LegalizeThe Medicines (Data Sheets for Veterinary Drugs) Regulations 2000
Made: 4th September 2000
Laid before Parliament: 8th September 2000
Coming into force: 1st October 2000
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Title, commencement and interpretation
1
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Form of data sheets
2
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Particulars in data sheets—general
3
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Particulars in data sheets—additional provisions for loose sheets
4
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Particulars in data sheets—special provisions for compendia
5
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Additional requirements for data sheets which are not SPCs
6
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Cessation of application of previous Regulations
7
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SCHEDULE — PARTICULARS REQUIRED IN DATA SHEETS WHICH ARE NOT SPCS
| Column 1 | Column 2 |
|---|---|
| Headings | Particulars |
| 1 Name of Product | Name of the medicinal product and, if the medicinal product has an approved name, the approved name. |
| 2 Presentation | Description of appearance and pharmaceutical form of the medicinal product together with the following information that is to say—(a)where the medicinal product contains active ingredients all of which can be definitively identified—(i)a list of such ingredients, each described by its approved name or monograph name or, where it has no approved name or monograph name, any other descriptive appellation, and(ii)the quantity of each such ingredient contained in each unit or dose of the medicinal product or, where there is no such unit or dose, the percentage of each such ingredient contained in the medicinal product;(b)where the medicinal product contains any active ingredient that cannot be definitively identified—(i)the information as required under (a) above in respect of each identifiable active ingredient (if any), and(ii)a description of the material to which the activity of any other ingredient is ascribed and, where appropriate, a statement of the activity or potency of the medicinal product;(c)where there are no active ingredients in the medicinal product, a statement indicating the material of which that medicinal product consists. |
| 3 Uses | Principal action (if any) of the medicinal product and the purposes for which it is recommended to be used. |
| 4 Dosage and Administration | Dosage (if any) for the medicinal product together with methods and routes of administration according to species and categories within species and, where appropriate, recommendations as to diluents. |
| 5 Contra-Indications, Warnings, etc. | Contra-indications, warnings, precautions, and action to be taken in the event of overdosage (including, where required in the interests of safety, antidote, emergency procedure or other appropriate action) relating to the medicinal product and main side effects and adverse reactions likely to be associated with the product and, where necessary, measures for the protection of—(a)operators,(b)consumers of the whole or any part of a carcase or any produce of an animal to which the medicinal product has been administered, including withdrawal periods, if any, and(c)livestock, wildlife and others, unless there are no such particulars to be given and there is a statement to that effect. |
| 6 Pharmaceutical Precautions | Special requirements for the storage of medicinal products and, where appropriate, pharmaceutical precautions including recommendations as to excipients, diluents and other additives and as to suitable containers, unless there are —(a)no such requirements, or(b)no such precautions,and a statement to that effect is made. |
| 7 Legal Category | References to statutory provisions relating to sale or supply of the medicinal product. |
| 8 Package Quantities | Quantity or amount of the medicinal product in each size of package or container for retail sale, or for supply in circumstances corresponding to retail sale. |
| 9 Further Information | Such further information (if any) as may be necessary to assist the practitioner in the proper understanding, recognition, administration and use of the medicinal product, such information not covering more than one-tenth of the total surface area of the data sheet. |
| 10 Licence or Authorisation Numbers, Names and Addresses | Licence or authorisation number of the medicinal product and the name and address of the licence or authorisation holder. |
| 11 Date of Preparation or Last Review | Date of preparation of the data sheet or, where since such preparation there has been a review or revision of the data sheet, the date of the last such review or revision. |
Signed
Hayman — Minister of State, Ministry of Agriculture, Fisheries and Food — 17th August 2000
Signed by authority of the Secretary of State for Health
Hunt — Parliamentary Under Secretary of State for Health — 4th September 2000
Bairbre de Brún — Minister of Health, Social Services and Public Safety — 30th August 2000
Bríd Rodgers — Minister of Agriculture and Rural Development — 31st August 2000
Explanatory note
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Footnotes
[^f00001]: 1968 c. 67; see the definition of “prescribed” in section 132(1); “the Ministers” referred to in section 129(1) is defined in section 1 (see also the following footnote). Section 96 was applied to marketing authorisations by S.I. 1994/3142 and amended by S.I. 1995/232.
[^f00002]: In the case of the Minister of Agriculture, Fisheries and Food by virtue of articles 2(2) and 5 of, and the Schedule to, the Transfer of Functions (Medicines and Poisons) Order 1999 (S.I. 1999/3142); in the case of the Secretary of State concerned with health in England by virtue of articles 2(1) and 5 of, and the Schedule to, the Transfer of Functions (Medicines and Poisons) Order 1999; and in the case of the Minister of Health, Social Services and Public Health and the Minister of Agriculture and Rural Development by virtue of section 95(5) of, and paragraph 10(1)(b) of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) and article 3(4) and (6) of the Departments (Northern Ireland) Order 1999 (S.I. 1999/283 (N.I. 1)).
[^f00003]: By S.I. 1972/1811.
[^f00004]: 1972 c. 68.
[^f00005]: S.I. 1994/3142, to which there are amendments not relevant to these Regulations.
[^f00006]: OJ No. L317, 6.11.81, p.1.
[^f00007]: OJ No. L373, 31.12.90, p.15.
[^f00008]: OJ No L214, 24.8.93, p.31.
[^f00009]: S.I. 1972/2076; relevant amending instruments are S.I. 1981/1633, 1989/1183, 1994/3142 (which was made under section 2(2) of the European Communities Act 1972 (c. 68)), 1996/2420.
Editorial notes
[^key-5b5a468cadb9ec333a8a4c00d32f2474]: Regulations revoked (30.10.2005) by The Veterinary Medicines Regulations 2005 (S.I. 2005/2745), reg. 1(a), Sch. 8 Pt. 1 (with Sch. 8 Pt. 4)
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