#SFHS2615032AFrance updates public-sector approved medicine listings
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order updates the official list of pharmaceutical products approved for use by hospitals, public bodies, and other public health services in France. The changes mainly replace old product labels with new ones for 17 listed medicines, including CEGFILA, ENBREL, FIXICAL, and FIXICAL VITAMINE D3. The practical effect is administrative: public buyers, hospital pharmacies, reimbursement teams, and suppliers should use the updated product labels and laboratory names in procurement, catalogues, dispensing systems, and compliance records.
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Key Changes
- Updates 17 pharmaceutical product labels in the public-sector approved medicines list
- Changes the listed laboratory for several ENBREL presentations from Pfizer to Teva Santé
- Updates listed laboratory information for products including CEGFILA and FIXICAL
Obligations
What this law requires
Public hospitals, public health services, and other collective-use purchasers must use the updated approved product label for CEGFILA 6 mg, CIP 34009 302 020 2 9, identifying the laboratory as Laboratoires MUNDIPHARMA SAS instead of Laboratoires BIOGARAN in procurement, catalogues, and compliance records.
Public hospitals, public health services, and other collective-use purchasers must use the updated approved product labels for ENBREL 10 mg, 25 mg, and 50 mg products listed under the specified CIP codes, identifying the laboratory as Laboratoires TEVA SANTE instead of Laboratoires PFIZER.
Hospital pharmacies and dispensing-system administrators must update internal medicine databases, dispensing systems, and stock records to reflect the new labels for the listed pharmaceutical specialties whose official labels are modified in the annex.
Suppliers of the affected approved pharmaceutical specialties must align product references, tender documents, catalogues, and public-sector supply records with the new official labels shown in the annex for the relevant CIP codes.