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

Explanatory Note

(This note is not part of the Regulations)

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(1) on the Community code relating to medicinal products for human use(2) (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.

(1)

Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community code relating to medicinal products for human use, OJ L311, 28.11.2001, p 67.

(2)

OJ No. L136, 30.4.2004, p.85.