MEDICINES Citation, commencement and scope 1 1 These Regulations may be cited as the Medicines (Products for Animal Use — Fees) Regulations 1995 and shall come into force on 29th September 1995. 2 These Regulations apply only to fees relating to products for animal use. Interpretation 2 1 In these Regulations, unless the context requires otherwise— “abridged standard application” means an application for a marketing authorisation, other than a simple application, which, by virtue of regulation 4(8) of the 1994 Regulations , need not be accompanied by the results of tests and trials of the type specified in Article 5.10 of Directive 81/851/EEC because the applicant has demonstrated that he is entitled to the benefit of paragraph (a)(i), (ii) or (iii) of that Article; “ the Act ” means the Medicines Act 1968 ; “active ingredient” means the ingredient of a product in respect of which efficacy is claimed; “application for assistance in connection with a mutual recognition application” means a request for the preparation of an assessment report of the type required by virtue of the second paragraph of Article 17.3 of Directive 81/851/EEC in order to make an application to another member State for mutual recognition of a marketing authorisation, or the updating of an existing assessment report for the purpose of enabling such an application to be made, and includes any assistance given of the type specified in Articles 18.2 and 18.3 of that Directive in connection with a subsequent application for mutual recognition in relation to which the assessment report or updated assessment report has been prepared; “biological product” includes an antigen, toxin, antitoxin, toxoid, serum, antiserum or vaccine or a fraction of any such product; “complex application” means an application, other than a major application, for, or for a variation of, a marketing authorisation, product licence or animal test certificate where the application— relates to a product which is intended to be used in accordance with an indication for use in respect of a different species of animal or as treatment for a new medicinal purpose; relates to a product containing a new combination of active ingredients which have not previously been included in that combination in a product in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; relates to a product containing a new adjuvant or a new excipient; relates to a product which is intended to be administered by a route of administration different from that used in the administration of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or a product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; relates to a sterile product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; relates to a product containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; relates to a biological product containing an active ingredient, the manufacture of which involves a growth substrate different from that used in the manufacture of the active ingredient of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence has previously been granted in the United kingdom; relates to a product which is a controlled release preparation and a marketing authorisation or product licence for animal use (other than a product licence of right) for such a preparation constituting the same active ingredient as the product in question has not previously been granted in the United Kingdom; relates to a sterile product the container of which is directly in contact with the product and is made from different material from the container of any product which contains the same ingredient as the product in question and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; names as manufacturer of the active ingredient of the product in question a different manufacturer from the manufacturer of the active ingredient of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously ben granted in the United Kingdom; or relates to a biological product containing an active ingredient derived from a strain of micro-organism different from that used in the manufacture of the active ingredient of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence has previously been granted in the United Kingdom; “Directive 81/851/EEC” means Council Directive 81/851/ EEC on the approximation of the laws of the Member States relating to veterinary medicinal products as amended by Council Directives 90/676/EEC and 93/40/EEC and as extended by Directive 90/677/EEC and widened by Directive 92/74/EEC ; “Directive 90/677/EEC” means Council Directive 90/677/EEC extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products; “Directive 92/74/EEC” means Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products; “emergency vaccines” means vaccines manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated in circumstances in which no other suitable authorised or licensed vaccines are readily available for such use; “immunological Veterinary Medicinal Product” has the same meaning as in Directive 90/677/EEC; “major application” means an application for a marketing authorisation or product licence in respect of a product containing a new active ingredient; “marketing authorisation” means an authorisation to place on the market in the United Kingdom a Veterinary Medicinal Product but shall not include a marketing authorisation granted by the European Commission under Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products ; “medicinal product” includes any substances or article specified in any Order made under— section 104 or 105(1)(a) of the Act which directs that Part II of the Act shall have effect in relation to such substance or article; or section 130(3A) of the Act which provides that such substance or article shall be treated as a medicinal product, and includes any substance or article to be administered in a medical test on animals under section 32(6)(c) of the Act; “the Ministers” has the meaning given by regulation 1(4) of the 1994 Regulations; “mutually recognised marketing authorisation” means a marketing authorisation which has been mutually recognised by another member State; “new active ingredient” means— an active ingredient that has not previously been included as an active ingredient in a product in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; or an active ingredient in a product derived from genetically engineered micro-organisms, recombinant DNA technology or monoclonal antibodies; or in the case of a biological product, a vaccine of a particular micro-organism whether in a live or inactivated form, other than a vaccine of a particular micro-organism which is derived from a strain of micro-organism which is antigenetically similar to that used in the manufacture of the active ingredient of a product in respect of which a marketing authorisation or product licence (not being a product licence of right) has previously been granted in the United Kingdom; “new excipient” means any ingredient of a product, other than an active ingredient, that has not previously been included in a product— which is intended to be administered by the same route of administration as that product; and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom, except that, in the case of a product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation) as an approved ingredient or additive— in food or food products; or in animal feedingstuffs where that product is intended for administration after being incorporated in the feedingstuff; “previously” means previously by virtue of the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1994 as read, in the case of marketing authorisations, with regulation 15 of the 1994 Regulations; “product” means— a Veterinary Medicinal Product, where it is used solely in relation to an application for, or relating to, a marketing authorisation; and a medicinal product where it is used solely in relation to any other application; except that, where it is used in relation to both an application for, or relating to, a marketing authorisation and any other application, it shall mean both a Veterinary Medicinal Product and a medicinal product; “reference member State” has the meaning given by Article 2.2 of Regulation (EC) No. 541/95 ; “Regulation (EC) No. 541/95” means Commission Regulation ( EC ) No 541/95 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State; “the 1994 Regulations” means the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 ; “relevant authority” insofar as it is used in relation to a marketing authorisation, or an application for, or relating to, such an authorisation, means the Ministers, and otherwise means the licensing authority; “simple application” means an application for a marketing authorisation or product licence when the application— is made by reference to an application for a particular product (“the existing product”) in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted; is made by permission of the marketing authorisation or licence holder for the existing product; relates to a product which is in all the following respects the same as the existing product— the formulation is identical; it is intended to be used in accordance with the same indications; it is intended to be administered by the same route of administration; the manufacturer named in the application is the same as the manufacturer of the existing product; the method of manufacture is the same; and in the case of a sterile product the method of sterilisation is the same and the container which is directly in contact with the product is made from the same material; “standard application” means an application which is not a major, complex, abridged standard or simple application; and “Veterinary Medicinal Product” means a veterinary medicinal product of the type specified in Article 1.2 of Directive 81/851/EEC and to which the provisions of that Directive apply. 2 Other expressions used in these Regulations have, in so far as the context admits, the same meanings as in Directive 81/851/EEC and Regulation (EC) No. 541/95. 3 In these Regulations, unless the context otherwise requires— a any reference to a numbered regulation or to a numbered Schedule is a reference to the regulation of or the Schedule to these Regulations so numbered in these Regulations; b any reference in a regulation or a Schedule or Part of a Schedule to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule or Part of a Schedule in which the reference occurs; and c any reference in a Schedule or Part of a Schedule to a lettered table is a reference to the table so lettered in the Schedule or Part of a Schedule in which the reference occurs. 4 Part 1 of Schedule 1 shall have effect for the purpose of the interpretation of Schedule 1. Fees relating to applications for the grant of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates 3 Subject to the following provisions of these Regulations, there shall be payable by the applicant in connection with an application for the grant of a marketing authorisation, a product licence, a manufacturer’s licence, a wholesaler dealer’s licence or an animal test certificate the relevant fee prescribed in Part II of Schedule 1. Fees relating to applications for assistance in connection with mutual recognition applications 4 Subject to the following provisions of these Regulations, there shall be payable by the applicant in connection with an application for assistance in connection with a mutual recognition application the relevant fee prescribed in Part III of Schedule 1. Fees relating to applications for the variation of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates 5 Subject to the following provisions of these Regulations, there shall be payable by the applicant in connection with an application for the variation of a marketing authorisation, a product licence, a manufacturer’s licence, a wholesale dealer’s licence or an animal test certificate the relevant fee prescribed in Part IV of Schedule 1. Applications relating to multiple variations 6 A separate fee shall be payable in respect of each variation of each provision of a marketing authorisation, licence or certificate applied for in any one application except that no separate fee shall be payable in respect of any variation which is related to or is consequential upon another variation of a provision of the same marketing authorisation, licence or certificate in the same application. Variations at the invitation of the relevant authority 7 No fee shall be payable for a variation made at the express written invitation of the relevant authority. Fees relating to applications for the renewal of marketing authorisations, product licences, manufacturer’s licences and animal test certificates 8 Subject to the following provisions of these Regulations, in connection with an application for the renewal of a marketing authorisation, a product licence, a manufacturer’s licence or an animal test certificate there shall be payable by the applicant the relevant fee prescribed in Part V of Schedule 1. Fees relating to applications for the renewal of marketing authorisations, product licences, manufacturer’s licences and animal test certificates in terms which are not identical to the existing marketing authorisation, licence or certificate 9 Where an applicant applies for renewal of a marketing authorisation, a product licence, a manufacturer’s licence or an animal test certificate so as to contain provisions which are not identical to that marketing authorisation, licence or certificate as in force at the date of that application, there shall be payable by the applicant the renewal fee plus the fee which would have been payable had a separate application been made for each variation. Fees relating to site inspections 10 1 Subject to the following provisions of these Regulations, in respect of any inspection carried out in connection with an application for the grant, variation or renewal of a manufacturer’s licence there shall be payable by the applicant the relevant fee prescribed in Schedule 2. 2 Subject to paragraph (4), the holder of a manufacturer’s licence shall pay the relevant fee prescribed in Schedule 2 in respect of any inspection of a site relating to that licence (except for any inspection for which a fee is payable relating to the grant, variation or renewal of a licence). 3 Where a manufacturing site outside the European Union is specified, and the site is inspected, the fee prescribed in Schedule 2 shall be payable by the marketing authorisation or product licence holder; and if there is more than one marketing authorisation or product licence holder, a fee shall be payable by each marketing authorisation or product licence holder, which shall be the amount prescribed in Schedule 2 divided between the holders of the marketing authorisations or product licences, as the case may be, in proportion to the number of marketing authorisations or product licences held. 4 No fee shall be payable in respect of any inspection of a site carried out within 6 months of a previous inspection in order to ascertain whether alterations or improvements to the premises concerned, which were required in writing by the relevant authority as the result of that previous inspection, have been implemented. Marketing authorisations and product licences: annual fees 11 1 The holder of any marketing authorisation or product licence shall pay an annual fee calculated in accordance with Schedules 3 and 4 in respect of each calendar year in which he has sold, supplied or manufactured any product to which the marketing authorisation or product licence relates. 2 All annual fees shall be payable during October of the year following the calendar year to which they relate. Manufacturer’s licences: annual fees 12 The holder of a manufacturer’s licence, other than one specified in paragraph 7(2) of Part II of Schedule 1, shall pay an annual fee of £205 (previously £200) payable on each anniversary of the grant of the licence. Wholesale dealer’s licences: annual fees 13 1 The holder of a wholesale dealer’s licence, other than one specified in paragraph (2), shall pay an annual fee of £415 (previously £400) payable on each anniversary of the grant of the licence. 2 In the case of the holder of a wholesale dealer’s licence who has a turnover in products— a of less than £40,000; or b of less than 15% of his total turnover, the annual fee for such a licence, if it is accompanied (in either case) by a declaration certifying the low turnover, shall be £205 (previously £200) and shall be payable on each anniversary of the grant of the licence. 3 For the purposes of this regulation, “turnover” means the gross value of all authorised or licensed products sold by way of wholesale dealing by the licence holder in the United Kingdom during the previous calendar year. Marketing authorisations, product licences and animal test certificates: fees for references to the Veterinary Products Committee or to the Medicines Commission 14 In respect of any reference to the Veterinary Products Committee or to the Medicines Commission— a under section 21 of the Act in connection with a product licence or an animal test certificate; or b under regulation 12 of the 1994 Regulations in connection with a marketing authorisation, there shall be payable by the applicant at the time of the application the relevant fee prescribed in Schedule 5. Payment of fees to the Minister 15 Fees under these Regulations shall be payable to the Minister of Agriculture, Fisheries and Food. Time for payment of fees in connection with applications or inspections and refunds of such fees 16 1 All fees payable under these Regulations in connection with any application (other than fees for inspections) shall be payable at the time of that application. 2 If, following either the determination of an application or an inspection, it becomes apparent that— a a lesser fee was properly payable, the excess shall be refunded to the applicant, or as the case may be, the holder of the marketing authorisation, licence or certificate concerned, within 28 days of a request for a refund; or b a higher fee was properly payable, the balance due shall be payable within 28 days following written notice from the relevant authority to the applicant or, as the case may be, the holder of the marketing authorisation, licence or certificate concerned. 3 All fees for inspections made either in connection with an application or during the currency of a marketing authorisation or licence shall become payable within 28 days following written notice from the relevant authority. Late payment of annual fees 17 1 Where the annual fee for a marketing authorisation or product licence has not been paid by the end of the period of three months from the due date, a further fee, calculated in accordance with the provisions of the following paragraphs, shall be payable. 2 The further fee referred to in the preceding paragraph shall be an amount equivalent to 5 per cent of the annual fee payable, in respect of every full calendar month during which the annual fee is not paid, rounded up to the nearest £10. 3 Where the holder or former holder of a marketing authorisation or product licence has not furnished evidence of his annual turnover in accordance with the provisions of Part I of Schedule 3 so that the annual fee payable cannot be determined before the due date, he may make a payment of an amount on account of the annual fee payable by him (in this regulation referred to as a “payment on account”). 4 Where the holder or former holder of a marketing authorisation or product licence has made a payment on account in the circumstances mentioned in the preceding paragraph the further fee payable by him shall be calculated as if, in paragraph (2) above, the reference to the annual fee payable were to the difference between the payment on account and the amount of the annual fee as subsequently determined. 5 In this regulation— a “due date” means the date upon which an annual fee became payable following written notice from the relevant authority; and b references to a period calculated from a day are references to the period inclusive of that day. Suspension of licences and certificates 18 Where any sum due by way of, or on account of, any fee or any part thereof payable under these Regulations remains unpaid by the holder of a licence or certificate, the relevant authority may serve a notice on him requiring payment of the sum unpaid and, if after a period of one month from the date of service of such notice, or such longer period as the relevant authority may allow, the said sum remains unpaid, the relevant authority may forthwith suspend the licence or certificate until such sum has been paid. Waiver, reduction or refund of fees 19 The relevant authority may waive payment of any fee, reduce any fee or part of a fee otherwise payable under these Regulations or refund the whole or part of any fee already so paid in exceptional circumstances or in any of the circumstances specified in Schedule 6. Revocation and savings 20 1 Subject to paragraph (2), the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1994 are hereby revoked. 2 Paragraph (1) shall not affect— a any notice given or any suspension made under those Regulations and any such notice or suspension shall have effect as if given or made under these Regulations; and b any proceedings instituted under those Regulations. Transitional provisions 21 1 Subject to paragraphs (2), (3) and (4), these Regulations shall not apply to any application made before the date these Regulations come into force. 2 A fee shall be payable in respect of any inspection made or any product testing required after the date these Regulations come into force in connection with any application made before that date as if these Regulations applied to that application. 3 Where an application to renew a marketing authorisation, licence or certificate is made before the date these Regulations come into force, and the authorisation, licence or certificate is due to expire on or after that date the fee shall be that payable under these Regulations, and the balance due shall be payable within 28 days following written notice from the relevant authority. 4 Nothing in these Regulations shall have effect in relation to an annual fee relating to a calendar year earlier than 1994. Signed by authority of the Secretary of State for Health Tom Sackville Parliamentary Under Secretary of State for Health 5th September 1995 Signed by authority of the Secretary of State for Wales Gwilym Jones Parliamentary Under Secretary of State, Welsh Office 24th August 1995 Lindsay Parliamentary Under Secretary of State, Scottish office 23rd August 1995 Angela Browning Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food 31st August 1995 Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland F. A. Elliott Permanent Secretary 25th August 1995. Sealed with the Official Seal of the Department of Agriculture for Northern Ireland J. Murray Permanent Secretary 7th September 1995 We consent, Bowen Wells Simon Burns Two of the Lords Commissioners of Her Majesty’s Treasury 31st August 1995