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

Regulations 3(a) and (c), 6(a) and 10(a)

SCHEDULE 1 CAPITAL FEES FOR APPLICATIONS, VARIATIONS AND RENEWALS OF LICENCES

PART I interpretation

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–

(a)

is subject to the procedure laid down in Article 17 of Council Directive 81/851/EEC(1) (notification to five or more Member States);

(b)

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;

(c)

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;

(d)

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

(e)

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;

(f)

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;

(g)

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;

(h)

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;

(i)

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;

(j)

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;

(k)

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

(l)

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–

(a)

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

(b)

an active ingredient in a medicinal product derived from genetically engineered micro-organisms, recombinant DNA technology or monoclonal antibodies; or

(c)

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–

(a)

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

(b)

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–

(i)

in food or food products; or

(ii)

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–

(a)

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;

(b)

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

(c)

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

(i)

it contains the same combination of active ingredients;

(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 named in the application is the same as the manufacturer of the existing product;

(v)

the method of manufacture is the same;

(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;

“standard application” means–

(d)

any application in respect of a medicinal product for animal use specified in Annex 1 of Council Directive 70/524/EEC(2) or made pursuant to the Medicines (Exportation of Specified Veterinary Products) Order 1971(3), which is not a simple application;

(e)

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

PART II capital fees for applications for licences

Product Licences

1.  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:

Column 1	Column 2
Kind of application	Appropriate Fee
1.  Major application	1.  £8,000
2.  Complex application	2.  £4,500
3.  Standard application	3.  £2,000
4.  Simple application	4.  £500

2.  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.

3.—(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.

Manufacturers' Licences

4.—(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(4) 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.

Wholesale Dealers' Licences

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

PART III capital fees for sample testing in connection with applications for licences

The fee payable under regulation 3(c) in respect of a sample requested by the Licensing Authority to be submitted for testing 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:

Column 1	Column 2
Kind of application	Appropriate Fee
1.  Major application	1.  £4,200
2.  Complex application	2.  £3,700
3.  Standard application	3.  £3,700
4.  Simple application	4.  £2,000

PART IV fees for applications for variations of licences or certificates

Product Licences

1.  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.

Manufacturers' Licences

2.  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.

Wholesale Dealers' Licences

3.  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.

Other Variations

4.  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.

PART V fees for applications for renewals of licences

Product Licences

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

Manufacturers' Licences

2.  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.

Wholesale Dealers' Licences

3.  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

Interpretation

1.—(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.

Fees

2.  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.

3.—(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.

4.  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.

5.  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).

(1)

O.J. No. L317, 28.9.81 p.1.

(2)

O.J. No. L270, 23.11.70 p. 1, as amended by Council Directive 84/587/EEC, O.J. No. L319, 8.12.84 p. 13.

(3)

S.I. 1971/1309.

(4)

S.I. 1971/1450; the relevant amending instrument is S.I. 1972/1200.