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Background Quality Safety & Residues Efficacy Immunologicals

Scientific Guidelines for Veterinary Medicinal Products

Quality Guidelines
= Concept Paper = Draft Guideline = Adopted Guideline = Overview of Comments
Reference Publication Effective Other
Title
Number Date Date Remarks

Non-Immunologicals
Development Pharmaceutics
u
Development pharmaceutics for veterinary medicinal EMEA/CVMP/315/98 Aug 1999 Mar 2000 Note for
products Guidance
 u
Annex: Development pharmaceutics for veterinary EMEA/CVMP/065/99 Feb 2000 Sep 2000
medicinal products (EMEA/CVMP/315/98): Decision
trees for the selection of sterilisation methods
Manufacture of the medicinal product
u
Manufacture of the finished dosage form EMEA/CVMP/126/95 Dec 1995 Jun 1996 Note for
Guidance

u
Annex: Manufacture of the finished dosage form: Start EMEA/CVMP/453/01 May 2001 Dec 2001
of shelf-life of the finished dosage form

u
Process validation EMEA/CVMP/598/99 Mar 2001 Sep 2001 Note for
Guidance

u
Annex II: Process Validation (EMEA/CVMP/598/99) - EMEA/CVMP/395/03 Aug 2004 Jan 2005
Non-Standard Processes

u
Limitations to the use of ethylene oxide in the EMEA/CVMP/271/01 Mar 2001 Apr 2001 Note for
manufacture of medicinal products Guidance

u
The use of ionising radiation in the manufacture of 3AQ4a Volume IIIA Dec 1991 Jul 1992
medicinal products
Active substance
u 
Revision: Active Substance Master File Procedure EMEA/CVMP/134/02-Rev.2 Release for End of
consultation consultation
Apr 2006 Aug 2006

u
Active Substance Master File Procedure EMEA/CVMP/134/02-Rev.1 Feb 2004 Aug 2004

u
Summary of requirements for active substances in the EMEA/CVMP/1069/02 Jun 2004 Feb 2005
quality part of the dossier (CHMP/QWP/297/97-Rev)
 u
Chemistry of New Active Substances EMEA/CVMP/541/03 May 2004 Dec 2004
Impurities
u u
VICH GL10: Impurities in new veterinary drug CVMP/VICH/837/99-Rev.1 Feb 2007 Jan 2008
substances

u u
VICH GL11: Impurities in new veterinary medicinal CVMP/VICH/838/99-Rev.1 Feb 2007 Jan 2008
products

u
VICH GL18: Impurities: Residual solvents CVMP/VICH/502/99 Jun 2000 Jun 2001

u
EMEA/CVMP/511/03 Feb 2005 Jan 2005
Annex: VICH GL 18 on Impurities: Residual Solvents

u
Application of VICH GL 18 on residual solvents to EMEA/CVMP/423/01 May 2001 May 2001
veterinary medicinal products containing existing
active substances

u
Control of Impurities of Pharmacopoeial Substances: EMEA/CVMP/059/04 Mar 2004 Mar 2004 CVMP
Compliance with the European Pharmacopoeia General Position
Monograph “Substances for Pharmaceutical Use” and Paper
General Chapter “Control of Impurities in Substances
for Pharmaceutical Use”
Excipients

Reflection Paper on Water for Injection prepared by u CHMP/CVMP/28271/08 Mar 2008

Reverse Osmosis

u
Quality of water for pharmaceutical use EMEA/CVMP/115/01-Rev.1 May 2002 Jun 2002 Note for
Guidance

u
Excipients in the dossier for application for marketing EMEA/CVMP/004/98 Feb 1999 Jun 1999 Note for
authorisation for veterinary medicinal products Guidance

u
Inclusion of antioxidants and antimicrobial CPMP/CVMP/QWP/115/95 Jul 1997 Jan 1998 Note for
preservatives in medicinal products Guidance
Packaging
u u
Plastic primary packaging materials EMEA/CVMP/205/04 May 2005 Dec 2005
Specifications, analytical procedures and analytical validation
u
CHMP/CVMP/QWP/136351/08 Release for Deadline for
Setting Specifications for Related Impurities in consultation comments
Antibiotics Jun 2008 Oct 2008

u
Revision: Use of near infrared spectroscopy by the EMEA/CHMP/CVMP/QWP/173698/2006 Release for End of
pharmaceutical industry and the data requirements for consultation consultation
new submissions and variations Jun 2006 Sep 2006

u
Use of near infrared spectroscopy by the EMEA/CVMP/961/01 Feb 2003 Aug 2003 Note for
pharmaceutical industry and the data requirements for Guidance
new submissions and variations

u u u
Parametric release EMEA/CVMP/QWP/339588/2005 Mar 2006 Jan 2007

u
VICH GL40: Test procedures and acceptance criteria EMEA/CVMP/VICH/811/04-Corr Nov 2005 Nov 2006
for new biotechnological/ biological veterinary
medicinal products

u
VICH GL39: Test procedures and acceptance criteria EMEA/CVMP/VICH/810/04-Corr Nov 2005 Nov 2006
for new veterinary drug substances and new medicinal
products: chemical substances

u
VICH GL2: Validation of analytical procedures: CVMP/VICH/591/98 Dec 1998 Oct 1999
Methodology

u
VICH GL1: Validation of analytical procedures: CVMP/VICH/590/98 Dec 1998 Oct 1999
Definition and terminology

u
Specifications and control tests on the finished product 3AQ11a Volume IIIA Dec 1991 Jun 1992
TSEs
u
Minimising the risk of transmitting animal spongiform EMEA/410/01-Rev.2 Oct 2003 Jul 2004 Note for
encephalopathy agents via human and veterinary Guidance
medicinal products
Stability
u
VICH GL45: Bracketing and matrixing designs for Feb 2008 Deadline for
stability testing of new veterinary drug substances and EMEA/CVMP/VICH/581467/2007 comments 11
medicinal products Aug 2008

u u
VICH GL3: Stability testing of new veterinary drug CVMP/VICH/899/99-Rev.1 Feb 2007 Jan 2008
substances and medicinal products

EMEA/CVMP/422/99-Rev.3 Dec 2007 Dec 2007

Annex to stability guidelines VICH GL3 and
EMEA/CVMP/846/99
* Declaration of storage conditions: u

1. in the product information of pharmaceutical

veterinary medicinal products
2. for active substances

u u u u
Revision: Stability testing of existing active substances EMEA/CVMP/846/99-Rev.1 Aug 2008 Sep 2011
and related finished products
 u
EMEA/CVMP/846/99 Nov 2000 Jul 2002 Note for
Stability testing of existing active substances and Guidance
related finished products
Annex to this guideline - see * above.

u
VICH GL4: Stability testing for new veterinary dosage CVMP/VICH/900/99 Jun 1999 May 2000
forms

u
VICH GL5: Stability testing: photostability testing of CVMP/VICH/901/00 Jun 1999 May 2000
new veterinary drug substances and medicinal
products

u
VICH GL8: Stability testing for medicated premixes CVMP/VICH/836/99 Dec 1999 Dec 2000

u
Stability Testing for Applications for Variations to a EMEA/CVMP/373/04 May 2005 Dec 2005
u
Marketing Authorisation

In-use stability testing of veterinary medicinal EMEA/CVMP/424/01 Feb 2002 Sep 2002 Note for
products (excluding immunological veterinary u Guidance
medicinal products)

Maximum shelf-life for sterile medicinal products after EMEA/CVMP/198/99 Jul 2000 Feb 2001 Note for
u
first opening or following reconstitution Guidance
Herbal Medicinal Products
u u u
Declaration of Herbal Substances and Herbal EMEA/HMPC/CHMP/CVMP/287539/05 Release for Deadline for
Preparations in Herbal Medicinal Products/Traditional Rev. 1 consultation comments 30
Herbal Medicinal Products in the SPC Oct 2008 Apr 2009

u u u u
Quality of Combination Herbal Medicinal Products / EMEA/HMPC/CHMP/CVMP/214869/06 Jun 2008 Nov 2008
Traditional Herbal Medicinal Products
Quality of herbal medicinal products/Traditional herbal EMEA/CVMP/814/00-Rev 1 Mar 2006 Oct 2006
u
medicinal products

u
Specifications: Test procedures and acceptance EMEA/CVMP/815/00-Rev 1 Mar 2006 Oct 2006
criteria for herbal drugs, herbal drug preparations and
herbal medicinal products
Specific veterinary dosage forms
u u
Quality aspects of single-dose veterinary spot-on EMEA/CVMP/QWP/544467/2007 Release for End of
products consultation consultation
Dec 2007 Jun 2008

u u
Quality Aspects of Pharmaceutical Veterinary EMEA/CVMP/540/03–Rev.1 Jul 2004 Jan 2005
Medicines for Administration via Drinking Water

u
Quality of Modified Release Dosage Forms for EMEA/CVMP/680/02 Jul 2003 Feb 2004 Note for
Veterinary Use Guidance

u
Maximum In-Use Shelf-Life for Medicated Drinking EMEA/CVMP/1090/02 Dec 2002 Dec 2002 CVMP
Water Position
Paper

u
Premixes for medicated feedingstuffs for veterinary EMEA/CVMP/199/97 Aug 1998 Aug 1998 CVMP
use versus powders/granules for oral use or use in Position
drinking water Paper

u
Additional quality requirements for products intended EMEA/CVMP/080/95 Dec 1996 Jul 1997 Note for
for incorporation into animal feeding-stuffs (medicated Guidance
pre-mixes)

Availability (minor uses / minor species)

 u u
Quality data requirements for veterinary medicinal EMEA/CVMP/QWP/128710/2004 Jul 2006 Feb 2007
products intended for minor uses or minor species

u
CVMP Guidelines on Data Requirements for Veterinary EMEA/CVMP/133672/2005-Rev.1 Explanatory
Medicinal Products intended for Minor Uses or Minor note
Species

Multidisciplinary Guidelines
Dossier requirements for anticancer medicinal
products for dogs and cats
See Efficacy - Specific Guidelines

u
Investigation of chiral active substances EMEA/CVMP/128/95 Jun 1997 Jan 1998 Note for
Guidance

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