Source: http://www.legislation.gov.uk/uksi/2005/2745/contents/made
Timestamp: 2019-01-20 15:45:07
Document Index: 722349038

Matched Legal Cases: ['ART 2', 'ART 3', 'ART 4', 'ART 5', 'ART 1', 'ART 2', 'art 1', 'ART 3', 'ART 4', 'ART 5', 'ART 6', 'ART 7', 'ART 8', 'ART 9', 'ART 1', 'ART 2', 'ART 3', 'ART 1', 'ART 2', 'ART 2', 'art 2', 'ART 3', 'art 3', 'ART 4', 'ART 5', 'ART 6', 'ART 2']

The Veterinary Medicines Regulations 2005
2005 No. 2745
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 with psychotropic drugs or narcotics
12.Defence of publication in the course of business
13.Wholesale dealing
14.Feedingstuffs
15.Exemptions
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 purchase and administration
20.Food-producing animals: retention of records
21.Records by holders of a manufacturing authorisation
22.Records by wholesale dealers
23.Records of products supplied on prescription
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.Representations to the Veterinary Products Committee
30.Duties on the Secretary of State relating to exports
31.Time limits
32.Appointment of inspectors
35.Inspection of pharmacies
37.Improvement notices
39.Powers of a court on appeal
40.Seizure notices
41.Publication of notices
43.Northern Ireland
44.Revocations and amendments
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
7.Bibliographic applications
8.Applications for products using a new combination of active substances
9.Applications 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
20.Products authorised in another member State
21.Assessment reports
22.Grant of a marketing authorisation
23.Marketing authorisations for food-producing animals
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 and revocation of a marketing authorisation
38.Suspension, etc., of a marketing authorisation
39.Suspension, etc., of a marketing authorisation of a product authorised in more than one member State
40.Prohibiting the supply of veterinary medicinal products
PART 6 Mutual recognition and multiple applications
41.Application for a marketing authorisation where one already exists in another member State
42.Application in another member State
43.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
44.Approval by the Secretary of State
45.Reference to being authorised
46.Language
47.Labelling with all the information on the immediate packaging
48.Products with immediate and outer packaging
49.Package leaflets
50.Ampoules
51.Small containers other than ampoules
52.Homoeopathic veterinary medicinal products
53.Variations
PART 8 Pharmacovigilance
54.Qualified persons responsible for pharmacovigilance
55.Duties relating to the qualified person
56.Adverse reactions to a veterinary medicinal product administered in the United Kingdom
57.Adverse reactions to a veterinary medicinal product administered in a third country
58.Periodic safety update reports
59.Release of information by the marketing authorisation holder
60.Action taken on account of pharmacovigilance
PART 9 Homoeopathic veterinary medicinal products
61.Meaning of “homoeopathic veterinary medicinal product”
62.Registration of a homoeopathic veterinary medicinal product
63.Application for registration
64.Procedure for registration
65.Products on the market before 1994
66.Administration
The manufacture of veterinary medicinal products
PART 1 Manufacturing authorisation
3.Granting the authorisation
4.The authorisation
5.Suspension or revocation of the authorisation
6.Representation to the Secretary of State
8.Report following inspection
9.Duties on the holder of a manufacturing authorisation
10.Qualified persons for manufacture
11.Refusal or revocation of appointment
12.Duties on a qualified person
14.Test sites
PART 2 Authorisation of manufacturers of autogenous vaccines
15.Authorisation to manufacture autogenous vaccines
16.Types of authorisation
17.Labelling
19.Adverse reactions
20.Inspection of premises
PART 3 Authorisation of blood banks
21.Authorisation of blood banks
22.Supply and administration of blood from a blood bank
23.Labelling
24.Records
25.Inspection of blood banks
Classification and supply and wholesale dealers
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.Supply of products for incorporation into feedingstuffs
6.Form of prescription
7.Labelling at the time of retail supply
8.Supply of veterinary medicinal products for use under the cascade
9.Supply by a suitably qualified person
10.Annual audit
11.Supply of sheep dip
PART 2 Requirements for a wholesale dealer’s authorisation
13.Time limits
14.Granting the authorisation
15.The authorisation
16.Suspension or revocation of the authorisation
17.Representations
18.Duties on the holder of a wholesale dealer’s authorisation
Administration of a veterinary medicinal product outside the terms of a marketing authorisation
2.Administration under the cascade
3.Withdrawal periods
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
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.Incorporation of a veterinary medicinal product into premixtures
7.Incorporation of a veterinary medicinal product into feedingstuffs
8.Additional record keeping requirements relating to veterinary medicinal products
9.Additional labelling requirement for premixtures containing a veterinary medicinal product
10.Labelling of feedingstuffs containing specified feed additives
11.Labelling of feedingstuffs containing a veterinary medicinal product
12.Supply of specified feed additives
13.Supply of premixture
14.Supply of feedingstuffs containing a veterinary medicinal product
15.Possession
16.Sampling and analysis
17.Storage
18.Packages and other containers
19.Transport
20.Possession, placing on the market and use of feedingstuffs
21.Prescriptions for feedingstuffs containing a veterinary medicinal product
22.Imports from third countries
23.Trade between member States
1.Animals to which this Schedule applies
2.Placing on the market
4.The active substance
5.The product
8.Pack size
9.Adverse reactions
1.Payment of fees
2.Time of payment
3.Multiple inspections
PART 2 Fees relating to national marketing authorisations
4.Scope of Part 2
5.Standard application for a marketing authorisation
6.Application for a marketing authorisation for a product with an active substance not contained in a veterinary medicinal product previously authorised in the United Kingdom
7.Application for a marketing authorisation involving other aspects not previously authorised in a veterinary medicinal product in the UK
8.Pharmacologically equivalent products
9.Application for a marketing authorisation using identical data
10.Application for a provisional marketing authorisation
11.Application for a marketing authorisation relating to a parallel import
12.Application for a variation
13.Application for the renewal of a marketing authorisation
14.Registration of a homoeopathic veterinary medicinal product
PART 3 Fees relating to decentralised and mutual recognition procedures
15.Scope of Part 3
16.Provision of information relating to the recognition of United Kingdom marketing authorisation
17.Mutual recognition of a marketing authorisation already granted in another member State
18.Decentralised procedure where the United Kingdom is the reference member State
19.Decentralised procedure where the United Kingdom is not the reference member State
20.Application for a variation
21.Application for the renewal of a marketing authorisation
PART 4 Fees payable by manufacturers
22.Application for a manufacturing authorisation
23.Application for a variation of a manufacturing authorisation
24.Application for an authorisation to manufacture an autogenous vaccine
25.Annual fees
26.Site inspections – type of site
27.Inspection of a site where immunological veterinary medicinal products are manufactured
28.Inspection of a site where sterile veterinary medicinal products are manufactured
29.Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
30.Inspection of a site where veterinary medicinal products are assembled
31.Test sites
32.Animal blood bank authorisations
33.Expenses
PART 5 Fees relating to a wholesale dealer’s authorisation
34.Application for a wholesale dealer’s authorisation
35.Variation of a wholesale dealer’s authorisation
36.Annual fee for a wholesale dealer’s authorisation
PART 6 Fees relating to feedingstuffs
37.Fees relating to feedingstuffs
38.Fees relating to distributors
39.Annual fees for marketing authorisations
40.Auditor’s certificate
41.Late payment of annual fees
42.Submission of samples in connection with applications for marketing authorisations and animal test certificates
43.Animal Test Certificates
44.Treatment under the cascade
45.Treatment in exceptional circumstances
46.Specific batch control
47.Submission of control tests of an immunological product
48.Export Certificates
49.Fees relating to premises for supply by suitably qualified persons
50.Application to the Veterinary Products Committee
51.Non-payment of fees
52.Waiver or reduction of fees
53.Reduction of fees when an application is withdrawn
Revocations and amendments.
PART 2 Instruments revoked on 1st January 2006
The Medicines (Standard Provisions for Licences and Certificates) Regulations 1971
1.After regulation 1 of the Medicines (Standard Provisions for Licences...
The Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971
2.After regulation 1 of the Medicines (Applications for Manufacturer’s and...
3.After article 1 of the Medicines (Control of Substances for...
The Medicines (Importation of Medicinal Products for Re-exportation) Order 1971
4.After article 1 of the Medicines (Importation of Medicinal Products...
5.(1) In article 1(2) of the Medicines (Exemption from Licences)...
The Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972
6.(1) In article 1(2) of the Medicines (Exemption from Licences)...
The Medicines (Extension to Antimicrobial Substances) Order 1973
7.After article 1 of the Medicines (Extension to Antimicrobial Substances)...
The Medicines (Exemptions from Licences) (Emergency Importation) Order 1974
8.After article 1 of the Medicines (Exemptions from Licences) (Emergency...
The Medicines (Exemption from Licences) (Ingredients) Order 1974
9.In the Medicines (Exemption from Licences) (Ingredients) Order 1974 (S.I....
The Medicines (Labelling) Regulations 1976
10.(1) The Medicines (Labelling) Regulations 1976 (S.I. 1976/1726) shall be...
The Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977
11.In the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977...
The Medicines (Certificates of Analysis) Regulations 1977
12.In the Medicines (Certificates of Analysis) Regulations 1977 (S.I. 1977/1399)...
13.(1) In article 1(2) of the Medicines (Retail Sale or...
14.After article 1 of the Medicines (Prohibition of Non-medicinal Antimicrobial...
The Medicines (Fluted Bottles) Regulations 1978
15.(1) In regulation 1(2) of the Medicines (Fluted Bottles) Regulations...
The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980
16.(1) In regulation 1(2)(a) of the Medicines (Sale or Supply)...
The Medicines (Pharmacy and General Sale – Exemption) Order 1980
17.(1) In article 1(2) of the Medicines (Pharmacy and General...
The Medicines (Control of Substances for Manufacture) Order 1985
18.After article 1 of the Medicines (Control of Substances for...
The Medicines Act 1968 (Hearings by Persons Appointed)(Scotland) Rules 1986
19.After rule 1 of The Medicines Act 1968 (Hearings by...
The Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986
20.After rule 1 of the Medicines Act 1968 (Hearings by...
The Medicines (Exemption from Licences) (Wholesale Dealing) Order 1990
21.(1) In article 1(2) of the Medicines (Exemption from Licences)...
The Medicines (Advisory Board On The Registration Of Homoeopathic Products) Order 1995
22.Article 2(1)(b) of the Medicines (Advisory Board on the Registration...
1.Conversions of authorisations, etc.
2.Suitably qualified persons
3.Existing applications
4.Existing procedures
8.References to “coming into force”