The Medicines (Products for Animal Use—Fees) Regulations 2004

Citation, commencement and scope

1.—(1) These Regulations may be cited as the Medicines (Products for Animal Use—Fees) Regulations 2004 and shall come into force on 17th November 2004.

(2) These Regulations apply only to fees relating to products for animal use.

Interpretation

2.—(1) In these Regulations—

“the Act” means the Medicines Act 1968;

“assistance in connection with a mutual recognition application” means the preparation of an assessment report of the type required by virtue of the second paragraph of Article 32.1 of Directive 2001/82/EC in order for an application to be made to a 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 Article 33 of that Directive in connection with the application for mutual recognition in relation to which the assessment report or updated assessment report has been prepared;

“Directive 2001/82/EC” means Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products(1);

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(2), amended as at the date of making these Regulations(3));

“EEA State” means a State which is a Contracting Party to the EEA Agreement other than the United Kingdom;

“export certificate” means a certificate issued under section 50 of the Act;

“marketing authorisation” means an authorisation to place on the market in the United Kingdom a veterinary medicinal product but does not include a marketing authorisation granted by the Community in accordance with the provisions of 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(4);

“product” means a medicinal product as defined in the Act save that—

(a)

it includes—

(i)

any substance or article to be administered in a medicinal test on animals under section 32(6)(c) of the Act;

(ii)

any article or substance in relation to which provisions of Part II of the Act have effect by virtue of an order under section 104 or 105 of that Act; and

(iii)

any veterinary medicinal product which would not otherwise count as a medicinal product; and

(b)

it excludes medicated feedingstuffs;

“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 the competent authority of a Member State(5), as it was immediately before repeal;

“Regulation (EC) No 1084/2003” means Commission Regulation (EC) No 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State(6);

“the 1994 Regulations” means the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(7);

“the relevant authority” insofar as it is used in relation to a marketing authorisation or an application therefor, means the Secretary of State, and otherwise means the licensing authority as defined in section 6 of the Act;

“specific batch control” means consideration by the relevant authority of a marketing authorisation or animal test certificate holder’s documentation relating to a specific batch of a veterinary medicinal product (other than an immunological product) where the quality characteristics of that product or of a material used during its manufacture or its packaging to produce the finished product for sale differ from those detailed in the marketing authorisation or animal test certificate, so that the relevant authority may decide whether action under Article 84 of Directive 2001/82/EC either to instigate a recall or to prohibit the placing on the market of the veterinary medicinal product would be required;

“variation with extras” means changes to a marketing authorisation falling within Annex II to Regulation (EC) No 541/95 except in the case of a mutually recognised marketing authorisation, where it means changes falling within Annex II to Regulation (EC) 1084/2003;

“veterinary medicinal product” has the same meaning as in Article 1.2 of Directive 2001/82/EC; and

“Veterinary Products Committee” means the committee established by the Medicines (Veterinary Products Committee) Order 1970(8).

(2) Expressions used in relation to variations to marketing authorisations (other than mutually recognised marketing authorisations) have the same meaning as in Directive 851/81/EC on the approximation of the laws of the Member States relating to veterinary medicinal products(9), as it was immediately before repeal, and Regulation (EC) No 541/95.

(3) Expressions used in relation to mutually recognised marketing authorisations have the same meaning as in Directive 2001/82/EC and Regulation (EC) No 1084/2003.

(4) Part 1 of Schedule 1 shall have effect for the purposes of interpretation of Schedule 1.

(5) Save as otherwise provided other expressions used in these Regulations have the same meaning as in the Act and the Medicines Act 1971.

Applications for authorisations, licences and certificates

3.—(1) Part 2 of Schedule 1 (application fees for a marketing authorisation, manufacturer’s licence, product licence, wholesale dealer’s licence, an animal test certificate or export certificate) shall have effect.

(2) Paragraph (1) shall not be taken to impose any obligation on an applicant for a new marketing authorisation or product licence falling within regulation 9(2) or on an applicant for a variation with extras.

Specific batch control

4.  Where the holder of a marketing authorisation (other than a mutually recognised marketing authorisation) or an animal test certificate requests the relevant authority to undertake specific batch control he shall pay a fee of £500.

Applications for assistance in connection with mutual recognition

5.  Part 3 of Schedule 1 (fees for assistance in connection with a mutual recognition application) shall have effect.

Applications for variation of authorisations, licences and certificates

6.—(1)  Part 4 of Schedule 1 (fees for an application to vary a marketing authorisation, product licence, manufacturer’s licence, wholesale dealer’s licence or an animal test certificate) shall have effect.

(2) Paragraph (1) extends to applications for a variation with extras.

(3) Paragraph (1) shall not apply to—

(a) a variation of a marketing authorisation, licence or certificate consequential upon another variation of the same marketing authorisation, licence or certificate applied for in the same application;

(b) a variation application made at the express written invitation of the relevant authority;

(c) a TSE variation application,

for which no fee is payable.

(4) For the purposes of paragraph (3), “TSE variation application” means an application (other than a complex application as defined in Schedule 1 or an application which seeks to demonstrate compliance by cross-referring to data held by the relevant authority) to vary—

(a) a marketing authorisation to comply with regulation 6(1)(d) of the 1994 Regulations; or

(b) a product licence to reduce the risk of revocation under section 28(3) of the Act by reason of the relevant authority not being satisfied that the product was manufactured in the manner carrying the least risk of transmitting animal spongiform encephalopathy agents.

Applications for renewal of authorisations, licences and certificates

7.—(1) The fee —

(a) for the renewal of a marketing authorisation, a product licence, a manufacturer’s licence or an animal test certificate;

(b) to terminate a marketing authorisation or product licence and for it to be replaced with a new marketing authorisation or product licence in respect of the same product,

is that prescribed in Part 5 of Schedule 1.

(2) Where a person applies for renewal of a marketing authorisation, a product licence, a manufacturer’s licence or an animal test certificate so as to contain variations, he shall pay the fee payable pursuant to paragraph (1) plus the fee which would have been payable had the application been an application to vary the authorisation, licence or certificate in question.

Site inspections

8.—(1) Fees for inspections in connection with an application for the grant, variation or renewal of a manufacturer’s licence or for any other inspection in connection with such a licence shall be paid by the applicant or holder of the licence in accordance with Schedule 2 except as provided below.

(2) Where a manufacturing site in a non-EEA state is specified in a marketing authorisation or product licence or an application therefor and the site is inspected by the relevant authority, the marketing authorisation or product licence holder or applicant shall pay the relevant fee prescribed in Schedule 2; and if there is more than one marketing authorisation or product licence or application therefor in which the site in question is inspected, liability to pay the relevant fee prescribed in Schedule 2 shall be divided between the holders of or applicants for those marketing authorisations or product licences, as the case may be, in proportion to the number of marketing authorisations or product licences for products manufactured at that site held or applied for by each.

(3) No fee is payable in respect of any inspection of a site carried out within 6 months of a previous inspection in order to ascertain whether an alteration or improvement to that site, which was required in writing by the relevant authority as the result of that previous inspection, has been implemented.

Marketing authorisations and product licences: annual fees

9.—(1) The holder of any marketing authorisation or product licence shall, following each anniversary of the grant of the authorisation or licence, provided that the product to which it relates has been sold, supplied or manufactured during the year ending on that date, pay an annual fee calculated in accordance with Schedule 3 in respect of that year.

(2) Where, during the course of the year in question, a new marketing authorisation or product licence has been granted in accordance with regulation 7(1)(b), any sale, supply or manufacture of a product covered by the previous authorisation or licence shall for the purposes of paragraph (1) be treated as covered by the new authorisation or licence.

Manufacturer’s licences: annual fees

10.  The holder of a manufacturer’s licence, other than one specified in paragraph 4(2) of Part 2 of Schedule 1, shall pay an annual fee of £230 following each anniversary of the grant of the licence.

Wholesale dealer’s licences: annual fees

11.—(1) The annual fee for a wholesale dealer’s licence is, where turnover is—

(a) certified to be lower than £40,000, £230; and

(b) otherwise £465.

(2) The annual fee is payable by the licence holder following 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 year, and it counts as certified to be lower than £40,000 when payment of the annual fee is accompanied by a declaration of that actual lower amount.

Registration of homoeopathic veterinary medicinal products

12.—(1) Schedule 4 (fees relating to applications for registration of homoeopathic veterinary medicinal products) shall have effect.

(2) A person who applies to the Ministers to renew the registration of a product shall pay a fee of £90.

(3) A person who applies to the Ministers for authorisation to alter an Article 8 dossier relating to a registered product shall pay a fee of £105.

(4) No fee is payable for an application for the registration of a product, for the renewal of a registration of a product, or for an application to alter an Article 8 dossier of a registered product, which is made at the express written invitation of the Ministers.

(5) For the purposes of this regulation and Schedule 4 the terms—

• “Article 8 dossier”;

• “the Board”;

• “the Ministers”

• “product”; and

• “registered”,

shall have the meanings respectively given to them by regulation 2(1) of the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997(10), as read, in the case of the expression “the Ministers”, with regulation 2(5) of those Regulations.

Fees for references to the Veterinary Products Committee or to the Medicines Commission

13.  In respect of any reference to the Veterinary Products Committee or to the Medicines Commission—

(a) notified to an applicant under section 21 of the Act in connection with his application for the grant or renewal of a product licence or under that section as adapted by section 38 of the Act in connection with his application for the grant or renewal of an animal test certificate;

(b) in relation to which notification is given to an applicant under the 1994 Regulations in connection with his application for the grant or renewal of a marketing authorisation; or

(c) in relation to an application for a variation with extras insofar as it falls within regulation 9 of the 1994 Regulations,

the applicant shall pay, within 14 days following notice of the reference being sent to him, the relevant fee prescribed in Schedule 5.

Payment of fees

14.—(1) Any fee due under these Regulations is payable to the Secretary of State.

(2) Fees for an application or request shall be paid by its maker at the time it is made.

(3) Paragraph (2) does not apply to fees due under regulation 9, 10 or 11 or for any inspection, which shall be paid no later than 30 days after the date of notice requiring payment being sent by the Secretary of State to the person by whom the fee is payable.

(4) If, for the purposes of processing or provision of assistance in connection with an application or carrying out an inspection, a fee has been paid and, following the determination of the application, or completion of the provision of assistance or inspection, it becomes apparent that—

(a) a lesser fee was due, the excess shall be refunded; or

(b) a higher fee was due, the balance shall be payable within 30 days from and including the date of the notice requiring payment of the balance being sent by the relevant authority.

(5) The relevant authority need not and to the extent required by Regulation (EC) 1084/2003 shall not process an application or request in connection with—

(a) a marketing authorisation, animal test certificate, export certificate or specific batch control; or

(b) a manufacturer’s or wholesale dealer’s licence relating to products to which Directive 2001/82/EC applies,

until receipt of the appropriate fee, unless the application is a relevant variation application.

(6) In the case of any relevant variation application, the relevant authority—

(a) may by notice sent to the applicant specify the difference between the appropriate fee payable and the fee paid, explaining the reason for it and stipulating that, if the difference in question is not paid by the date specified in the notice (being at least 14 days after the date that the notice is sent), the application may not be further processed; and

(b) if that difference is not paid, need not continue to process the application once the time specified for payment has expired, until receipt of that payment.

(7) Nothing in paragraph (6) shall be construed as preventing the relevant authority from fulfilling its obligations to observe the duties imposed on Member States under Articles 81 or 83 of Directive 2001/82/EC.

(8) For the purposes of paragraph (4), “relevant variation application” means any application falling within paragraph (b) of the definition of “individual variation” in Part 1 of Schedule 1 in relation to which a fee has been paid which is based on the applicant’s assessment of the appropriate fee but is less than the fee payable for the application.

Late payment of annual fees

15.—(1) Where a person fails to pay the annual fee for a marketing authorisation or product licence within 30 days from and including the due date, he shall pay an additional fee equivalent—

(a) where payment is received by the relevant authority after 30 but before 60 days have expired from and including the due date, to 1% of the annual fee;

(b) where payment is received by the relevant authority after 60 but before 90 days have expired from and including the due date, to 2% of the annual fee; and

(c) where payment has not been received by the relevant authority after the expiry of 90 days, to 5% of the annual fee.

(2) In calculating the sum due under paragraph (1) the additional fee shall in all cases be rounded up to the nearest £10.

(3) Where the person to whom regulation 9(1) applies has not furnished evidence of his annual turnover in accordance with the provisions of paragraph 2 of Schedule 3 so that the annual fee cannot be determined before the due date, he may make a payment of an amount on account of the annual fee.

(4) Where paragraph (3) applies and a payment on account has been made, any additional fee payable under this regulation shall be calculated as if, in paragraph (1) above, the reference to the annual fee were a reference to the difference between the payment on account and the amount of the annual fee as subsequently determined.

(5) In this regulation, “the due date” means the date of the written notice sent in accordance with regulation 14(3).

Suspension of licences and certificates

16.—(1) Where any sum payable under these Regulations remains unpaid by the holder of a licence or certificate, the relevant authority may send notice to him requiring payment 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 sum remains unpaid, the relevant authority may forthwith suspend the licence or certificate until the sum has been paid.

(2) In paragraph (1), “licence” does not include a manufacturer’s or wholesale dealer’s licence for products to which Directive 2001/82/EC applies.

Waiver, reduction or refund of fees

17.—(1) The relevant authority—

(a) may waive or reduce payment of any fee payable under these Regulations or refund the whole or part of any fee already so paid—

(i) on an individual application to do so, if it concludes that exceptional circumstances justify it;

(ii) in any of the circumstances specified in paragraphs 1 to 3 of Schedule 6; and

(b) shall do so as required by paragraph 4 of Schedule 6.

(2) Paragraph (1)(a)(ii) does not apply to products covered by regulation 12.

Revocation

18.  The following Regulations are hereby revoked:

(a) The Medicines (Products for Animal Use—Fees) Regulations 1998(11);

(b) The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 1999(12);

(c) The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2000(13);

(d) The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2001(14);

(e) The Medicines (Products for Animal Use—Fees) (Amendment) (No. 2) Regulations 2001(15);

(f) The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002(16); and

(g) The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003(17).

Transitional provisions

19.—(1) These Regulations shall not apply in respect of any application made before the date these Regulations come into force.

(2) Paragraph (1) does not apply where an—

(a) inspection is made after the date these Regulations come into force in connection with an application made before that date, in which case the inspection fee payable is that due under these Regulations; or

(b) application to renew a marketing authorisation, licence or certificate due to expire after these Regulations come into force is made before that date, in which case the fee payable is that due under these Regulations.

Ben Bradshaw

Parliamentary Under Secretary of State,

Department for Environment, Food and Rural Affairs

15th October 2004

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

L.S.

D C Gowdy

Permanent Secretary,

Department of Health, Social Services and Public Safety

14th October 2004

Sealed with the Official Seal of the Department of Agriculture and Rural Development

L.S.

Gerald Lavery

Deputy Secretary,

Department of Agriculture and Rural Development

15th October 2004

We consent.

Nick Ainger

Joan Ryan

Two of the Lords Commissioners of Her Majesty’s Treasury

21st October 2004