The Medicines (Products for Human Use) (Fees) Regulations 2009 (revoked)

Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 U.K.

50.—(1) The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M1 are amended as follows.

(2) In regulation 14 (fees for variation of certificates)—

(a) in paragraph (1)(a), for “£127” substitute “ £132 ”;

(b) in paragraph (1)(b)(i), for “£127” substitute “ £132 ”;

(c) in paragraph (1)(b)(ii), for “£63.50” substitute “ £66 ”;

(d) in paragraph (2)(a), for “£250” substitute “ £260 ”;

(e) in paragraph (2)(b)(i), for “£250” substitute “ £260 ”;

(f) in paragraph (2)(b)(ii), for “£250” substitute “ £260 ”;

(g) in paragraph 2(b)(iii), for “£127” substitute “ £132 ”; and

(h) in paragraph 2(b)(iv), for “£62.50” substitute “ £66 ”.

(3) In regulation 15 (fees payable by holders of certificates), in paragraph (1), for “£22” substitute “ £23 ”.

(4) After regulation 15, insert—

“Fee for a person appointed hearing

15A.— (1) The fee payable by an applicant or holder of a certificate of registration who gives notice under paragraph 12 of Schedule 5 of their wish to appear before or be heard by a person appointed by the licensing authority is £10,000.

(2) (2) The licensing authority will refund to that applicant or holder—

(a) 60% of that fee if the notice is withdrawn two weeks before the commencement of the hearing before the person appointed;

(b) 100% of that fee if the decision notified by the licensing authority in accordance with paragraph 12(10) of Schedule 5 is—

(i) not to revoke, vary or suspend the certificate of registration; or

(ii) to grant or renew the certificate of registration.

(3) The fee prescribed in paragraph (1) is payable at the time the notice is given.”.

(5) In the table in Schedule 2 (fees for applications for the grant of certificates of registration)—

(a) in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—

(i) for “£164” substitute “ £171 ”;

(ii) for “£492” substitute “ £512 ”;

(iii) for “£516” substitute “ £537 ”; and

(iv) for “£813” substitute “ £846 ”.

(b) in column (3) (fees for other applications)—

(i) for “£405” substitute “ £421 ”;

(ii) for “£725” substitute “ £754 ”;

(iii) for “£657” substitute “ £683 ”; and

(iv) for “£1,064” substitute “ £1,107 ”.

(6) In Schedule 2A (fees for assistance in obtaining certificates of registration in other EEA States) M2 , in paragraph 2—

(a) in sub-paragraph (a), for “£295” substitute “ £307 ”; and

(b) in sub-paragraph (b), for “£386” substitute “ £401 ”.

Marginal Citations

M1 S.I. 1994/105; relevant amending instruments are S.I. 1996/482, 1998/574, 1999/566, 2003/625, 2005/2753, 2006/494, 2007/610 and 803 and 2008/552.

M2 Schedule 2A was inserted by S.I. 2005/2753 and amended by S.I. 2007/610 and 2008/552.