The Medicines (Products for Human Use) (Fees) Regulations 2016

Fees for amendments to clinical trial authorisations

Fees for notification of changes and reports for broker's registrations

Fees for notification of changes and compliance Reports for active substance registrations

Applications for multiple variations

Fee for renewals of a marketing authorisation

27A

Where an application is made to the licensing authority for the renewal of a marketing authorisation in the case of a product for sale or supply in Great Britain and the application for renewal—

• (a) relates to a medicinal product which, at the time the marketing authorisation was granted, contained a new active ingredient; and

• (b) is the first renewal in relation to that product,

the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 2.

Fees for renewals in terms which are not identical to the existing authorisation, licence or registration

5

• (1) For the purpose of these Regulations, a company is a medium company if, for the financial year before that in which the application is made, the total value of products it has sold or supplied for the financial year is not more than the amount for the time being specified in item 1 in section 465(3) of the Companies Act 2006 (qualification of company as medium) and the conditions in sub-paragraph (2) are met.

• (2) The conditions for the purposes of sub-paragraph (1) are—

• (a) the company's balance sheet total as defined in section 465(5) of the Companies Act 2006 is not more than the amount for the time being specified in item 2 in section 465(3) 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 item 3 in section 465(3) of that Act.

• (3) In this paragraph “financial year” is to be construed in accordance with section 390 of the Companies Act 2006.

Fees where an application for a European Union marketing authorisation had been made before IP completion day

24A

• (1) This paragraph applies where, before IP completion day —

• (a) an application has been made to the EMA for a European Union marketing authorisation;

• (b) day 120 has passed; and

• (c) no final decision has been made by the European Commission in relation to the grant of an European Union marketing authorisation under Article 10 of Regulation (EC) No 726/2004.

• (2) Where this paragraph applies and the applicant for the European Union marketing authorisation applies for a UK marketing authorisation in accordance with paragraph 31(2) of Schedule 33A to the Human Medicines Regulations, the fee payable under regulation 12(1) shall be waived.

• (3) In this paragraph, “day 120” means the day during the assessment of an application for a European Union marketing authorisation on which the Committee for Medicinal Products for Human Use adopts the list of questions, as well as the overall conclusions and review of the scientific data, to be sent to the applicant.

Fees where application includes reclassification

Fees where person holds clinical trial certificate

Joint development

Application for multiple authorisations

Application by pre-assessment of modules

28A

• (1) Where an applicant for a United Kingdom marketing authorisation submits material in accordance with regulation 50(5) of the Human Medicines Regulations for pre-assessment by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is—

• (a) £31,049 in respect of Module 3 (chemical, pharmaceutical and biological information);

• (b) £31,049 in respect of Module 4 (non-clinical reports);

• (c) £31,049 in respect of Module 5 (clinical study reports).

• (2) Where an applicant for a United Kingdom marketing authorisation for a similar biological medicinal product submits material in accordance with regulations 53, 53A or 53B of the Human Medicines Regulations for pre-assessment of a complex abridged application by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is—

• (a) £5,802 in respect of Module 3 (chemical, pharmaceutical and biological information);

• (b) £5,802 in respect of Module 4 (non-clinical reports);

• (c) £5,802 in respect of Module 5 (clinical study reports).

• (3) The fee payable under sub-paragraphs (1) and (2) must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of the fee.

• (4) Where a fee has been paid under this paragraph, any fee payable under regulation 12(1) in connection with an application for the grant of a United Kingdom marketing authorisation in respect of the same product is reduced by the amount paid under this paragraph provided that no further assessment of the Module concerned is required.

Authorisation for a national homoeopathic product

Manufacturer's licences and authorisations

Wholesale dealer's licences

Broker's registrations

Active substance registrations

Clinical trial authorisations

Traditional herbal registrations

Online sellers of medicines

Variation of orphan marketing authorisations: small and medium companies

39A

• (1) Subject to sub-paragraph (2), if an application to vary an orphan marketing authorisation is made by, or on behalf of, a small or a medium company within 12 months of the date of grant of the marketing authorisation, the fee payable for that variation application shall be waived.

• (2) Sub-paragraph (1) does not apply to an application to authorise use of the medicinal product in a new therapeutic area which does not meet the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations.

Reclassification of marketing authorisations

Fees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion day

40A

• (1) Paragraph (2) applies where, before IP completion day —

• (a) an application for a variation to which paragraph 11(7) of Schedule 33A to the Human Medicines Regulations applies, has been made to the EMA; and

• (b) the Committee for Medicinal Products for Human Use has adopted a request for supplementary information to be sent to the applicant, or, in the case of an extension, day 120 has passed.

• (2) Where this paragraph applies and the holder of a converted EU marketing authorisation submits the application to the licensing authority in order to have the variation made to the converted EU marketing authorisation, the fee payable under regulation 19(1) shall be waived.

• (3) In this paragraph—

• “day 120” means the day during the assessment of an extension on which the Committee for Medicinal Products for Human Use adopts the list of questions, as well as the overall conclusions and review of the scientific data, to be sent to the applicant;

• “converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the Human Medicines Regulations; and

• “extension” has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations.

Variation of marketing authorisation: national homoeopathic products

Variation of parallel import licence

Manufacturer's authorisations and licences

Variation of manufacturer's authorisations and licences

Wholesale dealer's licences

Variation of wholesale dealer's licence

Variation of a broker's registration

Variation of an active substance registration

Clinical trial authorisations

Traditional herbal registrations

Identical variations

Complex Variation Applications

Multiple reclassification variation applications

Renewal of a marketing authorisation

Renewal of multiple marketing authorisations

PART 6A — Capital Fee for Conducting a Major Safety Review

57A

The fee payable under regulation 19D(1) in connection with the carrying out of a major safety review is—

• (a) £61,408, where one or two active ingredients, or combinations of active ingredients, are included in the assessment;

• (b) £71,357, where three active ingredients, or combinations of active ingredients, are included in the assessment;

• (c) £81,305, where four active ingredients, or combinations of active ingredients, are included in the assessment; or

• (d) £91,254, where five or more active ingredients, or combinations of active ingredients, are included in the assessment.

PART 6B — Capital Fee for Testing of Samples by the Appropriate Authority

57B

• (1) The fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of a medicinal product is £5,093 for each day taken to examine the sample for testing, the appropriate documentation (as defined in regulation 60A of the Human Medicines Regulations) or both (as the case may be), and the fee payable is to be adjusted pro rata for each period taken of less than 1 day.

• (2) In this paragraph, a “day” means a period of 8 hours and 30 minutes.

Orphan marketing authorisation

7A

Where the licensing authority grants an orphan marketing authorisation, the following percentage of the fee otherwise payable under regulation 12(1)(a) in connection with the application for that authorisation shall be refunded or, if it has not yet been paid, shall be waived—

• (a) in the case of an application made by or on behalf of a small or medium company, 100%;

• (b) in the case of a major application that is not made by or on behalf of a small or medium company but to which paragraph 6 of Part II of Annex 1 to the 2001 Directive applies, 50%; or

• (c) in any other case, 10%.

Parallel import licence

Surrender of marketing authorisation at same time as a variation application

Clinical trial authorisation

Scientific advice: paediatric indications

Refunds: treated as having been paid on account

Waiver or refund: converted EU marketing authorisations

2A

• (1) Where the licensing authority revokes a converted EU marketing authorisation in accordance with paragraph 6(3) of Schedule 33A to the Human Medicines Regulations, the periodic fee payable under regulation 38(1) in relation to that authorisation shall be refunded, or if it has not yet been paid, shall be waived.

• (2) In this paragraph, “converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the 2012 Regulations.

Refunds: treated as having been paid on account

Fee for assessment of clinical trial annual safety reports

19EA

The fee payable by a sponsor who submits an annual safety report to the licensing authority under regulation 35(1)(b) of the Clinical Trials Regulations is £343.

Fee for testing of samples by the appropriate authority

Time for payment of fees under regulations 19A to 19F

Fees for amendments to clinical trial authorisations

Fees for notification of changes and reports for broker's registrations

Fees for notification of changes and compliance Reports for active substance registrations

Applications for multiple variations

Early Access to Medicines Scheme fees

35A

The fee payable under regulation 12(1)(a) in connection with an application submitted under the Early Access to Medicines Scheme of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.

Online sellers of medicines

Fee for scientific or other advice

3A

• (1) Unless regulation 5 applies, the fee specified in paragraph (2) is payable by a person with whom the licensing authority holds a meeting in order to provide scientific or other advice relating to a medicinal product.

• (2) The fee payable by a person in relation to a meeting referred to in paragraph (1) is—

• (a) £17,516, if the advice provided at that meeting is on a matter of high complexity;

• (b) £13,137, if the advice provided at that meeting is on a matter of medium complexity;

• (c) £8,758, if the advice provided at that meeting is on a matter of low complexity;

• (d) £986, if the advice provided at that meeting is on a matter of simple complexity.

• (3) In paragraph (2), a matter is of—

• (a) high complexity if it requires more than twelve assessor days;

• (b) medium complexity if it requires more than seven, but not more than twelve, assessor days;

• (c) low complexity if it requires more than three, but not more than seven, assessor days;

• (d) simple complexity if it requires not more than three assessor days.

• (4) If the person paying the fee in accordance with paragraph (1) consents, the licensing authority may provide any advice in writing instead of at a meeting.

• (5) In this regulation—

• “assessor day” means—in the case of an assessor who is a member of the senior civil service, one assessor working for one day;in the case of an assessor who is not a member of the senior civil service, one assessor working for two days.

• “medicinal product”, in paragraph (e) of the definition of scientific or other advice in this regulation, includes a substance incorporated in a device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;

• “scientific or other advice” includes—scientific advice on an application for an EU marketing authorisation, or an application for the variation of an EU marketing authorisation, in relation to a medicinal product;advice before the publication of advertising of a medicinal product by the holder of a marketing authorisation for that product on whether that advertising conforms to the requirements of the Human Medicines Regulations;pharmacovigilance advice;regulatory advice;advice in relation to—scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product;the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product;the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed;other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorisation has been granted for that product or a product of that type.

Fee for scientific advice: application for, or variation to, EU marketing authorisation

Fee for scientific advice: classification of a medicinal product

Fee for advertising advice

Fee for pharmacovigilance advice

Fee for advice on labelling or leaflets

Fee for regulatory advice

Fee for advice for other purposes

Waiver for advice given to small and medium companies

Time for payment of fees under regulations 3A to 8