Citation, commencement and extent

1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interpretation

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traditional herbal registrations for traditional herbal medicinal products

4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Applications for the grant or renewal of a traditional herbal registration

5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Urgent safety restrictions

8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Consequential and other amendments of the Act and other enactments

10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application of enforcement provisions of the Act

11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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).

Regulation 4(2)

SCHEDULE 1EXEMPTIONS AND EXCEPTIONS FROM THE PROVISIONS OF REGULATION 4

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Regulations 6(2), 7(7)

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

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Regulation 9(6)

SCHEDULE 3OFFENCES, PENALTIES ETC

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Regulation 11(2)(a)

SCHEDULE 4MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT

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Regulation 12

SCHEDULE 5LABELS

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Regulation 12

SCHEDULE 6TRANSITIONAL PROVISION

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Regulation 12

SCHEDULE 7CONSEQUENTIAL AMENDMENTS TO ORDERS AND REGULATIONS

1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8. In the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003(3), 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

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

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

(b)in the definition of “the TSE Guideline” after “for human use” insert “as substituted by Commission Directive