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

Amendment of regulation 50 (accompanying material)

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

(2) In paragraph (4), omit “from a country other than an EEA State”.

(3) After paragraph (5) insert—

“(5A) The Ministers may by regulations amend Schedule 8B (modifications of Annex I) 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 exit 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(2);

(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(3); 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(4).”.

(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);”.

(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.”.

(1)

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

(2)

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.

(3)

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.

(4)

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.