# The Veterinary Medicines Regulations 2011 (revoked) S.I. 2011/2159 · made 25 August 2011 · revised to 1 October 2013 These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2009. PDFs: Printed copy https://openlegislation.uk/veterinary-medicines-regulations-2011-revoked/pdf/uksi_20112159_en.pdf ## Introductory text Medicines Made 25th August 2011 Laid before Parliament 7th September 2011 Coming into force 1st October 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 46 Revocations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 a product authorised in another country . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### 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 Marketing authorisations in exceptional circumstances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Refusal of a variation of a marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### 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 premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 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 Enforcement of Regulation (EC) No 767/2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Incorporation of a veterinary medicinal product into a premixture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Top dressing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Incorporation of a veterinary medicinal product into feedingstuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Additional record keeping requirements relating to veterinary medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Labelling a premixture containing a veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Labelling of feedingstuffs containing a specified feed additive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Labelling of feedingstuffs containing a veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Supply of specified feed additives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Supply of premixture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Supply of a complementary feedingstuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Supply of feedingstuffs containing a veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Prescriptions for feedingstuffs containing a veterinary medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Writing the prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Possession . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Sampling and analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Packages and other containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Possession, placing on the market and use of feedingstuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Imports from third countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Trade between Member States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Import for incorporation into premixture or feedingstuffs for export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 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 outside the United Kingdom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 an exceptional marketing authorisation (pharmaceutical) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Fees for an application for an exceptional marketing authorisation (immunological) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Fee for the conversion from an exceptional to a full marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Application for a marketing authorisation relating to a parallel import . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Application to change the distribution category of a product authorised through the centralised procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Application for a variation to a marketing authorisation dealt with under national or mutual recognition variation procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Application for a variation to a marketing authorisation dealt with under worksharing procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference Member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Exception for a variation relating to animal testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Application for the renewal of a national marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Registration of a homeopathic remedy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Annual fees for marketing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Auditor’s certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### 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 Importation of a veterinary medicinal product for treatment under the cascade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 48 Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 1986 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 49 Wholesale dealer’s import certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 50 Specific batch control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 51 Submission of control tests of an immunological product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 52 Export certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 53 Provision of advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 54 Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 55 Appeals to the Veterinary Products Committee: variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 56 Appeal to the Veterinary Products Committee: suspensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 57 Appeal to the Veterinary Products Committee: active substance under Schedule 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 58 Fee relating to an appointed person . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 59 Fees relating to a veterinary surgeon’s practice premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 60 Refund of fees relating to the Veterinary Products Committee or appointed persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 61 Fees relating to an improvement notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 62 Non-payment of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 63 Waiver or reduction of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 64 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 2009. Principal changes to the 2009 Regulations: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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.defra.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”. --- Source: https://www.legislation.gov.uk/uksi/2011/2159 (the official version) Page: https://openlegislation.uk/veterinary-medicines-regulations-2011-revoked Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.