Citation, commencement and extent

^F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interpretation

^F12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

^F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traditional herbal registrations for traditional herbal medicinal products

^F14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Applications for the grant or renewal of a traditional herbal registration

^F15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

^F16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

^F17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Urgent safety restrictions

^F18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

^F19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Consequential and other amendments of the Act and other enactments

^F110. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application of enforcement provisions of the Act

^F111. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other Schedules to have effect_I1

12.[^F1The following Schedules shall have effect, namely Schedule 5 (labels), Schedule 6 (transitional provision) and Schedule 7 (consequential amendments to orders and regulations).^F1]

Regulation 4(2)

^F1SCHEDULE 1EXEMPTIONS AND EXCEPTIONS FROM THE PROVISIONS OF REGULATION 4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulations 6(2), 7(7)

^F1SCHEDULE 2PROCEDURAL PROVISIONS RELATING TO THE GRANT, RENEWAL, VARIATION, REVOCATION AND SUSPENSION OF TRADITIONAL HERBAL REGISTRATIONS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation 9(6)

^F1SCHEDULE 3OFFENCES, PENALTIES ETC

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation 11(2)(a)

^F1SCHEDULE 4MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation 12

^F1SCHEDULE 5LABELS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation 12

^F1SCHEDULE 6TRANSITIONAL PROVISION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation 12

SCHEDULE 7CONSEQUENTIAL AMENDMENTS TO ORDERS AND REGULATIONS_I2,I3

^F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 (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”,

^F1(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F1(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”.