Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003.

(2) These Regulations shall come into force—

(a) for the purposes of—

(i) regulation 7(2)(a)(ii) and (b), (3) and (4)(a),

(ii) regulation 8(2)(b) & (3),

(iii) regulation 9,

(iv) regulation 11, except paragraphs (2)(c)(iii)(bb) and (5), and

(v) regulation 13,

on 1st October 2003, and

(b) for all other purposes, on 31st October 2003.

(3) In these Regulations, “ the General Fees Regulations ” means the Medicines (Products for Human Use—Fees) Regulations 1995 .

Amendment of the Medicines Act 1968

2. In the Medicines Act 1968 , in section 132 (interpretation), in paragraph (1), in the definition of “ the 2001 Directive ”, after “human use”insert “ , as amended ” .

Amendment of the Standard Provisions Regulations 1971

3. In the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 —

(a) in regulation 2 (interpretation), in paragraph (1), in the definition of “the 2001 Directive”, after “human useinsert “ , as amended ” ; and

(b) in Part I of Schedule 1 (standard provisions for product licences), in paragraph 16, for “Part 4G of Annex I to the 2001 Directive” substitute “ point 6 of Part II of Annex I to the 2001 Directive ” .

Amendment of the Product Licences Regulations 1993

4. In the Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993 —

(a) in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “ the 2001 Directive ”, after “human use” insert “ , as amended ” ; and

(b) in Schedule 1 (information, documents etc. required in respect of applications)—

(i) in paragraph 17, for “Part 3, paragraph 1.1, second sub-paragraph of the Annex I to the 2001 Directive” substitute “ paragraph (9) of the Introduction and general principles of Annex I to the 2001 Directive ” , and

(ii) in paragraph 18, for “Part 4, paragraph B.2 of the Annex I to the 2001 Directive” substitute “ paragraph 5.2(a) of Part I of Annex I to the 2001 Directive ” .

Amendment of the Homoeopathic Medicinal Products for Human Use Regulations 1994

5. In the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 , in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ” .

Amendment of the Advertising Regulations 1994

6. In the Medicines (Advertising) Regulations 1994 , in regulation 1 (interpretation), in paragraph (1), in the definition of “ the 2001 Directive ”, after “human use” insert “ , as amended ” .

Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

7. —(1)The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 shall be amended as follows.

(2) In regulation 1 (citation, commencement and interpretation)—

(a) in paragraph (2)—

(i) in the definition of “ the 2001 Directive ”, after “human use” insert “ , as amended ” , and

(ii) in the definition of “ the relevant Community provisions ” —

(aa) omit “Regulation

(bb) after “Regulation

“ Regulation (EC) No. 1084/2003 , and Regulation (EC) No. 1085/2003 ; ” ; and

(b) in paragraph (4), after sub-paragraph (b) insert the following sub-paragraph—

“ (bb) any reference in these Regulations to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification; and ” .

(3) After regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products), insert the following regulation—

“ Urgent safety restrictions

6A. —(1) The licensing authority may, subject to and in accordance with the relevant Community provisions, impose an urgent safety restriction on the holder of a United Kingdom marketing authorization.

(2) Where the licensing authority imposes an urgent safety restriction in accordance with paragraph (1), the holder of the marketing authorization shall—

(a) implement the restriction within a period specified by the licensing authority; and

(b) apply to vary the authorization so as to take account of that safety restriction immediately and in any event not later than 15 days after the restriction was imposed. ” .

(4) In Schedule 3 (offences, penalties etc) —

(a) after paragraph 3 insert the following paragraph—

“ 3A. Any person who is the holder of a marketing authorization who fails to implement an urgent safety restriction imposed on him by the licensing authority under regulation 6A or by the European Commission under Commission Regulation (EC) No. 1085/2003 shall be guilty of an offence. ” ; and

(b) in paragraph 6, in sub-paragraph (c), for “paragraph D of Part 2 of Annex I to the 2001 Directive” substitute “ paragraphs 3.2(9), 3.2.1.2(c) and 3.2.2.4(c) of Part I of Annex I to the 2001 Directive ” .

Amendment of regulation 2 of the General Fees Regulations

8. —(1) Regulation 2 of the General Fees Regulations (interpretation) is amended as follows.

(2) In paragraph (1)—

(a) in the definition of “ the 2001 Directive ”, after “human use” insert “ , as amended ” ; and

(b) in the definition of “ variation ” for “Article 2.1 of Commission Regulation “ Article 3.1 of Commission Regulation .

(3) After paragraph (2) insert the following paragraph—

“ (3) In these Regulations any reference to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification. ” .

Amendment of regulation 3B of the General Fees Regulations

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Amendment of Part II of Schedule 1 to the General Fees Regulations

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Amendment of Part III of Schedule 1 to the General Fees Regulations

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Amendment of Schedule 3 to the General Fees Regulations

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Amendment of Schedule 5 to the General Fees Regulations

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