The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

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.