Veterinary advisers

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). 

Advising on the establishment and membership of committees established under section 4 of the Medicines Act 1968. For example, the British Pharmacopoeia Commission (BPC) and Veterinary Products Committee (VPC) would be retained. 

Some contract laboratories and professional consultants (e.g., veterinary ophthalmologists and pathologists), may not be familiar with the GLP regulations. In such cases, mere notification of a requirement to provide GLP-compl3dng services may not be sufficient. It is advisable to spend time with contractors and professional consultants to review in detail the GLP requirements that will apply to the work they will perform. It is especially important to review with them the GLP requirements for documentation and document retention. 

A safety factor of 100 is usually used for an NEL based on the combined toxic effects of a drug residue. Where teratogenic effects (birth defects) are involved a safety factor of 1000 is employed. When licensing veterinary drugs the ADI is compared with the total amount of the substance that would be consumed in the daily diet (edible tissues, milk, etc.). If the daily intake of an extreme consumer of the substance is less than the ADI, a product licence can be granted. If the intake is greater than the ADI or the VPC was dissatisfied for some other reason about the concentration of residues present in the edible tissues, the pharmaceutical company would be advised to increase the recommended... 

The British Pharmacopoeia Commission was established in 1970 under Section 4 of the Medicines Act 1968. Members of the Commission (approximately 20) are appointed by the Minister of Health and are responsible for preparing new editions of the British Pharmacopoeia (BP) and the British Pharmacopoeia (Veterinary). The Commission also provides members for the UK delegation to meetings of the European Pharmacopoeia committees in Strasbourg and is responsible, under Section 100 of the Medicines Act, for selecting and advising on British Approved Names (BANs). 

The Licensing Authority is advised by expert committees, appointed by ministers, as advised by the Medicines Commission under Section 4 of the Medicines Act. These advisory committees consist of independent experts, such as hospital clinicians, general practitioners, pharmacists and clinical pharmacologists, not the staff of the DoH, and are appointed by ministers on the advice of the Medicines Commission. The relevant advisory committees since 1971 have been the Committee on Safety of Medicines (CSM), the Committee on Review of Medicines (CRM), the Committee on Dental and Surgical Materials (CDSM), the British Pharmacopoeia Commission (BPC) and the Veterinary Products Committee, which is administered through the Ministry of Agriculture, Food and Fisheries (MAFF). 

The European Union (EU) ageneies responsible for the scientific evaluation of the safety of feed additives and veterinary medicinal products are, respectively, the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA). The EFSA is advised on scientific aspects of feed additives, including the safety of target species, consumers, users and the environment, by the Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP). Some of the older evaluations of feed additive uses of coccidiostats under Directive 70/524/EEC were performed by the Scientific Committee on Animal Nutrition (SCAN), which reported to the European Commission prior to the establishment of EFSA. The Committee for Medicinal Products for Veterinary Use (CVMP) advises the EMA on scientific aspects of veterinary medicines. The distinction between medicinal and feed additive uses is not always clear, as some uses to prevent coccidiosis are considered to be medicinal e.g. use of lasalocid in poultry). 

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