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SCHEDULE 1U.K.MARKETING AUTHORISATIONS

PART 9U.K.Homeopathic remedies

Procedure for registrationU.K.

64.—(1) The procedure for registration is the same as the procedure for granting a marketing authorisation in accordance with Part 3, except—

(a)the applicant is not required to provide proof of therapeutic effect;

(b)the product shall not have a summary of product characteristics;

(c)the Secretary of State shall not publish an assessment report.

(2) The procedure for variation, suspension and revocation is the same as for a marketing authorisation.

Commencement Information

I1Sch. 1 para. 64 in force at 1.10.2006, see reg. 1