
2005 No. 2750
MEDICINES
The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005
Made 6th October 2005
Laid before Parliament 7th October 2005
Coming into force
Except for the purposes of paragraphs 4(2)(a) and 8(a)(i) of Schedule 7 30th October 2005
For the purposes of paragraphs 4(2)(a) and 8(a)(i) of Schedule 7 20th November 2005
The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 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
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Application of enforcement provisions of the Act
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Other Schedules to have effect
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The following Schedules shall have effect, namely Schedule 5 (labels), Schedule 6 (transitional provision) and Schedule 7 (consequential amendments to orders and regulations).
Signed by authority of the Secretary of State for Health
Warner
Minister of State,
Department of Health
6th October 2005
SCHEDULE 1
EXEMPTIONS AND EXCEPTIONS FROM THE PROVISIONS OF REGULATION 4
Regulation 4(2)
Interpretation
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7 
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SCHEDULE 2
PROCEDURAL PROVISIONS RELATING TO THE GRANT, RENEWAL, VARIATION, REVOCATION AND SUSPENSION OF TRADITIONAL HERBAL REGISTRATIONS
Regulations 6(2), 7(7)
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
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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
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Cases where suspension is to have immediate effect
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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
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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
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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
Regulation 9(6)
Offences
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Penalties
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Miscellaneous
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SCHEDULE 4
MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT
Regulation 11(2)(a)
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SCHEDULE 5
LABELS
Regulation 12
Interpretation
1 
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Introductory
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Dispensed traditional herbal medicinal products
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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
Regulation 12
1 
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SCHEDULE 7
CONSEQUENTIAL AMENDMENTS TO ORDERS AND REGULATIONS
Regulation 12
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8 
In the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003, 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”.