THE VETERINARY MEDICINES REGULATIONS 2006: PROPOSALS FOR THE ADMINISTRATION OF HOMOEOPATHIC VETERINARY MEDICINAL PRODUCTS
- 1. On 17 March the Veterinary Medicines Directorate (VMD) published a formal consultation package on the draft Veterinary Medicines Regulations 2006, which is due to end on 9 June (the full package, including a partial Regulatory Impact Assessment, is available on the VMD website www.vmd.gov.uk Publications/Consultations/Current page). These Regulations are intended to come into force on 1 October 2006 and will contain amendments to the legislation that have been proposed since the Veterinary Medicines Regulations 2005 came into force on 30 October 2005.
2. I am now writing to seek your views on a further proposal to incorporate a provision for the administration of homoeopathic veterinary medicinal products. The proposed amendment (attached at Annex A) is intended for inclusion in Schedule 4 of the Regulations.
- 3. Since the consultation period began, a legislative gap has been identified in the current Regulations, in relation to the administration of homoeopathic veterinary medicinal products - a specialised area with a small group of stakeholders. There is currently no provision in veterinary medicines legislation permitting homoeopathic remedies to be administered to animals by anyone unless the products are registered under our simplified registration scheme. There are no products currently registered. There are however, a large number of homoeopathic products on the market, which are entitled to grandfather rights exempting them from the
- registration scheme. There is no legislative basis in the Regulations for any of these products to be administered to animals.
- 4. There is also currently no provision for veterinary surgeons to administer homoeopathic products that are authorised for human use or that have been prepared extemporaneously. The proposed amendment will allow homoeopathic medicines to be administered to animals in accordance with EC legislation. This issue has only just been identified and is considered to require urgent attention to close the gap and clarify the legislative position in relation to these products.
SCOPE AND TIMING OF CONSULTATION
- 5. Due the short timeframe between now and the coming into force of these Regulations, this consultation is for a period of six weeks. Copies of this letter have been sent to an extensive list of interested parties and this list is published on the VMD website at www.vmd.gov.uk with the consultation papers.
- 6. Please send your comments by 7 July 2006 to Lea Reynolds, Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3LS, or e-mail firstname.lastname@example.org
CODE OF PRACTICE ON CONSULTATIONS
- 7. This consultation has been prepared in line with the Governments Code of Practice which is available on the Cabinet Office website at www.cabinetoffice.gov.uk/regulation/consultation/code.asp The Code of Practice requires that we:
- i) Consult widely throughout the process, allowing a minimum of 12 weeks for written consultation at least once during the development of the policy;
- ii) Be clear about what proposals are, who may be affected, what questions are being asked and the timescale for responses;
- iii) Ensure that consultation is clear, concise and widely accessible;
- iv) Give feedback regarding the responses received and how the consultation process influenced the policy;
- v) Defra monitors its effectiveness at consultation, including through the use of designated consultation co-ordinator;
- vi) Ensure the consultation follows Better Regulation best practice, including carrying out a Regulatory Impact Assessment.
- 8. Complaints or comments relating to the consultation process should be sent to Liz Ambekar, Defras Consultation Co-ordinator, Room 7C Nobel House, 17 Smith Square, London, SW1P 3JR.
MAKING COPIES OF REPLIES AVAILABLE TO THE PUBLIC
9. In line with Defras policy of openness, at the end of the consultation period copies of the responses we receive will be made publicly available through the Defra Information Resource Centre, Lower Ground Floor, Ergon House, 17 Smith Square, London, SW1P 3JR. The information they contain will also be published in a summary of responses to the main consultation on the VMDs website
www.vmd.gov.uk by the 26 June. An additional summary of comments to this proposal will be added to the website by 14 July.
10. If you do not consent to this, you must clearly request that your response be treated confidentially. Any confidentiality disclaimer generated by your IT system in e-mail responses will not be treated as such a request. You should also be aware that there may be circumstances in which Defra will be required to communicate information to third parties on request, in order to comply with its obligations under the Freedom of Information Act and the Environmental Information Regulations.
11. The Information Resource Centre will supply copies of consultation responses to personal callers or in response to telephone or e-mail requests (Tel: 0207 238 6575, e-mail: email@example.com). Wherever possible, personal callers should give the library at least 24 hours notice of their requirements. An administrative charge will be made to cover photocopying and postage costs.
Head of Regulation of Veterinary Medicines Team
PROPOSED AMENDMENT TO THE VETERINARY MEDICINES REGULATIONS 2006 TO ALLOW THE ADMINISTRATION OF HOMOEOPATHIC VETERINARY MEDICINES
Administration of a homoeopathic veterinary medicinal product
1.- (1) This paragraph controls the administration of a homoeopathic medicinal product to an animal, and for the avoidance of doubt it is in addition to the provisions of paragraph 2 relating to the cascade.
(2) A veterinary surgeon may administer, either himself or under his responsibility-
- (a) a medicinal product authorised as a homoeopathic medicinal product for human use, or
- (b) a homoeopathic veterinary medicinal product prepared extemporaneously by a pharmacist, a veterinary surgeon or a person holding a manufacturing authorisation authorising the manufacture of that type of product.
(3) Other than in the preceding sub-paragraph, only a homoeopathic veterinary medicinal product registered under these Regulations or a product that was on the market before 1st January 1994 may be administered to an animal, but such a product may be administered by anyone.
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