The Medicines (Products for Human Use) (Fees) Regulations 2016
PART 1General
1Citation and commencement
2Interpretation
PART 2Capital Fees for Pre-Application Meetings
3Interpretation of Part 2
4Fee for scientific advice: application for, or variation to, EU marketing authorisation
5Fee for scientific advice: classification of a medicinal product
6Fee for advertising advice
7Fee for pharmacovigilance advice
8Fee for advice on labelling or leaflets
9Fee for regulatory advice
10Fee for advice for other purposes
10A Waiver for advice given to small and medium companies
11Time for payment of fees under regulations 4 to 10
PART 3Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections
12Fees for applications for authorisations, registrations, licences or certificates etc.
13Fee for application to be included on the list of online sellers of medicines
14Fee for applications for additional copy certificates
15Fees for applications for certificates and copy certificates by exporters of medicinal products
PART 4Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
16Meaning of “set of applications”
17Fees for applications for regulatory assistance under the mutual recognition procedure
18Time for payment of fees under regulation 17
PART 5Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities
19Fees for variations of authorisations, registrations and licences
19AFees for certification of plasma master files
19BFee for certification of vaccine antigen master files
19CFees for assessment of post-authorisation safety studies
19DFee for carrying out a major safety review
19EFee for assessment of periodic safety update reports
19FFee for testing of samples by the appropriate authority
19GTime for payment of fees under regulations 19A to 19F
20Fees for amendments to clinical trial authorisations
21Fees for notification of changes and reports for broker's registrations
22Fees for notification of changes and compliance Reports for active substance registrations
23Applications for multiple variations
PART 6Capital Fees for Assessment of Labels and Leaflets
24Meaning of “set of proposed changes”
25Fees for assessment of a set of proposed changes to labels and leaflets
26Time for payment of fees under regulation 25
PART 7Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections
27Fees for renewals of certain manufacturer's licences
27AFee for renewals of a marketing authorisation
28Fees for renewals in terms which are not identical to the existing authorisation, licence or registration
PART 8Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorisations
29Fees for regulatory assistance for certain marketing authorisations
PART 9Capital Fees for Inspections
30Fees for inspections
31Fees for inspections of pharmacovigilance service providers
32Payer of inspection fee (contract laboratories and API manufacturing sites)
33Inspections in connection with multiple applications
34Fees for inspections relating to good clinical practice in clinical trials
35Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence
36Adjustment and refund of inspection fees in respect of a wholesale dealer's licence
37Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration
PART 10Periodic Fees for Authorisations, Registrations and Licences
38Periodic fees
39Periodic fee for persons included on the list of online sellers of medicines
PART 11Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
40Meaning of “good clinical practice accreditation scheme”
41Fees for applications for membership and certificates
PART 12Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing
42Fee for a review upon oral representations or a person appointed hearing
43Time for payment under regulation 42
PART 13Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)
44Interpretation
45Fees for applications made at the invitation of the licensing authority
46Fees for applications for certificates
47Fees for variations of certificates
48Time for payment of fees
PART 14Administration
49Payment of fees to Ministers
50Time for payment of capital fees in connection with applications or inspections
51Time for payment of capital fees – applications made by small companies
52Payment of fees in respect of a traditional herbal registration
53Time for payment of periodic fees
54Penalty fees for late payment of periodic fees
55Daily penalty fees for late payment of periodic fees
56Refund or waiver of fees under regulation 54 or 55
57Adjustment, waiver, reduction or refund of fees
58Suspension of licences and authorisations
59Civil proceedings to recover unpaid fees
PART 15Amendments to Other Legislation
60Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
61Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
62Amendment of the Human Medicines Regulations 2012
PART 16Revocations and Savings
63The Medicines (Products for Human Use) (Fees) Regulations 2013
SCHEDULES
SCHEDULE 1General interpretation provisions
1In these Regulations— “the 2001 Directive” means Directive 2001/83/EC of...
2For the purposes of these Regulations, a clinical trial authorisation...
3In these Regulations any reference to an application for the...
4In these Regulations any reference to an application to be...
5(1) For the purpose of these Regulations, a company is...
SCHEDULE 2Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates
PART 1General: interpretation and categories of applications and variations
1Interpretation
2General: categories of Applications and Variations
3Administrative variation application
4Extension application
5Complex application
6Complex registration application
7Complex variation application
8Decentralised procedure application
9Extended Type II Complex Variation Application
10Major application
11Mutual recognition procedure incoming application
12New excipient variation application
13New indication variation application
14Parallel Import Licence application
15Reclassification variation application
16Reduced registration application
17Simple application
18Standard application
19Standard registration application
20Standard variation application
21Standard variation application for a homoeopathic medicinal product
22Type IB and Type II Applications
23Type II Complex Variation Application
PART 2Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates
24Marketing authorisations
24AFees where an application for a European Union marketing authorisation had been made before IP completion day
25Fees where application includes reclassification
26Fees where person holds clinical trial certificate
27Joint development
28Application for multiple authorisations
28A Application by pre-assessment of modules
29Authorisation for a national homoeopathic product
30Manufacturer's licences and authorisations
31Wholesale dealer's licences
32Broker's registrations
33Active substance registrations
34Clinical trial authorisations
35Traditional herbal registrations
36Online sellers of medicines
PART 3Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
37Outgoing mutual recognition applications
PART 4Capital Fees for Applications for Variations of Authorisations, Licences and Registrations
38Marketing authorisations
39Variation of marketing authorisations
39AVariation of orphan marketing authorisations: small and medium companies
40Reclassification of marketing authorisations
40AFees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion day
41Variation of marketing authorisation: national homoeopathic products
42Variation of parallel import licence
43Manufacturer's authorisations and licences
44Variation of manufacturer's authorisations and licences
45Wholesale dealer's licences
46Variation of wholesale dealer's licence
47Variation of a broker's registration
48Variation of an active substance registration
49Clinical trial authorisations
50Traditional herbal registrations
51Identical variations
52Complex Variation Applications
53Multiple reclassification variation applications
PART 5Capital Fees for Assessment of Labels and Leaflets
54A set of changes
55More than one set of changes proposed
PART 6Capital Fee for the Renewal of a Marketing Authorisation
56Renewal of a marketing authorisation
57Renewal of multiple marketing authorisations
PART 6ACapital Fee for Conducting a Major Safety Review
57AThe fee payable under regulation 19D(1) in connection with the...
PART 6BCapital Fee for Testing of Samples by the Appropriate Authority
57B(1) Unless sub-paragraph (2) applies, the fee payable under regulation...
PART 7Relevant Substances
58Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b)
SCHEDULE 3Fees for inspections
1General provisions relating to fees for inspections
2Fees: general
3Traditional herbal medicinal products
4Sites concerned with starting materials for traditional herbal medicinal products
5Wholesale dealer's licence: general
6Wholesale dealer's licence: traditional herbal medicinal products
7Wholesale dealer's licences: inspection of short duration
8Broker's registrations
9Active substance registrations
10Office-based inspections
SCHEDULE 4Periodic fees for licences
PART 1Interpretation
1In this Schedule— “anthroposophic product” means a medicinal product prepared...
PART 2Value of the Product Sold or Supplied
2Determining the total value of the product
3Manufacturer's prices
4Information requirements
PART 3Periodic Fees for Marketing Authorisations and Licences
5Marketing authorisations
6Marketing authorisation: where Part 2 of the Act applies
7Marketing authorisation: derivatives
8Number of fee periods
9Authorisation for two or more kinds of medicinal product
10Reduced fees
11Manufacturer's licences or manufacturing authorisations
12Wholesale dealer's licences
13Wholesale dealer's licences: evidence
14Wholesale dealer's licences: special medicinal products
15Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products
16Traditional herbal registrations
17Online sellers of medicines
PART 4Types of Marketing Authorisation for which only One Periodic Fee is Payable
18Parallel import licences
SCHEDULE 5Fees for certificates of registration
SCHEDULE 6Time for payment of capital fees: small companies
1Interpretation
2Major application
3Complex application
4Multiple application
5Outgoing mutual recognition application
6Application for traditional herbal registration
7Traditional herbal registration: complex variation
8Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence
9Inspection fees in connection with applications
SCHEDULE 7Waiver, reduction or refund of capital fees
1Interruptions of manufacture, assembly, sale or supply
2Reclassification
3Variation of a traditional herbal registration
4Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation
5Withdrawal of application in relation to a certificate of registration
6Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration
7Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation
7AOrphan marketing authorisation
8Parallel import licence
9Surrender of marketing authorisation at same time as a variation application
10Clinical trial authorisation
11Scientific advice: paediatric indications
12Refunds: treated as having been paid on account
SCHEDULE 8Adjustment , waiver reduction or refund of periodic fees
1Refund on surrender or revocation of authorisation, registration or licence
2Adjustment and refund: licences relating to imported special medicinal products
2AWaiver or refund: converted EU marketing authorisations
3Refunds: treated as having been paid on account

2016 No. 190

Medicines
Fees And Charges

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

Made

Laid before Parliament

Coming into force

The Secretary of State for Health and the Minister for Health, Social Services and Public Safety, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971 F1 or, in the case of the Minister, the powers conferred by those provisions and now vested in him F2.

In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on him by section 2(2) of the European Communities Act 1972 F3 and section 56(1) and (2) of the Finance Act 1973 F4. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products F5.

The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.

In accordance with section 129(6) of the Medicines Act 1968 F6, the Secretary of State for Health and the Minister for Health, Social Services and Public Safety have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.

Annotations:
Amendments (Textual)
F1

1971 c.69; as amended by regulation 45(2) of S.I. 2008/2297 and section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the Medicines Act 1971 (“the 1971 Act”), expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) (“the 1968 Act”). See therefore section 1 of the 1968 Act, as substituted by paragraph 2 of Schedule 34 to the Human Medicines Regulations 2012 (S.I. 2012/1916) (“the 2012 Regulations”) which provides the meaning of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. By virtue of regulation 348 of, and paragraph 36 of Schedule 34 to, the 2012 Regulations, references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence, or for the variation or renewal of such a licence under Part 2 of the 1968 Act, shall have effect as a reference to any application under Parts 3 to 8 of the 2012 Regulations.

F2

In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142. In the case of the Minister for Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).

F3

1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7).

F4

1973 c.51. Section 56(1) was amended by article 6(1)(e) of the Treaty of Lisbon (Changes of Terminology) Order 2011 (S.I. 2011/1043).

F5

See article 2(1) of and Schedule 1 to the European Communities (Designation) Order 1972 (S.I. 1972/1811).

F6

Section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.