Guidelines Regulations
- Regulations
-
- Eudralex Volume 1 - Pharmaceutical Legislation Medicinal Products for Human Use
- Directives
- 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolided version: 26/07/2019).
- 2001/20/EC - 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 - (Consolidated version : 07/08/2009)
- 89/105/EEC - Council Directive 89/105/EEC of 21 December 1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems - English Version
- 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast)
- 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast)
- Regulations
- EC/726/2004 Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Consolidated version : 28/01/2019).
- EC/297/95 Council Regulation (EC) No 297/95, of 10 February 1995, on fees payable to the European Agency for the Evaluation of Medicinal Products (Consolidated version : 01/04/2018) Amended by Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products. Amendments
- EC/141/2000 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (Consolidated version : : 25/07/2019)
- EC/1901/2006 Regulation (EC) No 1901/2006 for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
- EC/1394/2007 Regulation of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Note: shall apply from 30 December 2008)(Consolidated version : 25/07/2019)
- EC/469/2009 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products version 2019)
- EU/658/2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (version 2020)
- EU/536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
- Non-legislative Acts
- EC/1662/95 Commission Regulation (EC) No 1662/95, of 7 July 1995, laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorizations for products for human or veterinary use.
- EC/2141/96 Commission Regulation (EC) No 2141/96, of 7 November 1996, concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EEC) No 2309/93.
- EC/847/2000 Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and‘clinical superiority’(version 2018)
- EC/2049/2005 Commission Regulation (EC) No 2049/2005, of 15 December 2005, laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises
- EC/507/2006 Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 92, 30/3/2006 p. 6 - 9).
- EC/2003/94 Commission Directive 2003/94/EC 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
- EC/658/2007 Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 155, 15/6/2007 p. 10 - 19).
- EC/1234/2008 Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Consolidated version: 13/05/2021)
- EC/668/2009 Commission Regulation (EC) of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises
- EU/520/2012 Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
- 2012/715/EU Commission implementing decision of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (version 2019)
- EU/51/2013 Decision on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities
- EU/198/2013 Commission Implementing Regulation on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring
- EU/357/2014 Commission Delegated Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC and Regulation (EC) No 726/2004 as regards situations in which post-authorisation efficacy studies may be required.
- EU/699/2014 Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity
- 2014/1252/EU Commission delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
- 2016/161/EU Commission Delegated Regulation (EU) No 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (version 2021)
- Miscellaneous
- 75/320/EEC - Council Decision 75/320/EEC, of 20 May 1975, setting up a Pharmaceutical Committee.
- 82/C 115/05 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorizations have already been granted
- COM/2003/839 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted. [Update of the 1982 Commission Communication].
- 94/C 82/04 Commission Communication on the implementation of the new marketing authorization procedures for medicinal products for human and veterinary use in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 and Council Directives 93/39/EEC, 93/40/EEC and 93/41/EEC, adopted on 14 June 1993.
- 98/C 229/03 Commission communication on the Community marketing authorisation procedures for medicinal products
- 2004/C 24/06 Note for guidance on minimising the risk of transmitting animal spongiform encephalopathyagents via human and veterinary medicinal products (EMEA/410/01 Rev. 2 - October 2003) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Veterinary Medicinal products (CVMP)
- 2006/C 133/05 Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7)
- 2013/C 223/01 Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures
- 2013/C 343/01 Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use(2013/C 343/01)
- 2014/C 338/01 Guideline on the format and content of applications for agreement or modif ication of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
- Eudralex Volume 2 - Pharmaceutical Legislation: Notice to Applicants and regulatory guidelines medicinal products for human use
- Eudralex Volume 2A - Procedures for marketing authorisation
- Eudralex Volume 2A Procedures for Marketing Authorisation Chapter 1 - Marketing Authorisation (updated version November 2018)
- Eudralex Volume 2A Chapter 2 - Mutual Recognition (updated version - February 2007)
- Eudralex Volume 2A Chapter 3 - Union Referral Procedures (updated version November 2018)
- Eudralex Volume 2A Chapter 5 - Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures
- Eudralex Volume 2A Chapter 6 - Decision Making Procedure for the Adoption of Commission Decisions (November 2005)
- Eudralex Volume 2B - Medicinal products for human use - Presentation and content of the dossier - Common Technical Document (CTD)
- Eudralex Volume 2B - Medicinal products for human use - Presentation and content of the dossier - Common Technical Document (CTD)
- QUESTIONS and ANSWERS - Volume 2B Presentation and content of the dossier Common Technical Document (CTD) - 2003 Edition - UPDATE Feb 2008
- EU Module 1 Specification
- EU Change Control Process for Change Requests in the Entire Area of Electronic Submissions for Human Medicinal Products
- Electronic Application Forms
- Eudralex Volume 2B Module 1.2: Administrative information application form
- Eudralex Volume 2B Module 1: Administrative information Application form HOMEOPATHIC MEDICINAL PRODUCT FOR HUMAN USE
- Eudralex Volume 2B APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION
- Eudralex Volume 2B APPLICATION FORM FOR RENEWAL OF A MARKETING AUTHORISATION
- User guide for the electronic application form for a Marketing Authorisation - Module 1: Administrative information Application form
- Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation
- Q&A on the use of eCTD in MRP/DCP
- Eudralex Volume 2C - Regulatory Guidelines
- Eudralex Volume 2C Guidance on a new therapeutic indication for a well established substance (November 2007)
- Eudralex Volume 2C Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007)
- Eudralex Volume 2C Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (July 2019)
- Eudralex Volume 2C Guideline on the processing of renewals in the centralised procedure
- CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures
- Eudralex Volume 2C Guideline on Summary of Product Characteristics (September 2009)
- Eudralex Volume 2C Guideline on the packaging information of medicinal products for human use authorised by the Union
- Eudralex Volume 2C Guideline on changing the classification for the supply of a medicinal product for human use
- Eudralex Volume 2C Guideline on the readability of the label and package leaflet of medicinal product for human use, revision 1 (12 January 2009)
- Eudralex Volume 2C Guideline on Vaccine Antigen Master File/ Plasma Master File (VAMF/PMF) (August 2004)
- Eudralex Volume 2C Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certification
- Eudralex Volume 2C Guideline on requirements for Plasma Master File (PMF) certification
- Eudralex Volume 2C Guideline on the “2nd step”, when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s).
- Eudralex Volume 2C Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7)
- Eudralex Volumen 2C Guideline on Excipients in the labelling and package leaflet of medicinal products for human use (March 2018)
- Eudralex Volumen 2C Guideline on Excipients in the labelling and package leaflet of medicinal products for human use (March 2018)
- Eudralex Volume 3 - Guidelines Medicinal Products for Human use - EMA Scientific Guidelines
- Quality Guidelines
- Active Substance
- Eudralex Volume 3 Requirements for selection and justification of starting materials for the manufacture of chemical active substances (update)
- Eudralex Volume 3 Use of cocrystals and other solid state forms of active substances in medicinal products
- Eudralex Volume 3 ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
- Eudralex Volume 3 Qualified Person's declaration concerning GMP compliance of the active substance manufacture "The QP declaration template"
- Eudralex Volume 3 Guidance for the template for the qualified preson's declaration concerning GMP compliance of active substance manufacture "The QP declaration template"
- Eudralex Volume 3 Questions and answers on the template for the Qualified Person’s declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain “The QP declaration template”
- Eudralex Volume 3 Guideline on Active Substance Master File Procedure
- Eudralex Volume 3 Additional guidance on documents relating to an active substance master file
- Eudralex Volume 3 Recommendation on the Assessment of the quality of medicinal products containing existing/ known active substances
- Eudralex Volume 3 Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier (CHMP/QWP/297/97 Rev. 1)
- Eudralex Volume 3 Guideline on the Chemistry of New Active Substances (CPMP/QWP/130/96 Rev. 1)
- Eudralex Volume 3 Guideline on the Chemistry of New Active Substances (EMA/454576/2016)
- Eudralex Volume 3 Investigation of Chiral Active Substances (3CC29A)
- Eudralex Volume 3 Guideline on the Chemistry of Active Substances (3AQ5A)
- Eudralex Volume 3 Guideline on the chemistry of active substances
- Eudralex Volume 3 Guideline on Quality of biological active substances produced by transgene expression in animals
- Eudralex Volume 3 Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products
- Eudralex Volume 3 Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances
- Eudralex Volume 3 Reflection paper on the use of cocrystals of active substances in medicinal products
- Eudralex Volume 3 Quality Working Party questions and answers on API mix
- Eudralex Volume 3 ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
- Manufacture of the medicinal product
- Eudralex Volume 3 Guideline on process validation for finished products - information and data to be provided in regulatory submissions
- Eudralex Volume 3 ICH Q8 (R2) Pharmaceutical development
- Eudralex Volume 3 ICH Q9 Quality risk management
- Eudralex Volume 3 ICH Q10 Pharmaceutical quality system
- Eudralex Volume 3 ICH Q8, Q9 and Q10 - questions and answers
- Eudralex Volume 3 Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products (CPMP/QWP/159/01)
- Eudralex Volume 3 Guideline on Manufacture of the Finished Dosage Form
- Eudralex Volume 3 Annex to Note for Guidance on Manufacture of the finished dosage Form: Start of Shelf-Life of the Finished Dosage Form (CPMP/QWP/072/96)
- Eudralex Volume 3 The use of Ionizing Radiation in the Manufacture of Medicinal Products 3AQ4A
- Eudralex Volume 3 Sterilisation of the medicinal product, active substance, excipient and primary container
- Impurities
- Eudralex Volume 3 ICH guideline Q3D on elemental impurities
- Eudralex Volume 3 Implementation strategy of ICH Q3D guideline (Draft)
- Eudralex Volume 3 Implementation strategy of ICH Q3D guideline
- Eudralex Volume 3 Elemental impurities in marketed products. Recommendations for implementation
- Eudralex Volume 3 Guideline on setting specifications for related impurities in antibiotics
- Eudralex Volume 3 Guideline on the specification limits for residues of metal catalysts or metal reagents
- Eudralex Volume 3 ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- Eudralex Volume 3 Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes
- Eudralex Volume 3 Questions and answers on the 'Guideline on the limits of genotoxic impurities'
- Eudralex Volume 3 Guideline on Control of Impurities of Pharmacopoeial Substances (CPMP/QWP/1529/04)
- Eudralex Volume 3 Note for Guidance on Impurities in new Drug Products (ICH Q3B(R2))(CPMP/ICH/2738/99)
- Eudralex Volume 3 Note for Guidance on Impurities Testing: Impurities in New Drug Substances (ICH Q3A (R2)) (CPMP/ICH/2737/99)
- Eudralex Volume 3 ICH guideline Q3C (R7) on impurities: guideline for residual solvents
- Specifications, analytical procedures and analytical validation
- Eudralex Volume 3 ICH guideline Q8, Q9 and Q10 - questions and answers volume 4
- Eudralex Volume 3 Guideline on setting specifications for related impurities in antibiotics EMA/CHMP/CVMP/QWP/199250/2009
- Eudralex Volume 3 ICH Topic Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
- ICH Q4B Annex 1 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
- Eudralex Volume 3 ICH Topic Q4B Annex 2 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter
- Eudralex Volume 3 ICH Topic Q4B Annex 3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter
- Eudralex Volume 3 ICH Topic Q4B Annex 4 A Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
- Eudralex Volume 3 ICH Topic Q4B Annex 4 B Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
- Eudralex Volume 3 ICH Topic Q4B Annex 4 C Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
- Eudralex Volume 3 ICH Topic Q4B Annex 5 Disintegration Test General Chapter
- Eudralex Volume 3 ICH guideline Q4B Annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage units – general chapter
- Eudralex Volume 3 ICH Topic Q4B Annex 7 Dissolution Test General Chapter
- Eudralex Volume 3 ICH Topic Q4B Annex 8 Sterility Test General Chapter
- Eudralex Volume 3 ICH Q4B Annex 9: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter
- Eudralex Volume 3 ICH Q4B Annex 10: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter
- Eudralex Volume 3 ICH Q4B Annex 11: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter
- Eudralex Volume 3 ICH Q4B Annex 12: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter
- Eudralex Volume 3 ICH Q4B Annex 13 Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bulk density and tapped density of powders – general chapter
- Eudralex Volume 3 ICH Q4B Annex 14 Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests – general chapter
- Eudralex Volume 3 Guideline on the use of Near Infrared Spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations
- Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 2: Defining the Scope of an NIRS Procedure
- Eudralex Volume 3 Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)
- Eudralex Volume 3 Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (ICH Q6A) CPMP/ICH/ 367/96-ICH Q6A
- Eudralex Volume 3 Validation of Analytical Procedures: Text and Methodology (ICH Q2) CPMP/ICH/381/95 - ICH Q2 (R1)
- Eudralex Volume 3 Specifications and control Tests on the Finished Product 3AQ11A
- Eudralex Volume 3 Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action
- Excipients
- Eudralex Volume 3 Questions and answers on cyclodextrins in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev.1)
- Eudralex Volume 3 Questions & answers on propylene glycol and esters in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev.1)
- Eudralex Volume 3 Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product CHMP/QWP/396951/06
- Eudralex Volume 3 Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev.1)
- Eudralex Volume 3 Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00)
- Eudralex Volume 3 Questions and Answers on Benzakonium chloride in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00)
- Eudralex Volume 3 Questions and Answers on Benzoic Acid and Benzoates in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00)
- Eudralex Volume 3 Questions and Answers on Benzyl alcohol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00)
- Eudralex Volume 3 VOLUME 3B Guidelines - Medicinal products for human use. Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use
- Eudralex Volume 3 Guideline on the quality of water for pharmaceutical use
- Eudralex Volume 3 Reflection Paper on Water for Injection prepared by Reverse Osmosis CHMP/CVMP/28271/08
- Eudralex Volume 3 Note for Guidance: Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products CPMP/CVMP/QWP /115/95
- Packaging
- Stability
- Eudralex Volume 3 Stability Testing for Applications for Variations to a Marketing Authorisation
- Eudralex Volume 3 Stability Testing of new Drug Substances and Products
- Eudralex Volume 3 Stability Testing of Existing Active Substances and Related Finished Products CPMP/QWP/ 122/02 Rev. 1 corr
- Eudralex Volume 3 Annex: Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances CPMP/QWP/ 609/96 Rev. 2
- Eudralex Volume 3 Evaluation of Stability Data (ICH Q1E) CPMP/ICH/ 420/02-ICH Q1E
- Eudralex Volume 3 Stability Data Package for Registration in Climatic Zones III and IV (ICH Q1F) CPMP/ICH/ 421/02-ICH Q1F
- Eudralex Volume 3 Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products (ICH Q1D) CPMP/ICH/ 4104/00-ICH Q1D
- Eudralex Volume 3 In-Use Stability Testing of Human Medicinal Products CPMP/QWP/2934/99
- Eudralex Volume 3 Maximum Shelf-Life for Sterile Products for Human Use after first opening or following Reconstitution CPMP/QWP/ 159/96 Corr.
- Eudralex Volume 3 Photostability Testing of New Active Substances and Medicinal Products (ICH Q1B) CPMP/ICH/279/95-ICH Q1B
- Eudralex Volume 3 Stability Testing: Requirements for New Dosage Forms (ICH Q1C) CPMP/ICH/ 280/95-ICH Q1C
- Pharmaceutical development
- Eudralex Volume 3 CONCEPT PAPER ON THE DEVELOPMENT OF A QUALITY GUIDELINE ON PHARMACEUTICAL DEVELOPMENT OF MEDICINES FOR PAEDIATRIC USE
- Eudralex Volume 3 ICH Topic Q 8 (R2)Pharmaceutical Development NOTE FOR GUIDANCE ON PHARMACEUTICAL DEVELOPMENT
- Eudralex Volume 3 Guideline on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/140/98 Rev. 1
- Eudralex Volume 3 NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE CPMP/EWP/QWP/1401/98
- Eudralex Volume 3 Annex to Development Pharmaceutics: Decision trees for selection of sterilisation methods CPMP/QWP/ 054/98
- Eudralex Volume 3 Note for Guidance on Development Pharmaceutics CPMP/QWP/155/96
- Specific types of products
- Eudralex Volume 3 Medicinal Gases: Pharmaceutical Documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) (CPMP/QWP/1719/00)
- Eudralex Volume 3 Specification Limits for Residues of Metal Catalysts (EMEA/CHMP/SWP/4446/2000)
- Eudralex Volume 3 Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials
- Eudralex Volume 3 Radiopharmaceuticals Based on Monoclonal Antibodies (3AQ21A)
- Eudralex Volume 3 Pharmaceutical Quality of Inhalation and Nasal Products
- Eudralex Volume 3 Radiopharmaceuticals (3AQ20A)
- Eudralex Volume 3 Development of CHMP Guideline on Dosing Delivery of Injectable Liquids (CHMP/QWP/1888/04)
- Eudralex Volume 3 Guideline on quality of oral modified release products
- Eudralex Volume 3 Draft: Guideline on Quality of Transdermal Patches
- Eudralex Volume 3 Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)
- Radiopharmaceuticals
- Eudralex Volume 3 Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
- Eudralex Volume 3 Suitability of the graduation of delivery devices for liquid dosage forms
- Eudralex Volume 3 Quality and equivalence of topical products
- Herbal Medicinal Products
- Eudralex Volume 3 Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products
- Eudralex Volume 3 Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products
- Eudralex Volume 3 Reflection Paper on Quality of Essential Oils as Active Substances in Herbal Medicinal Products/Traditional Herbal Medicinal Products
- Eudralex Volume 3 Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products
- Eudralex Volume 3 Concept Paper - Use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products
- Eudralex Volume 3 Questions & answers (Q&A) on quality of herbal medicinal products / traditional herbal medicinal products
- Eudralex Volume 3 Level of purification of extracts to be considered as herbal preparations EMEA/HMPC/186645/2008
- Eudralex Volume 3 Concept Paper on Non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products / traditional herbal medicinal products
- Eudralex Volume 3 Development of a guideline on preparation on herbal teas EMEA/HMCP/451978/08
- Eudralex Volume 3 Markers used for quantitative and qualitative analysis of Herbal Medicinal Products and traditional Herbal Medicinal Products EMEA/HMPC/253629/07
- Eudralex Volume 3 Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products EMEA/HMPC/CHMP/CVMP/287539/05 Rev. 1
- Eudralex Volume 3 Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products EMEA/HMPC/CHMP/CVMP/214869/06
- Eudralex Volume 3 The use of Fumigants EMEA/HMPC/125562/06
- Eudralex Volume 3 Good Agricultural and Collection Practice for starting materials of Herbal Origin EMEA/HMPC/246816/05
- Eudralex Volume 3 Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products CPMP/QWP/2819/00 Rev. 2
- Concept Paper on the Revision of the Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products
- Quality Implementation Working Group on Q8, Q9 and Q10 - Questions & Answers (R4)
- Biotechnology Guidelines
- Drug Substance
- Manufacture, Characterisation and Control of the Drug Substance
- Eudralex Volume 3 GUIDELINE ON ALLERGEN PRODUCTS: PRODUCTION AND QUALITY ISSUES
- Eudralex Volume 3 Human cell-based medicinal products
- Eudralex Volume 3 GUIDELINE ON PRODUCTION AND QUALITY OF MONOCLONAL ANTIBODIES AND RELATED SUBSTANCES
- Eudralex Volume 3 GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY MEDICINAL PRODUCTS FOR THE TREATMENT OF CANCER
- Eudralex Volume 3 GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS
- Eudralex Volume 3 GUIDELINE ON DEVELOPMENT AND MANUFACTURE OF LENTIVIRAL VECTORS
- Eudralex Volume 3 NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE
- Eudralex Volume 3 NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS
- Eudralex Volume 3 Concept Paper for the revision of Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products
- Eudralex Volume 3 NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
- Eudralex Volume 3 CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES
- Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY
- Eudralex Volume 3 Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells
- Eudralex Volume 3 NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)
- Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF CYTOKINE PRODUCTS DERIVED BY BIOTECHNOLOGICAL PROCESSES
- Eudralex Volume 3 USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE
- Eudralex Volume 3 CONCEPT PAPER ON THE NEED TO REVISE THE GUIDELINE ON THE USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE (3AB7A OF JULY 1995)
- Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF CYTOKINE PRODUCTS DERIVED BY BIOTECHNOLOGICAL PROCESSES
- Eudralex Volume 3 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (draft)
- Eudralex Volume 3 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
- Eudralex Volume 3 Concept paper on the revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
- Eudralex Volume 3 Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
- Specifications
- Comparability / Biosimilarity
- Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
- Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
- Eudralex Volume 3 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS
- Eudralex Volume 3 EMA Procedural advice for users of the centralised procedure for similar biological medicinal products applications
- Plasma-Derived Medicinal Products
- Eudralex Volume 3 The replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products
- Eudralex Volume 3 Guideline on plasma-derived medicinal products
- https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-plasma-derived-medicinal-products_en.pdf
- Eudralex Volume 3 Concept Paper: Revision of the Note for guidance on Plasma-Derived Medicinal Products
- Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
- Eudralex Volume 3 ANNEXES TO GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
- Eudralex Volume 3 GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (ANTI-HIV) IN PLASMA POOLS
- Eudralex Volume 3 GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) IN PLASMA POOLS
- Eudralex Volume 3 GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD TRANSMISSIBLE INFECTIONS
- Eudralex Volume 3 GUIDELINE ON THE REQUIREMENTS FOR PLASMA MASTER FILE (PMF) CERTIFICATION
- Eudralex Volume 3 GUIDELINE ON ASSESSING THE RISK FOR VIRUS TRANSMISSION – NEW CHAPTER 6 OF THE NOTE FOR GUIDANCE ON PLASMADERIVED MEDICINAL PRODUCTS
- Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
- Eudralex Volume 3 CHMP POSITION STATEMENT ON CREUTZFELDT-JACOB DISEASE and PLASMA-DERIVED AND URINE-DERIVED MEDICINAL PRODUCTS
- Eudralex Volume 3 Draft : Revision of CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products
- Eudralex Volume 3 CPMP POSITION STATEMENT ON WEST NILE VIRUS AND PLASMA-DERIVED MEDICINAL PRODUCTS
- Eudralex Volume 3 CPMP POSITION STATEMENT NON-REMUNERATED AND REMUNERATED DONORS: SAFETY AND SUPPLY OF PLASMA-DERIVED MEDICINAL PRODUCTS
- Eudralex Volume 3 PLASMA-DERIVED MEDICINAL PRODUCTS: POSITION PAPER ON ALT TESTING
- Eudralex Volume 3 Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products
- Eudralex Volume 3 Guideline on clinical investigation of recombinant and human plasma-derived factor IX products (replacing CPMP/BPWG/198/95 and CPMP/BPWG/1561/99)
- Eudralex Volume 3 Good Practice Guidelines for Blood Establishments and Hospital Blood Banks Required to Comply with EU Directive 2005/62/EC
- Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus
- Vaccines
- Eudralex Volume 3 GUIDELINE ON INFLUENZA VACCINES PREPARED FROM VIRUSES WITH THE POTENTIAL TO CAUSE A PANDEMIC AND INTENDED FOR USE OUTSIDE OF THE CORE DOSSIER CONTEXT.
- Eudralex Volume 3 GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE
- Eudralex Volume 3 EXPLANATORY NOTE ON IMMUNOMODULATORS FOR THE GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE
- Eudralex Volume 3 GUIDELINE ON DOSSIER STRUCTURE AND CONTENT FOR PANDEMIC INFLUENZA VACCINE MARKETING AUTHORISATION APPLICATION
- Eudralex Volume 3 GUIDELINE ON SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS FOR PANDEMIC INFLUENZA VACCINES THROUGH THE CENTRALISED PROCEDURE
- Eudralex Volume 3 GUIDELINE ON REQUIREMENTS FOR VACCINE ANTIGEN MASTER FILE (VAMF) CERTIFICATION
- Eudralex Volume 3 CPMP POSITION STATEMENT ON THE QUALITY OF WATER USED IN THE PRODUCTION OF VACCINES FOR PARENTERAL USE
- Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A VACCINE ANTIGEN MASTER FILE (VAMF)
- Eudralex Volume 3 CELL CULTURE INACTIVATED INFLUENZA VACCINES ANNEX TO NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES (CPMP/BWP/214/96)
- Eudralex Volume 3 Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture
- Eudralex Volume 3 POINTS TO CONSIDER ON THE DEVELOPMENT OF LIVE ATTENUATED INFLUENZA VACCINES
- Eudralex Volume 3 NOTE FOR GUIDANCE ON THE DEVELOPMENT OF VACCINA VIRUS BASED VACCINES AGAINST SMALLPOX
- Eudralex Volume 3 POINTS TO CONSIDER ON THE REDUCTION, ELIMINATION OR SUBSTITUTION OF THIOMERSAL IN VACCINES
- Eudralex Volume 3 Public Statement on the Evaluation of Bovine Spongiform Encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines
- Eudralex Volume 3 NOTE FOR GUIDANCE ON PHARMACEUTICAL AND BIOLOGICAL ASPECTS OF COMBINED VACCINES
- Eudralex Volume 3 NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES
- Eudralex Volume 3 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-live-recombinant-viral-vectored-vaccines_en.pdf
- Stability
- Drug product
- Pharmaceutical Development
- Product Information
- Eudralex Volume 3 GUIDELINE ON POTENCY LABELLING FOR INSULIN ANALOGUE CONTAINING PRODUCTS WITH PARTICULAR REFERENCE TO THE USE OF “INTERNATIONAL UNITS” OR “UNITS”
- Eudralex Volume 3 CORE SPC FOR PANDEMIC INFLUENZA VACCINES
- Eudralex Volume 3 NOTE FOR GUIDANCE ON THE WARNING ON TRANSMISSIBLE AGENTS IN SUMMARY OF PRODUCT CHARACTERISTICS (SPCs) AND PACKAGE LEAFLETS FOR PLASMA-DERIVED MEDICINAL PRODUCTS
- Eudralex Volume 3 GUIDANCE ON THE DESCRIPTION OF COMPOSITION OF PEGYLATED (CONJGATED) PROTEINS IN THE SPC
- Adventitious Agents Safety Evaluation Viral Safety
- Eudralex Volume 3 GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS
- Eudralex Volume 3 NOTE FOR GUIDANCE ON THE USE OF BOVINE SERUM IN THE MANUFACTURE OF HUMAN BIOLOGICAL MEDICINAL PRODUCTS
- Eudralex Volume 3 POSITION PAPER ON VIRAL SAFETY OF ORAL POLIOVIRUS VACCINE (OPV)
- Eudralex Volume 3 NOTE FOR GUIDANCE ON Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- Eudralex Volume 3 NOTE FOR GUIDANCE ON VIRUS VALIDATION STUDIES: THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES
- Transmissible Spongiform Encephalopathies (TSE) ( Animal and Human )
- Eudralex Volume 3 FIRST CASES OF BSE IN USA AND CANADA: RISK ASSESSMENT OF RUMINANT MATERIALS ORIGINATING FROM USA AND CANADA
- Eudralex Volume 3 NOTE FOR GUIDANCE ON GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS AMENDMENTS TO SECTIONS 6.2 AND 6.3
- Eudralex Volume 3 NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS (EMEA/410/01 REV. 3) (2011/C 73/01)
- Eudralex Volume 3 POSITION PAPER ON RE-ESTABLISHMENT OF WORKING SEEDS AND WORKING CELL BANKS USING TSE COMPLIANT MATERIALS
- Eudralex Volume 3 PUBLIC REPORT RISK AND REGULATORY ASSESSMENT OF LACTOSE AND OTHER PRODUCTS PREPARED USING CALF RENNET
- Eudralex Volume 3 JOINT CPMP/CVMP NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS - EXPLANATORY NOTE FOR MEDICINAL PRODUCTS FOR HUMAN USE IN THE SCOPE OF THE GUIDELINE
- Eudralex Volume 3 QUESTIONS AND ANSWERS ON BOVINE SPONGIFORM ENCEPHALOPATHIES (BSE) AND VACCINES
- Eudralex Volume 3 PUBLIC STATEMENT ON THE EVLAUATION OF SPONGIFORM ENCEPHALOPATHIES (BSE)-RISK VIA THE USE OF MATERIALS OF BOVINE ORIGIN IN OR DURING THE MANUFACTURE OF VACCINES
- Eudralex Volume 3 GELATIN FOR USE IN PHARMACEUTICALS: EXPLANATORY NOTE (13 DECEMBER 2000) ON THE MANUFACTURE OF GELATIN IN RELATIONSHIP TO THE CPMP NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPAHTY AGENTS VIA MEDICINAL PRODUCTS (CPMP/BWP/1230/98 REV 1)
- Eudralex Volume 3 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION STATEMENT ON POLYSORBATE 80
- Eudralex Volume 3 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON PRODUCTION OF TALLOW DERIVATIVES FOR USE IN PHARMACEUTICALS
- CJD related
- Investigational Medicinal Products
- GMO
- Eudralex Volume 3 Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products
- Scientific Guidelines
- Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- Draft: Question and answers on implementation of risk based prevention of cross contamination in production and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- Question and answers on implementation of risk based prevention of cross contamination in production and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- Eudralex Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing Practices
- Introduction to GMP Guide
- EC/2003/94 Commission Directive 2003/94/EC 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
- Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
- Commission Delegated Regulation (EU) 2017/1569 specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections
- Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use
- Part I - Basic GMP Requirements for Medicinal Products
- EU GMP Guide Part 1 GMP for Medicinal Products
- EU GMP Chapter 1: Pharmaceutical Quality System
- EU GMP Chapter 2: Personnel
- EU GMP Chapter 3: Premises and Equipment
- EU GMP Chapter 4: Documentation (Revision January 2011)
- EU GMP Chapter 5: Production
- EU GMP Chapter 6: Quality Control
- EU GMP Chapter 7: Outsourced Activities
- EU GMP Chapter 8: Complaints, Quality Defects and Product Recall
- EU GMP Chapter 9: Self Inspection
- Part II - Basic GMP Requirements for Active Substances used as Starting Materials
- Part III - GMP related documents
- Site Master File
- Q9 Quality Risk Management
- Q10 Pharmaceutical Quality System
- MRA Batch Certificate
- Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use
- Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
- Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
- Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders (EMA/419517/2021)
- Part IV GMP Requirements for Advanced Therapy Medicinal Products
- GMP Annexes
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products - revision November 2008
- EU GMP Annex 2: Manufacture of Biological Medicinal Products for Human Use
- EU GMP Annex 3: Manufacture of Radiopharmaceuticals
- EU GMP Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
- EU GMP Annex 5: Manufacture of Immunological Veterinary Medicinal Products
- EU GMP Annex 6: Manufacture of Medicinal Gases
- EU GMP Annex 7: Manufacture of Herbal Medicinal Products
- EU GMP Annex 8: Sampling of Starting and Packaging Materials
- EU GMP Annex 9: Manufacture of Liquids, Creams and Ointments
- EU GMP Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
- EU GMP Annex 11: Computerised Systems
- EU GMP Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products
- EU GMP Annex 13: Investigational Medicinal Products
- Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
- EU GMP Annex 14: Manufacture of Products derived from Human Blood or Human Plasma (May 2011) - Deadline for coming into operation: 30 November 2011
- EU GMP Annex 15: Qualification and Validation
- EU GMP Annex 16: Certification by a Qualified Person and Batch Release
- EU GMP Annex 17: Real Time Release Testing and Parametric Release
- EU GMP Annex 19: Reference and Retention Samples
- Glossary
- Other Documents related to GMP
- Compilation of Community Procedures on Inspections and Exchange of Information
- Guidelines on Good Distribution Practice of medicinal products for human use
- Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
- Eudralex Volume 9 - Pharmacovigilance
- Eudralex Volume 9 2001/82/EC on the Community code relating to veterinary medicinal products
- Eudralex Volume 9 726/2004 authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
- Eudralex Volume 9 Volume 9a - Guidelines on Pharmacovigilance for Medicinal Products for Human Use
- Eudralex Volume 9 Volume 9b - Pharmacovigilance for Medicinal Products for Veterinary Use
- Good Pharmacovigilance Practice Guidelines
- Guidelines on good pharmacovigilance practices (GVP): Introductory cover note
- Final GVP Modules
- Eudralex Volume 9 GVP Module I – Pharmacovigilance systems and their quality systems
- Eudralex Volume 9 GVP Module II – Pharmacovigilance system master file (Rev 2)
- Eudralex Volume 9 GVP Module III - Pharmacovigilance inspections (Rev 1)
- Eudralex Volume 9 GVP Module IV - Pharmacovigilance audits
- Eudralex Volume 9 GVP Module V – Risk management systems (Rev 2)
- Eudralex Volume 9 GVP Module VI – Management and reporting of adverse reactions to medicinal products
- Eudralex Volume 9 GVP Module VII – Periodic safety update report (Rev 1)
- GVP Module VIII – Post-authorisation safety studies
- Eudralex Volume 9 GVP Module IX – Signal management
- Eudralex Volume 9 GVP Module X - Additional monitoring
- Eudralex Volume 9 GVP Module XV – Safety Communication (Rev 1)
- Eudralex Volume 9 Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (EMA/204715/2012 Rev 2)
- Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum I – Educational materials
- Final GVP product- or population-specific considerations
- Eudralex Volume 9 Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases (EMA/488220/2012)
- Eudralex Volume 9 Product- or Population-Specific Considerations II: Biological medicinal products
- Eudralex Volume 9 Product- or Population-Specific Considerations IV: Paediatric population
- Final GVP annex I - Definitions
- Final GVP annex II - Templates
- Eudralex Volume 9 Annex II – Templates: Direct Healthcare Professional Communication (DHPC)(EMA/36988/2013)Rev 1
- Eudralex Volume 9 Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)
- Eudralex Volume 9 Annex II – Templates: Cover page of Periodic Safety Update Report (PSUR)(Rev 1)(EMA/170043/2013)
- Final GVP annex III - Other pharmacovigilance guidance
- Eudralex Volume 9 Consideration on core requirements for RMPs of COVID-19 vaccines
- Eudralex Volume 9 Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data (EMEA/CHMP/313666/2005)
- Eudralex Volume 9 Guideline on conduct of pharmacovigilance for medicines used by the paediatric population (EMEA/CHMP/PhVWP/235910/2005- rev.1)
- Eudralex Volume 9 Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (EMA/H/20665/04/Final Rev. 2)
- Eudralex Volume 9 Overview of comments received on draft note for guidance: EudraVigilance version 7.1 - Processing of safety messages and individual case safety reports (ICSRs) (EMEA/183240/2008)
- Eudralex Volume 9 Draft Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (EMA/553390/2007)
- Eudralex Volume 9 EudraVigilance access policy for medicines for human use (EMA/759287/2009 corr.)
- Final GVP annex IV - ICH guidelines for pharmacovigilance
- Eudralex Volume 9 ICH Topic E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
- Eudralex Volume 9 ICH Guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide
- Eudralex Volume 9 ICH Topic E2B (R5): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports - Question and Answers ((EMEA/CHMP/ICH/3943/03))
- Eudralex Volume 9 ICH Guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER)
- Eudralex Volume 9 ICH Topic E2D: Post Approval Safety Data Management: Definitions and standards for expedited reporting (CPMP/ICH/3945/03)
- Eudralex Volume 9 ICH Topic E2E: Pharmacovigilance Planning (Pvp) (CPMP/ICH/5716/03)
- Eudralex Volume 9 ICH Guideline E2F on development safety update report (EMA/CHMP/ICH/309348/2008)
- Final GVP annex V - Abbreviations
- Templates for submission of comments
- Eudralex Volume 10 - Clinical Trials
- Chapter 1: Application and Application Form
- Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)
- Eudralex Volume 10 Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)
- Eudralex Volume 10 Substantial Amendment Notification Form
- Eudralex Volume 10 Declaration of the end of trial form
- Eudralex Volume 10 Annex 1 revised: Clinical Trial Application Form
- Eudralex Volume 10 Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use
- Eudralex Volume 10 Detailed guidance on the European clinical trials database (EUDRACT Database)
- Chapter 2: Safety Reporting
- Chapter 3: Quality of the Investigational Medicinal Product
- Eudralex Volume 10 ANNEX 13 - Good Manufacturing Practice for the manufacture of investigational medicinal products
- Eudralex Volume 10 Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
- Eudralex Volume 10 Template for IMP batch release
- Eudralex Volume 10 Community basic format for manufacturing authorisation / Community basic format for manufacturers / importers
- Eudralex Volume 10 Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
- Eudralex Volume 10 Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
- Eudralex Volume 10 Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs)
- Eudralex Volume 10 Template for the qualified person's declaration equivalence to EU GMP for Investigational Medicinal Products manufactured in third countries
- Chapter 4: Inspections
- Eudralex Volume 10 Guidance for the preparation of GCP inspections
- Eudralex Volume 10 Recommendation on inspection procedures for the verification of good clinical practice compliance
- Guidance for the conduct of GCP inspections
- Eudralex Volume 10 Guidance for the conduct of GCP inspections
- Eudralex Volume 10 Annex I TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Investigator site
- Eudralex Volume 10 Annex II TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Clinical Laboratories
- Eudralex Volume 10 Annex III TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Computer Systems
- Eudralex Volume 10 Annex IV TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Sponsor and CRO
- Eudralex Volume 10 Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units
- Eudralex Volume 10 Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents
- Eudralex Volume 10 Annex VII TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials
- Eudralex Volume 10 Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures
- Eudralex Volume 10 Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC
- Eudralex Volume 10 Guidance for the communication on GCP inspections and findings
- Eudralex Volume 10 Guidance for the preparation of Good Clinical Practice inspection reports
- Eudralex Volume 10 Procedure for standardisation of GCP inspection entries in EudraCT
- Eudralex Volume 10 Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice
- Chapter 5: Additional Information
- Eudralex Volume 10 Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
- Eudralex Volume 10 Risk proportionate approaches in clinical trials
- Eudralex Volume 10 Summaries of Clinical Trial Results for Laypersons
- Eudralex Volume 10 Guideline for good clinical practice - ICH E6(R2)- EMA/CHMP/ICH/135/1995
- Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products
- Eudralex Volume 10 Detailed guidelines on good clinical practice specific to advanced therapy medicinal products
- Eudralex Volume 10 Recommendation on the content of the trial master file and archiving
- Eudralex Volume 10 Questions & Answers Document - Version 11
- Eudralex Volume 10 Ethical considerations for clinical trials on medicinal products conducted with the paediatric population
- Eudralex Volume 10 Guideline 2008/C168/02 on the data fields from the European clinical trials database (EudraCT) that may be included in the European database on Medicinal Products
- Eudralex Volume 10 List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02
- Eudralex Volume 10 Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006 (February 2009)
- Eudralex Volume 10 List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01
- Eudralex Volume 10 2012/302/03 Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
- Eudralex Volume 10 Technical Guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
- Eudralex Volume 10 EudraCT - List of additional fields contained in EudraCT (reasons for negative opinions of the Ethics Committee)
- Chapter 6: Legislation
- Eudralex Volume 10 DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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
- Eudralex Volume 10 COMMISSION DIRECTIVE 2005/28/EC 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
- EC/2003/94 Commission Directive 2003/94/EC 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
- TECHNICAL NOTICE TO SPONSORS REGARDING CONTINUOUS COMPLIANCE WITH THE EU LEGISLATION FOR CLINICAL TRIALS1 FOLLOWING THE WITHDRAWAL OF THE UNITED KINGDOM FROM THE EU
- GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC
- Medical Device (EU)
- Medical Device Regulation
- IVD Regulation
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
- DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices
- DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
- DIRECTIVE 2001/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices
- COMMISSION DIRECTIVE 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin
- DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
- MEDDEV-Dokumente
- COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices
- COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices
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