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The Human Medicines Regulations 2012
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Registrations granted under Chapter 4 of Title III of the 2001 Directive
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139.—(1) Regulations 135 to 138 do not apply in relation to a traditional herbal registration that—
(a)was granted in accordance with the provisions of Chapter 4 of Title III of the 2001 Directive (mutual recognition procedure and decentralised procedure); or
(b)was subject to the procedure laid down in Articles 32 to 34 of the 2001 Directive following a referral under Article 30 or 31 of that Directive, unless the procedure was limited to certain specific parts of the registration.
(2) A proposal by the licensing authority to vary, suspend or revoke a traditional herbal registration within paragraph (1), or an application by the holder of such a registration to vary or revoke it, is to be determined in accordance with Chapter 4 of Title III of the 2001 Directive.
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