Search


UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 18th october, 2024 updated multiple guidances such as " Orphan...

Sharan Murugan
Oct 22, 20242 min read
Â
Â


Updated Guidance for e-Submissions for CEP applications
As the eCTD format is mandatory for the submission of all applications for Certificates of Suitability to the monographs of the European...

Sharan Murugan
Sep 5, 20211 min read
Â
Â