopted, the ANSM could initiate delisting procedures independently or at the request of the Ministry of Health. Under this article, pharmaceutical companies would provide the necessary scientific data to the agency upon request for reassessment.