Legalize / United Kingdom / Statutory-Instrument

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

Type Statutory-Instrument

Publication 2005-10-06

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

Reform history JSON API PDF

Made: 6th October 2005

Laid before Parliament: 7th October 2005

Coming into force

The Secretary of State, being a Minister designated[^f00001] for the purposes of section 2(2) of the European Communities Act 1972[^f00002] in relation to medicinal products, in exercise of the powers conferred by the said section 2(2), makes the following Regulations—

Citation, commencement and extent

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Interpretation

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Responsibility for Member States' functions in relation to traditional herbal medicinal products

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Traditional herbal registrations for traditional herbal medicinal products

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Applications for the grant or renewal of a traditional herbal registration

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Consideration, and grant or refusal, of an application for, or for renewal or variation of, a traditional herbal registration

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Revocation, suspension or variation of a traditional herbal registration or the suspension of the use or marketing of traditional herbal medicinal products

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Urgent safety restrictions

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Obligations of holders of traditional herbal registrations, and offences by holders of traditional herbal registrations and other persons

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Consequential and other amendments of the Act and other enactments

10

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Application of enforcement provisions of the Act

11

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Other Schedules to have effect

12

The following Schedules shall have effect, namely Schedule 5 (labels), Schedule 6 (transitional provision) and Schedule 7 (consequential amendments to orders and regulations).

SCHEDULE 1 — EXEMPTIONS AND EXCEPTIONS FROM THE PROVISIONS OF REGULATION 4

Interpretation

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SCHEDULE 2 — PROCEDURAL PROVISIONS RELATING TO THE GRANT, RENEWAL, VARIATION, REVOCATION AND SUSPENSION OF TRADITIONAL HERBAL REGISTRATIONS

PART 1 — INTERPRETATION AND APPLICATION

Interpretation

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Scope and application of this Schedule

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PART 2 — PROCEDURES RELATING TO GRANT, RENEWAL, COMPULSORY VARIATION, REVOCATION OR SUSPENSION OF TRADITIONAL HERBAL REGISTRATIONS

Requirement to consult the appropriate committee

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Provisional opinion against traditional herbal registration

9

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Licensing authority’s decision after appropriate committee report

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Licensing authority proposals in other cases

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Right to be heard by a person appointed or to make further representations

12

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Cases where suspension is to have immediate effect

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14

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PART 3 — VARIATION OF TRADITIONAL HERBAL REGISTRATION ON APPLICATION OF HOLDER

Hearing before appropriate committee

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Licensing authority decision

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Right to be heard by a person appointed

17

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PART 4 — REFERRAL TO THE COMMITTEE FOR HERBAL MEDICINAL PRODUCTS IN ACCORDANCE WITH ARTICLE 16C(4) OF THE 2001 DIRECTIVE

Hearing before appropriate committee

18

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Licensing authority decision

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Right to be heard by a person appointed

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PART 5 — HEARING BEFORE PERSON APPOINTED

Hearing before person appointed

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SCHEDULE 3 — OFFENCES, PENALTIES ETC

Offences

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Penalties

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Miscellaneous

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SCHEDULE 4 — MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT

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SCHEDULE 5 — LABELS

Interpretation

1

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Introductory

2

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Dispensed traditional herbal medicinal products

3

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Traditional herbal medicinal products not on a general sale list

4

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Exemptions

5

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SCHEDULE 6 — TRANSITIONAL PROVISION

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SCHEDULE 7 — CONSEQUENTIAL AMENDMENTS TO ORDERS AND REGULATIONS

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8

In the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003[^f00029], in regulation 1 (citation, commencement and interpretation), in paragraph (2)—

(a) in the definition of “unlicensed product”—

(i) in sub-paragraph (a)(ii) after “Medicinal Products” insert “or under Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”,

(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) in the definition of “the TSE Guideline” after “for human use” insert “as substituted by Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.

Signed

Signed by authority of the Secretary of State for Health

Warner — Minister of State, — Department of Health — 6th October 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[^f00030] on the Community code relating to medicinal products for human use[^f00031] (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.

Footnotes

[^f00001]: S.I. 1972/1811.

[^f00002]: 1972 c. 68.

[^f00029]: S.I. 2003/1680, regulation 1(2) was amended by S.I. 2004/3224.

[^f00030]: 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.

[^f00031]: OJ No. L136, 30.4.2004, p.85.

Editorial notes

[^key-35d660182d7f8f5a4c2ffb7f5bb92ea0]: Reg. 12 in force at 30.10.2005, see reg. 1(a)

[^key-97b4fecba39893f857c61d9258d101a2]: Sch. 7 para. 8(a)(ii)(iii)(b) in force at 30.10.2005, see reg. 1(a)

[^key-33966709922d315d6c83abdd34bd1410]: Sch. 7 para. 8(a)(i) in force at 20.11.2005, see reg. 1(b)

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