The Medicines (Products for Human Use — Fees) Regulations 1991

• Citation: S.I. 1991/1474
• Sections: 77

Section 1 Citation, commencement and scope

(1) These Regulations may be cited as the Medicines (Products for Human Use — Fees) Regulations 1991, and shall come into force on 18th July 1991.

(2) Subject to paragraph (3) below, 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 Medicines Act 1968 relating wholly or partly to medicinal products for human use;

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

(c) in connection with the holding of such licences.

(3) No fee shall be payable under these Regulations in connection with any application for the grant, variation or renewal of a licence or certificate under Part II of the Act where that application is made at the specific written invitation of the licensing authority.

Section 2 Interpretation

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

“the Act” means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in that Act;

“capital fee” means any fee, other than a periodic fee, payable under the provisions of these Regulations;

“licence fee period” means the period beginning with the coming into force of these Regulations and ending on 31st March 1992 and subsequently, the period beginning with the first day of April in any year and ending with the last day of March in the following year;

“medicinal product” includes any substance or article specified in any order made under section 104 or 105(1)(a) of the Act which directs that Part II of the Act shall have effect in relation to such substance or article;

“periodic fee” means a fee payable under regulation 14;

“product licence (parallel import)” means a product licence in respect of a medicinal product which is imported into the United Kingdom from another Member State of the European Economic Community, in respect of which there has been granted a marketing authorisation in another Member State of that Community and which has no differences having therapeutic effect from a medicinal product in respect of which a product licence has previously been granted in the United Kingdom;

“relevant licence fee period” means any licence fee period during any part of which a licence in respect of which a periodic fee is payable is in force.

(2) The interpretation provisions contained in Part I of Schedule 1 and Parts I and II of Schedule 3 shall have effect.

(3) 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, Schedule or Part of a Schedule, to a numbered paragraph shall be construed as a reference to a paragraph of that regulation or, as the case may be, Schedule, or Part of a Schedule bearing that number.

Section 3 Fees payable in connection with applications and inspections

(1) Subject to paragraph (2), the amount of a capital fee payable in connection with an application is that payable in accordance with these Regulations as in force when the application is made.

(2) The amount of a fee payable in respect of an inspection is that payable in accordance with these Regulations as in force when the inspection is made.

Section 4 Applications for licences and certificates

Subject to regulations 5, 19 and 23, in connection with an application for a product licence, a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate, there shall be payable by the applicant—

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

(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.

Section 5 Inspections in connection with multiple applications for licences

Where an inspection mentioned in regulation 4(b) is made at a site which has been named as a possible site for manufacture or assembly of a medicinal product by more than one applicant for—

(a) a product licence and that site is located outside the United Kingdom; or

(b) a manufacturer’s licence and that site is located in the United Kingdom,

the fee in respect of that inspection shall be payable in equal proportions by each applicant in connection with an application for such licence.

Section 6 Applications for certificates by exporters 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 £150;

(b) in any other case, a fee of £75; and

(c) in either case—

(i) a fee of £75 for each set of certificates requested by the applicant in addition to one; and

(ii) a fee of £15 for each certified copy of the original certificate, not forming part of a set of certificates, requested by the applicant.

(2) In paragraph (1)(c)(i) above, “set of certificates” means an original certificate plus up to four certified copies of that certificate.

Section 7 Variations of licences and certificates

Subject to regulations 8, 9, 19 and 23, 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, and under section 39(4) for the variation of a clinical trial certificate, there shall be payable by the applicant—

(a) the fee prescribed in Part III of Schedule 1 in connection with that application; 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 8 Inspections in connection with multiple applications for variations of licences

Where an inspection mentioned in regulation 7(b) is made at a site which has been named as a possible site for manufacture or assembly of a medicinal product by more than one applicant for a variation to—

(a) a product licence and that site is located outside the United Kingdom; or

(b) a manufacturer’s licence and that site is located in the United Kingdom,

the fee in respect of that inspection shall be payable in equal proportions by each of those applicants.

Section 9 Applications for multiple variations

(1) Subject to paragraph (2), 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.

(2) In respect of a variation which is wholly consequential upon another variation of a provision of a licence or certificate which is applied for in the same application, no separate fee shall be payable.

Section 10 Renewals of clinical trial certificates

Subject to regulations 12, 19 and 23, in connection with an application under section 38(2) of the Act for renewal of a clinical trial certificate, there shall be payable by the applicant a fee of £3,500.

Section 11 Renewals of certain manufacturers' licences

(1) Subject to regulations 12 and 23, the fee payable in connection with an application for renewal of a manufacturer’s licence which is limited solely to the manufacture or assembly of 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 shall be £80.

(2) In respect of any inspection made in connection with an application referred to in paragraph (1), the fee payable shall be that prescribed in paragraph 2(d) of Schedule 2.

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

Where an applicant applies for the renewal of a certificate or licence so as to contain provisions which are not identical to that certificate or licence as in force at the date of that application, he shall pay, in addition to any fee otherwise payable in respect of that renewal under this Part of these Regulations, a fee 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 certificate or licence.

Section 13 Fees payable

(1) Subject to paragraph (5) and to regulations 19 and 23, 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) Subject to paragraph (4), 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 that 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) In a case where a site located in the United Kingdom is named as a possible site for the manufacture of a medicinal product and in respect of which two or more manufacturers' licences are in force, any fee payable under paragraph (1) shall be payable in equal proportions by the holders of those licences.

(5) 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 carried out.

Section 14 Fees payable

(1) Subject to paragraphs (2) and (4) and to regulations 19 and 23, there shall be payable by the holder of a product licence (including a product licence of right), a manufacturer’s licence or a wholesale dealer’s licence a fee in connection with the holding of the licence in respect of each licence fee period during any part of which the licence is in force.

(2) Product licences of a type referred to in Part IV of Schedule 3 shall be treated for the purposes of paragraph (1) above as if they were one product licence and only one periodic fee in respect of each relevant licence fee period shall be payable in connection with the holding of such product licences.

(3) The periodic fee shall be the appropriate fee prescribed in Part III of Schedule 3.

(4) No periodic fee shall be payable in respect of the licence fee period during which a licence is first granted.

Section 15 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 Ministers specified in section 1(1)(a) of the Act.

Section 16 Time for payment of capital fees in connection with applications or inspections

(1) Subject to paragraph (2) and to regulations 17 and 19, 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) All sums payable by way of fees in respect of inspections made either in connection with an application for, or during the currency of, a licence or certificate shall become payable within 14 days following written notice from the licensing authority requiring payment of those fees.

Section 17 Time for payment of capital fees — applications made by small companies

(1) Schedule 4 shall have effect with respect to the capital fee payable in connection with an application made by or on behalf of a small company.

(2) For the purpose of these Regulations, a company is a small company if, for the financial year before that in which the application is made, the amount of its turnover for the financial year is not more than the amount for the time being specified in section 248(1)(a) of the Companies Act 1985 ; and

(a) its balance sheet total (as defined in section 248(3) of that Act) is not more than the amount for the time being specified in section 248(1)(b) of that Act; or

(b) the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified in section 248(1)(c) of that Act.

Section 18 Time for payment of periodic fees

(1) Subject to paragraph (2), all periodic fees shall be payable on the first day of the licence fee period to which they relate.

(2) Periodic fees payable in respect of the licence fee period beginning with the date of coming into force of these Regulations, shall be payable within 28 days of receipt of a written notice given by the licensing authority requiring payment of such fees.

Section 19 Adjustment, waiver, reduction or refund of fees

(1) If after a capital or periodic fee was paid 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 requiring payment of that balance.

(2) The licensing authority shall, to the extent provided in Schedule 5 in relation to capital fees or in Schedule 6 in relation to periodic fees,

(a) adjust, waive payment of, or reduce any fee or part of a fee otherwise payable under these Regulations; or

(b) refund the whole or part of any fee already paid.

Section 20 Suspension of licences or certificates

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, that sum remains unpaid, the licensing authority may forthwith suspend the licence or certificate until that 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 Revocation and Savings

(1) Subject to paragraph (2), the following regulations (in this Part of these Regulations called “the revoked regulations”) are hereby revoked:—

(a) The Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989 ;

(b) The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment Regulations 1990 ; and

(c) The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment ( No. 2) Regulations 1990 .

(2) Paragraph (1) shall not affect—

(a) any notice given or any suspension made under the revoked regulations and any such notice or suspension shall have effect as if given or made under these Regulations; and

(b) any proceedings constituted under the revoked regulations for the recovery of any fees due as debts to the Crown.

Section 23 Transitional provisions

(1) In relation to capital fees, these Regulations shall not apply in connection with any application made before the date on which these Regulations come into force.

(2) In connection with any periodic fee payable under these Regulations, these Regulations shall not apply—

(a) to any licence in respect of which the licensing authority has received notice of surrender prior to the coming into force of these Regulations; or

(b) so as to impose any liability to pay a periodic fee in respect of any period prior to the coming into force of these Regulations.

(3) Where a fee was payable under the revoked regulations in connection with an application made before the date on which these Regulations come into force for the renewal of a licence, except a manufacturer’s licence of the type referred to in regulation 11(1), which is due to expire on or after that date, the fee shall be refunded or, if it has not yet been paid, shall be waived; but this paragraph does not apply to any increase in such a fee which was payable under regulation 12 of the Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989.

(4) Where a fee is payable in connection with an application made before the date on which these Regulations come into force for the renewal of a clinical trial certificate expiring on or after that date, the difference between the fee paid and the fee payable under regulation 10 shall be refunded or, if it has not yet been paid, that difference shall be waived but this paragraph does not apply to any increase in such a fee payable under regulation 12 of the Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989.

Section 1

In this Schedule—

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

“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 falls within one or more of the descriptions specified in sub-paragraphs (a) to (n) below:—

the application is subject to the procedure laid down in Article 9 of Council Directive 75/ 319/ EEC ;

the application relates to a medicinal product which is intended to be used in accordance with an indication for use in respect of a new category of patients or as treatment for a new category of disease;

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

the application relates to a medicinal product containing a new excipient;

the application relates to a medicinal product that is intended to be administered by a route of administation 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 (other than a product licence of right) has previously been granted in the United Kingdom;

the application 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 (other than a product licence of right) has previously been granted in the United Kingdom;

the application relates to a medicinal product which is a controlled release preparation except where—

the application is for a variation in connection with such preparation and does not relate to a matter mentioned in sub-paragraph (b), (c), (d), (f), (j), (k) or (n) of this definition or where the variation applied for does not affect the usage or formulation of the product; or

the application is a simple application;

the application 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 (other than a product licence of right) has previously been granted in the United Kingdom;

the application 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 (other than a product licence of right) has previously been granted in the United Kingdom;

the application is an application to vary a product licence (parallel import) to include—

importation of the same medicinal product bearing a marketing authorization issued in a different Member State of the European Economic Community; or

importation of a medicinal product which is differently formulated from any other medicinal product in respect of which a product licence (parallel import) has previously been granted in the United Kingdom;

the application names as manufacturer of the active ingredient of the medicinal product in question a different manufacturer from the manufacturer of that active ingredient included in a medicinal product in respect of which a product licence (other than a product licence of right) has previously been granted in the United Kingdom;

the application relates to a medicinal product which is an influenza vaccine and in respect of which the manufacturer or the manufacturing process is different from that specified in any other product licence which the applicant holds in respect of that product;

the application is for the grant of a product licence for a medicinal product which is an influenza vaccine, except where it relates only to an influenza vaccine containing a different strain or strains from that specified in any other product licence which the applicant holds; or

the application is to vary a product licence and relates to a change in the formulation of the medicinal product comprising one or more of the following—

a change in the quantity of that product’s active ingredient;

a change which necessitates in-vivo bioavailability studies to be performed on that product;

a change in that product’s preservative system; or

a change in two or more of that product’s excipients other than to colours, or substances which are present only in trace amounts in the finished product.

“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 (other than 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 (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 in a food product;

“simple application” means an application for a product licence to which Article 4.8(a)(i) of Council Directive 65/65/EEC applies other than one for a product licence for a medicinal product which is a new strength of a product in respect of which a product licence has previously been granted in the United Kingdom;

“standard application” means any application which is not a major, complex or simple application or an application for a product licence (parallel import).

Section 1 Product licences

Subject to paragraphs 2, 3, 4 and 5, the fee payable under regulation 4(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:

TABLE

(1) Major application

(a) in respect of any such application—

(1)

(a) £17,000

(i) to which paragraph 5 of Chapter III of Part 3 of the Annex to Council Directive 75/318/ EEC applies; or

(ii) which relates to an article or substance in relation to which Part II of the Act has effect by virtue of an order made under section 104 or 105(1)(a) of the Act;

(b) in any other case

(1)

(b) £92,000

(2) Complex application

(2) £17,000

(3) Standard application

(3) £7,000

(4) Simple application

(4) £2,000

(5) Application for a product licence (parallel import)

(5) £1,750

Section 1 Product licences

Subject to paragraphs 2, 3, 4, 11 and 12, the fee payable under regulation 7(a) in connection with an application for variation of a product licence shall be—

(a) in the case of any complex application, £8,500; and

(b) in any other case, £280.

Section 2 Product licences

Notwithstanding the provisions of paragraph 1, in the case of an article or substance to which Part II of the Act applies by virtue of the Medicines (Surgical Materials) Order 1971 , the fee payable under regulation 4(a) in connection with an application for a product licence shall be £250.

Section 2 Product licences

Where a product licence has been granted in accordance with an application to which paragraph 5 of Chapter III of Part 3 of the Annex to Council Directive 75/318/EEC applies, the fee in connection with the first application for variation of that product licence made within 5 years of the date of the grant of that product licence, so as to authorise use of the medicinal product in a new therapeutic area, shall, in addition to the fee payable under regulation 7(a), be the difference between the fee paid in connection with the application for the grant of that licence and the fee which would have been payable had that application been a major application and the provisions of that paragraph had not applied.

Section 3 Product licences

Where a major application is made by a person who is already the holder of a clinical trial 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 4(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 3 Product licences

The fee payable under regulation 7(a) in connection with an application for variation of a product licence (parallel import) which is a complex application, shall be the same as that payable in connection with an application for the grant of such a licence as specified in paragraph 1 of Part II of this Schedule.

Section 4 Product licences

(1) In this paragraph—

“joint development” means the development by two or more applicants for product licences relating to medicinal products—

each of which contains the same new active ingredient or combination of new active ingredients but with different proprietary names and which does not require separate consideration by a committee established under section 4 of the Act or by the Medicines Commission; and

the development of which has been notified to the licensing authority at or before the time the application is submitted, as being a joint development undertaken by those applicants; and

in respect of which applications for product licences have been received by the licensing authority within one month of each other;

“primary applicant” means that party to a joint development who first makes an application for a product licence relating to a new active ingredient which was the subject of that joint development; and

“secondary applicant” means any party to a joint development, other than the primary applicant, who makes an application for a product licence relating to the same new active ingredient as that which was the subject of the application made by the primary applicant.

(2) Where a joint development relates to a medicinal product and an application for a product licence is submitted to the licensing authority by a secondary applicant, the fee payable under regulation 4(a) shall be—

(a) in respect of the first or only product licence applied for by that secondary applicant, the amount payable in respect of a complex application under paragraph 1 above;

(b) in respect of each additional product licence applied for by that secondary applicant relating to that medicinal product which is of the same dosage form, the amount payable in respect of a standard application under paragraph 1 above;

(c) in respect of the first additional product licence applied for by that secondary applicant relating to that medicinal product which is of a different dosage form, the amount payable in respect of a complex application under paragraph 1 above, and in respect of any other such application by that secondary applicant, the amount payable in respect of a standard application under paragraph 1 above.

Section 4 Product licences

The fee payable under regulation 7(a) in connection with an application for variation of a product licence shall be £80 in respect of each variation applied for which falls within one of the following paragraphs—

(a) a change of either or both of the name and the address of the holder of the licence;

(b) a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise and any change of address does not involve a change of the site of manufacture, assembly or storage or from which distribution takes place;

(c) the removal from the licence of details of one or more sites of manufacture, assembly or storage or from which distribution takes place;

(d) the removal from the licence of details of any of the activities to which the licence relates;

(e) the removal from the licence of details of any of the indications authorised for administration of the medicinal product;

(f) n relation to a product licence (parallel import), the removal from the licence of details of any of the medicinal products which the holder of the licence is authorised to import.

Section 5 Product licences

(1) Subject to sub-paragraphs (2) and (3), where an application for a product licence (except an application by a secondary applicant within the meaning of paragraph 4) is for more than one such licence each relating to a medicinal product containing the same active ingredient or combination of ingredients, the fee payable under regulation 4(a) shall be of an amount equal to the aggregate of the amounts payable under paragraph 1 above 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 above 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 above; 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 above 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 above; 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 above.

Section 5 Manufacturers' licences

Subject to paragraphs 6 and 11, the fee payable under regulation 7(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 6(2) of Part II of this Schedule, £80; and

(b) in any other case, £200.

Section 6 Manufacturers' licences

(1) The fee payable under regulation 4(a) in connection with an application for a manufacturer’s licence shall be—

(a) in a case to which sub-paragraph (2) applies, £80;

(b) in any other case, £1,400.

(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 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.

Section 6 Manufacturers' licences

The fee payable under regulation 7(a) in connection with an application for variation of a manufacturer’s licence shall be £80 in respect of each variation applied for which consists of a change to the licence not requiring an inspection or medical, scientific or pharmaceutical assessment.

Section 7 Wholesale dealers' licences

(1) Subject to sub-paragraph (2), the fee payable under regulation 4(a) in connection with an application for a wholesale dealer’s licence shall be £750.

(2) The fee payable under regulation 4(a) shall be £400 where an application for a wholesale dealer’s licence relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total turnover of the sale of licensed medicinal products carried on at that pharmacy.

(3) For the purposes of sub-paragraph (2) above, turnover shall be calculated in accordance with the provisions of Part II of Schedule 3.

Section 7 Wholesale dealers' licences

Subject to paragraphs 8 and 11, the fee payable under regulation 7(a) in connection with an application for variation of a wholesale dealer’s licence shall be £200.

Section 8 Clinical trial certificates

The fee payable under regulation 4(a) in connection with an application for a clinical trial certificate shall be £17,000.

Section 8 Wholesale dealers' licences

The fee payable under regulation 7(a) in connection with an application for variation of a wholesale dealer’s licence shall be £80 in respect of each variation applied for which consists of a change to the licence not requiring an inspection or medical, scientific or pharmaceutical assessment.

Section 9 Clinical trial certificates

Subject to paragraphs 10 and 11, the fee payable under regulation 7(a) in connection with an application for variation of a clinical trial certificate shall be £280.

Section 10 Clinical trial certificates

Where an application is made for a variation to a provision of a clinical trial 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, the fee payable under regulation 7(a) shall be £80.

Section 11 Identical variations

Subject to paragraph 12 below, where more than one application is made at the same time by the same applicant for the variation of a product licence, a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate and where the applications are for identical variations, the fee payable under regulation 7(a)—

(a) in connection with the first application considered by the licensing authority shall be the appropriate amount specified in this Part of this Schedule;

(b) in connection with each of the other applications shall be 50% of that amount.

Section 12 Identical variations

Where more than one complex application is made at the same time by the same applicant for the variation of a product licence, the fee payable under regulation 7(a)—

(a) in connection with the first application considered by the licensing authority shall be the appropriate amount specified in this Part of this Schedule;

(b) in connection with each of the other applications where the applications are for identical variations and in respect of which no further medical, scientific or pharmaceutical assessment is required shall be the amount which would be payable if the application was not a complex application.

Section 1 Interpretation

(1) In this Schedule—

“major inspection” means an inspection at a site at which 60 or more, but fewer than 250, 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;

“supersite inspection” means 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 partly engaged in 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 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, £1,350;

(ii) in respect of a standard inspection, £2,700;

(iii) in respect of a major inspection, £5,100;

(iv) in respect of a supersite inspection, £10,200;

(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, £1,500;

(ii) in respect of a standard inspection, £5,500;

(iii) in respect of a major inspection, £8,500;

(iv) in respect of a supersite inspection, £17,000;

(c) except in the case of an inspection falling within sub-paragraph (b) above or subparagraph (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, £1,350;

(iii) in respect of a major inspection, £2,700;

(iv) in respect of a supersite inspection, £5,400;

(d) where the site inspected is limited solely to the manufacture or assembly of medicinal products, the sale or supply of which does 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, £100.

Section 3 Fees

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

(a) except in a case falling within sub-paragraphs (b) and (c) below, £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 specified in an Order made under section 51(1) of the Act, £300;

(c) where the site relates to a registered pharmacy as referred to in paragraph 7(2) of Part II of Schedule 1, £300.

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).

Section 1

In this Schedule

“anthroposophic product” means a medicinal product prepared in accordance with the methods of anthroposophic medicine which is or supplied as an anthroposophic product and is so described by the person who sells or supplies that medicinal product;

“complex application” has the same meaning as in Schedule 1 except that it relates only to an application for a product licence;

“derivative”, in relation to a limited use drug or a new active substance, means a medicinal product—

which contains the same active ingredient or combination of active ingredients as that drug or substance but which either—

is a different dosage form of that drug or substance, or

is of the same dosage form as, but of a different strength of active ingredient to, or of a different combination of active ingredients to, that drug or substance; and

in respect of which an application for a product licence was made before the determination of the application for the product licence for that drug or substance;

“general sales list medicine” means a medicinal product (not being an anthroposophic product, a herbal product or a homoeopathic product) of a description or falling within a class specified in an Order made under section 51(1) of the Act;

“herbal product” means a medicinal product which is a herbal remedy as defined in section 132(1) of the Act;

“homoeopathic product” means a medicinal product prepared in accordance with the methods of homoeopathic medicine or similar methods which is sold or supplied as a homoeopathic product and is so described by the person who sells or supplies that medicinal product;

“limited use drug” means a medicinal product in respect of which an application for a product licence has been submitted, to which paragraph 5 of Chapter III of Part 3 of the Annex to the Council Directive 75/318/EEC applies;

“maintenance fee” means the periodic fee payable where the licence holder has notified the licensing authority that the medicinal product to which the product licence relates, being a prescription only medicine, a pharmacy medicine or a general sales list medicine, is not expected either to be manufactured anywhere under the terms of that product licence, or to be imported into the United Kingdom during the relevant licence fee period; and

that during the period of 15 months preceding the commencement of the relevant licence fee period the medicinal product has not been either manufactured anywhere under the terms of that product licence, or imported into the United Kingdom; or

where the medicinal product had been either manufactured anywhere under the terms of that product licence, or imported into the United Kingdom during the period referred to in (a) above, that turnover did not exceed £1,000 during the relevant calendar year;

“new active substance” means a medicinal product which is not a limited use drug and which contains an active ingredient which has not previously been included as an active ingredient in a medicinal product in respect of which a product licence, other than a product licence of right, has been granted in the United Kingdom—

in the five years preceding the coming into force of these Regulations; or

in the five years preceding 31st December in the licence fee period preceding the relevant licence fee period.

“pharmacy medicine” means a medicinal product (not being an anthroposophic product, a herbal product or a homoeopathic product) which is neither a prescription only medicine nor a general sales list medicine;

“prescription only medicine” means a medicinal product (not being an anthroposophic product, a herbal product, a homoeopathic product, a new active substance or a derivative of a new active substance) of a description or falling within a class specified in an order made under section 58(1) of the Act;

“reduced rate fee” means the periodic fee payable where the turnover relating to a medicinal product, being a prescription only medicine, a pharmacy medicine or a general sales list medicine, does not exceed £30,000 in the relevant calendar year;

“standard fee” means the periodic fee payable where the turnover relating to a medicinal product, being a prescription only medicine, a pharmacy medicine or a general sales list medicine, does exceed £30,000 in the relevant calendar year;

“turnover” means the amount calculated in accordance with paragraphs 1 and 2 of Part II of this Schedule.