United Kingdom Statutory Instruments

(i) the formulation is identical;

(ii) it is intended to be used in accordance with the same indications;

(iii) it is intended to be administered by the same route of administration;

(iv) the manufacturer is the same;

(v) the method of manufacture is the same; and

(vi) 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;

but does not include an emergency vaccine application;

"standard", in relation to an application, describes an application which is not a major, complex, abridged standard or simple application;

"type A marketing authorisation" means an authorisation to which regulation 5(a) of the 1994 Regulations applies;

"type B marketing authorisation" means an authorisation to which regulation 5(b) of the 1994 Regulations applies;

"Type IA notification" means a variation of a mutually recognised marketing authorisation of a type listed in the Table in Annex I to Regulation (EC) No 1084/2003 in respect of which the note "IA" is entered in the final column of that Table;

"Type IB", in relation to a variation, describes a variation of a mutually recognised marketing authorisation of a type listed in the Table in Annex I to Regulation (EC) No 1084/2003 in respect of which the note "IB" is entered in the final column of that Table; and

"Type II", in relation to a variation, describes a variation of a mutually recognised marketing authorisation of the type referred to in Article 3.3 of Regulation (EC) No 1084/2003.

(a) where a major application was previously made in respect of the Article 26.3 marketing authorisation, £9,350;

(b) where a complex application was previously made in respect of the Article 26.3 marketing authorisation, £7,340.

     3.  - (1) This paragraph applies to fees which would, but for this paragraph, be payable by reference to paragraph 1, whether or not as qualified by paragraph 2.

    (2) Where a major or a complex application is made by a person who is already the holder of - 

(a) an animal test certificate, in respect of a product containing the same active ingredient;

(b) a marketing authorisation or product licence covering export only, relating to the same product,

the fee shall be reduced by the amount of the application fee paid for that certificate or licence.

    (3) Where an applicant has made an original request (that is to say a set of one or more applications where each product contains the same active ingredient or the same combination of active ingredients) and either - 

(a) withdraws each application in the original request and substitutes for them a new application for one or more products containing the same active ingredients or combination of active ingredients as those in the original request; or

(b) withdraws some but not all of the applications in the original request,

then there shall be payable in respect of the new or (as the case may be) remnant applications the total of the fees which would have been charged for them had they alone comprised the original request, but there shall be allowed against it the net total of any fees paid in respect of the original request.

    (4) Where an applicant has pending one or more major applications for a marketing authorisation or product licence and each product contains the same active ingredient or combination of active ingredients the fees payable shall be the fee for a major application under paragraph 1 in respect of the first application and for each additional application - 

(a) which relates to a product of a different dosage form, the fee for a complex application under paragraph 1;

(b) which relates to a product of the same dosage form but of a different strength of any active ingredient, the fee for a standard application under paragraph 1.

    (5) Where an applicant has pending one or more complex applications for a marketing authorisation or product licence and each product contains the same active ingredient or combination of active ingredients the fees payable shall be the fee for a complex application under paragraph 1 in respect of the first application and for each additional application - 

(a) which relates to a product of a different dosage form, the fee for a standard application under paragraph 1;

(b) which relates to a product of the same dosage form but of a different strength of any active ingredient, the fee for a simple application under paragraph 1.

Manufacturer's licences

     4.  - (1) The fee for an application for a manufacturer's licence shall be - 

(a) in a case to which sub-paragraph (2) below applies, £110; or

(b) in any other case £2,505; and

(c) in either case, if appropriate, a fee calculated in accordance with Schedule 2 in respect of any inspection made in connection with that application.

    (2) This sub-paragraph applies in the case of an application for a manufacturer's licence which is limited solely to the manufacture or assembly of - 

(a) £110 in respect of a licence to which paragraph 4(2) of Part 2 of this Schedule applies;

(b) £445 where scientific or pharmaceutical assessment is required.

Wholesale dealer's licences

     5. The fee for an application for a variation of a wholesale dealer's licence is £150 for each individual variation save that the fee is £445 where scientific or pharmaceutical assessment is required.

(a) for an emergency vaccine is £40;

(b) for a herbal product is £375; and

(c) in any other case is £1,110.

Manufacturer's licences

     2. The fee for an application to renew a manufacturer's licence only relating to products to which paragraph 4(2) of Part 2 of this Schedule applies is £110.

"biological product" has the same meaning as set out in Part 1 of Schedule 1;

"dormant biological product" means a biological product which is not currently being manufactured or sold and in respect of which there is no current intention to recommence the manufacture or sale;

"immunological veterinary medicinal product" has the same meaning as in Directive 2001/82/EC;

"major", in relation to an inspection, describes an inspection at a site at which 60 or more, but fewer than 250, relevant persons are employed;

"minor", in relation to an inspection, describes an inspection at a site at which fewer than 10 relevant persons are employed;

"relevant person" means any person directly or indirectly engaged, or assisting in the activity of manufacturing or assembling products and includes any person whose work involves management, quality control, site maintenance, packing, storage or distribution;

"standard", in relation to an inspection, describes an inspection at a site at which 10 or more, but fewer than 60, relevant persons are employed; and

"supersite", in relation to an inspection, describes an inspection at a site at which 250 or more relevant persons are employed.

    (2) In calculating the number of relevant persons for the purposes of this Schedule, any person operating partly as a relevant person (whether as a part-time employee or by virtue of being only partly employed in relevant work) shall be included in the calculation pro rata.

(a) products the sale or supply of which would require a product licence but for article 2(2)(i) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, in which case the fee payable is £105;

(b) emergency vaccines, in which case the fee payable is £115;

(c) products covered by paragraph (a) above and vaccines covered by paragraph (b), in which case the fee payable is £200.

     3. Paragraph 2 does not apply to a biological product (not being a dormant biological product), for which - 

(a) a marketing authorisation or product licence was granted because it was identical to an existing product, in which case the inspection fee is £65;

(b) the fee for any inspection limited to either or both of the premises where it is manufactured or assembled and the procedures for its quality control is £1,480.

     4.  - (1) The fee payable for an inspection at a site outside the United Kingdom shall be increased by an amount equal to the travelling and subsistence costs of one or more inspectors and any additional costs reasonably incurred by them on account of it being outside the United Kingdom.

    (2) For the purposes of sub-paragraph (1), the fees of an interpreter shall be regarded as an additional cost capable of being reasonably incurred.

"turnover" means the gross value at manufacturers' prices of all authorised or licensed products sold or supplied in the United Kingdom during the previous calendar year and in relation to which the person from whom the fee is due holds the marketing authorisation or product licence;

"manufacturers' prices" means the prices charged for authorised or licensed products by manufacturers to wholesalers, except to the extent that - 

(a) the products are supplied by manufacturers direct to retailers, in which case it means the prices charged for the products by the manufacturers to the retailers reduced by such sum as, in the opinion of the relevant authority, represents the difference between the prices paid by the retailers and those which could be expected to be charged by the manufacturers to wholesalers according to the practice prevailing during the period in question with regard to such products;

(b) a marketing authorisation or product licence holder sells or supplies products which he has neither manufactured nor obtained from the manufacturer, in which case it means the prices paid by him for those products.

     2.  - (1) The relevant authority may require a marketing authorisation or product licence holder to furnish an auditor's certificate evidencing his turnover.

    (2) If within one month of the date by which such certificate is required, or such longer period as the relevant authority may allow, the marketing authorisation or product licence holder has failed to furnish it, the annual fee payable shall be calculated as provided for in paragraph 4 or may be such lesser sum, based on the relevant authority's estimate of turnover, as the relevant authority shall specify in a notice served on the marketing authorisation or product licence holder.

(a) in the case of emergency vaccines, 0.71% of turnover, rounded up to the nearest £1, except that the minimum sum payable shall be £10; and

(b) in all other cases either 0.61% of turnover or £205 whichever is the greater, plus for each marketing authorisation or product licence held, where turnover is - 


(i) below £208,000, £26;

(ii) £208,000 or more, £208.

    (2) Where application of sub-paragraph (1)(b) incorporates an amount charged on a percentage basis the annual fee shall be rounded up to the nearest £10.

     4. Where this paragraph applies, the annual fee payable by the marketing authorisation or product licence holder shall be £10,000 together with an additional £2,000 for each product in respect of which a marketing authorisation or product licence is held.

     5. Where an annual fee calculated in accordance with paragraph 4 has been paid and the relevant authority is subsequently satisfied as to the turnover for the relevant calendar year, the difference between the amount paid and the annual fee calculated in accordance with paragraph 3 (if less) may be refunded by the relevant authority.

     6. Any sums payable to a person by way of refund under paragraph 5 may be treated as having been paid on account of any other fee which that person is liable to pay under these Regulations.

"formulation", in relation to a product, does not include the formulation of a homoeopathic stock contained in the product;

"homoeopathic stock" has the same meaning as in article 1.8 of Directive 2001/82/EC.

"identical" means in relation to - 

(a) the formulation of a product, identical as regards its qualitative composition, preparation and testing;

(b) a homoeopathic stock, identical as regards its source, composition, preparation and testing;

"product" includes a series of products which are all dilutions prepared from an identical homoeopathic stock or stocks and each of which has the same pharmaceutical dosage form;

"repeat formulation", in relation to an application, means - 

(a) the formulation of a product which is identical to the formulation of a registered product - 


(i) which the applicant markets; or

(ii) to which the applicant has been authorised in writing to make reference to in his application by the person responsible for marketing that product;



(b) the formulation of a product which is identical to another product in respect of which the applicant has made a simultaneous application;

"repeat stock", in relation to an application, means a homoeopathic stock which is used in the preparation of a product (either on its own or in combination with another homoeopathic stock or stocks), and which is identical to another homoeopathic stock which is used (whether on its own or in combination with any other homoeopathic stock or stocks) in the preparation of a  - 

(a) registered product - 


(i) which the applicant markets; or

(ii) to which the applicant has been authorised in writing to make reference in his application by the person responsible for marketing that product; or



(b) product in respect of which the applicant has made a simultaneous application; and

"simultaneous application" means the first of applications submitted at the same time by the same applicant to be considered by relevant authority.

(a) if no assessment (veterinary, scientific or pharmaceutical) has begun, 90%;

(b) if such assessment has begun but has not been completed, 50%.

    (2) If an application for registration is withdrawn either after veterinary, scientific or pharmaceutical assessment has been completed, or following consideration of that application by the Veterinary Products Committee or by the Medicines Commission, no refund or waiver of the fee payable in connection with that application shall be made.

(a) a marketing authorisation or licence is that specified in the table below;

(b) an animal test certificate is £610; and

(c) a variation with extras to which regulation 13(c) applies is £960.



Type of application	Fee (£)
Major	1,755
Complex	1,010
Standard	465
Simple	180

     2. For the purposes of this Schedule, the terms - 

"complex";

"major";

"simple"; and

"standard",

have the meanings given to them in Part 1 of Schedule 1.

(a) in connection with an application for the grant, variation or renewal of a marketing authorisation or product licence relating to such products; or

(b) in respect of any inspection made during the currency of such a marketing authorisation or product licence,

shall be waived during that period or, if the period will or is likely to exceed 3 months, during the first 3 months.

     2. The relevant authority may waive or reduce the payment of any fee payable under these Regulations in circumstances where - 

(a) in its opinion the interests of human or animal health require a marketing authorisation, product licence or certificate to be granted or varied or an inspection to be made; and

(b) the product in respect of which an application for, or for a variation of, a marketing authorisation, product licence or certificate has been made - 


(i) is not intended for sale; or

(ii) is intended only for use in the treatment of rare conditions or in the treatment of a minor species of animal or as an emergency vaccine.

     3.  - (1) Where the relevant authority - 

(a) is satisfied that the annual turnover (as calculated in accordance with Schedule 3) relating to a particular product during any calendar year of the first five years of the currency of its actual or prospective marketing authorisation or product licence, has not exceeded, or is unlikely to exceed, £40,000; and

(b) is of the opinion that the interests of human or animal health require a marketing authorisation or product licence for the products in question to be granted, varied or renewed (as the case may be),

a fee payable under these Regulations for a marketing authorisation or product licence application or for a variation or first application for a renewal thereof or for an inspection in relation to the product during the currency of that authorisation or licence, made during that five year period application may be reduced or, if the fee has already been paid, refunded in part in proportion to the difference between the maximum turnover of the product in any calendar year (during any of the first five years of the currency of the authorisation or product licence) as established or as estimated by the relevant authority and the sum of £40,000.

    (2) Before a marketing authorisation or product licence holder or applicant pays any reduced fee or receives any refund pursuant to sub-paragraph (1) he shall furnish evidence to the satisfaction of the relevant authority of the actual or estimated amount of annual turnover of the product for each calendar year of the first five years of the currency of the authorisation or product licence.

    (3) Where a reduced fee is determined in accordance with sub-paragraph (1) at the time of the application on the basis of the estimated maximum turnover of the product during any of the first five years of the currency of the authorisation or product licence, that fee shall be regarded as a provisional payment on account.

    (4) Where a provisional payment on account was made and evidence furnished to the relevant authority's satisfaction pursuant to sub-paragraph (2) shows that the maximum turnover in any of those years - 

(a) exceeded £40,000, the holder shall be liable to pay the balance of the full fee otherwise payable under these Regulations within 30 days from and including the date of written notice sent by the relevant authority in accordance with regulation 14(3);

(b) was less than the estimated maximum turnover, the relevant authority may refund the balance between the amount so paid and that payable calculated in accordance with sub-paragraph (1).

     4.  - (1) Where an application for a marketing authorisation or product licence or manufacturer's or wholesale dealer's licence is withdrawn before determination by the relevant authority, the relevant authority shall refund, or where no payment has been made, waive the following percentage of the fee otherwise payable in connection with that application:

(a) if no assessment (veterinary, scientific or pharmaceutical) has begun, 90%;

(b) if such assessment has begun but not been completed, 50%, except where paragraph (c) applies;

(c) if such assessment has begun but not been completed and a request for further information in connection with the application has been made by the relevant authority under section 44(1) of the Act, or under Article 23 of Directive 2001/82/EC as applied by regulation 5 of the 1994 Regulations, 25%.

    (2) In the case where an application has been withdrawn under sub-paragraph (1)(b), and a 50% refund of the fee has been made, any re-application in respect of the same product by the same applicant shall be charged at 50% of the fee otherwise payable under these Regulations.

    (3) If an application for a marketing authorisation or product licence is withdrawn either after scientific or veterinary pharmaceutical assessment has been completed or following consideration of that application by the Veterinary Products Committee or by the Medicines Commission, no refund or waiver of the fee payable shall be made under this paragraph.

(a) marketing authorisations under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142);

(b) licences and certificates under the Medicines Act 1968 insofar as they apply to medicinal products for animal use; and

(c) the registration of homoeopathic veterinary medicinal products under the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997 (S.I. 1997/322).

References to EC legislation have, where appropriate, been updated.

The only change to the fee structure in these Regulations is that in relation to annual fees for marketing authorisations and product licences, the differentiation between veterinary medicinal products with a turnover of under or over £2.8m is abolished. In addition there is an overall increase in fees of 8.7%,

The Regulations also provide for:

(a) the method and time for payment of fees (regulations 14 and 15);

(b) the suspension of licences and certificates where fees remain unpaid (regulation 16); and

(c) the waiver, reduction or refund of fees (regulation 17).

Regulation 19 (transitional provisions) provides that the Regulations (save for the exception in paragraph (2) of that regulation) only apply to applications made after the Regulations come into force.

A Regulatory Impact Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies may be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3LS.