Paragraph 64 Procedure for registrationI1

United Kingdom

(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.

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