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

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10.—(1) Section 7 of the Act (general provisions as to dealing with medicinal products) shall not apply in relation to traditional herbal medicinal products.

(2) Section 23 of the Act (special provisions as to effect of manufacturer’s licence) shall have effect as if any reference in subsection (1) to a product licence included a reference to a traditional herbal registration.

(3) Section 56 of the Act (exemptions in respect of herbal remedies) shall not apply in relation to traditional herbal medicinal products.

(4) Section 61 of the Act (special restrictions on persons to be supplied with medicinal products) shall have effect as if the reference to a product licence included a reference to a traditional herbal registration.

(5) The provisions of the Trade Descriptions Act 1968(1) shall apply to the application of a trade description to goods subject to a traditional herbal registration in the same way as, by virtue of section 2(5)(b) of that Act, they apply to the application of a trade description to goods subject to any provision made under Part V of the Act.

(6) Section 1(1) of the Medicines Act 1971(2) (fees payable for purposes of Part II of the Act) shall have effect as if the reference to any application in pursuance of the Act for a licence under Part II of the Act or for the variation or renewal of such a licence included a reference to any application under these Regulations for a traditional herbal registration or for the variation or renewal of such a registration.

(7) Section 19 of the Consumer Protection Act 1987(3) (interpretation of Part II) shall have effect as if in subsection (1) in the definition of “licensed medicinal product”, the reference to any medicinal product within the meaning of the Medicines Act 1968 in respect of which a product licence within the meaning of that Act is for the time being in force, included a reference to a traditional herbal medicinal product in respect of which a traditional herbal registration under these Regulations is for the time being in force.

(2)

1971 c. 69; section 1 was amended by section 21(1) of the Health and Medicines Act 1988 (c. 49).

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