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

PART 2 PROCEDURES RELATING TO GRANT, RENEWAL, COMPULSORY VARIATION, REVOCATION OR SUSPENSION OF TRADITIONAL HERBAL REGISTRATIONS

Licensing authority proposals in other cases

11.—(1) If—

(a) the appropriate committee was consulted pursuant to paragraph 8;

(b) the committee did not give a provisional opinion under paragraph 9(1); and

(c) the licensing authority propose—

(i) to determine the application in a way which differs from the advice of the committee,

(ii) to revoke, vary or suspend a traditional herbal registration against such advice, or

(iii) on grounds not relating to safety, quality or efficacy—

(aa) not to grant or renew a traditional herbal registration,

(bb) to grant or renew a traditional herbal registration otherwise than in accordance with an application, or

(cc) to revoke, vary or suspend a traditional herbal registration,

the licensing authority shall notify the applicant or holder accordingly.

(2) If—

(a) the appropriate committee has not been consulted pursuant to paragraph 8; and

(b) the licensing authority propose, on grounds not relating to safety, quality or efficacy—

(i) not to grant or renew a traditional herbal registration,

(ii) to grant or renew a traditional herbal registration otherwise than in accordance with an application, or

(iii) to revoke, vary or suspend a traditional herbal registration,

the licensing authority shall notify the applicant or holder accordingly.

(3) A notification given under sub-paragraph (1) or (2) shall state—

(a) the advice of the appropriate committee, if any, and the reasons stated by the committee for any such advice; and

(b) the proposals of the licensing authority and the reasons for them.