SCHEDULE 2PROCEDURAL PROVISIONS RELATING TO THE GRANT, RENEWAL, VARIATION, REVOCATION AND SUSPENSION OF TRADITIONAL HERBAL REGISTRATIONS

PART 1INTERPRETATION AND APPLICATION

Scope and application of this Schedule2

Subject to paragraphs 6 and 7, Part 2 applies to—

a

any application for the grant of a traditional herbal registration for a traditional herbal medicinal product except one made pursuant to the procedure in Article 28 of the 2001 Directive;

b

any application to renew a traditional herbal registration for a traditional herbal medicinal product; and

c

any proposal to revoke, vary or suspend a traditional herbal registration for a traditional herbal medicinal product, other than a variation on the application of the holder of that traditional herbal registration.