The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989

• Citation: S.I. 1989/583
• Sections: 75

Section 1 Citation, commencement and scope

(1) These Regulations may be cited as the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989 and shall come into force on 24th April 1989.

(2) These Regulations apply only to fees payable–

(a) in connection with applications for the grant, variation or renewal of licences or certificates under Part II of the Act relating wholly or partly to medicinal products for animal use; or

(b) in respect of inspections made in connection with applications for the grant, renewal or variation of, or during the currency of any such licence or certificate; or

(c) in respect of samples submitted for testing in connection with applications for the grant, renewal or variation of, or during the currency of a product licence.

Section 2 Interpretation

(1) In these Regulations, unless the context requires otherwise—

“the Act” means the Medicines Act 1968 ;

“annual fee” in relation to any product licence means the appropriate amount calculated in accordance with the provisions of Part II of Schedule 4;

“capital fee” means any fee (other than an annual fee) payable under the provisions of these Regulations;

“licence year” means the period beginning with the first day of April and ending with the last day of March of the year next ensuing;

“medicinal product” includes any substance or article specified in any Order made under (a) 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 (b) section 130(3A) of the Act which provides that such substance or article shall, or shall not, be treated as a medicinal product.

(2) In these Regulations any reference to a regulation or a Schedule shall be construed as a reference to a regulation contained in these Regulations, or as the case may be, to a Schedule thereto, and any reference in a regulation or a Schedule to a paragraph shall be construed as a reference to a paragraph of the regulation or, as the case may be, Schedule.

Section 3 Applications for Licences

Subject to regulations 22 and 24, in connection with an application for a product licence, a manufacturer’s licence or a wholesale dealer’s licence there shall be payable by the applicant–

(a) the fee prescribed in Part II of Schedule 1 in connection with that application;

(b) in respect of any inspection of a description falling within paragraph 1 of Schedule 2 made in connection with that application the fee payable in accordance with paragraphs 2 to 5 of that Schedule; and

(c) if appropriate, the fee prescribed in Part III of Schedule 1 in respect of samples submitted for testing at the request of the Licensing Authority in connection with that application.

Section 4 Applications for Animal Test Certificates

Subject to regulation 24, in connection with an application for an animal test certificate, there shall be payable by the applicant a fee of £2,500.

Section 5 Applications for certificates for exports of medicinal products

(1) In connection with an application for a certificate issued under section 50 of the Act, there shall be payable by the applicant–

(a) if the applicant requests that the certificate be issued within 24 hours of receipt of the application, a fee of £100; or

(b) in any other case, a fee of £50; and

(c) in either case–

(i) a fee of £10 for each certified copy of the original certificate requested by the applicant in excess of four, and

(ii) a fee of £50 for each set of certificates requested by the applicant in addition to one.

(2) In paragraph (1)(c)(ii) “set of certificates” means the original certificate plus up to four certified copies of that certificate.

Section 6 Variations of Licences

Subject to regulations 8, 9, 22 and 24, in connection with an application under section 30 of the Act for the variation of a provision of a product licence, a manufacturer’s licence or a wholesale dealer’s licence, there shall be payable by the applicant–

(a) the fee prescribed in Part IV of Schedule 1; and

(b) in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 5 of that Schedule.

Section 7 Variations of Animal Test Certificates

(1) Subject to paragraph (2) and regulations 8, 9, 22 and 24, in connection with an application under section 39(4) of the Act for the variation of a provision of an animal test certificate, there shall be payable by the applicant a fee of £200.

(2) Where an application is made for a variation to a provision of the animal test certificate and the variation applied for consists of no more than a change of either or both the name and address of the holder of the certificate, there shall be payable by the applicant a fee of £50.

Section 8 Applications for Multiple Variations

A separate fee shall be payable in respect of each variation of each provision of a 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 licence or certificate which is applied for in the same application.

Section 9 Variations at the Invitation of the Licensing Authority

Where an application for a variation is made at the express written invitation of the Licensing Authority, no fee shall be payable under this Part of these Regulations.

Section 10 Renewal of Licences

Subject to regulations 12, 22 and 24, in connection with an application under section 24(2) of the Act for renewal of a product licence, a manufacturer’s licence or a wholesale dealer’s licence, there shall be payable by the applicant–

(a) the appropriate fee prescribed in Part V of Schedule 1; and

(b) in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with that application a fee payable in accordance with paragraphs 2 to 5 of that Schedule.

Section 11 Renewal of Certificates

Subject to regulations 12 and 24, in connection with an application under section 38(2) of the Act for renewal of an animal test certificate there shall be payable by the applicant a fee of £500.

Section 12 Renewals in terms which are not identical to the existing licence or certificate

Where an applicant applies for renewal of a licence, or as the case may be, an animal test certificate so as to contain provisions which are not identical to that licence or certificate as in force at the date of that application, the fee payable under this Part of these Regulations shall be increased by an amount equal to the fee which would have been payable under Part III of these Regulations had he made a separate application for each variation of that licence or certificate.

Section 13

(1) Subject to paragraph (4) and to regulations 22 and 24, a fee in accordance with paragraphs 2 to 5 of Schedule 2 shall be payable in respect of any inspection of a site made during the currency of a product licence, a manufacturer’s licence or a wholesale dealer’s licence (except for any inspection in respect of which a fee is otherwise payable under Parts III or IV of these Regulations).

(2) The fee payable under paragraph (1) in respect of an inspection of a site made during the currency of a manufacturer’s licence or a wholesale dealer’s licence shall be payable by the holder of the manufacturer’s licence or, as the case may be, the wholesale dealer’s licence.

(3) Where a fee is payable under paragraph 1 in respect of an inspection of a site located outside the United Kingdom, the fee shall be payable in equal proportions by each holder of a product licence in which that site is named as a possible site for manufacture of the medicinal product in respect of which the product licence is granted.

(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 Licensing Authority as the result of that previous inspection, have been implemented.

Section 14

(1) A fee calculated in accordance with paragraph (2) shall be payable in respect of each product licence held, in which, as a condition of that licence there is a requirement that the licence holder shall submit for testing samples of each batch of the medicinal product which he has manufactured.

(2) During any licence year the fees referred to in paragraph (1) shall be–

(a) for the first sample and up to and including three samples, a fee of £600, payable by the licence holder at the time the first sample is submitted for testing;

(b) for four samples and up to and including ten samples, an additional fee of £200, payable by the licence holder at the time the fourth sample is submitted for testing;

(c) for ten samples or more, a further additional fee of £200 payable by the licence holder at the time the tenth sample is submitted for testing.

Section 15 Product Licences—annual fee

(1) Subject to paragraph (3) and regulation 24 in connection with any application for the grant or renewal of any product licence there shall be payable by the applicant an annual fee in respect of each licence year during any part of which a product licence, granted or renewed in pursuance of the application is in force, or a product licence already held by the applicant, is in force, save that no annual fee shall be payable in respect of the licence year during which the last to expire of such product licences expires if that licence expires on a date earlier than the anniversary of that date on which that licence was granted which falls in that licence year.

(2) The annual fee shall be calculated in accordance with Schedule 4.

(3) The annual fee may be adjusted or refunded in any of the circumstances set out in Schedule 5. PART VIII ADMINISTRATION

Section 16 Payment of fees to Ministers

Any sums which under the provisions of these Regulations become payable by way of, or on account of, fees shall be paid to one of the Agriculture Ministers specified in section 1(1)(b) of the Act as appropriate.

Section 17 Time for payment of capital fees in connection with applications or inspections and refunds of such fees

(1) Subject to paragraphs (2) and (3), all sums payable by way of capital fees under these Regulations in connection with any application shall be payable at the time of the 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 licence or certificate concerned; or

(b) a higher fee was properly payable, the balance due shall be payable within 14 days following written notice from the Licensing Authority to the applicant or, as the case may be, the holder of the licence or certificate concerned.

(3) All sums payable by way of fees in respect of inspections made either in connection with an application or during the currency of a licence or certificate or in respect of samples submitted for testing shall become payable within 14 days following written notice from the Licensing Authority.

Section 18 Time for payment of annual fees

(1) Subject to paragraphs (2) and (3), all annual fees shall be payable on 1st April of the licence year to which they relate: Provided that the annual fee payable under these Regulations for the licence year beginning 1st April 1989 shall not become payable until 1st September 1989.

(2) Subject to the proviso to paragraph (1), where an applicant first becomes liable to make any payment by way of annual fees of a particular kind during the course of a licence year, such fees shall be payable forthwith.

(3) Where an application is made by an applicant who has not previously held a product licence he shall be liable to pay a sum at the basic rate referred to in Part II of Schedule 4 at the time of the application in respect of the licence year in which the licence is granted.

Section 19 Late payment of annual fees

(1) Where an annual fee has not been paid by the holder or former holder of the licence 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 1 per cent of the annual fee payable multiplied by the number of complete months contained in the period from the day after the end of the period of three months from the due date until the date when the annual fee is paid, rounded down to the nearest £10. Where the annual fee payable is less than £10, no such fee shall be payable.

(3) Where the holder or former holder of a licence has not furnished evidence of his annual turnover in accordance with the provisions of Part I of Schedule 4 so that the annual fee payable in respect of a licence year 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 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 in accordance with the provisions of these Regulations;

(b) references to a period calculated from a day are references to the period inclusive of that day.

Section 20 Suspension of Licences

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 Licensing 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 Licensing Authority may allow, the said sum remains unpaid, the Licensing Authority may forthwith suspend the licence or certificate until such sum has been paid.

Section 21 Civil proceedings to recover unpaid fees

All unpaid sums due by way of, or on account of, any fees payable under these Regulations shall be recoverable as debts due to the Crown.

Section 22 Waiver, Reduction or Refund of Fees

The Licensing Authority may waive payment of, 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 3.

Section 23 Revocation and Savings

(1) Subject to paragraph (2), the Regulations specified in Schedule 6 are hereby revoked in so far as they apply in relation wholly or partly to medicinal products for animal use.

(2) Paragraph (1) shall not affect–

(a) any annual fee or part of such a fee under any of the Regulations specified in Schedule 6;

(b) any notice given or any suspension made under the Regulations specified in Schedule 6 and any such notice or suspension shall have effect as if given or made under these Regulations; and

(c) any proceedings constituted under the Regulations specified in Schedule 6 for the recovery of any fees due as debts due to the Crown.

Section 24 Transitional provisions

(1) Subject to paragraphs (2) and (3), 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 sample 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 is made before the date these Regulations come into force to review a licence or certificate which is due to expire on or after 1st October 1989 a fee shall be payable in accordance with Part IV of these Regulations in connection with that application within 14 days following written notice from the Licensing Authority.

Section 1

In this Schedule–

“active ingredient” means the ingredient of a medicinal product in respect of which efficacy is claimed;

“biological medicinal product” includes an antigen, toxin, antitoxin, serum, antiserum or vaccine;

“complex application” means an application, other than a major application, for a product licence or, as the case may be, for a variation to a product licence where the application–

is subject to the procedure laid down in Article 17 of Council Directive 81/851/ EEC (notification to five or more Member States);

relates to a medicinal 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 medicinal product containing a new combination of active ingredients which have not previously been included in that combination in a medicinal product in respect of which a product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;

relates to a medicinal product containing a new adjuvant or a new excipient;

relates to a medicinal product which is intended to be administered by a route of administration different from that used in the administration of any medicinal product which contains the same active ingredient as the product in question and in respect of which 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 medicinal product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any medicinal product which contains the same active ingredient as the product in question and in respect of which a product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;

relates to a medicinal product containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a medicinal product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any medicinal product which contains the same active ingredient as the product in question and in respect of which a product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;

relates to a biological medicinal 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 medicinal product which contains the same active ingredient as the product in question and in respect of which a product licence has previously been granted in the United Kingdom;

relates to a medicinal product which is a controlled release preparation and a 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 medicinal product the container of which is directly in contact with the medicinal product and is made from different material from the container of any medicinal product which contains the same active ingredient as the product in question and in respect of which a 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 medicinal product in question a different manufacturer from the manufacturer of the active ingredient of any medicinal product which contains the same active ingredient as the medicinal product in question and in respect of which a product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; or

relates to a biological medicinal 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 medicinal product which contains the same active ingredient as the product in question and in respect of which a product licence has previously been granted in the United Kingdom;

“major application” means an application for a product licence in respect of a medicinal product containing a new active ingredient;

“new active ingredient” means–

an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a 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 medicinal product derived from genetically engineered micro-organisms, recombinant DNA technology or monoclonal antibodies; or

in the case of a biological medicinal product, a vaccine of a particular micro-organism whether in a live or inactivated form, but this does not include 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 medicinal product in respect of which a product licence (not being a product licence of right) has previously been granted in the United Kingdom;

“new excipient” means any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product–

which is intended to be administered by the same route of administration as the product in question; and

in respect of which a 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 medicinal 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;

“simple application” means an application for a product licence when the application–

is made by reference to an application for a particular product (“the existing product”) in respect of which a product licence for animal use (other than a product licence of right) has previously been granted;

is made by permission of the licence holder for the existing product;

relates to a product which is in all the following respects the same as the existing product–

it contains the same combination of active ingredients;

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;

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–

any application in respect of a medicinal product for animal use specified in Annex 1 of Council Directive 70/524/EEC or made pursuant to the Medicines (Exportation of Specified Veterinary Products) Order 1971 , which is not a simple application;

any other application which is not a major, complex or simple application.

Section 1 Product Licences

Subject to paragraph 2, the fee payable under regulation 3(a) in connection with an application for a product licence of a kind described in Column 1 of the following Table shall be the fee specified in the corresponding entry in Column 2 of that Table:

(1) Major application

(1) £8,000

(2) Complex application

(2) £4,500

(3) Standard application

(3) £2,000

(4) Simple application

(4) £500

Section 1

Major application

Section 1

£4,200

Section 1 Product Licences

Subject to paragraph 4, the fee payable under regulation 6(a) in connection with an application for variation of a product licence shall be–

(a) in the case of a complex application £600; and

(b) in any other case £200.

Section 1 Product Licences

The fee payable under regulation 10(a) in connection with an application for renewal of a product licence shall be £250.

Section 1 Interpretation

(1) In this Schedule–

“major inspection” means an inspection at a site at which 60 or more relevant persons are employed;

“minor inspection” means an inspection at a site at which fewer than 10 relevant persons are employed;

“relevant person” means any person directly or indirectly engaged in, or assisting in, the manufacture or assembly of medicinal products and also includes any person connected with such production who is involved in management, quality control, site maintenance, packing, storage or distribution;

“standard inspection” means an inspection at a site at which 10 or more, but fewer than 60, relevant persons are employed.

(2) In calculating the number of relevant persons for the purposes of this Schedule, any person partly engaged or assisting in the manufacture or assembly of medicinal products (whether as a part-time employee or by virtue of being only partly employed in such work) shall be included in the calculation but only as a fraction calculated by reference to the amount of time spent by that person engaged or assisting in the manufacture or assembly of medicinal products or, where such a calculation is inappropriate, by reference to the percentage of his job which relates to the manufacture or assembly of such products and, in either case, by comparison with the average working week of a relevant person engaged in full-time employment at the same site.

Section 2 Product Licences

Where a major or a complex application is made by a person who is already the holder of an animal test certificate, in respect of a medicinal product containing the same active ingredient as the medicinal product in respect of which the product licence is applied for, the fee payable under regulation 3(a) in connection with that application shall be reduced by the amount of the fee paid in connection with the application for that certificate.

Section 2

Complex application

Section 2

£3,700

Section 2 Manufacturers' Licences

Subject to paragraph 4, the fee payable under regulation 6(a) in connection with an application for variation of a manufacturer’s licence shall be–

(a) in the case of a manufacturer’s licence referred to in paragraph 4(2) of Part II of this Schedule, £50;

(b) in any other case, £175.

Section 2 Manufacturers' Licences

The fee payable under regulation 10(a) in connection with an application for renewal of a manufacturer’s licence shall be–

(a) in the case of a manufacturer’s licence referred to in paragraph 4(2) of Part II of this Schedule, £50;

(b) in any other case, £500.

Section 2 Fees

Subject to paragraphs 3 to 5, the fee payable in respect of an inspection under these Regulations shall be–

(a) except in the case of an inspection falling within sub-paragraphs (b) to (d) below–

(i) in respect of a minor inspection, £750;

(ii) in respect of a standard inspection, £1,500;

(iii) in respect of a major inspection, £3,000;

(b) where the site inspected is wholly or partly concerned with the manufacture of sterile products or the filling of the containers directly in contact with such products–

(i) in respect of a minor inspection, £1,250;

(ii) in respect of a standard inspection, £2,500;

(iii) in respect of a major inspection, £5,000;

(c) except in the case of an inspection falling within sub-paragraph (b) above or sub-paragraph (d) below, where the site inspected is concerned only with the assembly of medicinal products–

(i) in respect of a minor inspection, £500;

(ii) in respect of a standard inspection, £1,000;

(iii) in respect of a major inspection, £2,000;

(d) where the site inspected is limited solely to the manufacture or assembly of–

(i) medicinal products, the sale or supply of which do not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies; or

(ii) emergency vaccines for use in poultry or other animals;£50.

(e) For the purposes of sub-paragraph (d)(ii) “emergency vaccines” means (i) no other suitable licensed vaccines are readily available for such use and (ii) the vaccines are manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated.

Section 3 Product Licences

(1) Subject to sub-paragraphs (2) and (3), where an application for a product licence consists of an application for more than one such licence each relating to a product containing the same active ingredient or combination of ingredients, the fee payable under regulation 3(a) shall be of an amount equal to the aggregate of the amounts payable under paragraph 1 in respect of a separate application for each such licence.

(2) If the application is a major application, the amount payable shall be the amount payable in respect of a major application under paragraph 1 plus–

(a) in respect of each additional product licence applied for which relates to a medicinal product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and

(b) in respect of each additional product licence applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 1.

(3) If the application is a complex application, the amount payable shall be the amount payable in respect of a complex application under paragraph 1 plus–

(a) in respect of each additional product licence applied for which relates to a medicinal product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and

(b) in respect of each additional product licence applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 1.

Section 3

Standard application

Section 3

£3,700

Section 3 Wholesale Dealers' Licences

Subject to paragraph 4, the fee payable under regulation 6(a) in connection with an application for variation of a wholesale dealer’s licence shall be £175.

Section 3 Wholesale Dealers' Licences

The fee payable under regulation 10(a) in connection with an application for renewal of a wholesale dealer’s licence shall be £325. 2Regulations 3(b), 6(b), 10(b) and 13FEES FOR INSPECTIONS

Section 3 Fees

(1) Subject to paragraph (2), unless the applicant or, as the case may be, the holder of the licence establishes that an inspection is a minor inspection or a standard inspection, the fee payable shall be the appropriate fee specified in paragraph 2 above for a major inspection.

(2) If, following an inspection, it becomes apparent that the inspection fell into a different category from that established by the applicant or the holder of the licence, the fee payable under these Regulations in respect of that inspection shall be the fee payable in respect of an inspection falling within the category into which the inspection should have fallen.

Section 4 Manufacturers' Licences

(1) The fee payable under regulation 3(a) in connection with an application for a manufacturer’s licence shall be–

(a) in a case to which sub-paragraph (2) below applies, £50; or

(b) in any other case £1,000; 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 to the case of an application for a manufacturer’s licence which is limited solely to the manufacture or assembly of–

(a) medicinal products the sale or supply of which do not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies; or

(b) emergency vaccines for use in poultry or other animals.

(3) For the purposes of sub-paragraph (2)(b) “emergency vaccines” means (a) no other suitable licensed vaccines are readily available for such use and (b) the vaccines are manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated.

Section 4

Simple application

Section 4

£2,000

Section 4 Other Variations

The fee payable under regulation 6(a) in connection with an application for variation of a product licence, a manufacturer’s licence or a wholesale dealer’s licence shall be £50 where–

(a) the variation applied for consists of no more than a change of either or both the name and the address of the holder of the licence; and

(b) in the case of an application for variation of a manufacturer’s licence or a wholesale dealer’s licence only, any change of address does not involve a change of the site of manufacture or wholesale dealing.

Section 4 Fees

In the case of an inspection in connection with the grant, variation or renewal of a wholesale dealer’s licence or during the currency of such a licence, the fee payable under these Regulations shall be–

(a) except in a case falling within sub-paragraph (b), £650;

(b) where the site is that of a wholesale dealer whose licence is limited to dealing only in medicinal products falling within a description or class of such products specified in an Order made under section 51(1) of the Act, £250.

Section 5 Wholesale Dealers' Licences

The fee payable under regulation 3(a) in connection with an application for a wholesale dealer’s licence shall be £650.

Section 5 Fees

The fee payable in respect of an inspection at a site outside the United Kingdom shall be increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs reasonably incurred by him in respect of that inspection as a result of its being at a site outside the United Kingdom (such as interpreter’s fees).