
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.
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”.
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 use” insert “, 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”.
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”.
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”.
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”.
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 (EC) No. 541/95, as amended” and “Regulation (EC) No. 542/95, as amended”, and(bb) after “Regulation (EC) No. 847/2000” insert the following entries—“
 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—“
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”.
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 (EC) No. 541/95” substitute “Article 3.1 of Commission Regulation (EC) No. 1084/2003”.
(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.”.
9 
In regulation 3B of the General Fees Regulations, after “an EC marketing authorization” insert “or an application for the variation of a marketing authorization”.
10 
In Part II of Schedule 1 of the General Fees Regulations (capital fees for applications for authorizations, licences and certificates), in paragraph 1, in sub-paragraph (1), in column 1 of the Table, in head (a) of entry 1, for “Section G of Part 4 of Annex I to the 2001 Directive” substitute “point 6 of Part II of Annex I to the 2001 Directive”.
11 

(1) Part III of Schedule 1 of the General Fees Regulations (capital fees for applications for variations of authorizations, licences and certificates) is amended as follows.
(2) In paragraph 1—
(a) before the definition of “reclassification variation application” insert the following definition—“
 “Extended Type II Complex Variation Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) so that the medicinal product is indicated for use—
(a) in a therapeutic area for which the product was not previously indicated for use, or
(b) in respect of an organ, or any other part, of the human body for which the product was not previously indicated for use, if the application is supported by data which comprises or includes the results of clinical trials or physico-chemical, microbiological or pharmacological and toxicological tests;”;
(b) for the definitions of “Type I Application” and “Type II Application” substitute the following definitions—“
 “Type IA Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation” of Type IA within the meaning of Article 3.2 of Commission Regulation (EC) No. 1084/2003;
 “Type IB Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation” of Type IB within the meaning of Article 3.2 of Commission Regulation (EC) No. 1084/2003;
 “Type II Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is not—
(a) a reclassification variation,
(b) a Type IA Application,
(c) a Type IB Application,
(d) a Type II Complex Variation Application,
(e) an Extended Type II Complex Variation Application, or
(f) a change to which Annex II to Commission Regulation (EC) No. 1084/2003 applies;”; and
(c) in the definition of “Type II Complex Variation Application”—
(i) after “variation of a marketing authorization” insert “, other than an Extended Type II Complex Variation Application,”,
(ii) in paragraph (a), for “paragraph 3 (changes to strength, pharmaceutical form and route of administration) of Annex II to Commission Regulation (EC) No. 541/95” substitute “paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex II to Commission Regulation (EC) No. 1084/2003”,
(iii) in paragraph (b)—(aa) for “article 3.1(b) of Commission Regulation (EC) No. 541/95” substitute “Article 3.3 of Commission Regulation (EC) No. 1084/2003”, and(bb) in sub-paragraph (ii), for “Section H of Part IV of Annex I to the 2001 Directive” substitute “paragraph 5.2.6 of Part I of Annex I to the 2001 Directive”, and
(iv) in paragraph (c), in sub-paragraph (ii), for the words from “the change is not a minor variation” to the end substitute “the change is not a variation which satisfies conditions 1, 3 and 4 specified in point 14 of Annex I to Commission Regulation (EC) No. 1084/2003 (change in the manufacturer of the active substance or starting material/reagent/intermediate in the manufacturing process of the active substance where no European Pharmacopoeia certificate of suitability is available)”.
(3) In paragraph 2—
(a) for sub-paragraph (a) substitute the following sub-paragraphs—“
(a) where the application is a Type IA Application, £140;
(aa) where the application is a Type IB Application, £214;”; and
(b) after sub-paragraph (c) insert the following paragraph—“
(cc) where the application is an Extended Type II Complex Variation Application, £21,990;”.
(4) In paragraph 3—
(a) for “Commission Regulation (EC) No. 541/95” substitute “Commission Regulation (EC) No. 1084/2003”;
(b) for “Article 2.2” substitute “Article 3.4”;
(c) for sub-paragraph (a) substitute the following sub-paragraphs—“
(a) where the application is a Type IA Application, £220;
(aa) where the application is a Type IB Application, £334;”; and
(d) at the end of sub-paragraph (c) insert—“
 ; and
(d) where the application is an Extended Type II Complex Variation Application, £30,738.”.
(5) In paragraphs 4 and 5, for “Section G of Part 4 of Annex I to the 2001 Directive”, in both places those words appear, substitute “point 6 of Part II of Annex I to the 2001 Directive”.
(6) In paragraph 14, after “Type II Complex Variation Application” insert “or Extended Type II Complex Variation Application”.
12 
In Schedule 3 of the General Fees Regulations (periodic fees for licences), in Part I (interpretation), in paragraph 1, in the definition of “limited use drug”, for “Section G of Part 4 of Annex I to the 2001 Directive” substitute “point 6 of Part II of Annex I to the 2001 Directive”.
13 

(1) Schedule 5 to the General Fees Regulations (waiver, reduction or refund of capital fees) is amended as follows.
(2) After paragraph 1, insert the following paragraph—“
1A. 

(1) Where the licensing authority holds a meeting with a person for the purpose of providing scientific advice and that meeting was held—
(a) at the request of the authority; or
(b) with a view to that person making—
(i) an application for a marketing authorization which includes a reclassification element within the meaning of paragraph 1A of Part II of Schedule 1, or
(ii) a reclassification variation application within the meaning of paragraph 1 of Part III of Schedule 1,
the fee payable under regulation 3B may be waived.
(2) In this paragraph, “scientific advice” has the meaning given by regulation 3A.”.
(3) In paragraph 2, after “the licensing authority” insert “or in response to the imposition of an urgent safety restriction under regulation 6A of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994”.
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
5th September 2003Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
D.C. Gowdy
Permanent Secretary,
Department of Health, Social Services and Public Safety
5th September 2003Sealed with the Official Seal of the Department of Agriculture and Rural Development
Pat Toal
Permanent Secretary,
Department of Agriculture and Rural Development
5th September 2003We consent,
Nick Ainger
Joan Ryan
Two of the Lords Commissioners of Her Majesty’s Treasury
8th September 2003