Medicines (Products for Human Use--Fees) Amendment Regulations 1994

Publication Date:January 01, 1994
 
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1994No. 696

MEDICINES

The Medicines (Products for Human Use--Fees) Amendment Regulations 1994

10thMarch1994

11thMarch1994

1stApril1994

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 1971 ( a) or, as the case may be, those conferred by the said provisions and now vested in them ( b) and of all other powers enabling them in that behalf, with the consent of the Treasury, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations ( c), hereby make the following Regulations:

Citation, commencement and interpretation

1.-(1) These Regulations may be cited as the Medicines (Products for Human Use - Fees) Amendment Regulations 1994 and shall come into force on 1st April 1994.

(2) In these Regulations, "the principal Regulations" means the Medicines (Products for Human Use"Fees) Regulations 1991 ( d).

Amendment of the principal Regulations

2. For each amount specified in Column 3 of the Schedule to these Regulations, where it appears in the provision of the principal Regulations specified in relation to it in Column 1 of that Schedule (the subject matter of which is indicated in Column 2 of that Schedule), there shall be substituted the amount specified in relation to it in Column 4 of that Schedule.

(a) 1971 c.69; section 1(1) was amended by section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the 1971 Act expressions in that section have the same meaning as in the Medicines Act 1968 (c.67), as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388) and specified provisions of that Act, including section 129(2), (3)(c), (5) and (6), have effect as if any reference to that Act in those provisions included a reference to section 1 of the 1971 Act. The expression "the Ministers" is defined in section 1(1) of the 1968 Act as so amended.

(b) In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I 1978/272); in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c.36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to the Northern Ireland Act 1974 (c.28).

(c) See section 129(6) of the Medicines Act 1968 (c.67) as extended to include regulations made under the Medicines Act 1971 by section 1(3)(b) of that Act.

(d) S.I. 1991/1474; the relevant amending instrument is S.I. 1992/756.

Amendment of regulation 2 of the principal Regulations

3. In paragraph (1) of regulation 2 of the principal Regulations (interpretation)-

(a) after the definition of "the Act" there shall be inserted the following definition-

" "the Applications Regulations" means the Medicines (Applications for the Grant of Product Licences"Products for Human Use) Regulations 1993;" ( a); and

(b) the definition of "radiopharmaceutical" shall be omitted.

Amendment of regulation 5 of the principal Regulations

4. In regulation 5 of the principal Regulations (inspections in connection with multiple applications for licences) after "medicinal product" there shall be inserted ", or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product,".

Amendment of regulation 8 of the principal Regulations

5. In regulation 8 of the principal Regulations (inspections in connection with multiple applications for variations of licences) after "medicinal product- there shall be inserted ", or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product,".

Amendment of regulation 14 of the principal Regulations

6. For paragraph (4) of regulation 14 of the principal Regulations (periodic fees for licences) there shall be substituted the following paragraph-

"(4) No periodic fee shall be payable in respect of the licence fee period during which a licence is first granted except where that licence was granted pursuant to-

(a) a change of ownership application; or(b) an application, made no later than three months after the expiry of a licence, which is for a licence containing identical provisions to those contained in the expired licence and which is made by the person who held the expired licence,

and, in each case, a periodic fee has not been paid in respect of that licence fee period in connection with the holding of a licence for the medicinal product to which the licence relates.".

Amendment of Schedule 1 to the principal Regulations

7.-(1) Schedule 1 to the principal Regulations (capital fees for applications for, and variations to, licences and certificates) shall be amended in accordance with the following paragraphs of this regulation.

(2) In paragraph 1 of Part I-

(a) in the definition of "active ingredient", the word "therapeutic" shall be omitted and after the word "efficacy" there shall be inserted "(whether therapeutic, diagnostic or otherwise)";(b) in the definition of "complex application"-(i) for "(a) to (n)" there shall be substituted "(a) to (q)";(ii) at the end of sub-paragraph (m), "or" shall be omitted;(iii) after sub-paragraph (n), the following paragraphs shall be inserted-"(o) the application is for the grant of a product licence for a medicinal product which is to be administered by way of a metered dose inhaler;"(p) the application is for the grant of a product licence for a medicinal product which is in a powdered form and is to be administered by way of inhalation; or(q) the application relates to a medicinal product-(i) which is administered to the site of action by a different route from that used in relation to any other medicinal product which contains the same active ingredient as the product in question and,(ii) in respect of that other product, a product licence (other than a product licence of right) has previously been granted in the United Kingdom.";

(a) S.I. 1993/2538.

(c) in the definition of "simple application"-(i) after the word "means" there shall be inserted "(a)",(ii) at the end there shall be inserted-

"or (b) an application, made no later than three months after the expiry of a product licence, which is for a product licence containing identical provisions to those contained in the expired licence and which is made by the person who held the expired licence;".

(3) In Part II (capital fees for applications for licences and certificates)-

(a) in Column 1 of the Table in paragraph 1, in entry 1(a)(i) for "paragraph 5 of Chapter III of Part 3 of the Annex to Council Directive 75/318/EEC(a)" there shall be substituted " paragraph 5 of Schedule 2 to the Applications Regulations";(b) in paragraph 4-(i) in sub-paragraph (1), in the definition of "primary applicant", before "; and" there shall be inserted "or that party to a joint development who first makes an application for a product licence relating to a different dosage form or strength of that new active ingredient",(ii) at the beginning of sub-paragraph (2) there shall be inserted "Subject to sub-paragraph (3) below,",(iii) after sub-paragraph (2) there shall be inserted the following sub-paragraph (3) below,",

"(3) Where a primary applicant and one or more secondary applicants each submit an application for a product licence to the licensing authority, both or all of which applications relate to identical dosage forms and strengths of the medicinal product to which the joint development relates-

(a) where the amount payable by the primary applicant is that in respect of a complex application, the fee payable under regulation 4(a) by each secondary applicant shall be that in respect of a standard application under paragraph 1 above;(b) where the amount payable by the primary applicant is that in respect of a standard application, the fee payable under regulation 4(a) by each secondary applicant shall be that in respect of a simple application under paragraph 1 above.";(c) for sub-paragraph (2) of paragraph 7, there shall be substituted-

"(2) The fee payable under regulation 4(a) shall be £500 where an application for a wholesale dealer"s licence-

(a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounting to wholesale dealing, where such dealing constitutes no more than 15% of the total turnover of the saleof licensed medicinal products carried on at that pharmacy; or(b) does not relate to anything done in a registered pharmacy but where the applicant"s total turnover of the sale by way of wholesale dealing of licensed medicinal products does not exceed £30,000.".

(4) In Part III (capital fees for variations of licences and certificates)-

(a) in paragraph 1-(i) the word "and" after sub-paragraph (a) shall be omitted,(ii) after sub-paragraph (a) there shall be inserted-"(aa) in the case of an application relating to a product licence (parallel import) to which paragraph 3 or 4 does not apply, £325; and";(b) in paragraph 2-(i) at the beginning, there shall be inserted "Subject to paragraph 2A,",(ii) for "paragraph 5 of Chapter III of Part 3 of the Annex to Council Directive 75/318/EEC" there shall be substituted "paragraph 5 of Schedule 2 to the Application Regulations";(c) after paragraph 2, there shall be inserted the following paragraph-

"2A. Paragraph 2 shall not apply where the first...

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