- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
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
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 Variations of marketing authorisations on the application of the holder
ADMINISTRATION OF A VETERINARY MEDICINAL PRODUCT OUTSIDE THE TERMS OF A MARKETING AUTHORISATION
MEDICATED FEEDINGSTUFFS AND SPECIFIED FEED ADDITIVES
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
15.Supply of feedingstuffs containing a veterinary medicinal product
21.Possession, placing on the market and use of feedingstuffs
22.Prescriptions for feedingstuffs containing a veterinary medicinal product
PART 2 Fees relating to marketing authorisations
7.Decentralised pharmaceutical application where the United Kingdom is the reference member State
8.Application for a marketing authorisation for an immunological product
9.Decentralised immunological application where the United Kingdom is the reference member State
10.Application for a marketing authorisation using identical data
12.Application for a marketing authorisation relating to a parallel import
14.Application for a variation to a marketing authorisation that has been issued in other member States
15.Application for an extension to a marketing authorisation
16.Decentralised application for an extension where the United Kingdom is the reference member State
17.Provision of information relating to the recognition of a United Kingdom marketing authorisation
18.Application for the renewal of a national marketing authorisation
19.Application for the renewal of a marketing authorisation granted in more than one member State
PART 3 Fees payable by manufacturers
25.Application for a variation of a manufacturing authorisation
26.Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade
29.Inspection of a site where immunological veterinary medicinal products are manufactured
30.Inspection of a site where sterile veterinary medicinal products are manufactured
31.Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
32.Inspection of a site where veterinary medicinal products are assembled
AMENDMENTS TO THE MEDICINES ACTS ETC.
PART 1 Consequential amendments to the Medicines Acts 1968 and 1971
2.In section 1 (Ministers responsible for administration of the Act)—...
3.In section 3 (functions of the Commission), in subsection (1),...
4.In section 4 (establishment of committees)— (a) in subsection (1),...
5.In section 5 (supplementary provisions as to Commission and committees)—...
6.In section 6 (the licensing authority)— (a) in subsection (1),...
7.In section 7 (general provisions as to dealing with medicinal...
8.In section 8 (provisions as to manufacture and wholesale dealing)—...
9.In section 9 (exemptions for doctors, dentists, veterinary surgeons and...
10.In section 10 (exemptions for pharmacists)— (a) in subsection (1),...
11.In section 15 (provision for extending or modifying exemptions)—
12.In section 18 (application for licence), omit subsection (3).
13.In section 23 (special provisions as to effect of manufacturer’s...
14.In section 28 (general power to suspend, revoke or vary...
16.In section 44 (provision of information to the licensing authority)—...
19.In section 47 (standard provisions for licences or certificates)—
20.In section 48 (postponement of restrictions in relation to exports),...
21.In section 49 (special provisions in respect of exporting certain...
22.In section 51 (general sale lists)— (a) in subsection (1),...
23.In section 52 (sale or supply of medicinal products not...
24.In section 53 (sale or supply of medicinal products on...
25.In section 54 (sale of medicinal products from automatic machines),...
26.In section 55 (exemptions for doctors, dentists, veterinary surgeons and...
27.In section 56 (exemptions in respect of herbal remedies), in...
30.In section 58A (requirement to specify certain products for human...
31.Section 58B (requirement to specify certain products for veterinary use...
32.In section 59 (special provisions in relation to new medicinal...
33.In section 60 (restricted sale, supply and administration of certain...
34.In section 61 (special restrictions on persons to be supplied...
35.In section 62 (prohibition of sale or supply, or importation,...
36.In section 65 (compliance with standards specified in monographs in...
37.In section 66 (further powers to regulate dealings with medicinal...
38.In section 72A (the responsible pharmacist)— (a) in subsection (2),...
40.In section 76 (supplementary provisions as to registration of premises),...
41.In section 79 (provision for modifying or extending restrictions under...
42.In section 85 (labelling and marking of containers and packages),...
43.In section 86 (leaflets), in subsection (1), omit “appropriate”.
44.In section 87 (requirements as to containers), in subsection (1)—...
45.In section 88 (distinctive colours, shapes and markings of medicinal...
46.In section 89 (display of information on automatic machines), in...
47.Section 90 (provisions as to medicated animal feeding stuffs) shall...
48.In section 91 (offences under Part V, and supplementary provisions)—...
49.In section 95 (powers to regulate advertisements and representations)—
50.In section 99 (new editions of British Pharmacopoeia, and other...
52.In section 102 (supplementary provisions)— (a) in subsection (2)—
53.In section 103 (construction of references to specified publications), in...
54.In section 104 (application of Act to certain articles and...
55.In section 105 (application of Act to certain other substances...
57.In section 109 (enforcement in Scotland), in subsection (2), omit...
59.In section 116 (liability to forfeiture under Customs and Excise...
60.Section 117 (special enforcement and sampling provisions relating to animal...
61.In section 121 (contravention due to default of other person),...
62.In section 122 (warranty as defence), in subsection (2), omit...
65.In section 129 (orders and regulations)— (a) in subsection (2),...
66.In section 130 (meaning of “medicinal product” and related expressions)—...
67.In section 132 (general interpretation provisions)— (a) in subsection (1)—...
PART 2 Consequential amendments to secondary legislation
2.The Medicines (Specified Articles and Substances) Order 1976
4.The Medicines (Administration of Radioactive Substances) Regulations 1978
6.The Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986
7.The Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992
8.The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
10.The Medicines (Monitoring of Advertising) Regulations 1994
11.The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
12.The Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003
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