# The Veterinary Medicines Regulations 2008 S.I. 2008/2297 · made 26 August 2008 · revised to 1 October 2009 These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2007. Made under: European Communities Act 1972 (repealed) (Section 2); Finance Act 1973 (Section 56) PDFs: Printed copy https://openlegislation.uk/veterinary-medicines-regulations-2008/pdf/uksi_20082297_en.pdf; Explanatory Memorandum https://openlegislation.uk/veterinary-medicines-regulations-2008/pdf/uksiem_20082297_en.pdf ## Introductory text Medicines Made 26th August 2008 Laid before Parliament 1st September 2008 Coming into force 1st October 2008 The Secretary of State is a Minister designated for the purposes of making Regulations under section 2(2) of the European Communities Act 1972 in relation to measures in the veterinary and phytosanitary fields for the protection of public health. The Secretary of State has carried out the consultation required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. In accordance with section 56(1) of the Finance Act 1973, the Treasury consent to the making of these Regulations. The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973. ## Part 1: Introduction ## 1 Title and commencement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Definition of “veterinary medicinal product”, interpretation and scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Products to which these Regulations do not apply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 2: Authorised veterinary medicinal products ## 4 Placing a veterinary medicinal product on the market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Manufacture of veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 The finished product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Classification, supply and possession of the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Administration of the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Importation of authorised veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Advertising the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Advertising of prescription products and products containing psychotropic drugs or narcotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Defence of publication in the course of business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Wholesale dealing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Feedingstuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Exemptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 3: Records ## 17 Food-producing animals: proof of purchase of veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Food-producing animals: records of administration by a veterinary surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Food-producing animals: records of acquisition and administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Food-producing animals: retention of records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Records by a holder of a manufacturing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Records by a holder of a wholesale dealer’s authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Records of the receipt or supply of prescription products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Records of products administered to a food-producing animal under the cascade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 4: Unauthorised veterinary medicinal products ## 25 Importation of an unauthorised veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Possession of an unauthorised veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Supply of an unauthorised veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 5: Miscellaneous provisions, enforcement and offences ## 28 The Veterinary Products Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Veterinary Products Committee appeals procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 Appeals to an appointed person . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Exports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Time limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 33 Appointment of inspectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Powers of entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 35 Powers of an inspector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 36 Inspection of pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 37 Obstruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 38 Improvement notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 39 Appeals against improvement notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 40 Powers of a court on appeal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 41 Seizure notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 42 Publication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 43 Penalties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 44 Northern Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 45 Revocations and consequential amendment (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (2) In section 1 of the Medicines Act 1971 (fees), in subsection (3), for “as amended by the Transfer of Functions (Wales) Order 1969 have the same meanings in this section as in that Act as so amended” substitute “(as amended) have the same meanings in this section as in that Act (as amended)”. ## Signature Jonathan Shaw Parliamentary Under Secretary of State Department for Environment, Food and Rural Affairs Dave Watts Alan Campbell Two of the Lords Commissioners of Her Majesty’s Treasury ## Schedule 1: Marketing authorisations ### Part 1: Application for a marketing authorisation ## 1 Application for a marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Information with the application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Summary of product characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Supply of a copy of the summary of product characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Time limits for applications for products for use in food-producing animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: Derogations from some of the requirements in Part 1 ## 6 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Bibliographic application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Application for a product using a new combination of active substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Application using existing data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Application for a pharmacologically equivalent medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Extension of time limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Parallel imports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Specific batch control scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Similar immunological products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Marketing in exceptional circumstances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: Grant of a marketing authorisation ## 17 Time limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Place of establishment of applicant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Products authorised in another member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Assessment reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Grant of a marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Marketing authorisations for food-producing species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Refusal of a marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Publication following the grant of a marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Provisional marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Provisions of samples and expertise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Supply of information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Duties on the holder of a marketing authorisation relating to an immunological product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 Control tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Placing on the market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Duration and validity of a marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 4: Variations of marketing authorisations on the application of the holder ## 33 Variation of a marketing authorisation for a mutually recognised veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Variation of a marketing authorisation not authorised in another member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 35 Administrative variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 36 Changes after a marketing authorisation has been issued . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 37 Compulsory variation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 5: Suspension, etc. of a marketing authorisation ## 38 Suspension of a marketing authorisation: grounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 39 Suspension of a marketing authorisation: procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 40 Revocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 41 Prohibiting the supply of veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 6: Mutual recognition and multiple applications ## 42 Application for a marketing authorisation where one already exists in another member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 43 Application in another member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 44 Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 7: Labelling and package leaflets ## 45 Approval by the Secretary of State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 46 Reference to being authorised . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 47 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 48 Labelling with all the information on the immediate packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 49 Products with immediate and outer packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 50 Package leaflets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 51 Ampoules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 52 Small containers other than ampoules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 53 Homeopathic remedies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 54 Variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 8: Pharmacovigilance ## 55 Qualified persons responsible for pharmacovigilance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 56 Duties relating to the qualified person . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 57 Adverse reactions to a veterinary medicinal product administered in the United Kingdom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 58 Adverse reactions to a veterinary medicinal product administered in a third country . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 59 Periodic safety update reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 60 Release of information by the marketing authorisation holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 61 Action taken on account of pharmacovigilance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 9: Homeopathic remedies ## 62 Meaning of “homeopathic remedy” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 63 Placing a homeopathic remedy on the market in accordance with a registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 64 Application for registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 65 Procedure for registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 66 Products on the market before 1994 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 67 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 2: The manufacture of veterinary medicinal products ### Part 1: Manufacturing authorisations ## 1 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Time limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Granting the authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 The authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Suspension, variation or revocation of the authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Inspection of premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Report following inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Duties on the holder of a manufacturing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Qualified persons for manufacture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Refusal or revocation of appointment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Duties on a qualified person . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Register . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Test sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: Authorisation of manufacturers of autogenous vaccines ## 14 Authorisation to manufacture autogenous vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Types of authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Inspection of premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: Authorisation of blood banks ## 20 Authorisation of blood banks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Supply and administration of blood from a blood bank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Inspection of blood banks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 4: Authorisation of manufacturers of products for administration under the cascade ## 25 Authorisation to manufacture products for administration under the cascade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Inspection of premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 5: Authorisation of equine stem cell centres ## 30 Authorisation of stem cell centres . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Supply and administration of stem cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 33 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Inspection of equine stem cell centres . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 3: Classification and supply, wholesale dealers and sheep dip ### Part 1: Classification and supply of authorised veterinary medicinal products ## 1 Classification of veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Wholesale supply of veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Retail supply of veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Prescriptions by a veterinary surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Prescriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Written prescriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Duties when a product is prescribed or supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Supply by a veterinary surgeon from registered practice premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Supply by a veterinary surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Supply by a pharmacist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Supply of a veterinary medicinal product for incorporation into feedingstuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Labelling at the time of retail supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Supply of veterinary medicinal products for use under the cascade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Supply by a suitably qualified person . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Annual audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: Requirements for a wholesale dealer’s authorisation ## 16 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Time limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Granting the authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 The authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Suspension, variation or revocation of the authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Duties on the holder of a wholesale dealer’s authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: Sheep dip ## 22 Supply of sheep dip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Use of sheep dip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 4: Administration of a veterinary medicinal product outside the terms of a marketing authorisation ## 1 Administration under the cascade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Withdrawal periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Administration to food-producing horses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Immunological products for serious epizootic disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Immunological products for an imported or exported animal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Administration by veterinary surgeons from other member States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Treatment in exceptional circumstances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Administration of a homeopathic remedy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Administration under an animal test certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 5: Medicated feedingstuffs and specified feed additives ## 1 Scope and interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Enforcement of Regulation (EC) No. 178/2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Enforcement of Regulation (EC) No. 1831/2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Enforcement of Regulation (EC) No. 882/2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Enforcement of Regulation (EC) No. 183/2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Incorporation of a veterinary medicinal product into a premixture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Incorporation of a veterinary medicinal product into feedingstuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Additional record keeping requirements relating to veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Labelling a premixture containing a veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Labelling of feedingstuffs containing a specified feed additive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Labelling of feedingstuffs containing a veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Supply of specified feed additives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Supply of premixture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Supply of feedingstuffs containing a veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Prescriptions for feedingstuffs containing a veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Writing the prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Possession . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Sampling and analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Packages and other containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Possession, placing on the market and use of feedingstuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Imports from third countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Trade between member States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Import for incorporation into premixture or feedingstuffs for export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Animals on domestic premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 6: Exemptions for small pet animals ## 1 Animals to which this Schedule applies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Placing on the market, importing and administering the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Manufacture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Approval of the active substance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 The product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Pack size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 7: Fees ### Part 1: Introduction ## 1 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Payment of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Time of payment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Multiple inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Expenses for inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Translation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: Fees relating to marketing authorisations ## 7 Fees for specified pharmaceutical applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Decentralised pharmaceutical application where the United Kingdom is the reference member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Application for a marketing authorisation for an immunological product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Decentralised immunological application where the United Kingdom is the reference member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Application for a marketing authorisation using identical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Application for a provisional marketing authorisation (pharmaceutical) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Fees for an application for a provisional marketing authorisation (immunological) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Fee for the conversion from a provisional to a full marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Application for a marketing authorisation relating to a parallel import . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Application for a variation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Application for a variation to a marketing authorisation that has been issued in other member States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Application for an extension to a marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Decentralised application for an extension where the United Kingdom is the reference member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Provision of information relating to the recognition of a United Kingdom marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Application for the renewal of a national marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Application for the renewal of a marketing authorisation granted in more than one member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Registration of a homeopathic remedy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Annual fees for marketing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Auditor’s certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Late payment of annual fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: Fees payable by manufacturers ## 27 Application for a manufacturing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Application for a variation of a manufacturing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 Annual fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Site inspections – type of site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Inspection of a site where immunological veterinary medicinal products are manufactured . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 33 Inspection of a site where sterile veterinary medicinal products are manufactured . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 35 Inspection of a site where veterinary medicinal products are assembled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 36 Test sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 37 Animal blood bank or equine stem cell centre authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 4: Fees relating to a wholesale dealer’s authorisation ## 38 Application for a wholesale dealer’s authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 39 Variation of a wholesale dealer’s authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 40 Annual fee for a wholesale dealer’s authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 41 Inspection of a wholesale dealer’s premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 5: Fees relating to feedingstuffs ## 42 Fees relating to feedingstuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 43 Fees relating to premises for supply by suitably qualified persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 44 Reduced fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 6: General ## 45 Testing samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 46 Animal test certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 47 Treatment under the cascade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 48 Treatment under the Animals (Scientific Procedures) Act 1986 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 49 Treatment in exceptional circumstances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 50 Specific batch control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 51 Submission of control tests of an immunological product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 52 Export certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 53 Appeals to the Veterinary Products Committee: marketing authorisations and ATCs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 54 Appeals to the Veterinary Products Committee: variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 55 Appeal to the Veterinary Products Committee: suspensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 56 Appeal to the Veterinary Products Committee: active substance under Schedule 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 57 Fee relating to an appointed person . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 58 Fee for the inspection of a veterinary surgeon’s practice premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 58A Fee for the registration of veterinary practice premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 59 Refund of fees relating to the Veterinary Products Committee or appointed persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 60 Fees relating to an improvement notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 61 Non-payment of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 62 Waiver or reduction of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 63 Reduction of fees when an application is withdrawn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Explanatory note (This note is not part of the Regulations) These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2007. Principal changes to the 2007 Regulations The new Regulations introduce a fee for the registration of veterinary premises for the supply of veterinary medicinal products. They provide comprehensive rights of appeal to an appointed person when applications for the authorisation or approval of manufacture or retail premises are refused. They introduce new controls on the collection and supply of equine stem cells. They introduce compulsory variations by the Secretary of State for manufacturers and wholesale dealers. They allow suitably qualified persons to supply veterinary medicines to retail customers from pharmacies or registered veterinary premises without dual registration. They introduce record-keeping requirements in relation to adverse reactions to products marketed under the small animals exemption scheme. They update fees. They have been changed so that the drafting is now gender-neutral. They make an amendment to the Medicines Act 1971 arising from veterinary medicinal products no longer being licensed under the Medicines Act 1968. The Regulations The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products. They implement Directive 2001/82/EC. They enforce Regulations (EC) No. 178/2002, No. 1831/2003, No. 882/2004 No. 183/2005, in so far as they apply to veterinary medicinal products used in feedingstuffs, and to some specified feed additives used in feedingstuffs. They implement Council Directive 90/167 so far it is not superseded by Regulation (EC) No. 183/2005. They provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1). They specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2). They regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3). They provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the rules of the “cascade” (regulation 8 and Schedule 4). They control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12). They control wholesale dealing (regulation 13 and Schedule 3). They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5). They provide for exemptions (regulation 15 and Schedule 6). They provide for fees (regulation 16 and Schedule 7). They require records to be kept (regulations 17 to 24). They create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27). They make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for an appeals procedure in the case of a refusal, etc., of a marketing authorisation (regulation 29). They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41). Under regulation 43 breach of the Regulations is an offence punishable— (a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or (b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both. A full impact assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available, together with a transposition note and a table showing fee changes, on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”. --- Source: https://www.legislation.gov.uk/uksi/2008/2297 (the official version) Page: https://openlegislation.uk/veterinary-medicines-regulations-2008 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.