The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

UK Statutory Instrument 1994 No. 3144 — creates 14 criminal offences.

14offences created

0recorded in force

0revoked

Made: 8 December 1994
In force from: 1 January 1995
Extent: Not stated
Subject: Drugs and medicines
Made under: European Communities Act 1972

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 for the United Kingdom, and in so far as they are concerned with medicinal products for human use, the Council Directives mentioned in regulation 1(2) in the definition of “relevant Community provisions”. They also contain provisions supplementing the provisions of Council Regulation (EEC) No. 2309/93. Both the Directives and the Regulation are concerned with the marketing of medicinal products. The Regulations provide that the functions of a member state or the competent authority of a member State under the relevant Community provisions are, except as otherwise provided, to be performed in the United Kingdom by the licensing authority (ie the Ministers in the United Kingdom concerned with health and agriculture— see sections 1 and 6 of the Medicines Act 1968) (regulation 2). They also provide that no medicinal product for human use which is subject to the relevant Community provisions may be placed on the market in the United Kingdom or be dealt with by way of wholesale dealing unless there is in force in respect of it a marketing authorization granted either by the European Commission or by the licensing authority (regulation 3). Regulations 4 to 7 and Schedules 2 and 3 provide for the manner of making applications for the grant, renewal or variation of a United Kingdom marketing authorization, the procedure for the consideration of such an application, the revocation and suspension of a marketing authorization and the suspension of the use or marketing of medicinal products and the obligations of applicants for and holders of marketing authorizations. In particular regulation 7(4) and Schedule 3 create certain offences in connection with those obligations. Regulation 8 is about the control of retail sale or supply of relevant medicinal products. Regulation 9 makes consequential and other amendments to the Medicines Acts 1968 and 1971. Schedule 1 makes certain exceptions and exemptions from the requirement to hold a marketing authorization. Schedule 4 contains provisions applying with modifications the provisions of the Medicines Act 1968 about enforcement. Schedule 5 contains provisions about the labelling of medicinal products, Schedule 6 contains transitional provisions and Schedule 7 makes consequential amendments to other regulations. An assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in the libraries of both Houses of Parliament and further copies of which may be obtained from the Medicines Control Agency, Department of Health, Room 1207, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Offences created by this instrument

Any person who, in breach of the relevant Community provisions or of these Regulations, places a relevant medicinal… paragraph 1 of SCHEDULE 3 · Status not determined · Strict liability
Any person who, while employed or engaged as an appropriately qualified person responsible for pharmacovigilance for… paragraph 10 of SCHEDULE 3 · Status not determined · Strict liability
Any holder of a marketing authorization who sells or supplies or procures the sale or supply of a relevant medicinal… paragraph 11 of SCHEDULE 3 · Status not determined · Strict liability
Where, in relation to a relevant medicinal product— a the labelling of the product, or any package leaflet… paragraph 12 of SCHEDULE 3 · Status not determined · Objective fault
Any person who fails to keep any record required under paragraph 6 of Schedule 1, or to give notice or make it… paragraph 13 of SCHEDULE 3 · Status not determined · Strict liability
Miscellaneous paragraph 15(1) of SCHEDULE 3 · Status not determined · Strict liability
Any person who, in the course of a business carried on by him, sells, supplies, manufactures or assembles, or procures… paragraph 2 of SCHEDULE 3 · Status not determined · Objective fault
Without prejudice to any other sanction which may be available for the enforcement of conditions attaching to… paragraph 3 of SCHEDULE 3 · Status not determined · Strict liability
Where the use, supply or marketing of a relevant medicinal product is suspended in accordance with regulation 6 or… paragraph 4 of SCHEDULE 3 · Status not determined · Objective fault
Any person who is or, immediately before its revocation or suspension, was the holder of a marketing authorization who… paragraph 5 of SCHEDULE 3 · Status not determined · Objective fault
Any holder of a marketing authorization who fails promptly to— a update information concerning the product or any… paragraph 6 of SCHEDULE 3 · Status not determined · Strict liability
Any person responsible for placing on the market a relevant medicinal product authorized by the Community or by the… paragraph 7 of SCHEDULE 3 · Status not determined · Strict liability
Any person responsible for placing a relevant medicinal product on the market who fails to report to the licensing… paragraph 8 of SCHEDULE 3 · Status not determined · Strict liability
Any person responsible for placing a relevant medicinal product on the market who fails to make or maintain a detailed… paragraph 9 of SCHEDULE 3 · Status not determined · Strict liability

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

Dietary Supplements Commons · Commons Chamber · 10 March 1999 · Dr. Brian Iddon (Bolton, South-East)
I congratulate my hon. Friend the Member for South Derbyshire (Mr. Todd) on his timely Adjournment debate. I have nothing to declare other than an interest in the topic that has been created by workers in a factory in my constituency who make health products and by hundreds of constituents who wrote to me during the B6 saga. I do not use health products myself, although I must confess to having been brought up during world war two on a lot of spoonfuls of cod liver oil and rosehip syrup. I made a lot of pocket money by collecting rosehips from hedgerows in the fields where I used to play as…
Health And Social Care (Community Health And Standards) Bill Lords · Lords Chamber · 20 October 2003
"28TA GMS CONTRACTS: PRESCRIPTION OF DRUGS ETC (1) A general medical services contract must contain provision requiring the contractor or contractors to comply with any directions given by the appropriate authority for the purposes of this section as to the drugs, medicines or other substances which may or may not be ordered for patients in the provision of medical services under the contract. (2) A direction under this section must, subject to subsection (3), be given by regulations. (3) A direction under this section may be given by an instrument in writing where it gives effect to a…
Government of Wales Bill Commons · Commons Chamber · 23 January 2006 · The Chairman of Ways and Means (Sir Alan Haselhurst)
With this it will be convenient to discuss the following: New schedule 1— 'RESERVED MATTERS— PART 1 GENERAL RESERVATIONS The Constitution 1 The following aspects of the constitution are reserved matters, that is— (a) the Crown, including succession to the Crown and a regency, (b) the Parliament of the United Kingdom, (c) the continued existence of the High Court of Justiciary as a criminal court of first instance and of appeal, (d) the continued existence of the Court of Session as a civil court of first instance and of appeal. 2 (1) Paragraph 1 does not reserve— (a) Her Majesty's…

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