Regulation of Human medicines

This section of the website provides information for companies and individuals involved in developing and marketing medicines for use in the European Union.

In this section you will find information on many different work areas in which the European Medicines Agency is a stakeholder including:

• Procedural advice, documents and contact information for a marketing authorisation application
• Procedural advice, documents and contact information for an orphan designation application
• Procedural advice, documents and contact information for a Paediatric Investigation Plan Application
• Information on support to companies in their R&D activities including the SME Office, the Innovation Task Force (ITF) and the Scientific advice and Protocol Assistance team
• Procedural advice, documents and contact information for monitoring activities such as inspections, PSURs, product defects and recalls
• Procedural advice, documents and contact information for referral procedures

For further information on EU legislation and procedures for the regulation of medicines, see also Volumes 1-4 and 9-10 of The Rules Governing Medicinal Products in the European Union.