The Medicines (Advisory Bodies) (No. 2) Regulations 2005

PART 1TRANSITIONAL PROVISIONS IN RELATION TO THE GRANT, RENEWAL, REVOCATION, SUSPENSION OR VARIATION OF LICENCES UNDER THE MEDICINES ACT 1968

Licence applications or proposals where appropriate committee has given provisional opinion before 30th October 2005

1.  Paragraphs 2 to 6 apply where, before 30th October 2005—

(a)the licensing authority have, in relation to a licence, consulted a committee established under section 4 of the Act in accordance with—

(i)section 20(3) of the Act, or

(ii)paragraph 1 of Schedule 2 to the Act;

(b)the committee have sent notification to the applicant for, or holder of, that licence—

(i)under section 21(1) of the Act, that they may be unable to advise the licensing authority to grant or renew the licence, or may be unable to advise the licensing authority to grant it unless it contains provisions otherwise than in accordance with the application, or

(ii)under paragraph 2 of Schedule 2 to the Act, that they may have to advise the licensing authority that the product licence ought to be suspended, revoked or varied;

(c)the committee have not reported findings and advice to the licensing authority in relation to the application or the proposal to suspend, revoke or vary the licence.

2.—(1) This sub-paragraph applies if, before 30th October 2005, the applicant or holder—

(a)has not given notice of his wish to make written or oral representations in relation to the matters set out in the notification referred to in paragraph 1(b); or

(b)has made representations in writing in relation to those matters.

(2) If sub-paragraph (1) applies, the applicant or holder may, by 30th November 2005, give notice of his wish to make—

(a)oral representations, or

(b)written representations, or additional written representations, as the case may be,

to the appropriate committee.

(3) If the applicant or holder does not give notice in accordance with sub-paragraph (2)—

(a)the appropriate committee shall—

(i)if the applicant or holder made written representations before 30th October, take those representations into account; and

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

(b)subject to sub-paragraphs (4) and (5), the report shall be treated as if—

(i)in the case where the report relates to an application for a licence, it has been given under section 21(8)(b) of the Act, or

(ii)in the case where the report relates to a proposal to suspend, revoke or vary a licence, it has been given under paragraph 2(8)(b) of Schedule 2 to the Act.

(4) Where sub-paragraph (3)(b)(i) applies, section 21(11)(a) and (b) of the Act shall apply as if for “representations in accordance with this section” there were substituted “written representations prior to 30th October”.

(5) Where sub-paragraph (3)(b)(ii) applies, paragraph 5(4)(a) of Schedule 2 to the Act shall apply as if for the words from “in accordance with” to “Schedule” there were substituted “written representations prior to 30th October”.

3.—(1) This paragraph and paragraph (4) apply if the applicant or holder—

(a)gave notice of his wish to make written or oral representations to the appropriate committee before 30th October 2005, but has not made any such representations; or

(b)gives notice under paragraph 2(2).

(2) The applicant or holder shall, before 31st May 2006, provide the appropriate committee with—

(a)his written representations, or any additional written representations, if he provided written representations before 30th October 2005; or

(b)a summary of the oral representations he intends to make,

and any documents on which he wishes to rely in support of those representations.

(3) If the applicant or holder so requests, the appropriate committee may extend the time limit referred to in sub-paragraph (2), up to a maximum of twelve months from 30th November 2005.

(4) The applicant or holder may not submit any additional written representations or documents once the time limit referred to in sub-paragraphs (2) and (3) has expired, except with the permission of the appropriate committee.

4.—(1) When the applicant or holder has submitted the representations and documents referred to in paragraph 3(2), the appropriate committee shall—

(a)take into account the representations and documents which he has provided; and

(b)notify the applicant or holder if, on grounds which are additional to or different from those notified to him before 30th October 2005, they are of the provisional opinion that they—

(i)may be unable to advise the licensing authority to grant or renew the licence, or may be unable to advise the licensing authority to grant it unless it contains provisions in accordance with the application, or

(ii)may have to advise the licensing authority that the licence ought to be suspended, revoked or varied.

(2) If the appropriate committee give the notification referred to in sub-paragraph (1)(b)—

(a)they shall state in the notification which, if any, of the grounds notified before 30th October 2005 they consider still apply; and

(b)the provisions of—

(i)section 21(2) to (7) to the Act; or

(ii)paragraph 2(2) to (7) of Schedule 2 to the Act,

whichever is applicable, shall apply in relation to the grounds set out in the notification, including any grounds notified under paragraph (a).

5.—(1) This paragraph applies if—

(a)the appropriate committee do not give any notification under paragraph 4(1)(b); and

(b)the applicant or holder gave notice of his wish to make oral representations—

(i)before 30th October 2005; or

(ii)under paragraph 2(2).

(2) The appropriate committee shall, after receiving a written summary and any other documents in accordance with paragraph 3(2), arrange for the applicant or holder to make such representations at a hearing before the committee.

6.—(1) The appropriate committee shall—

(a)take into account such representations as are made in accordance with paragraphs 3 to 5; and

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

(2) Subject to sub-paragraphs (3) and (4)—

(a)where the report of the appropriate committee relates to an application for a licence, it shall be treated as if it has been given under section 21(8)(b) of the Act;

(b)where the report of the appropriate committee relates to a proposal to revoke, suspend or vary a licence, it shall be treated as if it had been given under paragraph 2(8)(b) of Schedule 2 to the Act.

(3) Where sub-paragraph 2(a) applies, section 21 of the Act shall apply as if, in subsection (11)(a) and (b), for “this section” there were substituted “paragraphs 3 to 5 of Part 1 of Schedule 5 to the Medicines (Advisory Bodies) (No. 2) Regulations 2005”;

(4) Where sub-paragraph 2(b) applies, paragraph 5(4) of Schedule 2 to the Act shall apply as if, in paragraph (a), for “paragraph 2(4) to (7) of this Schedule” there were substituted “paragraphs 3 to 5 of Part 1 of Schedule 5 to the Medicines (Advisory Bodies) (No. 2) Regulations 2005”.

Licence applications or proposals where appropriate committee has given advice to the licensing authority before 30th October 2005

7.  Paragraphs 8 to 11 apply where, before 30th October 2005, a committee established under section 4 of the Act have given advice to the licensing authority—

(a)that an application for the grant or renewal of a licence ought to be refused, or ought if granted to contain provisions specified in their advice; or

(b)that a licence ought to be suspended, revoked or varied.

8.—(1) This paragraph applies where the licensing authority has not, before 30th October 2005, notified the applicant for, or holder of, the licence of the advice referred to in paragraph 7.

(2) The licensing authority shall so notify the applicant or holder.

(3) The applicant or holder may, within the time allowed, give notice to the licensing authority that he wishes to make written or oral representations to the Commission with respect to that advice.

9.—(1) This paragraph applies where, before 30th October 2005, the licensing authority has notified the applicant or holder of the advice referred to in paragraph 7.

(2) If, before 30th October 2005—

(a)the applicant or holder has not given notice of his desire to be heard by, or to make written representations to, the Medicines Commission; and

(b)the period of 28 days after the service of the notification referred to in sub-paragraph (1), or such longer period as the licensing authority has allowed in the particular case, has not expired,

the applicant or holder may, by 30th November 2005, give notice to the licensing authority of his wish to make written or oral representations to the Commission.

(3) If, before 30th October 2005—

(a)the applicant or holder made written representations in relation to the advice referred to in paragraph 1(b); and

(b)those representations were made within—

(i)the period of 28 days after the service of the notification referred to in sub-paragraph (1); or

(ii)such longer period as the licensing authority had allowed,

the applicant or holder may, by 30th November 2005, give notice of his wish to make oral representations, or additional written representations, to the Commission.

10.—(1) This paragraph applies where—

(a)the applicant or holder gives the notice referred to in paragraph 8(3), or 9(2) or (3); or

(b)before 30th October 2005, the applicant or holder gave notice of his wish to make written or oral representations to the Medicines Commission, within—

(i)the period of 28 days after the service of the licensing authority’s notification referred to in paragraph 9(1), or

(ii)such longer period as the licensing authority had allowed.

(2) The applicant or holder shall, before the end of the period of six months beginning with the date of his notice referred to in sub-paragraph (1), provide the Commission with—

(a)his written representations, or any additional written representations, if he provided written representations before 30th October 2005; or

(b)a summary of the oral representations he intends to make,

and any documents on which he wishes to rely in support of those representations.

(3) If the applicant or holder so requests, the Commission may extend the time limit referred to in sub-paragraph (2), up to a maximum of twelve months from the date of the notice referred to in sub-paragraph (1).

(4) The applicant or holder may not submit any additional representations or documents when the time limit referred to in sub-paragraph (2) and (3) has expired, except with the permission of the Commission.

(5) If the applicant or holder gave notice of his wish to make oral representations, the Commission shall, after receiving a written summary and any other documents in accordance with sub-paragraph (2), arrange for the applicant to make such representations at a hearing before the Commission.

11.—(1) The Commission shall—

(a)take into account—

(i)such representations as are made in accordance with paragraph 10; or

(ii)any written representations made before 30th October 2005; and

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

(2) Subject to sub-paragraphs (3) and (4)—

(a)where the report of the Commission relates to an application for a licence, it shall be treated as if it has been given under section 21(8)(b) of the Act;

(b)where the report of the Commission relates to a proposal to revoke, suspend or vary a licence, it shall be treated as if it had been given under paragraph 2(8)(b) of Schedule 2 to the Act.

(3) Where sub-paragraph (1)(a) applies, section 21 of the Act shall apply as if, in subsection (11)(a) and (b), for “this section” there were substituted “paragraph 10 of Part 1 of Schedule 5 to the Medicines (Advisory Bodies) (No. 2) Regulations 2005, or has made written representations before 30th October 2005”;

(4) Where sub-paragraph (1)(b) applies, paragraph 5(4)(a) of Schedule 2 to the Act shall apply as if for “paragraph 2(4) to (7) of this Schedule” there were substituted “paragraph 10 of Part 1 of Schedule 5 to the Medicines (Advisory Bodies) (No. 2) Regulations 2005, or has not made written representations before 30th October 2005”.

Right to be heard by person appointed in relation to licence applications or proposals made before 30th October 2005

12.—(1) This paragraph applies where, before 30th October 2005—

(a)the Medicines Commission have reported findings and advice to the licensing authority under—

(i)section 21(4) of the Act; or

(ii)paragraph 5 of Schedule 2 to the Act; and

(b)the licensing authority have not notified the applicant or holder of its proposals following the advice of the Medicines Commission.

(2) If the licensing authority propose to determine the application or matter in a way which differs from the advice of the Medicines Commission referred to in sub-paragraph (1)(a)—

(a)the licensing authority shall notify the applicant or holder accordingly; and

(b)the applicant or holder may, within the time allowed—

(i)notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to those proposals; or

(ii)make written representations to the licensing authority.

13.—(1) This paragraph applies where, before 30th October 2005—

(a)the licensing authority have notified an applicant or holder of advice of a committee established under section 4 of the Act;

(b)the applicant did not give notice to the licensing authority that he wished to make representations to the Medicines Commission within—

(i)28 days after the service of the notification referred to in paragraph (a); or

(ii)such longer period as the licensing authority had allowed; and

(c)the licensing authority have not notified the applicant or holder of any decision.

(2) If the licensing authority—

(a)propose to determine the application; or

(b)propose to refuse to renew or revoke, vary or suspend the licence,

in a way which differs from the advice given by the committee established under section 4 of the Act, the licensing authority shall notify the applicant or holder accordingly.

(3) If the applicant or holder is so notified, he may, within the time allowed—

(a)give notice to the licensing authority of his wish to appear before and be heard by a person appointed by the licensing authority with respect to those proposals; or

(b)make written representations to the licensing authority.

14.—(1) This paragraph applies where, before 30th October 2005—

(a)the appropriate committee—

(i)have been consulted under—

(aa)section 20(3) of the Act; or

(bb)paragraph 1 of Schedule 2 to, the Act; and

(ii)have not given a provisional opinion in accordance with—

(aa)section 21(1) of the Act, or

(bb)paragraph 2 of Schedule 2 to the Act; and

(b)the licensing authority have not notified the applicant of any proposals.

(2) If the licensing authority propose to—

(a)refuse to grant or renew the licence,

(b)grant it otherwise than in accordance with the application, or

(c)revoke, vary or suspend the licence;

the licensing authority shall notify the applicant of their proposals and the reasons for them.

(3) If the applicant or holder is so notified, he may within the time allowed—

(a)notify the licensing authority that he wishes to be heard by a person appointed by the licensing authority with respect to the proposal; or

(b)make written representations to the licensing authority.

15.—(1) This paragraph applies where—

(a)before 30th October 2005, the licensing authority have consulted the appropriate committee in accordance with section 20(3) of or paragraph 1 of Schedule 2 to, the Act;

(b)the licensing authority propose to—

(i)refuse to grant or renew the licence,

(ii)grant it otherwise than in accordance with the application, or

(iii)revoke, vary or suspend the licence;

on grounds not relating to safety, quality or efficacy; and

(c)the licensing authority have not notified the applicant or holder of their proposals.

(2) The licensing authority shall notify the applicant of their proposals and the reasons for them.

(3) The applicant or holder may, within the time allowed—

(a)notify the licensing authority that he wishes to be heard by a person appointed by the licensing authority with respect to the proposal; or

(b)make written representations to the licensing authority.

16.—(1) This paragraph applies where—

(a)paragraph 8 or 9 applies;

(b)the applicant or holder does not give notice that he wishes to make representations to the Commission in accordance with paragraph 8(3), or 9(2) or (3); and

(c)the licensing authority propose to determine the application or matter in a way which differs from the advice of the committee established under section 4 of the Act.

(2) The licensing authority shall notify the applicant or holder accordingly.

(3) The applicant or holder may, within the time allowed—

(a)notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to those proposals; or

(b)make written representations to the licensing authority.

Other licensing authority proposals notified to applicant or holder before 30th October 2005

17.—(1) This paragraph applies where, before 30th October 2005—

(a)the licensing authority have notified an applicant for, or holder of, a licence of their proposals under—

(i)section 21(5) of the Act, or

(ii)paragraph 6 of Schedule 2 to the Act;

(b)the applicant or holder has not—

(i)given notice of his desire to appear before and be heard by a person appointed by the licensing authority; or

(ii)made representations in writing,

with respect to the relevant proposal; and

(c)the licensing authority has not determined the application or matter.

(2) The applicant or holder may, by 30th November 2005—

(a)notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to the proposals; or

(b)make written representations to the licensing authority.

Licence applications or proposals where there was no requirement to refer to appropriate committee before 30th October 2005

18.—(1) This paragraph applies where, before 30th October 2005—

(a)the licensing authority—

(i)have served notice on an applicant under section 22(2) of the Act that they propose to refuse to grant or renew an application for a licence, or propose to grant it otherwise than in accordance with the application; or

(ii)have served notice on the holder of a licence under paragraph 8(a) or (b) of Schedule 2 to the Act that they propose to suspend, revoke or vary a licence;

(b)the applicant or holder of the licence has not—

(i)given notice of his desire to appear before and be heard by a person appointed by the licensing authority; or

(ii)made representations in writing,

with respect to the relevant proposal;

(c)the period of 28 days after the service of the notification by the licensing authority referred to in sub-paragraph (a), or such longer period as the licensing authority has allowed in the particular case, has not expired.

(2) The applicant or holder may, by 30th November 2005—

(a)notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority;

(b)make representations in writing to the licensing authority.

Applicant has given notice of wish to appear before person appointed prior to 30th October

19.—(1) This paragraph applies where, before 30th October 2005, an applicant for, or holder of, a licence has given notice to the licensing authority of his wish to appear before, or be heard by, a person appointed by the licensing authority under—

(a)section 21(5), or 22(3) of, or

(b)paragraph 6 or 8 of Schedule 2 to,

the Act.

(2) If, before 30th October 2005, the licensing authority—

(a)have not made that appointment—

(i)they shall do so; and

(ii)the person so appointed shall not, except with the consent of the applicant or holder, be an officer or servant of any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of the Act;

(b)have made that appointment, the person appointed shall be treated as if he had been appointed under paragraph (a).

(3) Where this paragraph applies—

(a)the provisions of—

(i)section 22A of the Act; or

(ii)paragraph 7 of Schedule 2 to, the Act

shall not apply;

(b)the licensing authority shall arrange for the applicant to have an opportunity of appearing before and being heard by the person appointed;

(c)if the applicant or holder so requests—

(i)the hearing shall be in public, and

(ii)the licensing authority shall furnish to him a copy of the report of the person so appointed;

(d)the hearing before the person appointed shall be conducted in accordance with the Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986(1); and

(e)the licensing authority shall take into account the report of the person so appointed before determining the application or matter.

Notice of wish to appear before person appointed given under this Part

20.  Where, under any provision of any Part of this Schedule, an applicant or holder gives notice of his desire to be appear before and be heard by a person appointed by the licensing authority—

(a)where the matter relates to an application for a licence, the notice shall be treated as having been given under section 21(11), or 22(3) of the Act; and

(b)where the matter relates to a proposal to revoke, vary or suspend a licence, the notice shall be treated as having been given under paragraph 5(1) or 6(3)(a) of Schedule 2 to the Act.

Written representations made before 30th October 2005 or under this Part

21.  Where—

(a)before 30th October, an applicant for, or holder of, a licence made written representations to the licensing authority pursuant to—

(i)section 21(5) or 22(3) of the Act; or

(ii)paragraph 6 or 9 of Schedule 2 to the Act, but the licensing authority had not yet determined the application or matter; or

(b)an applicant or holder makes written representations to the licensing authority under any provision of this Part,

the licensing authority shall take those representations into account before determining the application or matter.

Emergency suspensions in force on 30th October 2005

22.—(1) This sub-paragraph applies where—

(a)before 30th October 2005, the licensing authority have suspended a licence under paragraph 11 of Schedule 2 to the Act; and

(b)the suspension is in effect.

(2) Where sub-paragraph (1) applies, the suspension shall be treated as if it had been made under paragraph 8 of Schedule 2 to the Act.

(3) This sub-paragraph applies where—

(a)before 30th October 2005, the licensing authority have further suspended a licence under paragraph 14 of Schedule 2 to the Act; and

(b)the suspension is in effect.

(4) Where sub-paragraph (3) applies, the suspension shall be treated as if it had been made under paragraph 11(2) of Schedule 2 to the Act.