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Pharmacovigilance in the Animal Health Industry
Article by Dana Winstanley from the April issue of Quasar
Annexe 13 - Question to the Committee - published in July issue of Quasar
Veterinary Legislation
The EMEA Committee for Medicines for Veterinary Use (CVMP) has released an amending directive to EC Directive 2001/82/EC.
Among other changes the amending directive states, 'Pharmacological, toxicological, residue and safety tests shall be carried out in conformity with the provisions related to Good Laboratory Practice (GLP)'. Previously directive 2001/82/EC required residue and safety studies to be undertaken to GLP. Amended EC Directive 2009/9/EC can be viewed at the European legislation website http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol5_en.htm
10th July 2009
For GLP Practitioners Biologicals
VICH have released guidelines for Target Animal Safety Testing (TAS).
This has an implementation date of July 2009
This new guidelines TAS for veterinary live and inactivated vaccines, VICH GL 44, is available for review at the VICH website
http://www.vichsec.org/en/guidelines.htm
10th July 2009
Changes in Agency Responsibilities
The Veterinary Medicinal Directorate (VMD) have taken over responsibility for inspection and licensing of all new and existing Veterinary Manufacturing Authorisations that name veterinary only sites. e.g. VMD now undertake routine GMP monitoring of veterinary manufacturing sites. Where sites manufacture both Veterinary and Human Pharmaceuticals the MHRA will remain the monitoring agency.
See VMD website at http://www.vmd.gov.uk/Industry/Manufacture/manufacture.htm
10th July 2009