Paragraph 64 Procedure for registration
(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.