UK Offence Report

The Medicines (Data Sheets for Veterinary Drugs) Regulations 2000 (revoked)

UK Statutory Instrument 2000 No. 2386 — creates 1 criminal offence.

1offences created
0recorded in force
0revoked
Made
4 September 2000
In force from
1 October 2000
Extent
Not stated
Subject
Drugs and medicines
Made under
European Communities Act 1972, Medicines Act 1968

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations replace the Medicines (Data Sheet) Regulations 1972 as amended in so far as they relate to data sheets for veterinary drugs. These Regulations prescribe the form of data sheets (regulation 2) and the particulars to be contained in them (regulations 3 to 6 and the Schedule) which the holder of a product licence or marketing authorisation is required under the Medicines Act 1968 to send or deliver to practitioners in connection with any advertisement or representation. These Regulations enable documents which are summaries of the product characteristics to which a marketing authorisation relates, containing the particulars prescribed by Article 5a of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ No. L317, 6.11.81, p.1), to be used as data sheets for the purposes of advertisements and representations directed to practitioners in section 96 of the Medicines Act 1968. A “marketing authorisation” is defined as one to which the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142) apply, being one which is granted pursuant to Council Directive 81/851/EEC or one pursuant to Council Regulation (EEC) No. 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ No. L214, 24.8.93, p.1). The Medicines (Data Sheet) Regulations 1972, S.I. 1972/2076, as amended, cease to apply to veterinary drugs (regulation 7). These Regulations have been notified to the European Commission and the other member states in accordance with Directive 98/34/EC of the European Parliament and of the Council (OJ No. L204, 21.7.98, p.37) as amended by Directive 98/48/EC of the European Parliament and of the Council (OJ No. L217, 5.8.98, p.18).

Offences created by this instrument

What Parliament said about it

Hansard was searched for this instrument by name and returned nothing. That is the ordinary outcome: an instrument laid under the negative procedure is usually never debated, and becomes law without a word said about it in either House.

How Parliament handled it

Parliament's Statutory Instruments service records procedure from May 2017 onwards, and this instrument predates it. That is a limit of the source, not a statement that nothing happened.

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