The Human Medicines Regulations 2012

Accompanying materialU.K.

This section has no associated Explanatory Memorandum

50.—(1) An applicant for the grant of a UK marketing authorisation for a relevant medicinal product must provide the material specified in Schedule 8 in relation to the product.

[F1(1A) An applicant for the grant of a parallel import licence for a relevant medicinal product must provide the material specified in Schedule 8A in relation to the product.]

[F2(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.]

(2) An applicant for the grant of a UK marketing authorisation [F3or parallel import licence] for a radionuclide generator must, in addition, provide—

(a)a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation; and

(b)qualitative and quantitative particulars of the eluate or the sublimate.

(3) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for dealing with the application.

[F4(3A) Paragraph (4) does not apply in respect of an application under the unfettered access route.]

[F5(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.]

(5) Material that is submitted under this regulation [F6for the purposes of a UK marketing authorisation] must be submitted in accordance with the applicable provisions of Annex I to the 2001 Directive.

[F7(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 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;

(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; 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.]

(6) [F8Unless the application is for a parallel import licence this] regulation is subject to—

[F9(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);]

[F10(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);]

[F11(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);]

[F12(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);]

(d)regulation 54 (applications relating to products in well-established medicinal use);

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

(f)regulation 56 (applications containing information supplied in relation to another medicinal product with consent); and

(g)Schedule 10 (applications relating to national homoeopathic products).

[F13(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

F2Reg. 50(1A) inserted after subparagraph (1) (31.12.2020) by virtue of S.I. 2019/775, regs. 1, 49(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(a))

F3Words in reg. 50(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 50(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(c)

F6Words in reg. 50(5) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 6(4) and words in reg. 50(5) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 6(4)

F8Words in reg. 50(6) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 6(5) and words in reg. 50(6) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 6(5)