EMA Regulation of Medicines

Human medicines

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

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

Important note on document formats:  All Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with MS Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted.

In this section you will find the following topics, click on a link to go to the page:

Pre-authorisation Post-opinion Post-authorisation Product information Scientific advice and protocol assistance Scientific guidelines Innovation Task Force Regulatory and procedural guidance SME office Paediatric medicine Orphan designation Herbal products

Referral procedures Article 58 applications Compassionate use Pharmacovigilance Advanced therapies Inspections Product defects and recalls Parallel distribution Non-pharmaceutical products New countries/EFTA Fees

Source

Pre-authorisation

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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 application pre-submission activities including:

• A pre-submission Q&A for innovative products and for generic/hybrid products
• Information on support to companies in their R&D activities specifically the Innovation Task Force (ITF), the SMEs office andScientific advice and protocol assistance
• Assessment templates and guidance issued by the Committee for Human Medicinal Products (CHMP) to be used in new applications
• Submissions dates and procedural timetables for applications
• Procedural and regulatory guidance on the application procedure

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.

Important note on document formats: All Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with MS Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted.