The French National Agency for the Safety of Medicines and Health Products (ANSM) has ruled. On May 24, 2024, the European Commission imposed the suspension of marketing authorizations (MAs) for nearly 400 generic medicines across Europe. In France, this represents 72 drugs. The ANSM, the sector’s regulator in France, was to decide on the fate of drugs sold in France. This was therefore done on Wednesday, July 3.
In its news, the ANSM indicates that it is suspending the marketing authorizations (MA) of 7 drugs in France as of July 3, 2024. In addition, the batches present in pharmacies are being recalled. But the drug regulator specifies that “certain drugs benefit from a 24-month suspension of marketing authorization, in order to guarantee continuity of patient care”. 41 drugs are affected, “pending further bioequivalence studies.”
Why are 7 generic drugs being withdrawn from sale?
This withdrawal follows the decision of the European Commission of 24 May. In question, “a European inspection of the company Synapse Labs, in India, which highlighted the fact that the bioequivalence studies of this company did not meet European requirements”, explained the ANSM at the beginning of June. The drug regulator specifies that there is no identified risk of shortage. “To date, no reports of safety or loss of efficacy have been reported for the affected drugs.”we can read in the press release.
Which generic drugs are being withdrawn from sale?
Also, here are the generic drugs that are subject to a suspension of marketing authorization and (a batch recall if they are concerned):
- Olanzapine Arrow 5 mg tablet
- Olanzapine Arrow 7.5 mg tablet
- Olanzapine Arrow 10 mg tablet
- Nevirapine Arrow LP 400 mg prolonged-release tablet
- Metformin Almus 500 mg, film-coated tablet
- Tramadol Almus 50 mg, capsule
- Liderlens Ibuprofen 400 mg, soft capsule, Nutra Essential OTC SL (not affected by the batch recall as it is not marketed)
However, the ANSM specifies that 41 drugs benefit from a postponement of marketing authorization suspension. These drugs are “indicated in cardiology, oncology, hematology, diabetology, gastroenterology and in the HIV treatmentwhich in particular do not have sufficient quantities of therapeutic alternatives.” The drug regulator specifies that “the cessation of marketing would create a critical situation for the continuity of patient care”.
The list is available on the site from ANSM.
Generic drug recall: what should I do if I have one of these drugs?
On its website, the ANSM calls on patients not to stop or modify treatment, even if the marketing authorization is suspended or benefits from a postponement of suspension. Indeed, it is specified that:“No reports of safety or loss of efficacy have been reported for these drugs.” When renewing your treatment, if it no longer has marketing authorization, then “the pharmacist will give you a box of another medicine (marketed by another laboratory)”.
Sources :
- Synapse Labs: we are making a statement on the marketing authorizations of certain drugs – ANSM – 03/07/2024
- Synapse Labs: European Commission imposes suspension of marketing authorisations for certain drugs – 06/07/2024
