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PART II Quality PDF Print E-mail
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EMA and VICH Guidelines

Here you can find a list of quality guidelines for veterinary medicinal products as published by European Medicines Agency (EMA) and Veterinary International Co-operation on Harmonization (VICH). These guidelines together with requirements of the current version of European and Czech Pharmacopoeia should be taken into consideration for the preparation of the quality part of a registration dossier.

Apart from the following guidelines, EMA also publishes and continuously updates a list of questions and answers ( Part 1 and Part 2 ) concerning interpretation and implementation of the guidelines.

 

1. Development pharmaceuticals

NameNumber Effective fromSourceNote
Development pharmaceutics for veterinary medicinal products EMEA/CVMP/315/98 March 2000 EMA Guideline
Sterilisation of the medicinal product, active substance, excipient and primary container EMA/CHMP/CVMP/QWP/BWP/850374/2015 - EMA Draft Guideline
Decision trees for selection of sterilisation methods (Annex to note for guidance on development pharmaceutics for veterinary medicinal products) EMEA/CVMP/065/99 September 2000 EMA Annex to Guideline

 

2. Manufacture of medicinal product

NameNumber Effective fromSourceNote
Manufacture of the finished dosage form EMEA/CVMP/126/95 June 1996 EMA Guideline
Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) EMEA/CVMP/453/01 December 2001 EMA Annex to Guideline
Process validation for finished products – information and data to be provided in regulatory submissions EMA/CHMP/CVMP/QWP/BWP/70278/2012 August 2014 EMA Guideline
Limitations to the use of ethylene oxide in the manufacture of medicinal products EMEA/CVMP/271/01 March 2001
EMA Guideline
Use of ionizing radiation in the manufacture of medicinal products 3AQ4A July 1992 Eudralex Guideline

 

3. Active substance

NameNumber Effective fromSourceNote
Active substance master file procedure EMEA/CVMP/134/02 October 2012 EMA Guideline
Chemistry of active substances/new active substances EMA/CVMP/QWP/707366/2017 July 2018 EMA Guideline
Summary of requirements for active substances in the quality part of the dossier EMEA/CVMP/1069/02 February 2005 EMA Guideline
Template for the qualified person’s (QP) declaration concerning good manufacturing practice compliance of active substance manufacture 'The QP declaration template' EMA/196292/2014 June 2014 EMA Guideline and template
Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary EMA/CVMP/QWP/3629/2016 October 2017 EMA Reflection paper
Use of cocrystals of active substances in medicinal products CHMP/CVMP/QWP/284008/2015 July 2015 EMA Reflection paper

 

4. Impurities

NameNumber Effective fromSourceNote
Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products EMA/CVMP/QWP/631010/2017 January 2018 EMA Guideline
HAssessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products EMA/CVMP/SWP/377245/2016 - EMA Draft Guideline
Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use” EMEA/CVMP/059/04 March 2004 EMA Position paper
Setting specifications for related impurities in antibiotics CHMP/CVMP/QWP/199250 June 2013 EMA Guideline
VICH GL10 Impurities in new veterinary drug substances CVMP/VICH/837/99 Rev.1 January 2008 VICH Guideline
VICH GL11 Impurities in new veterinary medicinal products CVMP/VICH/838/99 Rev.1 January 2008 VICH Guideline
VICH GL18 Residual solvents in new veterinary medicinal products, active substances and excipients CVMP/VICH/502/99 July 2012 VICH Guideline
Annexes to VICH GL 18 EMEA/CVMP/511/03 March 2013 EMA Annex to Guideline
Application of VICH GL 18 on residual solvents to veterinary medicinal products containing existing active substances EMEA/CVMP/423/01 May 2001 EMA Guideline

 

5. Excipients

NameNumber Effective fromSourceNote
Excipients in the dossier for application for marketing authorisation for veterinary medicinal products EMEA/CVMP/004/98 June 1999 EMA Guideline
Inclusion of antioxidants and antimicrobial preservatives in medicinal products CVMP/QWP/115/95 January 1998 EMA Guideline
Quality of water for pharmaceutical use CPMP/QWP/158/01 June 2002 EMA Guideline
Water for injection prepared by reverse osmosis CHMP/CVMP/28271/08 March 2008 EMA Reflection paper

 

6. Packaging

NameNumber Effective fromSourceNote
Plastic primary packaging materials EMEA/CVMP/205/04 December 2005 EMA Guideline

 

7. Specifications, analytical procedures and analytical validation

NameNumber Effective fromSourceNote
Parametric release EMA/CVMP/QWP/339588/2005 January 2007 EMA Guideline
Specifications and control tests on the finished product 3AQ11A June 1992 Eudralex Guideline
VICH GL1 Validation of analytical procedures: definition and terminology CVMP/VICH/590/98 October 1999 VICH Guideline
VICH GL2 Validation of analytical procedures: methodology CVMP/VICH/591/98 October 1999 VICH Guideline
VICH GL39 Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances EMEA/CVMP/VICH/810/04 November 2006 VICH Guideline
VICH GL40 Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products EMEA/CVMP/VICH/811/04 November 2006 VICH Guideline
Dissolution specification for generic oral immediate release products EMA/CHMP/CVMP/QWP/336031/2017 August 2017 VICH Reflection paper

 

8. TSE

NameNumber Effective fromSourceNote
Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products EMEA/410/01 July 2011 EMA Guideline

 

9. Stability

NameNumber Effective fromSourceNote
Declaration of storage conditions: 1. in the product information of pharmaceutical veterinary medicinal products, 2. for active substances (Annex) EMEA/CVMP/422/99 October 2003 EMA Annex to Guideline
In-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products) EMEA/CVMP/424/01 September 2002 EMA Guideline
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution EMEA/CVMP/198/99 February 2001 EMA Guideline
Stability testing for applications for variations to marketing authorisation EMA/CHMP/CVMP/QWP/441071/2011 October 2014 EMA Guideline
Stability testing of existing active substances and related finished products EMEA/CVMP/846/99 September 2011 EMA Guideline
VICH GL3 Stability testing of new veterinary drug substances and medicinal products CVMP/VICH/899/99 January 2008 VICH Guideline
VICH GL4 Stability testing for new veterinary dosage forms CVMP/VICH/900/99 May 2000 VICH Guideline
VICH GL5 Stability testing: photostability testing of new veterinary drug substances and medicinal products CVMP/VICH/901/00 May 2000 VICH Guideline
VICH GL8 Stability testing for medicated premixes CVMP/VICH/836/99 December 2000 VICH Guideline
VICH GL45 Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products EMEA/CVMP/VICH/581467/2007 April 2011 VICH Guideline
VICH GL51 Quality: statistical evaluation of stability data EMA/CVMP/VICH/858875/2011 February 2014 VICH Guideline

 

10. Herbal medicinal products

NameNumber Effective fromSourceNote
Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products EMEA/HMPC/CHMP/CVMP/287539/05 October 2010 EMA Guideline
Quality of combination herbal medicinal products/traditional herbal medicinal products EMEA/HMPC/CHMP/CVMP/287539/05 November 2008 EMA Guideline
Quality of herbal medicinal products/traditional herbal medicinal products CPMP/QWP/2819/00 April 2012 EMA Guideline
Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products CPMP/QWP/2820/00 September 2011 EMA Guideline

 

11. Specific veterinary dosage forms

NameNumber Effective fromSourceNote
Additional quality requirements for products intended for incorporation into animal feeding-stuffs (medicated premixes) EMEA/CVMP/080/95 July 1997 EMA Guideline
Quality aspects of pharmaceutical veterinary medicines for administration via drinking water EMEA/CVMP/540/03 January 2005 EMA Guideline
Quality aspects of single-dose veterinary spot-on products EMEA/CVMP/QWP/544461/2007 February 2010 EMA Guideline
Quality of modified release dosage forms for veterinary use EMEA/CVMP/680/02 February 2004 EMA Guideline
Maximum in-use shelf-life for medicated drinking water EMEA/CVMP/1090/02 December 2002 EMA Position paper
Premixes for medicated feeding stuffs for veterinary use versus powders/granules for oral use or use in drinking water EMEA/CVMP/199/97 August 1998 EMA Position paper

 

12. Minor uses / minor species (MUMS)

NameNumber Effective fromSourceNote
Quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market EMA/CVMP/QWP/128710/2004 February 2007 EMA Guideline
CVMP guidelines on data requirements for veterinary medicinal products intended for minor uses or minor species EMEA/CVMP/133672/2005 July 2007 EMA CVMP note

 

Last Updated on Tuesday, 17 April 2018 10:11