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

Provisional opinion against traditional herbal registration

9.—(1) Where the appropriate committee are consulted under the preceding paragraph and are of the provisional opinion that, on grounds relating to safety, quality or efficacy, they—

(a) may be unable to advise the licensing authority to grant or renew the traditional herbal registration; or

(b) may be unable to advise the licensing authority to grant it unless it contains provisions otherwise than in accordance with the application; or

(c) may have to advise the licensing authority that the traditional herbal registration ought to be revoked, varied or suspended,

the appropriate committee shall notify the applicant or holder accordingly.

(2) A person who has been so notified may, within the time allowed, give notice of his wish to make written or oral representations to the appropriate committee.

(3) The appropriate committee shall give the applicant or holder an opportunity to make such representations in accordance with sub-paragraphs (4) to (7).

(4) Subject to sub-paragraph (5), the applicant or holder shall provide the appropriate committee with—

(a) his written representations or 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 six months beginning with the date of the notice referred to in sub-paragraph (2), or within such shorter period as the appropriate committee may specify in the notification under sub-paragraph (1).

(5) If the applicant or holder so requests, the appropriate committee may extend the time limit referred to in sub-paragraph (4), up to a maximum period of twelve months beginning with the date of the notice referred to in sub-paragraph (2).

(6) The applicant or holder may not submit any additional written representations or documents once the time limit referred to in sub-paragraphs (4) and (5) has expired, except with the permission of the appropriate committee.

(7) If the applicant or holder gave notice of his wish to make oral representations, the appropriate committee shall, after receiving a written summary and any other documents in accordance with sub-paragraph (4), arrange for the applicant or holder to make such representations at a hearing before the committee.

(8) The appropriate committee shall—

(a) take into account such representations as are made in accordance with this paragraph; and

(b) report their findings and advice to the licensing authority, together with the reasons for their advice.