EU Regulatory Directory

The directory comprises of important links in the pharma domain pertaining to the EU Region, for your reference.

Medicines & Healthcare products Regulatory Agency , UK

• MHRA
• MAH
• FEES

European Medicines Agency, EU

• EMA
• EMA Partners
• Agencies
• Member States
• National Competent Authorities (Human)
• National Competent Authorities (Veterinary)
• Pharmaceutical Industry
• News & Events
• BREXIT

Veterinary Medicines

• Veterinary Medicines Link
• MA
• Application Guidance
• Pre-submission Q&A
• Post-Authorisation Variations

Human Medicines

• Human Medicines Link
• MA
• Generics & Hybrid Applications
• Marketing authorisation guidance documents
• Templates for Accessors
• Post-Authorisation Variations

Heads of Medicines Agency (EU)

• Heads of Medicines Agency (EU) Link

BREXIT

• BREXIT

CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human)

• CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human)
• National Contacts
• Procedural Guidance
• General Information
• Application for MA
• eSubmissions
• Generics in MRP and DCP
• Variation Procedure
• Q&A

CMDv (Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary)

• CMDv (Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary)
• National Contacts
• Procedural Guidance
• eSubmission
• Application for MA
• Post Marketing Procedures
• ASMF
• Q&A