The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

UK Statutory Instrument 2005 No. 2750 — creates 23 criminal offences.

23offences created

0recorded in force

0revoked

Made: 6 October 2005
In force from: 30 October 2005
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 Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (the “2001 Directive”). Directive 2004/24/EC amended the 2001 Directive to introduce a simplified registration procedure for the marketing of traditional herbal medicinal products for human use. These Regulations introduce a scheme of traditional herbal registrations (defined in Regulation 2). Regulation 3 provides that the licensing authority established under section 6 of the Medicines Act 1968 (consisting of the Secretary of State for Health, the Secretary of State for Environment and Rural Affairs, and the Northern Ireland Department for Health, Social Services and Public Safety and the Northern Ireland Department for Agriculture and Rural Development) will perform the functions of the competent authority in relation to the provisions of the 2001 Directive which apply to traditional herbal medicinal products. Regulation 4(1) requires all traditional herbal medicinal products placed on the market or distributed by wholesale dealing to be registered in accordance with these Regulations. Regulation 4(2) and Schedule 1 set out exemptions under which traditional herbal medicinal products may be supplied or administered without a traditional herbal registration provided the conditions set out in Schedule 1 are complied with. In particular, doctors, dentists and supplementary prescribers may prepare, or order to be prepared, traditional herbal medicinal products to be used by their individual patients. Regulations 5 to 7 and Schedule 2 make provision for applications for the grant, renewal and variation of traditional herbal registrations, and for the licensing authority to revoke, vary or suspend traditional herbal registrations. In particular, Schedule 2 makes provision for reference to the appropriate committee of decisions to refuse traditional herbal registrations, proposals to refer applications in certain circumstances to the Committee for Herbal Medicinal Products, and to revoke, vary or suspend a registration. Regulation 8 makes provision for the licensing authority to impose an urgent safety restriction on the holder of a traditional herbal registration. Regulation 9 imposes obligations on the holders of traditional herbal registrations. Regulations 9(6) and 11 and Schedules 3 and 4, make provision for enforcement and related matters, including powers of inspection, offences and penalties for breaches of the Regulations. Regulation 12 and Schedule 5 impose labelling requirements for traditional herbal medicinal products which are prepared or dispensed in accordance with a prescription, or available only from a pharmacy. Regulations 10 and 12 and Schedules 6 and 7, contain miscellaneous provisions for the consequential amendment of legislation and for transitional arrangements. A Regulatory Impact Assessment in relation to these Regulations, and a Transposition Note in relation to the implementation of Directive 2004/24/EC, have been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Offences created by this instrument

Any person who, in breach of these Regulations, places a traditional herbal medicinal product on the market without… paragraph 1 of SCHEDULE 3 · Status not determined · Strict liability
Any person who is the holder of a traditional herbal registration who fails to ensure appropriate and continued… paragraph 10 of SCHEDULE 3 · Status not determined · Strict liability
Any holder of a traditional herbal registration who communicates to the general public information relating to… paragraph 11 of SCHEDULE 3 · Status not determined · Strict liability
Any holder of a traditional herbal registration who fails to ensure that information relating to pharmacovigilance… paragraph 12 of SCHEDULE 3 · Status not determined · Strict liability
Any person responsible for placing on the market a traditional herbal medicinal product authorised by the licensing… paragraph 13 of SCHEDULE 3 · Status not determined · Strict liability
Any person responsible for placing a traditional herbal medicinal product on the market who fails to report to the… paragraph 14 of SCHEDULE 3 · Status not determined · Strict liability
Any person responsible for placing a traditional herbal medicinal product on the market who fails to make or maintain… paragraph 15 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 16 of SCHEDULE 3 · Status not determined · Strict liability
Any person who in the course of an application for the grant, renewal or variation of a traditional herbal… paragraph 17(1) of SCHEDULE 3 · Status not determined · Strict liability
Any person who— a is responsible for placing a traditional herbal medicinal product on the market; b is the… paragraph 17(2) of SCHEDULE 3 · Status not determined · Strict liability
Any holder of a traditional herbal registration who sells or supplies or procures the sale or supply of a traditional… paragraph 18 of SCHEDULE 3 · Status not determined · Strict liability
Where, in relation to a traditional herbal medicinal product — a the labelling of the product, or any package leaflet… paragraph 19 of SCHEDULE 3 · Status not determined · Objective fault
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
Any person who fails to keep any record required under paragraph 6 of Schedule 1, or to give notice or make it… paragraph 20 of SCHEDULE 3 · Status not determined · Strict liability
Any person who— a sells or supplies a traditional herbal medicinal product in accordance with any of paragraphs 2 to 5… paragraph 21 of SCHEDULE 3 · Status not determined · Strict liability
Miscellaneous paragraph 23(1) of SCHEDULE 3 · Status not determined · Strict liability
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
Any person who is the holder of a traditional herbal registration who fails to implement an urgent safety restriction… paragraph 4 of SCHEDULE 3 · Status not determined · Strict liability
Where the use, supply or marketing of a traditional herbal medicinal product is suspended in accordance with… paragraph 5 of SCHEDULE 3 · Status not determined · Objective fault
Any person who is or, immediately before its revocation or suspension, was the holder of a traditional herbal… paragraph 6 of SCHEDULE 3 · Status not determined · Objective fault
Any holder of a traditional herbal registration who fails promptly to— a take any steps reasonably necessary to take… paragraph 7 of SCHEDULE 3 · Status not determined · Strict liability
Any holder of a traditional herbal registration who fails to forward to the licensing authority any data requested by… paragraph 8 of SCHEDULE 3 · Status not determined · Strict liability
Any holder of a traditional herbal registration who fails to forward to the licensing authority any data requested by… paragraph 9 of SCHEDULE 3 · Status not determined · Strict liability

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.

Check the source

This instrument on legislation.gov.uk The authoritative text, including amendments made since
Other instruments from 2005