UK Offence Report

The Medicines (Standard Provisions for Manufacturer’s Licences for Veterinary Medicinal Products) Regulations 1994

UK Statutory Instrument 1994 No. 2852 — creates 1 criminal offence.

1offences created
0recorded in force
0revoked
Made
26 October 1994
In force from
1 December 1994
Extent
Not stated
Subject
Drugs and medicines
Made under
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 implement Articles 27, 29 to 33, 35 and 37 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), amended by Council Directive 90/676/ EEC (OJ No. L373, 31.12.90, p.15) and Council Directive 93/40/EEC (OJ No. L214, 24.8.93, p.31), and implement Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ No. L228, 17.8.91, p.70). They prescribe by standard provisions for manufacturer’s licences for veterinary medicinal products the requirements of Council Directive 81/851/EEC including the requirements in connection with the Qualified Person (regulations 4 to 7), and the provisions as to good manufacturing practice set out in Commission Directive 91/412/ EEC (regulation 8). The standard provisions for manufacturer’s licences prescribed by the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (S.I. 1971/972), as amended, are superseded by these Regulations in so far as those provisions apply to manufacturer’s licences for veterinary medicinal products (regulation 9). A Compliance Cost Assessment has been prepared and a copy has been placed in the library of each House of Parliament.

Offences created by this instrument

What Parliament said about it

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