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50.—(1) The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(1) 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—
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) 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(a)60% of that fee if the notice is withdrawn two weeks before the commencement of the hearing before the person appointed;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)(2), in paragraph 2—
(a)in sub-paragraph (a), for “£295” substitute “£307”; and
(b)in sub-paragraph (b), for “£386” substitute “£401”.
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.
Schedule 2A was inserted by S.I. 2005/2753 and amended by S.I. 2007/610 and 2008/552.
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