SCHEDULE 1MARKETING AUTHORISATIONS

PART 9Homeopathic remedies

Procedure for registrationI164

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.