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

Amendment of regulation 50 (accompanying material) U.K.

49.—(1) Regulation 50 M1 is amended as follows.

[F1 (1A) After paragraph (1) insert—

“(1A) An applicant for the grant of a UK marketing authorisation for a relevant medicinal product must provide—

(a) in the case of an application under the unfettered access route—

(i) the material specified in Schedule 8C, and

(ii) any material specified in Schedule 8 which is not included in the material specified in Schedule 8C, and

(b) in all other cases, the material specified in Schedule 8,

in relation to the product.”;

(1B) After paragraph (3) insert—

“(3A) Paragraph (4) does not apply in respect of an application under the unfettered access route.”].

[F2 (2) For paragraph (4) substitute—

“(4) If any of the medicinal products to which the application for a UK marketing authorisation relates—

(a) in the case of a UKMA(NI) or a UKMA(UK), is liable to be imported from a country other than an EEA State, or

(b) in the case of a UKMA(GB), is liable to be imported,

the material or information referred to in paragraph (3) may include an undertaking from the manufacturer of the product to comply with the matters set out in Schedule 9.”.]

(3) After paragraph (5) insert—

[F3 “(5A) The Secretary of State may by regulations in respect of Great Britain amend Schedule 8B (modifications of Annex I) in relation to a UKMA(GB) for the purpose of further modifying Annex I to the 2001 Directive in order to take account of scientific and technical progress.]

(5B) The licensing authority may publish, for the purposes of applications made pursuant to this regulation—

(a) guidance on the presentation and content of the material specified in Schedule 8;

(b) scientific guidelines relating to the quality, safety and efficacy of medicinal products; and

(c) guidelines describing the active substance manufacturing process and process controls.

(5C) Unless replaced by guidance or guidelines published under the power conferred by paragraph (5B), the following guidance and guidelines continue to apply as they applied immediately before [F4 IP completion day] (subject to any amendments or variations published under that paragraph)—

(a) the guidance published by the European Commission in the rules governing medicinal products in the European Community, Volume 2B, Notice to Applicants, Medicinal Products for human use, Presentation and content of the dossier, Common Technical Document M2 ;

(b) the scientific guidelines relating to the quality, safety and efficacy of medicinal products as adopted by the Committee for Medicinal Products for Human Use and published by the EMA and the other pharmaceutical Community guidelines published by the European Commission in the different volumes of the rules governing medicinal products in the European Community M3 ; and

(c) guidelines published by the EMA for the purposes of paragraph 3.2.1.2 of Part I of Annex I to the 2001 Directive M4 .”.

(4) In paragraph (6), before sub-paragraph (a), insert—

“(za) regulation 50A (requirement for certain applications to include results of paediatric investigation plan);

(zb) regulation 50E (application for paediatric use marketing authorisation);

(zc) regulation 50F (other applications including paediatric indications);

(zd) regulation 50G (applications relating to orphan medicinal products);

(ze) regulation 50H (applications relating to advanced therapy medicinal products);

(zf) regulation 50I (applications relating to conditional marketing authorisations);

(zg) regulation 50J (applications relating to medicinal products containing or consisting of genetically modified organisms);”.

[F5 (4A) In paragraph (6)—

(a) for sub-paragraph (a), substitute—

“(a) regulation 51 (application for UKMA(NI) relating to generic medicinal products)

(aa) regulation 51A (application for UKMA(GB) relating to generic medicinal products);

(ab) regulation 51B (application for UKMA(UK) relating to generic medicinal products);”;

(b) for sub-paragraph (b), substitute—

“(b) regulation 52 (application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc)

(ba) regulation 52A (application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc);

(bb) regulation 52B (application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc);”;

(c) for sub-paragraph (c), substitute—

“(c) regulation 53 (application for UKMA(NI) relating to similar biological medicinal products)

(ca) regulation 53A (application for UKMA(GB) relating to similar biological medicinal products);

(cb) regulation 53B (application for UKMA(UK) relating to similar biological medicinal products);”.]

(5) After paragraph (6), insert—

“(7) The licensing authority may make appropriate arrangements with any EEA State or the EMA in order to obtain the information it considers necessary to satisfy itself that a product to be imported under a parallel import licence is essentially similar to a product that has been granted a UK marketing authorisation.

(8) If the licensing authority makes arrangements under paragraph (7), it must publish a list of the EEA States or the organisation with which it has made such arrangements.”.

Textual Amendments

F1 Reg. 49(1A)(1B) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(a)

F2 Reg. 49(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(b)

F3 Words in reg. 49(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(c)(i)

F4 Words in reg. 49(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(c)(ii)

F5 Reg. 49(4A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(d)

Commencement Information

I1 Reg. 49 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 Regulation 50 was amended by S.I. 2014/1878.

M2 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.

M3 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.

M4 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.