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

Hearing before person appointed

21.—(1) If an applicant or holder of a traditional herbal registration gives notice under paragraphs 12, 17 or 20 of his wish to appear before or be heard by a person appointed by the licensing authority, the authority shall—

(a) make that appointment; and

(b) arrange for the applicant or holder to have an opportunity of appearing before that person.

(2) The person appointed—

(a) shall not be, or at any time have been, a member of—

(i) the Commission on Human Medicines or any of its Expert Advisory Groups,

(ii) the Medicines Commission formerly established under section 2 of the Act or any of its committees, or

(iii) a committee established under section 4 of the Act, or any sub-committee of such a committee; and

(b) shall not be an officer or servant of a Minister of the Crown.

(3) Subject to sub-paragraph (4), the applicant or holder shall provide the person appointed with—

(a) a written summary of the oral representations he intends to make; and

(b) any documents on which he wishes to rely in support of those representations,

before the end of the period of three months beginning with the date of the notice referred to in sub-paragraph (1).

(4) If the applicant or holder so requests, the person appointed may, after consulting the licensing authority, extend the time limit referred to in sub-paragraph (3), up to a maximum period of six months beginning with the date of the notice referred to in sub-paragraph (1).

(5) If the applicant or holder fails to comply with the time limit in sub-paragraph (3) or, where he has been granted an extended time limit under sub-paragraph (4), that time limit—

(a) he may not appear before or by heard by the person appointed; and

(b) the licensing authority shall decide whether—

(i) to confirm or alter their decision,

(ii) to refer the application to the Committee for Herbal Medicinal Products,

(iii) to grant or renew the traditional herbal registration,

(iv) to grant or renew the traditional herbal registration otherwise than in accordance with the application, or

(v) to revoke, vary or suspend the traditional herbal registration,

as the case may be.

(6) The applicant or holder may not submit any additional written representations or documents once the time limit has expired, except with the permission of the person appointed.

(7) At the hearing before the person appointed, both the applicant or holder and the licensing authority may make representations.

(8) If the applicant or holder so requests the hearing shall be in public.

(9) After the hearing—

(a) the person appointed shall provide a report to the licensing authority; and

(b) the licensing authority shall take this report into account and decide whether—

(i) to confirm or alter their decision,

(ii) to refer the application to the Committee for Herbal Medicinal Products,

(iii) to grant or renew the traditional herbal registration,

(iv) to grant or renew the traditional herbal registration otherwise than in accordance with the application, or

(v) to revoke, vary or suspend the traditional herbal registration,

as the case may be.

(10) The licensing authority shall then—

(a) notify the applicant or holder of their decision;

(b) if the applicant or holder so requests, provide the applicant or holder with a copy of the report of the person appointed.