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Table of contents
- Good manufacturing practice and good distribution practice
- Falsified medicines
- Good clinical practice
- Pharmacovigilance inspections
- Sampling and testing
- Product defects
- Certificates
Good manufacturing practice and good distribution practice
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Reflection paper on a proposed solution for dealing with minor deviations from the detail described in the marketing authorisation for human and veterinary medicinal products | (English only) | 06/01/2009 | |||
| Standard operating procedure for co-ordination of GCP inspections | (English only) | adopted | 16/05/2007 | 27/09/2012 | 27/09/2012 |
Related links
- Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
- EudraLex Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice
- Questions and Answers on GMP
- Compilation of Community procedures on inspections and exchange of information
- Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice - Basic Requirements Part II: The Principles of Good Manufacturing Practice for Active Substances used as Starting Materials (Integrated in EudraLex Vol 4)
- Specific Conditions of the Application of the Principles and Guidelines of GMP for Certain Excipients
- Excipients Impact Assessment Report Final
- EMA webpage on GMP
Falsified medicines
Related links
Good clinical practice
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Reflection paper on advice to applicants/sponsors/CROS of bioequivalence studies | (English only) | adopted | 19/09/2008 | ||
| Standard operating procedure for co-ordination of GCP inspections | (English only) | adopted | 16/05/2007 | 27/09/2012 | 27/09/2012 |
Related links
- Directive 2001/20/EC of the European parliament and of the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
- Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
- EudraLex - Volume 10 Clinical trials guidelines
- Structure and Content of Clinical Study Reports (ICH E3)
- Good Clinical Practice (ICH E6)
- Inspection procedures and guidance for GCP inspections conducted in the context of the Centralised Procedure
- EMA webpage on GCP
Pharmacovigilance inspections
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Procedure for coordinating pharmacovigilance inspections requested by the CHMP | (English only) | adopted | 12/11/2007 | ||
| Procedure for conducting pharmacovigilance inspections requested by the CHMP | (English only) | adopted | 12/11/2007 | ||
| Procedure for reporting of pharmacovigilance inspections requested by the CHMP | (English only) | adopted | 12/11/2007 |
Related links
Sampling and testing
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Sampling and testing of centrally authorised products: Objectives and description of the programme | (English only) | 06/01/2005 | |||
| Sampling and testing of centrally authorised products: Development of risk based approach for the selection of products | (English only) | 10/01/2008 | |||
| Ten years of sampling and testing of centrally authorised products: 1998-2007 | (English only) | 21/07/2008 | |||
| Standard operating procedure for sampling and testing of centrally authorised products | (English only) | adopted | 01/10/2007 | 13/05/2011 | 13/05/2011 |
| Standard operating procedure for sampling and testing of centrally authorised products – Reports circulation and follow-up procedure | (English only) | adopted | 01/10/2007 | 13/05/2011 | 13/05/2011 |
Product defects
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Crisis Management regarding Defects of Centrally Authorised Products - Classification of Batch Recalls for Quality Defects | (English only) | adopted | 03/07/2008 | ||
| Defective Product Report template | (English only) | 03/07/2008 | |||
| Standard operating procedure for dealing with reports of defective medicinal products | (English only) | adopted | 01/04/2007 | 08/10/2012 | 08/10/2012 |