The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

SCHEDULE 8 — Consequential provision

PART 1 — Amendment of primary legislation

Amendment of the National Health Service Act 2006

1

• (1) Section 88 of the National Health Service Act 2006 (GMS contracts: prescription of drugs, etc) is amended as follows.

• (2) In subsection (3), for “Community marketing authorization or United Kingdom” substitute “ UK ”.

• (3) For subsection (4) substitute—

(4) “UK marketing authorisation” has the meaning given by regulation 8(1) of the Human Medicines Regulations 2012 (S.I. 2012/1916) .

Amendment of the Access to Medical Treatments (Innovation) Act 2016

2

In section 3(2)(b) and (4)(a), (b) and (c) of the Access to Medical Treatments (Innovation) Act 2016 (provision supplementary to section 2: database of innovative treatments) insert “ UK ” before “marketing authorisation”.

PART 2 — Amendment of secondary legislation

Amendment of the Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977

3

In article 2 of the Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977 (prohibition of sale, supply and importation of Bal Jivan Chamcho) —

• (a) for paragraph (4) substitute—

(4) The prohibition imposed by paragraph (1) does not apply where the medicinal product— (a) is imported from an approved country for import; and (b) is being, or is to be, exported to a country other than the United Kingdom.

; and

• (b) for paragraph (5) substitute—

(5) In paragraph (4), “approved country for import” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012.

Amendment of the Prescription Only Medicines (Human Use) Order 1997

4

After article 5(1) of the Prescription Only Medicines (Human Use) Order 1997 (exempt medicinal products) , insert—

(1A) In paragraph (1) “marketing authorisation” means— (a) in relation to medicinal products for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK); (b) in relation to medicinal products for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), an EU marketing authorisation or a parallel import licence.

Amendment of the Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001

5

• (1) The Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001 is amended as follows.

• (2) In article 1 (citation, commencement and interpretation) —

• (a) omit the definitions of “free circulation in member States” and “third country”; and

• (b) insert at the appropriate place—

“approved country for import” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;

• (3) In article 4 (exceptions to the prohibition imposed by articles 2 and 3) —

• (a) for paragraph (3) substitute—

(3) The prohibition imposed by articles 2 and 3 does not apply where the medicinal product— (a) is imported from an approved country for import; and (b) is being, or is to be, exported to a country other than the United Kingdom.

; and

• (b) in paragraph (4), for “marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation” substitute “ UK marketing authorisation, certificate of registration or traditional herbal registration ”.

Amendment of the Medicines for Human Use (Kava-kava) (Prohibition) Order 2002

6

• (1) The Medicines for Human Use (Kava-kava) Prohibition) Order 2002 is amended as follows.

• (2) In article 1 (citation, commencement and interpretation) —

• (a) omit the definitions of “free circulation in member States” and “third country”; and

• (b) insert at the appropriate place—

“approved country for import” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;

• (3) In article 3 (exceptions to the prohibition imposed by article 2) —

• (a) for paragraph (c) substitute—

(c) imported from an approved country for import, and is being, or is to be, exported to a country other than the United Kingdom; or

; and

• (b) in paragraph (d), for “marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation” substitute “ UK marketing authorisation, certificate of registration or traditional herbal registration ”.

Amendment of the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003

7

In regulation 1(2) of the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 (citation, commencement and interpretation), for the definition of “unlicensed product” substitute—

• “unlicensed product” means—in the case of a product to be imported or marketed in Great Britain, a medicinal product for human use, other than an excluded medicine, in respect of which no UKMA(GB), UKMA(UK), THR(UK) or THR(GB) has been granted;in the case of a product to be imported or marketed in Northern Ireland, a medicinal product for human use, other than an excluded medicine, in respect of which no UKMA(NI), UKMA(UK), THR(UK) or THR(NI), EU marketing authorisation or Article 126a authorisation has been granted,and “Article 126a authorisation”, “EU marketing authorisation”, “THR(GB)”, “THR(NI)”, “THR(UK)”, “UKMA(GB)”, “UKMA(NI)” and “UKMA(UK)” have the meanings given in regulation 8 of the 2012 Regulations;.;

Amendment of the Blood Safety and Quality Regulations 2005

8

In regulation 1A of the Blood Safety and Quality Regulations 2005 , after paragraph (10) insert—

(10A) Paragraph 7.1 is to be read as if the reference to “Directive 2003/94/EC” were to “the Good Manufacturing Practice Directive, within the meaning of paragraph (a) of the definition of that term in regulation 8(1) of the Human Medicines Regulations 2012.

Amendment of the Natural Mineral Water, Spring Water and Bottled Drinking Water (England) Regulations 2007

9

In regulation 3(1)(a) of the Natural Mineral Water, Spring Water and Bottled Drinking Water (England) Regulations 2007 (exemptions) for “Directive” to the end substitute “ regulation 2(1) of the Human Medicines Regulations 2012 ”.

Amendment of the Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008

10

• (1) The Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008 is amended as follows.

• (2) In article 1 (citation, commencement and interpretation) —

• (a) omit the definitions of “free circulation in member States” and “third country”; and

• (b) insert at the appropriate place—

“approved country for import” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;

• (3) In article 3 (exceptions to the prohibition imposed by article 2) —

• (a) for paragraph (c) substitute—

(c) is imported from an approved country for import, and is being, or is to be, exported to a country other than the United Kingdom; or

; and

• (b) in paragraph (d), for “marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation” substitute “ UK marketing authorisation, certificate of registration or traditional herbal registration ”.

Amendment of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

11

• (1) The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 are amended as follows.

• (2) In paragraph 8(10) of Schedule 4 (terms of service of NHS pharmacists: providing ordered drugs or appliances), insert “ UK ” before “marketing authorisation” in both places it appears.

• (3) In paragraph 6(8) of Schedule 7 (mandatory terms for LPS schemes: providing ordered drugs or appliances), insert “ UK ” before “marketing authorisation” in both places it appears.

Amendment of the Genetically Modified Organisms (Contained Use) Regulations 2014

12

In regulation 3(2)(b) of the Genetically Modified Organisms (Contained Use) Regulations 2014 (application) , at the end insert—

; or (iv) a medicinal product for human use marketed in accordance with the Human Medicines Regulations 2012;

Amendment of the Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015

13

• (1) The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 are amended as follows.

• (2) In regulation 1(4) (citation, commencement and interpretation), insert “ UK ” before “marketing authorisation”.

• (3) In regulation 5(2)(c)(i) (exception for medicines indicated for the treatment of persons under 18), insert “ UK ” before “marketing authorisation”.

Amendment of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015

14

In regulation 3(2)(b) of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015 (application) , at the end insert—

; or (iv) a medicinal product for human use marketed in accordance with the Human Medicines Regulations 2012;

Amendment of the Health Service Products (Provision and Disclosure of Information) Regulations 2018

15

In regulation 29(4) of the Health Service Products (Provision and Disclosure of Information) Regulations 2018 —

• (a) in the definition of “notifiable presentation”—

• (i) insert “ UK ” before “marketing authorisation”, and

• (ii) omit from “other than” to the end;

• (b) in the definition of “designated producer” insert “ UK ” before “marketing authorisation”; and

• (c) in the definition of “marketing authorisation” insert “ UK ” before “marketing”.

Amendment of the Branded Health Service Medicines (Costs) Regulations 2018

16

• (1) The Branded Health Service Medicines (Costs) Regulations 2018 are amended as follows.

• (2) In regulation 1(2) (interpretation)—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (e) in the definition of “supplementary protection certificate” omit from “means” to the end and insert “ has the meaning given by section 128B(2) of the Patents Act 1977 ”.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) In regulation 9 (new presentation)—

• (a) in paragraph (10)—

• (i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (ii) in sub-paragraph (b), after “Article 21” insert “or regulation 64(6) of the 2012 Regulations”; and

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 9 — Retained EU law: revocations

1

Insofar as they apply to medicinal products for human use, and subject to the transitional provisions in Schedule 33A to the Human Medicines Regulations 2012 , the following instruments are revoked—

• (a) Council Decision 75/320/EEC of 20 May 1975 setting up a Pharmaceutical Committee;

• (b) Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the evaluation of medicinal products;

• (c) Commission Regulation (EC) No 1662/95 of 7 July 1995 laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorisations for products for human or veterinary use;

• (d) Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93;

• (e) Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products;

• (f) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products;

• (g) Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’;

• (h) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

• (i) Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency;

• (j) Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises;

• (k) Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council;

• (l) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004;

• (m) Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation (EC) No 1901/2006 on medicinal products for paediatric use;

• (n) Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council;

• (o) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) NO 726/2004;

• (p) Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicines;

• (q) Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises;

• (r) Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and Regulation (EC) No 1394/2007 on advanced therapy medicinal products;

• (s) Commission Regulation (EU) No 488/2012 of 8 June 2012, amending Regulation (EC) no 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council;

• (t) Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council;

• (u) Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products;

• (v) Regulation (EU) N0 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance;

• (w) Commission Implementing Decision of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC;

• (x) Commission Implementing Decision of 23 January 2013 on the assessment of a third country's regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC;

• (y) Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring;

• (z) Commission implementing Decision of 24 April 2013 amending implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union;

• (aa) Commission implementing Decision of 4 June 2013 amending implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union;

• (bb) Commission implementing Decision of 11 June 2013 amending implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union;

• (cc) Commission Delegated Regulation (EC) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required;

• (dd) Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use ;

• (ee) Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83 with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use;

• (ff) Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity;

• (gg) Commission implementing Decision of 1 July 2015 amending implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union;

• (hh) Commission Delegated Regulation (EU) No 2016/161 of 2 October 2015 supplementing Directive 2001/83 of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use;

• (ii) Commission Regulation (EU) 2018/781 of 29 May 2018 amending Regulation (EC) No 847/2000 as regards the definition of the concept “similar medicinal product”;

• (jj) Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Signed

Signed by authority of the Secretary of State for Health and Social Care.

Jackie Doyle-Price — Mike Freer — Jeremy Quin — Parliamentary Under-Secretary of State, — Two of the Lords Commissioners of Her Majesty's Treasury

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 2018 c. 16.

[^f00002]: S.I. 2012/1916.

[^f00003]: S.I. 2016/190.

[^f00004]: Schedule 1 was amended by S.I. 2014/490.

[^f00005]: Regulation 8 was amended by S.I. 2013/1855 and 2593, 2015/1503, 2016/186, 190 and 696, 2017/715, 2018/199 and 2019/62.

[^f00006]: S.I. 2002/618. It was amended by S.I. 2008/2936.

[^f00007]: Regulation 137 is inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

[^f00008]: OJ No. L 106, 17.4.2001, p. 1, as last amended by Commission Directive (EU) 2018/350.

[^f00009]: Regulation 69 is inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

[^f00010]: OJ No. L 018, 22.01.2000, p. 1.

[^f00011]: 1977 c. 37. Section 128B was inserted by S.I. 2007/3293 and subsection (2) was amended by S.I.2014/2411.

[^f00012]: The definition of “import” was inserted by S.I. 2013/1855.

[^f00013]: The definition of “care home” was inserted by S.I. 2019/62.

[^f00014]: The definition of “Commission Regulation 2016/161” was inserted by S.I. 2019/62.

[^f00015]: The definition of “healthcare institution” was inserted by S.I. 2019/62.

[^f00016]: The definition of “hospice” was inserted by S.I. 2019/62.

[^f00017]: Paragraph (8) was inserted by S.I. 2013/1855.

[^f00018]: Regulation A17 was inserted by S.I. 2013/1855.

[^f00019]: The principles and guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00020]: Regulation 18 was substituted by S.I. 2013/1855 and further amended by S.I. 2016/186.

[^f00021]: Regulation 19 was amended by S.I. 2013/1855.

[^f00022]: 1990 c. 37. Schedule 3A was inserted by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007/1522, regulation 30.

[^f00023]: S.I. 2007/1523.

[^f00024]: Schedule 5 was amended by S.I. 2013/1855.

[^f00025]: S.I. 2005/50. It was amended by S.I. 2005/1098 and2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.

[^f00026]: Sections 33A to 33D were inserted by the Human Fertilisation and Embryology Act 2008, c. 22.

[^f00027]: Regulation 36 was amended by S.I. 2013/1855 and 2019/62.

[^f00028]: Regulation 37 was substituted by S.I. 2013/1855.

[^f00029]: S.I. 2005/50. It has been amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.

[^f00030]: Regulation 38 was amended by S.I. 2015/1503.

[^f00031]: Regulation 39 was amended by S.I. 2013/1855, 2015/354 and 2019/62.

[^f00032]: Regulation 42 was amended by S.I. 2013/1855 and 2019/62.

[^f00033]: Schedule 7 was amended by S.I. 2019/62.

[^f00034]: Regulation 43 was amended by S.I. 2013/1855 and 2016/186.

[^f00035]: Regulation 43A was inserted by S.I. 2019/62.

[^f00036]: Regulation 44 was amended by S.I. 2013/1855, 2015/1503 and 2016/186.

[^f00037]: Regulation 45A was inserted by S.I. 2013/1855.

[^f00038]: Regulation 45D was inserted by S.I. 2013/1855.

[^f00039]: Regulation 45E was inserted by S.I. 2013/1855.

[^f00040]: Regulation 45F was inserted by S.I. 2013/1855.

[^f00041]: Regulation 45M was inserted by S.I. 2013/1855.

[^f00042]: Schedule 7A was inserted by S.I. 2013/1855.

[^f00043]: Regulation 45O was inserted by S.I. 2013/1855.

[^f00044]: Regulation 48 was amended by S.I. 2014/1878.

[^f00045]: Regulation 49 was amended by S.I. 2014/1878.

[^f00046]: 2006 c.46.

[^f00047]: Regulation 50 was amended by S.I. 2014/1878.

[^f00048]: The guidance is available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00049]: The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00050]: The guidance is available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00051]: Schedule 8 was amended by S.I. 2013/1855.

[^f00052]: Schedule 8A was inserted by S.I. 2014/1878.

[^f00053]: S.I. 2002/618, as amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

[^f00054]: S.I. 2002/2443, as amended by S.I. 2004/2411.

[^f00055]: S.I. 2002/3188, as amended by S.I. 2005/1913.

[^f00056]: S.S.I. 2002/541, as amended by S.S.I. 2004/439.

[^f00057]: S.R. 2003/167, as amended by S.R. 2005/272.

[^f00058]: The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00059]: The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00060]: S.I. 2002/618, as amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

[^f00061]: Regulation 59 was amended by S.I. 2014/1878.

[^f00062]: 2012 c.7.

[^f00063]: Regulation 65A was inserted by S.I. 2014/1878.

[^f00064]: The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00065]: Regulation 66A was inserted by S.I. 2014/1878.

[^f00066]: Regulation 68 was amended by S.I. 2013/1855 and 2014/1878.

[^f00067]: Regulation 69 was amended by S.I. 2014/1878.

[^f00068]: Regulation 71 was amended by S.I. 2014/1878.

[^f00069]: Regulation 73 was amended by S.I. 2013/2593: regulation 3 inserted sub-paragraphs (5A) to (5C).

[^f00070]: Regulation 75 was amended by S.I. 2014/1878.

[^f00071]: Regulation 76 was amended by S.I. 2014/1878.

[^f00072]: 1990 c. 37. Sections 33A to 33D were inserted by the Human Fertilisation and Embryology Act 2008, c. 22.

[^f00073]: S.I. 2005/50. It was amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.

[^f00074]: S.I. 2007/1523.

[^f00075]: Regulation 82 was previously amended by S.I. 2013/2593 and regulation 84 was amended by S.I. 2013/1855.

[^f00076]: Regulation 94A was inserted by S.I. 2019/62.

[^f00077]: Regulation 96 was amended by S.I. 2014/1878.

[^f00078]: Regulation 97 was substituted by S.I. 2014/1878.

[^f00079]: Regulation 101 was amended by S.I. 2014/1878.

[^f00080]: Regulation 110 was amended by S.I.2013/1855.

[^f00081]: Paragraph (3A) was inserted by S.I. 2013/2593.

[^f00082]: Regulation 135 was amended by S.I. 2013/1855.

[^f00083]: Regulation 142 was amended by S.I. 2013/2593.

[^f00084]: Regulation 177 was amended by S.I. 2013/1855 and 2014/1878.

[^f00085]: Regulation 182 was amended by S.I. 2013/1855.

[^f00086]: Regulation 195 was amended by S.I. 2014/1878.

[^f00087]: Regulation 196 was amended by S.I. 2013/2593.

[^f00088]: Regulation 206 was amended by S.I. 2013/1855.

[^f00089]: Regulation 210 was amended by S.I. 2013/1855.

[^f00090]: Regulation 210A was inserted by S.I. 2013/1855.

[^f00091]: Regulation 213 was amended by S.I. 2013/235 and 2014/490 and 1878.

[^f00092]: The definition was substituted by S.I. 2014/1878.

[^f00093]: Regulation 214 was amended S.I. 2013/1855, 2014/490, 2016/186 and 2018/199.

[^f00094]: Regulation 217 was amended by S.I. 2014/490.

[^f00095]: Regulation 217A was inserted by S.I. 2014/490.

[^f00096]: Regulation 218 was amended by S.I. 2014/490 and 1878 and 2015/903.

[^f00097]: Regulation 219 was amended by S.I. 2015/903 and 2016/696.

[^f00098]: Regulation 219A was amended by S.I. 2015/903.

[^f00099]: Regulation 229 was amended by S.I. 2013/325, 2015/323, 2016/186 and 2018/199.

[^f00100]: Regulation 230 was amended by S.I. 2013/325.

[^f00101]: Regulation 233 was amended by S.I. 2013/235 and 2015/1503.

[^f00102]: Regulation 234 was amended by S.I. 2015/323.

[^f00103]: Schedule 17 was amended by S.I. 2014/1878, 2015/1503, 2016/186 and 2017/715,

[^f00104]: 1990 c. 37. Sections 33A to 33D were inserted by the Human Fertilisation and Embryology Act 2008, c. 22.

[^f00105]: S.I. 2005/50. It has been amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/604, 2017/1320 and 2018/231.

[^f00106]: S.I. 2007/1523.

[^f00107]: Regulations 255A to 255C were inserted by S.I. 2019/62.

[^f00108]: Part 12A was inserted by S.I. 2013/1855.

[^f00109]: Regulations 257A and 257B were inserted by S.I. 2019/62.

[^f00110]: The guidance is available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00111]: Paragraph (18A) was inserted by S.I. 2019/62.

[^f00112]: 1990 c. 37. Schedule 3A was inserted by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007/1522, regulation 30.

[^f00113]: S.I. 2007/1523.

[^f00114]: Schedule 27 was amended by S.I. 2014/1878.

[^f00115]: Regulation 268 was amended by S.I. 2019/62.

[^f00116]: Regulation 269 was amended by S.I. 2015/903 and 2019/62.

[^f00117]: Schedule 30 was amended by S.I. 2014/1878.

[^f00118]: Regulation 323 was amended S.I. 2019/62.

[^f00119]: Regulation 327 was amended by S.I. 2013/1855 and 2019/62.

[^f00120]: The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

[^f00121]: Regulation 346 was substituted by S.I. 2013/1855 and then amended by S.I. 2013/2593, 2014/490 and 1878, 2015/323, 903 and 1503, 2016/186, 2017/715, 2018/199 and 2019/62.

[^f00122]: Section 465 was amended by S.I. 2015/980

[^f00123]: S.I. 2002/2677

[^f00124]: S.I. 2004/1157.

[^f00125]: S.I. 1999/3106.

[^f00126]: 1986 c. 14, as amended by S.I. 2012/3039.

[^f00127]: S.I. 2004/1157.

[^f00128]: S.I. 2002/618.

[^f00129]: S.I. 2005/50.

[^f00130]: S.I. 1999/3106.

[^f00131]: 1990 c. 37.

[^f00132]: S.I. 2007/1523.

[^f00133]: S.I. 2005/50.

[^f00134]: S.I. 2002/618.

[^f00135]: International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med 1997; 336:309-15.

[^f00136]: OJ No. L 387, 27.12.2006, p. 1.

[^f00137]: OJ No. L 92, 30.3.2006, p. 6.

[^f00138]: 2018 c. 12.

[^f00139]: 2006 c.41.

[^f00140]: S.I. 2012/1916.

[^f00141]: 2016 c.9.

[^f00142]: S.I. 1977/670. Article 2 was amended by S.I. 1990/2487, 1997/856, 2008/548 and 2012/1809.

[^f00143]: S.I. 1997/1830. Article 5(1) was amended by S.I. 2012/1916.

[^f00144]: S.I. 2001/1841.

[^f00145]: Article 1 was amended by S.I. 2008/548 and 2012/1809.

[^f00146]: Article 4 was amended by S.I. 2008/548 and 2012/1916.

[^f00147]: S.I. 2002/3170.

[^f00148]: Article 1 was amended by S.I. 2008/548 and 2012/1809.

[^f00149]: Article 3 was amended by S.I. 2008/548 and 2012/1916.

[^f00150]: S.I. 2003/1680. Regulation 2(1) has been previously amended by S.I. 2004/3224, 2005/2750 and 2754 and 2012/1916.

[^f00151]: S.I. 2005/50. Regulation 1A was inserted by S.I. 2019/4.

[^f00152]: S.I. 2007/2785. Regulation 3(1)(a) was substituted by S.I. 2018/352.

[^f00153]: S.I. 2008/548.

[^f00154]: Article 1 was amended by S.I. 2012/1809.

[^f00155]: Article 3 was amended by S.I. 2012/1916.

[^f00156]: S.I. 2013/349.

[^f00157]: S.I. 2014/1663.

[^f00158]: S.I. 2015/895.

[^f00159]: S.R. 2015 No. 339.

[^f00160]: S.I. 2018/677.

[^f00161]: S.I. 2018/345.

[^f00162]: S.I. 2012/1916.

[^f00163]: OJ No, L 189, 27.6.2014, p. 112.

Amendment of regulation 24 (standard provisions of licences)

19A

In regulation 24, after paragraph (2) insert—

(3) In Schedule 4, in relation to a licence holder in Great Britain, references to the principles and guidelines set out in the Good Manufacturing Practice Directive are to those principles and guidelines as they apply under or by virtue of regulation B17.

Amendment of Schedule 4 (standard provisions of licences under Part 3)

Amendment of regulation 26 (general power to suspend, revoke or vary licences)

Amendment of Schedule 5 (review upon oral representations)

Amendment of regulation 29 (variation of licence on the application of the holder)

Amendment of regulation 31 (certification of manufacturer's licence)

Amendment of regulation 33 (offence concerning data for advanced therapy medicinal products)

Amendment of Schedule 6 (manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products)

Amendment of regulation 36 (conditions for manufacturer's licence)

Amendment of regulation 37 (manufacturing and assembly)

Amendment of regulation 38 (imports)

Amendment of regulation 39 (further requirements for manufacturer's licence)

Amendment of regulation 42 (conditions for wholesale dealer's licence)

Amendment of Schedule 7 (qualified persons)

Amendment of regulation 43 (obligations of licence holder)

Amendment of regulation 43A (requirement for wholesale dealers to decommission the unique identifier)

Amendment of regulation 44 (requirement for wholesale dealers to deal only with specified persons)

Amendment of regulation 45 (requirement as to responsible persons)

Insertion of new regulations 45AA and 45AB (responsible persons: import)

Amendment of regulation 45A (brokering in medicinal products)

Amendment of regulation 45D (grant or refusal of a broker's registration)

Amendment of regulation 45E (criteria of broker's registration)

Amendment of regulation 45F (provision of information)

Amendment of regulation 45M (criteria for importation, manufacture or distribution of an active substance)

Amendment of Schedule 7A (information to be provided for registration as an importer, manufacturer or distributor of active substances)

Amendment of regulation 45O (requirements for registration as an importer, manufacturer or distributor of an active substance)

Insertion of new Schedule 8C in relation to material to accompany unfettered access applications

51A

Schedule 2A inserts a new Schedule 8C after Schedule 8B.

Amendment of Schedule 9 (undertakings by non-United Kingdom manufacturers)

New regulation 50A to 50J (applications in relation to particular medicinal products)

Insertion of new Schedule in relation to orphan provisions

Amendment of Schedule 10 (national homoeopathic products)

Substitution of regulation 51 (applications relating to generic medicinal products)

Substitution of regulation 52 (applications relating to certain medicinal products that do not qualify as generic etc)

Substitution of regulation 53 (applications relating to similar biological medicinal products)

Amendment of regulation 54 (applications relating to products in well-established medicinal use)

Substitution of regulation 55 (applications relating to new combinations of active substances)

Amendment of regulation 56 (applications containing information supplied in relation to another product with consent)

Amendment of regulation 58 (consideration of application)

Amendment of Schedule 11 (advice and representations)

Insertion of provisions concerning consideration of certain applications for UK marketing authorisations

Amendment of regulation 59 (conditions of UK marketing authorisation or parallel import licence: general)

Amendment of regulation 60 (conditions of UK marketing authorisation: exceptional circumstances)

Insertion of new regulations 60A (condition as to the submitting of samples and other information to the appropriate authority) and 60B (submitting of samples and other information: EU marketing authorisations)

Amendment of regulation 61 (conditions of UK marketing authorisation)

Amendment of regulation 64 (duties of licensing authority in connection with determination)

Obligation of licensing authority in case of change of classification

Amendment of regulation 65 (validity of UK marketing authorisation)

Validity of conditional marketing authorisation and variation of a UK marketing authorisation

Insertion of new Schedule 10A (variations to a UK marketing authorisation)

Amendment of regulation 66 (application for renewal of authorisation)

Amendment of regulation 66A (application for renewal of a parallel import licence)

Renewal of conditional marketing authorisation

Amendment of regulation 67 (failure to place on the market etc.)

76A

• (1) Regulation 67 (failure to place on the market etc.) is amended as follows.

• (2) In paragraph (1) after “in the United Kingdom” insert “(or, in the case of a UKMA(GB) granted after an application under the unfettered access route, in Great Britain)”.

• (3) In paragraph (2) after “in the United Kingdom” insert “(or, in the case of a UKMA(GB) granted after an application under the unfettered access route, in Great Britain)”.

Amendment of regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)

Amendment of regulation 69 (suspension of use etc of relevant medicinal product)

Omission of regulation 70 (authorisations granted under Chapter 4 of Title III of the 2001 Directive

Amendment of regulation 71 (withdrawal of medicinal product from the market)

Amendment of regulation 72 (sale etc of suspended medicinal product)

Amendment of regulation 73 (obligation to notify placing on the market etc)

Amendment of regulation 75 (obligation to provide information relating to safety etc)

Amendment of regulation 76 (obligation in relation to product information)

Amendment of regulation 77 (record-keeping obligations)

Amendment of regulation 78 (obligation to ensure appropriate and continued supplies)

Post authorisation requirements in relation to UK marketing authorisations with paediatric aspects and advanced therapy medicinal products

Amendment of regulation 79 (failure to provide information on marketing authorisations to EMA)

Amendment of regulation 80 (urgent safety restrictions)

Application of regulations 81 to 94 (offences relating to EU marketing authorisations)

Amendment of regulation 89 (offences in connection with withdrawal of product from market)

90A

In regulation 89(1)(b) (offences in connection with withdrawal of product from market) for “any of Articles 36, 37 and 38” substitute “Article 37 or 38”.

Omission of regulation 91 (failure to notify results of third country clinical trials)

90B

Omit regulation 91.

Amendment of regulation 94A (offences relating to Commission Regulation 2016/161)

Amendment of regulation 95 (offences in connection with application)

Amendment of regulation 96 (provision of misleading information)

Amendment of regulation 97 (breach of pharmacovigilance condition)

Amendment of regulation 98 (general offence of breach of Part 5)

Amendment of regulation 99 (penalties)

Amendment of regulation 101 (defences)

Amendment of regulation 109 (failure to place on the market etc.)

101A

• (1) Regulation 109 (failure to place on the market etc.) is amended as follows.

• (2) In paragraph (1) after “in the United Kingdom” insert “(or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain)”.

• (3) In paragraph (2) after “in the United Kingdom” insert “(or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain)”.

Amendment of regulation 110 (revocation, variation and suspension of certificate of registration)

Omission of regulation 111 (certificates granted under Chapter 4 of Title III of the 2001 Directive)

Amendment of regulation 112 (withdrawal of homoeopathic medicinal product from the market)

Amendment of regulation 113 (obligation to notify placing on the market etc)

Amendment of regulation 115 (obligation to provide information relating to safety etc)

Amendment of regulation 116 (obligation in relation to product information)

Amendment of regulation 134 (failure to place on the market etc.)

118A

• (1) Regulation 134 (failure to place on the market etc.) is amended as follows.

• (2) In paragraph (1) after “in the United Kingdom” insert “(or, in the case of a THR(GB) granted after an application under the unfettered access route, in Great Britain)”.

• (3) In paragraph (2) after “in the United Kingdom” insert “(or, in the case of a THR(GB) granted after an application under the unfettered access route, in Great Britain)”.

Amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration)

Amendment of regulation 136 (revocation by licensing authority: further provisions)

Amendment of regulation 138 (suspension of use etc of traditional herbal medicinal product)

Omission of regulation 139 (registrations granted under Chapter 4 of Title III of the 2001 Directive)

Amendment of regulation 140 (withdrawal of traditional herbal medicinal product from the market)

Amendment of regulation 141 (sale etc of suspended traditional herbal medicinal product)

Amendment of regulation 142 (obligation to notify placing on the market etc)

Insertion of new regulation 143A (establishment of herbal monographs)

Substitution of regulation 144 (obligation following new herbal monograph)

Amendment of regulation 145 (obligation to provide information relating to safety etc)

Amendment of regulation 146 (obligation in relation to product information)

Insertion of regulation 148A (urgent safety restrictions)

Substitution of regulation 149 (urgent safety restrictions)

Amendment of regulation 156 (article 126a authorisations)

Amendment of regulation 157 (requests from other member States)

132A

In regulation 157(1)—

• (a) in the heading for “other member States” substitute “EU member States”; and

• (b) in paragraph (1)—

• (i) after “where the licensing authority” insert “, in relation to a UKMA(NI),”; and

• (ii) for “another member State” substitute “a member State”.

New regulation 135ZA (amendment of regulation 167 (supply to fulfil special patient needs))

135ZA

In regulation 167 (supply to fulfil special patient needs)—

• (a) in paragraph (6), for “or imported into the United Kingdom from a country other than an EEA State” substitute “, imported into Northern Ireland from a country other than an EEA State or Great Britain, or imported into Great Britain from a country other than an approved country for import or Northern Ireland”;

• (b) in paragraph (7)—

• (i) for “imported from an EEA State” substitute “imported into Northern Ireland from an EEA State or imported into Great Britain from a country other than an approved country for import”;

• (ii) for sub-paragraph (a) substitute—

(a) it is manufactured or assembled in that State or country (as appropriate) by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with— (i) in the case of a product for sale or supply in Northern Ireland, the provisions of the 2001 Directive as implemented in that State, and (ii) in the case of a product for sale or supply in Great Britain, in accordance with the provisions applicable in that country; or

• (iii) for sub-paragraph (b) substitute—

(b) it is manufactured or assembled as an investigational medicinal product in that State or country (as appropriate) by the holder of an authorisation in relation to its manufacture or assembly in accordance with— (i) in the case of a product for sale or supply in Northern Ireland, Article 13 of the Clinical Trials Directive as implemented in that State, and (ii) in the case of a product for sale or supply in Great Britain, regulations 13 and 43 of the Clinical Trials Regulations,

Amendment of regulation 168 (use of non-prescription medicines in the course of a business)

Amendment of regulation 169 (mixing of general sale medicinal products)

Amendment of regulation 171 (exempt advanced therapy medicinal products)

Amendment of regulation 173 (exemption for certain radiopharmaceuticals)

Amendment of regulation 179 (obligation on licensing authority to operate pharmacovigilance system)

139A

In regulation 179—

• (a) in paragraph (1), after “pharmacovigilance system” insert “in relation to medicinal products for sale or supply in Great Britain”;

• (b) after paragraph (1) insert—

(1A) The licensing authority must operate a pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland.

• (c) in paragraph (2) for “The pharmacovigilance system” substitute “Each pharmacovigilance system”; and

• (d) in paragraph (3)(a) for “the pharmacovigilance system” substitute “each pharmacovigilance system”.

Amendment of regulation 180 (obligation on licensing authority to audit pharmacovigilance system)

Amendment of regulation 181 (delegation of obligations under Part 11)

Amendment of regulation 182 (obligation on holder to operate a pharmacovigilance system)

Amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)

Amendment of regulation 185 (recording obligations on the licensing authority)

Amendment of regulation 186 (reporting obligations on the licensing authority)

Insertion of new regulation 187A (collaboration with the World Health Organisation)

Amendment of regulation 187 (recording obligations on holders)

Amendment of regulation 188 (reporting obligations on holders)

Amendment of regulation 189 (signal detection: licensing authority obligations)

Amendment of regulation 190 (signal detection: holder obligation)

Amendment of regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)

Amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements)

Amendment of regulation 193 (harmonisation of PSUR frequency or date of submission)

Amendment of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive)

Amendment of regulation 195 (obligation on licensing authority to assess PSURs)

Amendment of regulation 196 (urgent action)

156ZA

In regulation 196—

• (a) in the italic heading immediately preceding it, after “Urgent action” insert “and major safety review”;

• (b) in paragraph (1), for “The licensing authority must initiate the Section 4 procedure by informing” substitute “In the case of a medicinal product authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority must inform”;

• (c) omit sub-paragraph (2B);

• (d) omit paragraphs (4) to (7);

• (e) in paragraph (8), omit the definition of “EU urgent action procedure” and “Section 4 procedure”.

Insertion of new regulation 196A (major safety review by the licensing authority)

Amendment of regulation 197 (EU urgent action procedure)

Amendment of regulation 198 (post-authorisation safety studies: general provisions)

Amendment of regulation 199 (submission of draft study protocols for required studies)

Amendment of regulation 200 (amendment to study protocols for required studies)

Amendment of regulation 201 (submission and evaluation of final study reports for required studies)

Amendment of regulation 202 (follow up of final study reports)

Insertion of new regulation 202A (medicinal products subject to additional monitoring)

Amendment of regulation 203 (obligations on licensing authority in relation to national medicines web-portal)

Amendment of regulation 204 (obligation on licensing authority in relation to public announcements)

Amendment of regulation 205 (obligations on holders in relation to public announcements)

Insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)

Insertion of new Schedule 12A (further provision as to performance of pharmacovigilance activities)

Insertion of regulation 205B (guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies)

Amendment of regulation 206 (infringement notices)

Amendment of regulation 207 (offences)

Amendment of regulation 208 (false and misleading information)

Amendment of regulation 209 (penalties)

Omission of regulation 210 (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004)

Amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation)

Amendment of regulation 211 (persons liable)

Amendment of regulation 212 (transitional arrangements)

Amendment of Schedule 33 (transitional arrangements: pharmacovigilance)

Amendment of regulation 251 (compliance with standards specified in certain publications)

194A

In regulation 251 (compliance with standards specified in certain publications), after paragraph (5) insert—

(6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where— (a) the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and (b) the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph. (7) In paragraph (6), “relevant marketing authorisation” means— (a) an EU marketing authorisation; (b) an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or (c) a UKMA(GB) granted under the unfettered access route.

Amendment of regulation 254 (prohibitions concerning traceability of treatment with advanced therapy medicinal products)

Amendment of regulation 255B (exception to Article 25 of Commission Regulation 2016/161: health care institutions)

Amendment of regulation 255B (exception to Article 25 of Commission Regulation 2016/161: health care institutions)

196A

In regulation 255B, after “medicinal products to the public” in the first place it occurs insert “in Northern Ireland”.

Amendment of Part 12A

Amendment of regulation 257A (packaging requirements: medicinal products required to bear safety features)

Amendment of regulation 257B (transitional arrangements)

199A

In regulation 257B, after “unless the product” insert “is one to which Article 54a of the 2001 Directive applies and”.

Insertion of regulations 257C (packaging requirements: advanced therapy medicinal products) and 257D and 257E (guidance and regulations in relation to packing, leaflets and labelling)

Amendment of Schedule 24 (packaging information requirements)