RegulatoryOfficial

ANSM adds three generics to French hospital retrocession list

🇫🇷 ANSM · Thu 12 Nov 2026

A decision of 12 November 2026 extends the list under Article L. 5126-6, 1° of the Public Health Code with an anticancer, an antiviral and a multiple sclerosis capsule.

France's medicines agency ANSM has amended the list referred to in 1° of Article L. 5126-6 of the Public Health Code. The decision is dated and was published on 12 November 2026, and it amends the annex to the agency's decision of 16 January 2024, as modified. ANSM files the notice under its retrocession decisions. Article L. 5126-6 sits within the provisions on in-house hospital pharmacies (pharmacies à usage intérieur).

Three products are added, and the decision removes none. In the "Anticancéreux/Immunosuppresseurs" category, it adds Azacitidine Seacross 25 mg/mL, powder for injectable suspension (CIS code 62178796), marketed by Sun Pharma France. In the "Antiviraux" category, it adds Emtricitabine/Rilpivirine/Tenofovir Alafenamide Accord 200 mg/25 mg/25 mg film-coated tablets (CIS 60774160), operated by Accord Healthcare France SAS.

The third addition falls under "Autres médicaments": Fingolimod Viatris Santé 0.5 mg capsules (CIS 66262836), operated by Viatris Santé.

The decision is signed by ANSM director general Catherine Paugam-Burtz and cites Articles L. 5126-6, R. 5126-58 and R. 5126-59 of the Public Health Code. Its second article provides for publication on ANSM's website. The text does not give a separate date of effect or explain the reasons for the additions.

What it means for your team

  • Hospital pharmacy and market-access teams should check the three CIS codes against their own retrocession product lists and dispensing procedures.
  • Sun Pharma France, Accord Healthcare France and Viatris Santé, as operators of the added products, should confirm how the listing affects their hospital supply arrangements.
  • The decision only amends the annex to the 16 January 2024 decision. Teams should consult ANSM's consolidated list of medicines in retrocession for the current position.

Official source: ANSM ↗

Article written by VigiEye from the official source (ANSM). AI-assisted; check the source before acting.

More Regulatory All →