#52026XC01816Summary of European Union Decisions on Marketing Authorisations for Medicinal Products from 1 February 2026 to 28 February 2026
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law provides a summary of the European Union's decisions regarding the marketing authorisations for various medicinal products over the month of February 2026. It includes details such as product names, their active ingredients (INN), the holding companies, and the respective notification and entry numbers in the Community Register. The decisions cover both new authorisations and modifications of existing ones as stipulated by European regulations.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Issuance of new marketing authorisations for multiple medicinal products
- Modifications to existing marketing authorisations noted
- Withdrawal of specific authorisations as detailed
Obligations
What this law requires
Marketing authorisation holders must maintain the registered medicinal product information in the Community Register, including product name, INN, pharmaceutical form, ATC code, and holder details as listed in the official EU decisions
Marketing authorisation holders must notify competent authorities of any modifications to their marketing authorisation within the timeframe specified in Article 13 of Regulation (EC) No 726/2004
Authorised holders must publish or disclose marketing authorisation decisions through the Official Journal of the European Union in accordance with Article 13 or Article 38 of Regulation (EC) No 726/2004 or Article 5 of Regulation (EU) 2019/6
Medicinal product holders must maintain accurate entry numbers in the Community Register and ensure consistency between their authorisation documentation and registered information