Legalize / United Kingdom / Statutory-Instrument

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

Type Statutory-Instrument

Publication 2016-02-11

Last updated 2025-04-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

(a) an application for variation of a parallel import licence falls within paragraph 42 (1)(a) of Part 4 of Schedule 2; and

(b) the licensing authority is satisfied that the application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,

50% of the fee payable under that paragraph shall be refunded, or if it has not yet been paid, shall be waived.

(4) For the purposes of sub-paragraphs (1) to (3), a reclassification element or, as the case may be, a variation application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products where—

(a) the licensing authority is satisfied that the application does not require consideration by the Commission, committee or board; and

(b) the Commission, committee or board are consulted only by virtue of, or in accordance with any Community provision, referred to the Committee for Medicinal Products for Human Use or the Committee on Herbal Medicinal Products for the application of the procedure laid down in Articles 32 to 34 of the Directive.

(5) In sub-paragraph (4), “Committee for Medicinal Products for Human Use” and “Committee on Herbal Medicinal Products” mean the Committee for Medicinal Products for Human Use and Committee on Herbal Medicinal Products established under Regulation (EC) No 726/2004.

Variation of a traditional herbal registration

3

Where at the specific written request of the licensing authority, or in response to the imposition of an urgent safety restriction under regulation 149 (urgent safety restrictions) of the Human Medicines Regulations, an application is made for the variation of a traditional herbal registration so as to—

(a) restrict any one or more of the indications, dosage or target population; or

(b) add a new contraindication or a warning or both of these,

as a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 19(1) shall be refunded or, if it has not yet been paid, shall be waived.

Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation

4

(1) Subject to sub-paragraph (2), where an application for the grant of, or for a variation to, a marketing authorisation or traditional herbal registration, or, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 12(1)(a), 19(1) or 20(1) in connection with that application or notice shall be refunded or, if it has not yet been paid, shall be waived—

(a) if the application or notice has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90%;

(b) except in a case to which sub-paragraph (c) applies, if medical, scientific or pharmaceutical assessment has begun but not been completed, 50%;

(c) if a request for further information in connection with the application has been made by the licensing authority under regulation 30 (provision of information) of the Human Medicines Regulations or in pursuance of a European Union provision which applies to applications for marketing authorisations or traditional herbal registrations, 25%.

(2) If an application for the grant of, or for a variation to, a marketing authorisation or traditional herbal registration, or an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products, no refund or waiver of the fee payable under regulation 12(1)(a), 19(1) or 20(1) in connection with that application or notice shall be made under this paragraph.

Withdrawal of application in relation to a certificate of registration

5

Where a person withdraws an application for the grant of a certificate of registration before it has been determined by the licensing authority the following percentage of the fee otherwise payable under regulation 46 of these Regulations shall be refunded, or if it has not yet been paid, shall be waived—

(a) if the application has been received but no medical, scientific or pharmaceutical assessment of the application has begun, 90%;

(b) if medical, scientific or pharmaceutical assessment of the application has begun but has not been completed, 50%;

(c) if medical, scientific or pharmaceutical assessment or consideration by the Advisory Board on the Registration of Homoeopathic Products of the application has been completed, no refund or waiver of the fee shall be made.

Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration

6

(1) Where an application for the grant of, or for a variation to, a manufacturing authorisation, a manufacturer's licence, a wholesale dealer's licence, a broker's registration or an active substance registration is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 12(1)(a) or 19(1) in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—

(a) if the application is withdrawn before any inspection in connection with that application has been made, 90%; or

(b) if such an inspection has been made, 50%.

Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation

7

Where an application for the grant of a marketing authorisation or traditional herbal registration, or an application for a clinical trial authorisation is refused by the licensing authority and—

(a) the information contained in it, or submitted with it, was not sufficient to enable a full medical, scientific or pharmaceutical assessment to be undertaken; and

(b) if the applicant had withdrawn it before it was refused, part of the fee payable in respect of it would have been refunded or waived under paragraph 3,

there shall be refunded or waived the amount which would have been refunded or waived if the application had been withdrawn before it was refused by the licensing authority.

Parallel import licence

8

The fee payable for an application to vary a parallel import licence shall be waived if the application is made only—

(a) because of a change to the number of an authorisation granted under the provisions of the 2001 Directive by another member State for a product to which the licence relates; and

(b) so that the number of that authorisation shown on the licence can be changed.

Surrender of marketing authorisation at same time as a variation application

9

(1) Subject to sub-paragraphs (2) and (3), where an applicant applies to vary a marketing authorisation in the circumstances set out in paragraph 8(3) of Part 3 of Schedule 4, the fee payable under regulation 19(1) shall be refunded or waived.

(2) Subject to sub-paragraph (3), where an applicant on the same occasion submits more than one such application which relates to medicinal products containing the same active ingredients but no other active ingredient, sub-paragraph (1) shall apply only to one of those applications.

(3) Where in respect of any two or more of the applications mentioned in sub-paragraph (2) provision is made for fees of different amounts by paragraphs 51 and 52 of Part 4 of Schedule 2, sub-paragraph (1) shall apply to the application in respect of which of those paragraphs make provision for the higher or highest fee.

Clinical trial authorisation

10

(1) In relation to an application for a clinical trial authorisation in relation to a Phase I trial or a Phase II or Phase III trial, the fee payable in respect of such an application may be reduced in accordance with the following sub-paragraphs.

(2) Where the licensing authority is satisfied that the investigational medicinal product dossier submitted in accordance with paragraph 11 of Part 2 of Schedule 3 to the Clinical Trials Regulations does not require a full medical, scientific or pharmaceutical assessment, the fee may be reduced by an amount which the authority considers to be the cost of the assessment work which is not required.

(3) The fee payable may not be reduced below £100.

(4) Where the fee has been reduced by the licensing authority but the applicant has paid the full fee, the amount by which the fee has been reduced shall be refunded.

(5) In this paragraph, “Phase I trial” and “Phase II or Phase III trial” have the same meaning as in paragraph 1 of Schedule 2.

Scientific advice: paediatric indications

11

(1) Where the licensing authority holds a meeting referred to in regulation 3A in order to provide scientific advice with a view to a person making an application other than a major application or an application for a paediatric use marketing authorisation the fee shall be waived if—

(a) sub-paragraphs (2) or (3) apply to the application; and

(b) the meeting is held solely for the purpose of providing advice in relation to the application.

(2) This sub-paragraph applies to the application if—

(a) the application relates to a medicinal product which is intended to be used in accordance with an authorisation for a paediatric indication; and

(b) no other product which has the same active ingredient and is intended to be used in accordance with the same indication and for the same part of the paediatric population as the product in question has previously been granted a marketing authorisation.

(3) This sub-paragraph applies to the application if—

(a) the application relates to a medicinal product which is intended to be used in accordance with an authorisation for a paediatric indication;

(b) as a result of the application the medicinal product will be available in a formulation which the licensing authority considers to be of significant benefit to that population in comparison to other medicinal products on the market in the United Kingdom; and

(c) no other product which has the same active ingredient and is in the same formulation as proposed for the product in question has previously been granted a marketing authorisation.

(4) In this paragraph—

(a) a medicinal product is authorised for a paediatric indication if it is authorised for use in part or all of that part of the population aged between birth and 18 years and the details of the authorised indication are specified in the summary of characteristics drawn up in accordance with Article 11 of the 2001 Directive ;

(b) “paediatric use marketing authorisation” means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate or by a patent which qualifies for the granting of such a certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product; and

(c) “supplementary protection certificate” means a certificate granted under Council Regulation (EC) No 469/2009 concerning the creation of a supplementary protection certificate for medicinal products and a patent qualifies for the granting of such a certificate if the provisions of that Regulation so provide.

Refunds: treated as having been paid on account

12

Any sums payable to the applicant by way of refund of any fees under the provisions of this Schedule may be treated as having been paid on account of any other fee which the applicant is liable to pay (whether by instalments or otherwise) under the provisions of these Regulations.

SCHEDULE 8 — Adjustment , waiver reduction or refund of periodic fees

Refund on surrender or revocation of authorisation, registration or licence

1

Where, after payment of a periodic fee payable in accordance with the provisions of these Regulations, the marketing authorisation, traditional herbal registration or licence in respect of which such a fee has been paid is either—

(a) surrendered at the specific written invitation of the licensing authority; or

(b) revoked by the licensing authority on a date earlier than the date of expiry stated in the marketing authorisation, traditional herbal registration or licence,

the licensing authority shall refund the whole or any part of the difference between such periodic fee as has been paid and the amount of the periodic fee payable on the basis of the actual duration of the marketing authorisation, traditional herbal registration or licence up to the date of such surrender or revocation.

Adjustment and refund: licences relating to imported special medicinal products

2

(1) This paragraph applies to periodic fees payable in connection with a manufacturer's licence or a wholesale dealer's licence which relates to imported special medicinal products.

(2) If during a fee period the number of special import notices given by a licence holder is greater than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 4, the periodic fee payable in relation to that period shall be increased by the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

(3) If during a fee period the number of special import notices given by a licence holder is less than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 4, the licensing authority shall refund the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

Refunds: treated as having been paid on account

3

Signed

Signed by authority of the Secretary of State for Health.

George Freeman — Parliamentary Under-Secretary of State, — 2016-02-08

Simon Hamilton — Minister for Health, Social Services and Public Safety — 2016-02-10

John Penrose — George Hollingbery — Two of the Lords Commissioners of Her Majesty's Treasury — 2016-02-11

Explanatory note

(This note is not part of the Regulations)

Footnotes

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.

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).

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).

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).

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

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

OJ No L 169, 12.7.1993, p1. This Directive has been amended by Directive 98/79/EC of the European Parliament and of the Council (OJ No L 331, 7.12.1998, p1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No L 313, 13.12.2000, p22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No L 6, 10.1.2002, p50), Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ No L 284, 31.10.2003, p1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No L 247, 21.9.2007, p21).

Regulation 3 has been amended by S.I. 2006/1928.

Regulation 44 has been amended by S.I. 2006/1928 and S.I. 2013/532.

Regulation 24 has been amended by S.I. 2006/1928 and S.I. 2013/532.

OJ No L 334, 12.12.2008, p.7. This Regulation has been amended by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4).

OJ No L 22, 9.2.1965, P 369/65. This Directive has been codified and assembled with others into Directive 2001/83/EC.

OJ No L 15, 17.1.1987, p38. This Directive has been repealed by Council Directive 93/41/EEC, OJ No L 214, 24.8.1993, p40.

Regulation 45H was inserted by S.I. 2013/1855.

Regulation 45R was inserted by S.I. 2013/1855.

Regulation 256J was inserted by S.I.2013/1855.

Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754.

Paragraph 4 of Schedule 8 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754.

Article 28 has been substituted by Article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

Article 29 has been substituted by article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

2006 c.46. A relevant amendment was made by S.I. 2015/980.

S.I. 1995/449; relevant amendments are made by S.I. 2007/803, 2008/530 and 2010/557.

S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928 and 2013/532.

Regulation 8 was amended by S.I. 2013/1855 and 2593.

S.I. 2013/532.

OJ No L 311, 28.11.2001, p67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council (OJ No L 33, 8.2.2003, p30), Commission Directive 2003/63/EC (OJ No L 159, 27.6.2003, p46), Directive 2004/24/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p85), Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34), Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (OJ No L 324, 10.12.2007, p121), Directive 2008/29/EC of the European Parliament and of the Council (OJ No L 81, 20.3.2008, p51), Directive 2009/53/EC of the European Parliament and of the Council (OJ No L 168, 30.6.2009, p33), Commission Directive 2009/120/EC (OJ No L 242, 15.9.2009, p3), Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74), Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74) and Directive 2012/26/EU of the European Parliament and of the Council (OJ No L 299, 27.10.2012, p1).

1968 c.67.

S.I. 2004/1031; relevant amending instruments are S.I. 2004/3224, 2005/2754 and 2759, 2006/562, 1928 and 2984, 2007/289 and 3101, 2008/941, 2009/1164, 2010/1882 and 2012/1916.

OJ No L 334, 12.12.2008, p7. This regulation has been amended by Commission Regulation (EC) No 712/2012 (OJ No L 209, 4.8.2012, p4).

S.I. 1971/972; relevant amending instruments are S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.

OJ No L 262, 14.10.2003, p22.

OJ No L 147, 9.6.1975, p13. This Directive has been codified and assembled with others into Directive 2001/83/EC.

OJ No L 214, 24.8.1993, p1. This Regulation has been amended by Commission Regulation (EC) No 649/98 (OJ No L 88, 24.3.1998, p7), Council Regulation (EC) No 807/2003 (OJ No L 122, 16.5.2003, p36) and Council Regulation (EC) No 1647/2003 (OJ No L 245, 29.9.2003, p19).

S.I. 2012/1916.

Regulation 256A was inserted by S.I. 2013/1855.

Section 104 has been amended by S.I. 2004/1031, 2006/2407, 2012/1916.

Relevant amending instrument is S.I. 2012/1916.

OJ No L 18, 22.1.2000, p1, as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council (OJ No L 188, 18.7.2009, p14).

OJ No L 136, 30.4.2004, p1; relevant amending instruments are Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (OJ No L 324, 10.12.2007, p121), Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ No L 87, 31.3.2009, p109), Regulation (EC) No. 470/2009 of the European Parliament and of the Council (OJ No L 152, 16.6.2009, p11), Regulation (EU) No 1235/2010 of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p1) and Corrigendum (OJ L 201, 27.7.2012, p.138).

Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.

Regulation 256C was inserted by S.I. 2013/1855.

2006 c.46.

Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)

Paragraph 9 of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4).

Copies of the documents can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to info@mhra.gsi.gov.uk.

S.I. 1971/1267: Part 2 of the Act is applied by article 3 of the Order which has been amended by S.I. 1994/3119, 2004/1031 and 2006/2407.

Article 11 has been amended by Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34) and Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74).

OJ No L 152, 16.6.2009, p1.

Editorial notes

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.

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).

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

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

Regulation 44 has been amended by S.I. 2006/1928 and S.I. 2013/532.

Regulation 24 has been amended by S.I. 2006/1928 and S.I. 2013/532.

Regulation 45H was inserted by S.I. 2013/1855.

Regulation 45R was inserted by S.I. 2013/1855.

Regulation 256J was inserted by S.I.2013/1855.

Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754.

Paragraph 4 of Schedule 8 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754.

Article 28 has been substituted by Article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

Article 29 has been substituted by article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

2006 c.46. A relevant amendment was made by S.I. 2015/980.

S.I. 1995/449; relevant amendments are made by S.I. 2007/803, 2008/530 and 2010/557.

S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928 and 2013/532.

Regulation 8 was amended by S.I. 2013/1855 and 2593.

S.I. 2013/532.

1968 c.67.

S.I. 2004/1031; relevant amending instruments are S.I. 2004/3224, 2005/2754 and 2759, 2006/562, 1928 and 2984, 2007/289 and 3101, 2008/941, 2009/1164, 2010/1882 and 2012/1916.

OJ No L 334, 12.12.2008, p7. This regulation has been amended by Commission Regulation (EC) No 712/2012 (OJ No L 209, 4.8.2012, p4).

S.I. 1971/972; relevant amending instruments are S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.

OJ No L 262, 14.10.2003, p22.

OJ No L 147, 9.6.1975, p13. This Directive has been codified and assembled with others into Directive 2001/83/EC.

S.I. 2012/1916.

Regulation 256A was inserted by S.I. 2013/1855.

Section 104 has been amended by S.I. 2004/1031, 2006/2407, 2012/1916.

Relevant amending instrument is S.I. 2012/1916.

Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.

Regulation 256C was inserted by S.I. 2013/1855.

2006 c.46.

Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)

Copies of the documents can be downloaded from the licensing authority's website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to info@mhra.gsi.gov.uk.

S.I. 1971/1267: Part 2 of the Act is applied by article 3 of the Order which has been amended by S.I. 1994/3119, 2004/1031 and 2006/2407.

OJ No L 152, 16.6.2009, p1.

Sum in Sch. 3 para. 8(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(6)(a)(i)

Sum in Sch. 2 para. 24(5) Table Item 3(g) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(v)

Sch. 2 para. 35A inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(14)

Sum in reg. 15(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 14(b)

Sum in Sch. 4 para. 5 Table Entry 3(b)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(d)

Sum in Sch. 5 Table Item 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(iv)

Sum in Sch. 2 para. 41(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(16)(c)

Sum in Sch. 3 para. 6(2)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(4)(a)

Sum in reg. 27(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 22

Sum in Sch. 2 para. 28(2)(a)(i) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(6)(a)(i)

100

Sum in Sch. 2 para. 38(6) Table 3 Entry (a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(c)(i)

101

Sum in Sch. 4 para. 7(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(4)(a)

102

Sum in Sch. 2 para. 25(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(4)(a)

103

Sum in Sch. 2 para. 54(2) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(26)(b)

104

Sch. 2 para. 39A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(11) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

105

Sum in Sch. 2 para. 29(4) Table Entry 3 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(7)(a)(ii)(cc)

106

Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(vi)

107

Sch. 2 para. 24(5) Table Item 4(e) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(d)(iii)

108

Sum in Sch. 2 para. 35(5) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(d)

109

Sum in Sch. 2 para. 31(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(9)(a)

110

Reg. 4 omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 4

111

Sum in Sch. 4 para. 11(2) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(5)

112

Sum in Sch. 2 para. 24(5) Table Item 1(e) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(iii)

113

Sum in Sch. 2 para. 29(4) Table Entry 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(7)(a)(i)(bb)

114

Sum in Sch. 2 para. 48 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(23)

115

Sum in Sch. 2 para. 35(3)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(b)(ii)

116

Sum in Sch. 2 para. 25(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(4)(b)

117

Sum in Sch. 3 para. 8(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(6)(a)(ii)

118

Sum in Sch. 2 para. 42(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(17)(a)

119

Sum in Sch. 3 para. 9(3)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(c)(ii)

120

Sch. 2 para. 40A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(12) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(viii)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

121

Words in Sch. 1 para. 1 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 6(a)(iii) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

122

Sum in reg. 47(1)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(a)(i)

123

Sum in reg. 19C substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 17

124

Sum in Sch. 2 para. 24(5) Table Item 2(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(b)(ii)

125

Sum in reg. 47(2)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(i)

126

Sum in reg. 27(3) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 20(b)

127

Words in Sch. 1 para. 1 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 6(a)(i) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

128

Sum in Sch. 3 para. 9(1)(b)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(b)(ii)

129

Sch. 2 para. 27(3)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(7)(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

130

Sum in Sch. 4 para. 5 Table Entry 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(a)

131

Sum in Sch. 2 para. 35A Table Entry 4 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(d)

132

Sum in Sch. 2 para. 28(3)(c)(i) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(6)(b)

133

Sum in Sch. 3 para. 7(3) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(5)

134

Sch. 2 para. 28A inserted by S.I. 2019/775, Sch. 1 para. 7(8A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vi))

135

Reg. 19EA inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 17

136

Words in Sch. 2 para. 39(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(10)(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

137

Sum in Sch. 2 para. 29(4) Table Entry 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(7)(a)(ii)(aa)

138

Sum in Sch. 2 para. 57A(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(29)(a)

139

Sum in Sch. 2 para. 38(6) Table 2 Item 6 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(vi)

140

Sum in Sch. 4 para. 12(2) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(6)(b)

141

Sum in Sch. 3 para. 9(1)(b)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(b)(i)

142

Sum in Sch. 2 para. 50(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(25)(a)

143

Words in Sch. 2 para. 39(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(10)(a) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

144

Sum in Sch. 5 Table Item 7 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(v)

145

Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(iv)

146

Sum in Sch. 4 para. 7(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(4)(b)

147

Words in reg. 12(1) inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 10

148

Sum in Sch. 2 para. 32(2) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(10)(b)

149

Sch. 2 para. 24(5) Table Item 3(f) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(iv)

150

Words in Sch. 2 para. 1 inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(2)(a)

151

Sch. 2 Pts. 6-6B, substituted for Sch. 2 Pt. 6 (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(13) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ix)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

152

Sum in Sch. 2 para. 56(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(27)(b)

153

Sum in Sch. 3 para. 10(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(8)(b)

154

Sum in Sch. 2 para. 33(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(10)(a)

155

Sum in Sch. 2 para. 24(5) Table Item 5(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(e)(ii)

156

Sum in reg. 5(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 5(a)

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.