MEDICINES 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 . 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. 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; ; 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. ; 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 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 application for variation of the product licence relates to a particular therapeutic area in respect of which the applicant would be entitled (had he not already held a product licence) to apply for a product licence without, under paragraph 5 of Schedule 2 to the Applications Regulations, having to provide the results of tests or trials in accordance with paragraph 8 of Schedule 1 to those Regulations . Amendment of Schedule 2 to the principal Regulations 8 1 Schedule 2 to the principal Regulations (fees for inspections) shall be amended in accordance with the following paragraphs of this regulation. 2 After sub-paragraph (2) of paragraph 1 the following sub-paragraph shall be inserted— 3 Any reference in sub-paragraphs (1) and (2) above to the manufacture or assembly of medicinal products includes a reference to the preparation of substances which are used in the manufacture of an immunological product or a blood product. . 3 In sub-paragraph (1) of paragraph 2A, for “facilities” there shall be substituted “operations”. Amendment of Schedule 3 to the principal Regulations 9 1 Schedule 3 to the principal Regulations (periodic fees for licences) shall be amended in accordance with the following paragraphs of this regulation. 2 In Part I (interpretation), in the definition of “limited use drug”in paragraph 1, for the words “paragraph 5 of Chapter III of Part 3 of the Annex to the Council Directive 75/318/EEC ” there shall be substituted “paragraph 5 of Schedule 2 to the Applications Regulations”. 3 In Part III (periodic fees for licences)— a in paragraph 4, for sub-paragraph (4) there shall be substituted the following sub-paragraph— 4 Where a product licence is surrendered and at the same time another product licence held by the licence holder is varied so as to include in that other licence the provisions of the surrendered licence— a where the varied licence relates to a new active substance, the fee payable in respect of the varied licence shall, for each fee period mentioned in sub-paragraph (1) above, be that specified at entry 1 of the Table in paragraph 1; b in all other cases, the fee payable in respect of the varied licence shall, for each fee period mentioned in sub-paragraph (3) above, be that specified at entry 2(a) of that Table. ; b in sub-paragraph 2(a) of paragraph 8, after “that pharmacy” there shall be inserted “or, where the licence does not relate to anything done in a registered pharmacy, where the licence holder’s total turnover of the sale by way of wholesale dealing of licensed medicinal products does not exceed £30,000.”. Amendment of Schedule 5 to the principal Regulations 10 In paragraph 2 of Schedule 5 to the principal Regulations (waiver, reduction or refund of capital fees)— a in sub-paragraph (1), for “sub-paragraph (2),” there shall be substituted “sub-paragraphs (1A) and (2) below,”; b after sub-paragraph (1) the following sub-paragraph shall be inserted— 1A Where paragraph (1)(a) applies and the fee otherwise payable under regulation 4(a), 7(a) or 10 exceeds £15,000, the amount of the refund or the amount waived shall be the difference between that fee and £1,500, rather than 90% of that fee. . Revocation 11 The following provisions shall be revoked— a Part IIIA (that is, regulation 9A) (capital fees for renewals of certain product licences) of, and paragraph 2A of Schedule 4 (time for payment of capital fees—applications made by small companies) to, the principal Regulations, and b regulations 4 (insertion of Part IIIA into the principal Regulations) and 11 (amendment of Schedule 4 to the principal Regulations) of the Medicines (Products for Human Use-Fees) Regulations 1992 . Signed by authority of the Secretary of State for Health Tom Sackville Parliamentary Under Secretary of State, Department of Health 4th March 1994 John Redwood Secretary of State for Wales 7th March 1994 Fraser of Carmyllie Minister of State, The Scottish Office 9th March 1994 In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on Gillian Shephard Minister of Agriculture, Fisheries and Food 7th March 1994. Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on F. A. Elliott Permanent Secretary 7th March 1994. Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on J. Murray Permanent Secretary 7th March 1994. We consent, Irvine Patnick Tim Wood Two of the Lords Commissioners of Her Majesty’s Treasury 10th March 1994