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The Human Medicines Regulations 2012

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Application for UK marketing authorisationU.K.

Application for grant of UK marketing authorisation [F1or parallel import licence] U.K.

49.—[F2(1) The licensing authority may grant—

(a)subject to regulation 58, [F358C, 58E, 58F and 58G,] a UK marketing authorisation; or

(b)a parallel import licence,

for a relevant medicinal product in response to an application made in accordance with this Part.]

[F4(1ZA) If the licensing authority determines to grant a UKMA(UK) under paragraph (1), it must determine if one or more of the following criteria are met in relation to the medicinal product—

(a)it belongs to a category of medicinal product referred to in Article 3(1) of Regulation (EC) No 726/2004;

(b)it belongs to a category of medicinal product referred to in Article 3(2) of Regulation (EC) No 726/2004 and—

(i)the medicinal product contains an active substance which, on 20th May 2004, was not authorised in the European Union, or

(ii)the licensing authority considers that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that granting the marketing authorisation is in the interest of patients’ health in the United Kingdom.

(1ZB) If the licensing authority determines that one or more of the criteria in paragraph (1ZA) are met, the marketing authorisation granted is a UKMA(UK)(Category 1).

(1ZC) If the licensing authority determines that none of the criteria in paragraph (1ZA) are met, the marketing authorisation granted is a UKMA(UK)(Category 2).

(1ZD) The licensing authority may grant a UKMA(NI) under Chapter 4 of Title III of the 2001 Directive where there is an application for a marketing authorisation for a medicinal product, unless there is a UKMA(UK), or an application yet to be determined for a UKMA(UK), for the same medicinal product.]

[F5(1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a [F6UKMA(UK)(Category 2)] only where—

[F7(a)there is in place, or will be at the time the UKMA(UK)(Category 2) is granted, a UKMA(NI) in respect of the product authorising sale or supply in Northern Ireland,]

(b)the applicant complies with the requirements in regulation 50(1A), and

(c)the medicinal product satisfies the definition of qualifying Northern Ireland goods.

(1B) The licensing authority may only grant a parallel import licence if it is able to obtain the information necessary, whether from a competent authority of an EEA State or otherwise, to satisfy itself that the medicinal product to be imported—

(a)has been granted an EU marketing authorisation or a marketing authorisation under the 2001 Directive; and

(b)is essentially similar to a product that has already been granted a UK marketing authorisation.

(1C) A marketing authorisation or parallel import licence must state whether it is in force in—

(a)the whole United Kingdom;

(b)Great Britain only; or

(c)Northern Ireland only,

and in these Regulations the meaning of a reference to that authorisation or licence being “in force” is limited to that territory.]

(2) A marketing authorisation [F8or parallel import licence] granted under paragraph (1) shall contain terms approved by the licensing authority.

[F9(3) The applicant, where it is applying for—

[F10(a)[F11a UK marketing authorisation must, subject to sub-paragraph (b),] be established in the United Kingdom or an EEA State;]

(b)a [F12UKMA(UK)(Category 2)] —

(i)under the unfettered access route, must be established in Northern Ireland;

F13(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)a [F14parallel import licence], must be established in the United Kingdom.]

[F15(3ZA) Where a UKMA(UK)(Category 2) is granted under the unfettered access route, any UKMA(NI) granted in relation to the same medicinal product ceases to have effect.]

[F16(3A) An application for a parallel import licence may not be made by—

(a)the holder of the marketing authorisation, within the meaning of the 2001 Directive, or the EU marketing authorisation, in respect of the relevant medicinal product to be imported; or

(b)a company which is in the same group as the holder of that marketing authorisation.]

(4) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(5) An application is treated as signed for the purposes of paragraph (4)(b) if it is signed with an electronic signature.

(6) The application and any accompanying material must be in English.

(7) The application must include a statement indicating whether the product to which the application relates should be available—

(a)only on prescription;

(b)only from a pharmacy; or

(c)on general sale.

(8) The application must include a statement indicating—

(a)whether any terms of the authorisation are proposed relating to the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product); and

(b)if so, what terms are proposed.

[F17( 9) The application must include a statement indicating whether the authorisation or licence sought is for sale or supply of the product in—

(a)the whole United Kingdom;

(b)F18...; or

(c)Northern Ireland only.

(10) In this regulation “group” has the same meaning as in Part 15 of the Companies Act 2006 (see section 474(1) of that Act).]

Textual Amendments

F1Words in reg. 49 heading 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. 49 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(a)

F8Words in reg. 49(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. 49(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)(b)

Accompanying materialU.K.

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.

[F19(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.]

[F20(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 [F21or 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.

[F22(3A) Paragraph (4) does not apply in respect of an application under the unfettered access route.]

[F23(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 [F24UKMA(UK)(Category 2)], is liable to be imported from a country other than an EEA State, or

(b)in the case of a [F25UKMA(UK)(Category 1)], 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 [F26for the purposes of a UK marketing authorisation] must be submitted in accordance with the applicable provisions of Annex I to the 2001 Directive.

[F27(5A) The Secretary of State may by regulationsF28... amend Schedule 8B (modifications of Annex I) in relation to a [F29UKMA(UK)(Category 1)] 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) [F30Unless the application is for a parallel import licence this] regulation is subject to—

[F31(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);]

[F32(a)regulation 51 (application for UKMA(NI) relating to generic medicinal products);

F33(aa). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

[F34(b)regulation 52 (application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc);

F35(ba). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

[F36(c)regulation 53 (application for UKMA(NI) relating to similar biological medicinal products);

F37(ca). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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).

[F38(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

F20Reg. 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))

F21Words 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)

F26Words 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)

F30Words 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)

[F39Requirement for certain applications to include results of paediatric investigation planU.K.

50A.—(1) This regulation applies in relation to an application—

(a)under regulation 49 for a F40... UKMA(UK) for a relevant medicinal product which is an initial marketing authorisation for the purposes of a global marketing authorisation, as described in regulation 48(5), or

(b)under regulation 49 or 65C for a new indication (including a paediatric indication), a new pharmaceutical form or a new route of administration in relation to a relevant medicinal product which is already the subject of a UKMA(GB) or UKMA(UK).

(2) Paragraph (1)(b) only applies if the medicinal product in relation to which the new indication, new pharmaceutical form or new route of administration is sought is protected in the United Kingdom by a supplementary protection certificate or a patent which qualifies for the granting in the United Kingdom of a supplementary protection certificate.

(3) An applicant making an application to which this regulation applies must, in addition to the material specified in regulation 50, or in Schedule 10A, provide to the licensing authority the results of all studies performed, and details of all information collected, in compliance with an agreed paediatric investigation plan.

(4) Where paragraph (1)(b) applies, the material provided pursuant to paragraph (3) must cover both the existing and new indication, pharmaceutical form or route of administration.

(5) Paragraph (3) does not apply–

(a)to the extent that the licensing authority has, in relation to all or part of the paediatric population, granted—

(i)a deferral under regulation 50C of the initiation or completion of some or all of the measures set out in a paediatric investigation plan, or

(ii)a waiver under regulation 50D of the obligation to produce the information referred to in paragraph (3); or

(b)if one of regulations 51 to 54 applies to the application.

(6) The applicant making an application to which this regulation applies must include in the application details of the measures intended to ensure the follow up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product.

(7) In the case of an application for a [F41UKMA(UK)(Category 2)] under the unfettered access route, an agreed paediatric investigation plan in respect of the product’s marketing authorisation in Northern Ireland applies also to that application as regards the UK marketing authorisation.

(8) This regulation does not remove, in respect of an application for [F42a UKMA(UK)(Category 2)], the obligation also to comply with the requirements of the Paediatric Regulation in connection with the agreement of, and compliance with, an EU agreed paediatric investigation plan in relation to Northern Ireland.

Textual Amendments

Agreement and modification of paediatric investigation planU.K.

50B.—(1) Any person may prepare a paediatric investigation plan for the purposes of an application to which regulation 50A applies and submit it to the licensing authority with a request for agreement.

(2) A paediatric investigation plan must—

(a)specify the timing and measures proposed to assess the safety, quality and efficacy of a medicinal product in the paediatric population; and

(b)describe any measures to adapt the formulation of the medicinal product so as to make its use more acceptable, easier, safer or more effective for different subsets of the paediatric population.

(3) A person who requests the agreement of a paediatric investigation plan must submit it to the licensing authority not later than upon completion of the human pharmaco-kinetic studies in adults in relation to the medicinal product to which the plan relates, as specified in section 5.2.3 of Part I of Annex I to the 2001 Directive, unless the licensing authority agrees to accept a later request.

(4) The licensing authority may request the person applying for agreement of a paediatric investigation plan to supply further information in relation to the plan or to submit proposed modifications to it.

(5) The licensing authority must decide whether or not—

(a)the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets of it; and

(b)the expected therapeutic benefits of the medicinal product justify the studies proposed; and

in doing so must consider whether or not the measures proposed to adapt the formulation of the medicinal product for use in different subsets of the paediatric population are appropriate.

(6) If, following a decision by the licensing authority to agree a paediatric investigation plan, the person carrying out the plan encounters such difficulties with its implementation as to render the plan unworkable or no longer appropriate, that person may propose changes or request a deferral or a waiver, by submitting a request to the licensing authority, explaining the grounds for the request.

(7) Schedule 11 makes provision about advice and representations in relation to proposals to agree, or to refuse to agree, a paediatric investigation plan under paragraph (5) or to grant, or to refuse to grant, a deferral or waiver requested under paragraph (6).

Textual Amendments

Deferral of initiation or completion of measures in paediatric investigation planU.K.

50C.—(1) At the same time as the paediatric investigation plan is submitted under regulation 50B(1), the person requesting agreement of it may request the agreement of the licensing authority to a deferral of the initiation or completion of some or all of the measures set out in the plan.

(2) If the licensing authority is satisfied that a deferral of the initiation or completion of some or all of the measures set out in a paediatric investigation plan can be justified on scientific and technical grounds, or on grounds related to public health, it may—

(a)agree to a request by the applicant to grant a deferral; or

(b)decide of its own motion to grant a deferral.

(3) If the licensing authority is satisfied as set out in paragraph (2), it must decide to grant a deferral where it is satisfied that—

(a)it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population; or

(b)studies in the paediatric population will take longer to conduct than studies in adults.

(4) If the licensing authority grants an application to which regulation 50A applies, it must, if it also grants a deferral in accordance with this regulation—

(a)record that fact in the product's summary of product characteristics, and, if it considers that it would be appropriate to do so, in the package leaflet; and

(b)specify in the document notifying the applicant of the grant of the deferral the time limits for the initiation or completion of the measures to which the deferral relates.

(5) Schedule 11 makes provision about advice and representations in relation to proposals to grant, or to refuse to grant, a deferral under paragraph (2) or (3).

Textual Amendments

Waiver of production of information in a paediatric investigation planU.K.

50D.—(1) The applicant making an application to which regulation 50A applies is exempt from the obligation to provide to the licensing authority the results of all studies performed, and details of all information collected, in compliance with an agreed paediatric investigation plan, if a waiver is granted in accordance with this regulation.

(2) The licensing authority may grant a waiver in accordance with this regulation if it is satisfied that there is evidence showing that—

(a)the medicinal product or class of medicinal products is likely to be ineffective or unsafe in all or part of the paediatric population;

(b)the disease or condition for which the medicinal product or class of medicinal products is intended occurs only in adult populations; or

(c)the medicinal product does not represent a significant therapeutic benefit over existing treatments for patients in the paediatric population.

(3) The licensing authority may grant a waiver in accordance with this regulation—

(a)in respect of the entire paediatric population, or a subset of it;

(b)in respect of all of the therapeutic indications for the medicinal product concerned, or only some of them;

(c)of its own motion, or at the request of the applicant; or

(d)in respect of a specific product or a class of medicinal products.

(4) A person who requests a waiver in accordance with this regulation must submit the request to the licensing authority not later than upon completion of the human pharmaco-kinetic studies in adults in relation to the medicinal product concerned, as specified in section 5.2.3 of Part I of Annex I to the 2001 Directive, unless the licensing authority agrees to accept a later application.

(5) The licensing authority must maintain and publish a list of waivers which are granted under this regulation in respect of a class of medicinal products.

(6) The licensing authority may review a waiver which it has granted under this regulation and may revoke it if it considers it appropriate, having regard to the matters specified in paragraph (2).

(7) If the licensing authority revokes a waiver granted under this regulation, the holder of the UK marketing authorisation to which the waiver relates must, at the end of the period of 36 months beginning with the date of publication of the decision to revoke the waiver, submit the information referred to in regulation 50A(3) to the licensing authority.

(8) If the licensing authority grants an application to which regulation 50A applies, it must, if it also grants a waiver in accordance with this regulation, record that fact in the product's summary of product characteristics, and, if it considers that it would be appropriate to do so, in the package leaflet.

(9) Schedule 11 makes provision about advice and representations in relation to proposals to grant, or to refuse to grant, a waiver in response to a request made in accordance with paragraph (4) and to revoke a waiver under paragraph (6).

Textual Amendments

Application for paediatric use marketing authorisationU.K.

50E.—(1) This regulation applies in relation to an application for a F43... UKMA(UK)—

(a)for a relevant medicinal product which is not protected in the United Kingdom by a supplementary protection certificate or by a patent which qualifies for the granting of a supplementary protection certificate; and

(b)which covers exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets of it, including the appropriate strength, pharmaceutical form or route of administration for that product.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority material necessary to establish the quality, safety and efficacy of the product in the paediatric population, including any specific data needed to support an appropriate strength, pharmaceutical form or route of administration for the product, in accordance with an agreed paediatric investigation plan.

(3) An application to which this regulation applies may, in accordance with regulations 51 to 55, refer to material supplied by the holder of a UK marketing authorisation.

(4) The applicant for a UK marketing authorisation to which this regulation applies must include in the application details of the measures intended to ensure the follow up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product.

(5) This regulation does not remove, in respect of an application for [F44a UKMA(UK)(Category 2)], the obligation also to comply with the requirements of the Paediatric Regulation in connection with the agreement of, and compliance with, an EU agreed paediatric investigation plan in relation to Northern Ireland.

Textual Amendments

Other applications including paediatric indicationsU.K.

50F.—(1) This regulation applies in relation to an application to which neither regulation 50A nor 50E applies and which is—

(a)an application for a [F45UKMA(UK)(Category 1)] for a relevant medicinal product which includes a paediatric indication; or

(b)an application to include a paediatric indication in an existing UKMA(GB) [F46or a UKMA(UK)(Category 1)].

(2) The applicant making an application to which this regulation applies must include in the application details of the measures intended to ensure the follow up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product.

Textual Amendments

Applications relating to orphan medicinal productsU.K.

50G.—(1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product—

(a)in relation to which the applicant intends to demonstrate that the orphan criteria are met[F47.]

F48(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The orphan criteria are that—

(a)the medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition;

(b)either—

(i)the condition referred to in sub-paragraph (a) affects not more than five in 10,000 persons in [F49the United Kingdom]; or

(ii)the medicinal product is unlikely, when marketed, to generate sufficient financial return to justify the necessary investment; and

(c)there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in [F49the United Kingdom], or if such method exists, the medicinal product will be of significant benefit to those affected by the condition.

(3) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority material that demonstrates that the orphan criteria are met.

(4) Schedule 9A makes further provision about the orphan criteria and terms used in regulation 58D.

(5) The Ministers may by regulations amend Schedule 9A.

Textual Amendments

Applications relating to advanced therapy medicinal productsU.K.

50H.—(1) This regulation applies in relation to an application for [F50a UKMA(UK)(Category 1)] for a relevant medicinal product which is an advanced therapy medicinal product.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority information about the measures the applicant envisages putting in place to ensure the follow up of the efficacy of the product and of any adverse reactions to it.

(3) In relation to an application for [F51a UKMA(UK)(Category 1)] for a combined advanced therapy medicinal product, the applicant must, in addition to the material specified in regulation 50 and paragraph (2), provide to the licensing authority evidence of conformity with the requirements of the Medical Devices Regulations 2002, including, where available, the results of the assessment of a notified body in accordance with those Regulations.

Textual Amendments

Applications relating to conditional marketing authorisations F52...U.K.

50I.—(1) This regulation applies in relation to an application for [F53a UKMA(UK)(Category 1)] for a relevant medicinal product which falls within paragraph (2).

(2) A relevant medicinal product falls within this paragraph if it is—

(a)aimed at the treatment, prevention or diagnosis of seriously debilitating or life-threatening diseases; or

(b)to be used in emergency situations, in response to public health threats.

(3) The applicant for a UK marketing authorisation to which this regulation applies may request that the licensing authority grant a conditional marketing authorisation if—

(a)comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied; and

(b)the applicant can demonstrate that—

(i)the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product,

(ii)it is likely that the applicant will be in a position to provide the comprehensive clinical data,

(iii)unmet medical needs will be fulfilled, and

(iv)the benefit to the public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.

(4) In this regulation, “unmet medical needs” means medical needs in relation to a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the United Kingdom, or, even if such method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.

(5) The applicant for a UK marketing authorisation to which this regulation applies must include in the application material which demonstrates that the criteria in paragraph (3)(b) are met.

Textual Amendments

Applications in relation to medicinal products containing or consisting of genetically modified organismsU.K.

50J.—(1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product which contains or consists of genetically modified organisms.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority—

(a)a copy of the consent to the deliberate release into the environment of the genetically modified organisms for research and development purposes given pursuant to—

(i)regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002,

(ii)regulation 22 of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002,

(iii)regulation 21 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002, or

(iv)regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003;

(b)a complete technical dossier supplying the information specified in Annexes III and IV to Directive 2001/18/EC;

(c)an environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and

(d)the results of any investigations performed for the purposes of research or development.

(3) In this regulation, “genetically modified organism” has the meaning given in Article 2(2) of Directive 2001/18/EC.]

Textual Amendments

[F54Application for UKMA(NI) relating to generic medicinal productsU.K.

51.—(1) An applicant for a UKMA(NI) for a relevant medicinal product that is a generic medicinal product may provide information in relation to the application in accordance with Article 10(1), (5) and (6) of the 2001 Directive.

(2) If the licensing authority grants a UKMA(NI) for the generic medicinal product in accordance with paragraph (1), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in Northern Ireland before the time at which it may be placed on the market in accordance with Article 10(1) of the 2001 Directive F55....

F56(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F57(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

Textual Amendments

Application for UKMA(GB) relating to generic medicinal productsU.K.

F5851A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F59Application for UKMA(UK) relating to generic medicinal productsU.K.

51B.—(1) An applicant for a UKMA(UK) for a generic medicinal product may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials if the applicant can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised for not less than eight years under regulation 49(1)(a) (subject to paragraphs (2) and (3)).

(2) In the case of an application under this regulation in relation to a salt, ester, ether, isomer, mixture of isomers, complex or derivative of an authorised active substance which differs significantly in properties with regard to safety or efficacy from the active substance in the reference medicinal product, the applicant must supply additional information providing proof of the safety or efficacy of the salt, ester, ether, isomer, mixture of isomers, complex or derivative.

(3) The applicant may omit bioavailability studies from an application under this regulation if the applicant can demonstrate that the generic medicinal product meets the relevant criteria as specified in the guidelines referred to in paragraph (4).

(4) The licensing authority may publish guidelines specifying the criteria to be met by generic medicinal products for the purpose of omitting bioavailability studies from an application in accordance with paragraph (3).

(5) Until replaced by guidelines published under paragraph (4), the guidelines published by the EMA under Article 10(2)(b) of the 2001 Directive continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under paragraph (4)).

(6) If the licensing authority grants a UKMA(UK) in relation to the generic medicinal product in accordance with paragraph (1), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in the United Kingdom before the expiry of ten years beginning with the date on which the UK marketing authorisation for the reference medicinal product was granted.

(7) If during the first eight of the ten years referred to in paragraph (6) the marketing authorisation holder for the reference medicinal product obtained a UK marketing authorisation for one or more new therapeutic indications, and, during the scientific evaluation prior to their authorisation, the licensing authority considers the new indications bring a significant clinical benefit in comparison with existing therapies, the period of ten years referred to in paragraph (6) is extended to eleven years.

(8) Where an application for grant or variation of a UKMA(UK) is made in relation to a new indication for a well-established substance; and significant pre-clinical or clinical studies were carried out in relation to the new indication, the applicant for a UKMA(UK) under paragraph (1) or regulation 52B or 53B, may not refer in its application to those studies for the period of one year beginning with the date on which the licensing authority grants or varies the UKMA(UK) in relation to the new indication.]

Textual Amendments

[F60Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etcU.K.

52.—(1) This regulation applies where—

(a)an application is made for a UKMA(NI) by reference to another medicinal product as reference medicinal product; and

(b)one or more of the circumstances listed in Article 10(3) of the 2001 Directive applies in respect of the application.

(2) The applicant must provide information in accordance with Article 10(3) and (6) of the 2001 Directive.

(3) [F61Paragraph (2) of regulation 51 applies to the application as it applies] in relation to an application made in accordance with paragraph (1) of that regulation.]

Textual Amendments

Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etcU.K.

F6252A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F63Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.U.K.

52B.—(1) This Regulation applies where an application is made for a UKMA(UK) by reference to another medicinal product as reference medicinal product which is, or has been, authorised for not less than eight years under regulation 49(1)(a) and one or more of the following circumstances applies in respect of the application—

(a)the medicinal product to which the application relates does not fall within the definition of generic medicinal product;

(b)bioequivalence with the reference medicinal product cannot be demonstrated through bioavailability studies; or

(c)the medicinal product to which the application relates differs from the reference medicinal product in terms of changes in the active substance, therapeutic indications, strength, pharmaceutical form or route of administration.

(2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials relating to the reference medicinal product, but must provide the results of the appropriate pre-clinical tests or clinical trials relating to the applicable circumstances in paragraph (1).

(3) Paragraphs (2), (6) and (7) of regulation 51B apply to the application as they apply to an application made in accordance with paragraph (1) of that regulation.]

Textual Amendments

[F64Application for UKMA(NI) relating to similar biological medicinal productsU.K.

53.—(1) This regulation applies if an applicant for a UKMA(NI) for a biological medicinal product is not able to show that product meets a condition for its being a generic version of a similar medicinal product because of any of the reasons described in Article 10(4) of the 2001 Directive.

(2) The applicant must provide information in accordance with Article 10(4) and (6) of the 2001 Directive.

(3) [F65Paragraph (2) of regulation 51 applies to the application as it applies] in relation to an application made in accordance with paragraph (1) of that regulation.]

Textual Amendments

Application for UKMA(GB) relating to similar biological medicinal productsU.K.

F6653A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F67Application for UKMA(UK) relating to similar biological medicinal productsU.K.

53B.—(1) This regulation applies in relation to an application for a UKMA(UK) for a biological medicinal product where the applicant is not able to show that it meets a condition for it being a generic version of a similar medicinal product because of differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference medicinal product which is the subject of a UKMA(UK).

(2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials relating to a reference medicinal product which is or has been authorised for not less than eight years, but must provide the results of appropriate pre-clinical tests or clinical trials relating to the differences referred to in paragraph (1).

(3) The type and quantity of supplementary data to be provided by the applicant under paragraph (2) must comply with the relevant criteria in Annex 1 to the 2001 Directive and in the related detailed guidelines published by the licensing authority under paragraph (4), or (as the case may be) as mentioned in paragraph (5).

(4) The licensing authority may publish guidelines concerning the type and quantity of supplementary data to be provided by an applicant under paragraph (2).

(5) Unless replaced by guidelines published under paragraph (4), the guidelines published by the EMA under Article 10(4) of the 2001 Directive continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under that paragraph).

(6) If the licensing authority grants a UKMA(UK), in relation to the similar biological medicinal product in accordance with paragraph (2), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in the United Kingdom before the expiry of ten years beginning with the date on which the UK marketing authorisation for the reference medicinal product was granted.

(7) If during the first eight of the ten years referred to in paragraph (6), the marketing authorisation holder for the reference medicinal product requested and obtained a UKMA(UK) for one or more new therapeutic indications, and, during the scientific evaluation prior to their authorisation, the licensing authority considers that new indications bring a significant clinical benefit in comparison with existing therapies, the period of ten years is extended to eleven years.

(8) Where an application is made for the grant or variation of a UKMA(UK) in relation to a new indication for a well-established substance, and significant pre-clinical or clinical studies were carried out in relation to the new indication, the applicant for a UKMA(UK) under paragraph (1) may not refer in its application to those studies for the period of one year beginning with the date on which the licensing authority grants or varies a UKMA(UK) in relation to the new indication.]

Textual Amendments

Applications relating to products in well-established medicinal useU.K.

54.—(1) This regulation applies if an applicant for a UK marketing authorisation for a relevant medicinal product is able to demonstrate that the active substances of the product have been in well-established medicinal use within the [F68United Kingdom or the] European Union for at least 10 years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I to the 2001 Directive.

[F69(2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, replace the results of pre-clinical tests or clinical trials with appropriate scientific literature.]

Textual Amendments

Applications relating to new combinations of active substancesU.K.

[F7055.—(1) This regulation applies to an application for a UK marketing authorisation for a relevant medicinal product that contains active substances, provided those active substances—

(a)have not been used in that combination for therapeutic purposes; and

(b)where the application is for—

(i)a UKMA(NI), have been used in medicinal products that have been the subject of a marketing authorisation under these Regulations, the 2001 Directive or Regulation (EC) No 726/2004;

(ii)F71... or

(iii)a UKMA(UK), have been used in medicinal products that have been the subject of—

(aa)a UKMA(UK) under these Regulations; or

[F72(bb)a UKMA(NI).]

(2) The applicant must provide the results of new pre-clinical tests or new clinical trials relating to that combination in accordance with paragraph 10 of Schedule 8, but does not need to provide scientific references relating to each individual active substance.

F73(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

Applications containing information supplied in relation to another product with consentU.K.

56.—(1) This regulation applies to an application for a UK marketing authorisation for a relevant medicinal product where—

(a)the product that is the subject of the application (“product A”) has the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form as a product (“product B”);

(b)product B is the subject of a UK marketing authorisation; and

(c)the holder of the marketing authorisation for product B has allowed use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on product B with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.

(2) The documentation referred to in paragraph (1)(c) in relation to product B may be used in relation to the application in relation to product A F74...

Textual Amendments

Obligation to update information supplied in connection with applicationU.K.

57.—(1) The applicant for a UK marketing authorisation must update information supplied in accordance with paragraphs 18 to 21 of Schedule 8 (material to accompany an application for a UK marketing authorisation) in connection with the application.

(2) The applicant must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.

(3) Updated information within paragraphs (1) or (2) must be provided as soon as is reasonably practicable after the applicant becomes aware of it.

[F75Obligation to update information supplied in connection with parallel import licence applicationU.K.

57A.—(1) The applicant for a parallel import licence must update information supplied in accordance with Schedule 8A (material to accompany an application for a parallel import licence) in connection with the application.

(2) The applicant must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.

(3) Updated information within paragraphs (1) or (2) must be provided as soon as is reasonably practicable after the applicant becomes aware of it.]

Textual Amendments

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