Adaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances
As of 15 November 2026, the prior registration of active substances in the EMA SMS database (Substances Management Services) will become a mandatory requirement for their inclusion in establishment licences and GMP certificates.
10.01.2024
New forms for applications for discontinuation of an establishment licence for medicinal products must be used with immediate effect.
Companies wishing to discontinue their establishment licence for medicinal products or TPs/GTPs/GMOs must submit not only the form “Application for establishment licence – Basic form Medicinal products (incl. blood)” (I-301.AA.05-A02) or the form “Application for establishment licence – Basic form TPs/GTPs/GMOs” (I-301.AA.05-A18), but also the new form “Application for establishment licence – Discontinuation of establishment licence Medicinal products (incl. blood), or TPs/GTPs/GMOs” (I-301.AA.05-A33) as well as the requested information and documentary evidence related to the activities carried out by the company.
The new forms must be used effective immediately to submit applications for discontinuation of establishment licences.
