VET:-Veterinary Guide lines.

Non-Immunologicals:-

Development Pharmaceutics

Development pharmaceutics for veterinary medicinal products ( EMEA/CVMP/315/98 ) Aug 1999 Mar 2000.

Annex to Guideline: Development pharmaceutics for veterinary medicinal products (EMEA/CVMP/315/98): Decision trees for the selection of sterilisation methods (EMEA/CVMP/065/99)  Feb 2000-Sep 2000.

Manufacture of the medicinal product:-

Manufacture of the finished dosage form (EMEA/CVMP/126/95) Dec 1995-Jun 1996.

Annex to guideline: Manufacture of the finished dosage form (EMEA/CVMP/126/95): Start of shelf-life of the finished dosage form (EMEA/CVMP/453/01) May 2001-Dec 2001.

Process validation (EMEA/CVMP/598/99) Mar 2001-Sep 2001.

Annex II to Note for Guidance on Process Validation (EMEA/CVMP/598/99) - Non-Standard Processes (EMEA/CVMP/395/03) Aug 2004 -Jan 2005

The use of ionising radiation in the manufacture of medicinal products (3AQ4a Volume IIIA ) Dec 1991 -Jul 1992

Limitations to the use of ethylene oxide in the manufacture of medicinal products (EMEA/CVMP/271/01) Mar 2001-Apr 2001

Active substance:-

Guideline on the Chemistry of New Active Substances (EMEA/CVMP/541/03) May 2004-Dec 2004.

Summary of requirements for active substances in the quality part of the dossier (EMEA/CVMP/1069/02) Jun 2004 - Feb 2005.

Investigation of chiral active substances (EMEA/CVMP/128/95) June1997-Jan 1998

Guideline on Active Substance Master File Procedure (EMEA/CVMP/134/02-Rev 1) Feb-Aug 2004

Guideline on Active Substance Master File Procedure (EMEA/CVMP/134/02-Rev 2)Release for consultation Apr 2006 - End of consultation 30 Aug 2006.

Impurities

VICH Topic GL10: Impurities in new veterinary drug substances (CVMP/VICH/837/99-Rev 1) Feb 2007 - Jan 2008.

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

VICH Topic GL18: Impurities: Residual solvents (CVMP/VICH/502/99) Jan 2000 - June2001.

Annexes to Guidelines on Impurities: Residual Solvents (Annex to VICH GL 18 - EMEA/CVMP/VICH/502/99) (EMEA/CVMP/511/03) Feb 2005 - Jan 2005.

Application of the VICH guideline on residual solvents to veterinary medicinal products containing existing active substances (refers to VICH GL 18 – CVMP/VICH/502/99) (EMEA/CVMP/423/01) May 2001 - May 2001.

Position Paper on 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)  Mar 2004 - Mar 2004.

Excipients

Quality of water for pharmaceutical use (EMEA/CVMP/115/01-Rev 1) May 2002 - June2002.

Excipients in the dossier for application for marketing authorisation for veterinary medicinal products (EMEA/CVMP/004/98) Feb 1999 - June1999.

Inclusion of antioxidants and antimicrobial preservatives in medicinal products (CPMP/CVMP/QWP/115/95) July 1997 Jan 1998.

Packaging

Plastic primary packaging materials (EMEA/CVMP/205/04) May 2005 - Dec 2005.

Specifications, analytical procedures and analytical validation :-

VICH Topic GL1: Validation of analytical procedures: Definition and terminology (CVMP/VICH/590/98) Dec1998 - Oct 1999.

VICH Topic GL2: Validation of analytical procedures: Methodology (CVMP/VICH/591/98) Dec 1998.

VICH Topic GL39: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances (EMEA/CVMP/VICH/810/04-Corrigendum) Nov 2005.

VICH Topic GL40: Test procedures and acceptance criteria for new biotechnological/ biological veterinary medicinal products (EMEA/CVMP/VICH/811/04-Corrigendum) Nov 2005.

Specifications and control tests on the finished product (3AQ11a Volume IIIA) Dec 1991.

Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations (EMEA/CVMP/961/01) Feb 2003.

Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations (EMEA/CHMP/CVMP/QWP/173698/2006) Release for consultation Jun 2006 - End of consultation 30 Sep 2006 .

Parametric release (EMEA/CVMP/QWP/339588/2005) Mar 2006 - Jan 2007.

TSEs :-

Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01-Rev 2) Oct 2003 - Jul 2004.

Stability:-

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

Annex to stability guidelines VICH GL3 and CVMP/846/99 * Declaration of storage conditions:
1. in the product information of pharmaceutical veterinary medicinal products
2. for active substances (EMEA/CVMP/422/99-Rev 2) Jul 2003 - Oct 2003.

VICH Topic GL4: Stability testing for new veterinary dosage forms (CVMP/VICH/900/99) Jun 1999 - May 2000.

VICH Topic GL5: Stability testing: photostability testing of new veterinary drug substances and medicinal products (CVMP/VICH/901/00) Jun 1999 - May 2000.

VICH Topic GL8: Stability testing for medicated premixes (CVMP/VICH/836/99) Dec 1999 - Dec 2000.

Stability testing of existing active substances and related finished products
Annex to this guideline - see * above.(EMEA/CVMP/846/99) Nov 2000 - Jul 2002.

Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation (EMEA/CVMP/373/04) May 2005 - Dec 2005.

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

Maximum shelf-life for sterile medicinal products after first opening or following reconstitution (EMEA/CVMP/198/99) Jul 2000 - Feb 2001.

Herbal Medicinal Products:-

Quality of herbal medicinal products/Traditional herbal medicinal products (EMEA/CVMP/814/00-Rev 1) Mar 2006 - Oct 2006.

Specifications: Test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products (EMEA/CVMP/815/00-Rev 1) Mar 2006 - Oct 2006.

Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products in the SPC (EMEA/HMPC/287539/2005) Release for consultation Jun 2006 - End of consultation 31 Dec 2006.

Quality of Combination Herbal Medicinal Products/Traditional Herbal Medicinal Products (EMEA/HMPC/CHMP/CVMP/58222/2006) Release for consulation Jun 2006 - End of consultation 30 Sep 2006.

Specific veterinary dosage forms:-  

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

Position Paper on premixes for medicated feedingstuffs for veterinary use versus powders/granules for oral use or use in drinking water (EMEA/CVMP/199/97) Aug 1998 - Aug 1998.

Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for Administration via Drinking Water (EMEA/CVMP/540/03–Rev 1) Apr 2005 - Jan 2005.

Position Paper on the Maximum In-Use Shelf-Life for Medicated Drinking Water (EMEA/CVMP/1090/02) Dec 2002 - Dec 2002.

Guideline on Quality of Modified Release Dosage Forms for Veterinary Use (EMEA/CVMP/680/02) Jul 2003 - Feb 2004.

Multidisciplinary Guidelines:-

Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01-Rev 2) Jan 2004 - Jul 2004.

Investigation of chiral active substances (EMEA/CVMP/128/95) Jun 1997 - Jan 1998.

Guideline on quality data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/QWP/128710/2004) Jul 2006 - Feb 2007.

Dossier requirements for oncology products (EMEA/CVMP/EWP/79590/2005) Release for consultation Jun 2005 - End of consultation 30 Sep 2005.

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