The Veterinary Medicines Regulations 2009 (revoked)

1Title and commencement

2Definition of “veterinary medicinal product”, interpretation and scope

3Products to which these Regulations do not apply

4Placing a veterinary medicinal product on the market

5Manufacture of veterinary medicinal products

6The finished product

7Classification, supply and possession of the product

8Administration of the product

9Importation of authorised veterinary medicinal products

10Advertising the product

11Advertising of prescription products and products containing psychotropic drugs or narcotics

12Defence of publication in the course of business

13Wholesale dealing

14Feedingstuffs

17Food-producing animals: proof of purchase of veterinary medicinal products

18Food-producing animals: records of administration by a veterinary surgeon

19Food-producing animals: records of acquisition and administration

20Food-producing animals: retention of records

21Records by a holder of a manufacturing authorisation

22Records by a holder of a wholesale dealer’s authorisation

23Records of the receipt or supply of prescription products

24Records of products administered to a food-producing animal under the cascade

25Importation of an unauthorised veterinary medicinal product

26Possession of an unauthorised veterinary medicinal product

27Supply of an unauthorised veterinary medicinal product

28The Veterinary Products Committee

29Veterinary Products Committee appeals procedure

30Appeals to an appointed person

33Appointment of inspectors

34Powers of entry

35Powers of an inspector

36Inspection of pharmacies

38Improvement notices

39Appeals against improvement notices

40Powers of a court on appeal

41Seizure notices

44Northern Ireland

SCHEDULE 1Marketing authorisations

1Application for a marketing authorisation

2Information with the application

3Summary of product characteristics

4Supply of a copy of the summary of product characteristics

5Time limits for applications for products for use in food-producing animals

7Bibliographic application

8Application for a product using a new combination of active substances

9Application using existing data

10Application for a pharmacologically equivalent medicinal product

11Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product

12Extension of time limits

13Parallel imports

14Specific batch control scheme

15Similar immunological products

16Marketing a product authorised in another country

18Place of establishment of applicant

20Products authorised in another member State

21Assessment reports

22Grant of a marketing authorisation

23Marketing authorisations for food-producing species

24Refusal of a marketing authorisation

25Publication following the grant of a marketing authorisation

26Marketing authorisations in exceptional circumstances

27Provisions of samples and expertise

28Supply of information

29Duties on the holder of a marketing authorisation relating to an immunological product

30Control tests

31Placing on the market

32Duration and validity of a marketing authorisation

33Variation of a marketing authorisation where the product is authorised using mutual recognition or the decentralised procedure

34Variation of a marketing authorisation not authorised in another member State

35Administrative variations

36Changes after a marketing authorisation has been issued

37Compulsory variation

38Suspension of a marketing authorisation: grounds

39Suspension of a marketing authorisation: procedure

41Prohibiting the supply of veterinary medicinal products

42Application for a marketing authorisation where one already exists in another member State

43Application in another member State

44Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State

45Approval by the Secretary of State

46Reference to being authorised

48Labelling with all the information on the immediate packaging

49Products with immediate and outer packaging

50Package leaflets

52Small containers other than ampoules

53Homeopathic remedies

55Qualified persons responsible for pharmacovigilance

56Duties relating to the qualified person

57Adverse reactions to a veterinary medicinal product administered in the United Kingdom

58Adverse reactions to a veterinary medicinal product administered in a third country

59Periodic safety update reports

60Release of information by the marketing authorisation holder

61Action taken on account of pharmacovigilance

62Meaning of “homeopathic remedy”

63Placing a homeopathic remedy on the market in accordance with a registration

64Application for registration

65Procedure for registration

66Products on the market before 1994

67Classification

SCHEDULE 2The manufacture of veterinary medicinal products

3Granting the authorisation

4The authorisation

5Suspension, variation or revocation of the authorisation

6Inspection of premises

7Report following inspection

8Duties on the holder of a manufacturing authorisation

9Qualified persons for manufacture

10Refusal or revocation of appointment

11Duties on a qualified person

14Authorisation to manufacture autogenous vaccines

15Types of authorisation

18Adverse reactions

19Inspection of premises

20Authorisation of blood banks

21Supply and administration of blood from a blood bank

24Inspection of premises

25Authorisation to manufacture products for administration under the cascade

28Adverse reactions

29Inspection of premises

30Authorisation of stem cell centres

31Supply and administration of stem cells

34Inspection of premises

SCHEDULE 3Classification and supply, wholesale dealers and sheep dip

1Classification of veterinary medicinal products

2Wholesale supply of veterinary medicinal products

3Retail supply of veterinary medicinal products

4Prescriptions by a veterinary surgeon

6Written prescriptions

7Duties when a product is prescribed or supplied

8Supply by a veterinary surgeon from registered premises

9Supply by a veterinary surgeon

10Supply by a pharmacist

11Supply of a veterinary medicinal product for incorporation into feedingstuffs

12Labelling at the time of retail supply

13Supply of veterinary medicinal products for use under the cascade

14Supply by a suitably qualified person

18Granting the authorisation

19The authorisation

20Suspension, variation or revocation of the authorisation

21Duties on the holder of a wholesale dealer’s authorisation

22Supply of sheep dip

23Use of sheep dip

SCHEDULE 4Administration of a veterinary medicinal product outside the terms of a marketing authorisation

1Administration under the cascade

2Withdrawal periods

3Administration to food-producing horses

4Immunological products for serious epizootic disease

5Immunological products for an imported or exported animal

6Administration by veterinary surgeons from other member States

7Treatment in exceptional circumstances

8Administration of a homeopathic remedy

9Administration under an animal test certificate

SCHEDULE 5Medicated feedingstuffs and specified feed additives

1Scope and interpretation

2Enforcement of Regulation (EC) No 178/2002

3Enforcement of Regulation (EC) No 1831/2003

4Enforcement of Regulation (EC) No 882/2004

5Enforcement of Regulation (EC) No 183/2005

6Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

7Incorporation of a veterinary medicinal product into a premixture

9Incorporation of a veterinary medicinal product into feedingstuffs

10Additional record keeping requirements relating to veterinary medicinal products

11Labelling a premixture containing a veterinary medicinal product

12Labelling of feedingstuffs containing a specified feed additive

13Labelling of feedingstuffs containing a veterinary medicinal product

14Supply of specified feed additives

15Supply of premixture

16Supply of feedingstuffs containing a veterinary medicinal product

17Prescriptions for feedingstuffs containing a veterinary medicinal product

18Writing the prescription

20Sampling and analysis

22Packages and other containers

24Possession, placing on the market and use of feedingstuffs

25Imports from third countries

26Trade between member States

27Import for incorporation into premixture or feedingstuffs for export

28Animals on domestic premises

SCHEDULE 6Exemptions for small pet animals

1Animals to which this Schedule applies

2Placing on the market, importing and administering the product

4Approval of the active substance

7Administration

9Adverse reactions

1Interpretation

2Payment of fees

3Time of payment

4Multiple inspections

5Expenses for inspections

7Fees for specified pharmaceutical applications

8Decentralised pharmaceutical application where the United Kingdom is the reference member State

9Application for a marketing authorisation for an immunological product

10Decentralised immunological application where the United Kingdom is the reference member State

11Application for a marketing authorisation using identical data

12Application for an exceptional marketing authorisation (pharmaceutical)

13Fees for an application for an exceptional marketing authorisation (immunological)

14Fee for the conversion from an exceptional to a full marketing authorisation

15Application for a marketing authorisation relating to a parallel import

16Application for a variation obtained under a national procedure

17Application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures: fees until 1st January 2010

18Application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures: fees from 1st January 2010

19Application for an extension to a marketing authorisation

20Decentralised application for an extension where the United Kingdom is the reference member State

21Provision of information relating to the recognition of a United Kingdom marketing authorisation

22Application for the renewal of a national marketing authorisation

23Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure

24Registration of a homeopathic remedy

25Annual fees for marketing authorisations

26Auditor’s certificate

27Late payment of annual fees

28Application for a manufacturing authorisation

29Application for a variation of a manufacturing authorisation

30Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade

32Site inspections – type of site

33Inspection of a site where immunological veterinary medicinal products are manufactured

34Inspection of a site where sterile veterinary medicinal products are manufactured

35Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured

36Inspection of a site where veterinary medicinal products are assembled

38Animal blood bank or equine stem cell centre authorisations

39Application for a wholesale dealer’s authorisation

40Variation of a wholesale dealer’s authorisation

41Annual fee for a wholesale dealer’s authorisation

42Inspection of a wholesale dealer’s premises

43Fees relating to feedingstuffs

44Fees relating to premises for supply by suitably qualified persons

46Testing samples

47Animal test certificates

48Importation of a veterinary medicinal product for treatment under the cascade

49Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 1986

50Wholesale dealer’s import certificate

51Specific batch control

52Submission of control tests of an immunological product

53Export certificates

54Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates

55Appeals to the Veterinary Products Committee: variations

56Appeal to the Veterinary Products Committee: suspensions

57Appeal to the Veterinary Products Committee: active substance under Schedule 6

58Fee relating to an appointed person

59Fees relating to a veterinary surgeon’s practice premises

60Refund of fees relating to the Veterinary Products Committee or appointed persons

61Fees relating to an improvement notice

62Non-payment of fees

63Waiver or reduction of fees

64Reduction of fees when an application is withdrawn

2009 No. 2297

Medicines

The Veterinary Medicines Regulations 2009 (revoked)F1

Made12th August 2009

Laid before Parliament27th August 2009

Coming into force1st October 2009

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F1

Regulations revoked (1.10.2011) by The Veterinary Medicines Regulations 2011 (S.I. 2011/2159), regs. 1, 46(1)