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

(2A) The licensing authority must consult the appropriate committee if the authority proposes to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.

• (2B) In paragraph 3 (exceptions to requirement to consult)—

• (a) in sub-paragraph (1), after “traditional herbal registration” insert “ , or to a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation, ”; and

• (b) in sub-paragraph (1)(a), after “determined”, insert “ or the decision to be made ”.

• (2C) In paragraph 5 (provisional opinion against authorisation)—

• (a) after sub-paragraph (2), insert—

(2A) If the appropriate committee is consulted under paragraph 2(2A), it may give a provisional opinion that it may be unable to advise the licensing authority to decide that the orphan criteria are met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.

; and

• (b) in sub-paragraph (3), after “grant or renewal”, insert “ , the applicant intending to demonstrate that the orphan criteria are met in relation to a medicinal product, ”.

• (2D) In paragraph 10 (decision of licensing authority)—

• (a) omit the “or” at the end of sub-paragraph (1)(b); and

• (b) at the end of sub-paragraph (1)(c) insert—

; or (d) decide whether to proceed with its proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,

• (3) In paragraph 12 (licensing authority decisions in other cases)—

• (a) in sub-paragraph (1), insert “ , parallel import licence ” after “ UK marketing authorisation ” in each place it appears;

• (b) in sub-paragraph (5), insert “ , licence ” after “ the authorisation ”; and

• (c) after sub-paragraph (4), insert—

(4A) This paragraph also applies if, having been consulted under paragraph 2(2A), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2A) and the licensing authority proposes to decide, against that committee's advice, that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.

• (3A) After Part 1 insert—

(13A) This Part applies to a proposed decision by the licensing authority— (a) to refuse to agree a paediatric investigation plan (including a waiver or deferral proposed to be included in that plan), or to agree such a plan otherwise than in accordance with the request for agreement; (b) to refuse to agree a modification to a paediatric investigation plan (including a waiver or deferral which is, or is proposed to be, included in that plan), or to agree such a modification otherwise than in accordance with the request for the modification; (c) to impose, revoke or refuse to grant a waiver of the obligation under regulation 50A(3) 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; or (d) to revoke a waiver which was agreed as part of an agreed paediatric investigation plan. (13B) (1) If the licensing authority proposes to make a decision to which this Part applies, the licensing authority must notify the person to whom the proposed decision would be addressed (“the applicant”). (2) The applicant may, by notice in writing to the licensing authority, request the opportunity to make written or oral representations to the appropriate committee. (3) The applicant must make the request before the end of the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow. (4) The licensing authority must inform the appropriate committee of the applicant's request. (13C) (1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them— (a) before the end of the period of 28 days beginning with the date of the request; or (b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 13B. (2) The appropriate committee may at the request of the applicant extend the period mentioned in sub-paragraph (1) up to a maximum of 56 days beginning with the date of the request under paragraph 13B. (3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee. (4) The appropriate committee must— (a) take the representations made under this paragraph into account; and (b) report its findings and advice to the licensing authority together with the reasons for that advice. (13D) (1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them— (a) before the end of the period of 28 days beginning with the date of the request; or (b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 13B. (2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of 56 days beginning with the date of the request under paragraph 13B. (3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee. (4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the committee. (5) The appropriate committee must— (a) take the representations made under this paragraph into account; and (b) report its findings and advice to the licensing authority together with the reasons for that advice. (13E) (1) This paragraph applies if the applicant— (a) requests the opportunity to make written representations, but fails to make those representations within the period for doing so; or (b) requests the opportunity to make oral representations, but— (i) fails to provide a summary of those representations or the documents in support of them within the period for doing so, or (ii) fails to make oral representations at a hearing before the appropriate committee. (2) The appropriate committee must notify the licensing authority of that fact. (13F) (1) The licensing authority must decide whether to proceed with its proposed decision— (a) if the applicant requested the opportunity to make written or oral representations, after receiving the appropriate committee's report under paragraph 13C or 13D or notification under paragraph 13E; or (b) if the applicant did not request the opportunity to make written or oral representations, after the expiry of the period of time for notifying a request for that opportunity. (2) If the appropriate committee gives a report under paragraph 13C or 13D, the licensing authority must take that into account in making its decision. (3) The licensing authority must notify the applicant of— (a) its decision; and (b) any advice given to it by the appropriate committee and the reasons for that advice. (13G) (1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 13F. (2) The applicant may notify the licensing authority in writing that the applicant wishes the licensing authority to submit the decision to review upon oral representations. (3) The applicant must give the notification before the end of the period of 28 days beginning with the day on which the notification is given to the applicant under paragraph 13F or such longer period as the licensing authority may allow. (4) The review must be conducted in accordance with Schedule 5. (5) This paragraph does not apply if the applicant has not made any representations in accordance with paragraph 13C or 13D.

• (4) In paragraph 14(a) (application of Part 2), after “veterinary medicinal products” insert “or paragraph 1 of Schedule 10A”.

• (5) In paragraph 15(2) and (3)(b), insert “ UK ” before “marketing authorisation”.

• (6) In paragraph 16—

• (a) in sub-paragraph (2)(b), insert “ UK ” before “marketing authorisation”; and

• (b) in sub-paragraph (5), omit the words from “or in any Directive” to the end.

• (7) For paragraph 17 substitute—

(17) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.

• (8) In Part 3 (referral to the Committee for Herbal Medicinal Products)—

• (a) in the heading to Part 3, for “Committee for Herbal Medicinal Products” substitute “ appropriate committee for traditional herbal registrations ”;

• (b) in paragraph 24—

• (i) in sub-paragraph (1), for the words from “Committee” to the end substitute “ appropriate committee in accordance with regulation 130A(1) ”; and

• (ii) for sub-paragraph (2) substitute—

(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.

; and

• (c) in paragraph 29(1), for “proceed with its proposal” substitute “ grant or refuse the application ”.

• (9) In Part 4 (exceptions to Schedule) omit paragraphs 31, 34, 35, 37 and 38.

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

64

After regulation 58, insert—

(58A) (1) Paragraph (2) applies if— (a) an application— (i) to which regulation 50A (requirement for certain applications to include the results of a paediatric investigation plan) applies, and in relation to which there is an agreed paediatric investigation plan; or (ii) to which Article 7 or 8 of the Paediatric Regulation applies, and in relation to which there is an EU agreed paediatric investigation plan, is granted by the licensing authority; and (b) the licensing authority is satisfied that the material provided by the applicant pursuant to— (i) regulation 50A(3), where paragraph (1)(a)(i) applies; or (ii) Article 7 or 8 of the Paediatric Regulation, where paragraph (1)(a)(ii) applies, demonstrates compliance with the agreed paediatric investigation plan. (2) Where this paragraph applies, the licensing authority must— (a) include in the UK marketing authorisation a statement to the effect that it is satisfied as set out in paragraph (1)(b); and (b) ensure that the results of all studies referred to in the paediatric investigation plan are included in the summary of product characteristics and, if the licensing authority considers that the information would be useful to patients, in the package leaflet. (3) Where— (a) paragraph (2) applies; or (b) an application to which Article 7 or 8 of the Paediatric Regulation applies— (i) includes the results of all studies conducted in compliance with an EU agreed paediatric investigation plan; or (ii) confirms completion of an EU agreed paediatric investigation plan which failed to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, the package leaflet of the medicinal product, the holder of a patent or supplementary protection certificate covering the medicinal product to which the application relates is entitled to a six month extension of the period referred to in Articles 13(1) and 13(3) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (subject to paragraphs (4) to (5)). (4) Paragraph (3) does not apply if the grant of the application referred to in paragraph (1)(a)— (a) relates to a new paediatric indication; and (b) the holder of the UK marketing authorisation is entitled to a one year extension of the ten year period referred to in regulation 51A(6), under regulation 51A(12). (4A) Paragraph (3) does not apply where— (a) the territorial protection conferred by the supplementary protection certificate referred to in paragraph (3) does not cover the whole of the United Kingdom; and (b) the UK marketing authorisation in which the statement of compliance is included is not in force in the same part of the United Kingdom as the supplementary protection certificate. (4B) Where— (a) the territorial protection conferred by the supplementary protection certificate referred to in paragraph (3) does cover the whole of the United Kingdom; and (b) the UK marketing authorisation in which the statement of compliance is included is in force in in Great Britain only or in Northern Ireland only, the extension provided for in paragraph (3) only applies in relation to Great Britain only or Northern Ireland only (as appropriate). (5) If the UK marketing authorisation to which this regulation applies is an orphan marketing authorisation, paragraph (3) does not apply and regulation 58D(5) (orphan rewards) applies. (6) Paragraphs (7) and (8) apply if the licensing authority grants a UK marketing authorisation in response to an application to which regulation 50E (paediatric use marketing authorisation) applies. (7) Where this paragraph applies, the medicinal product to which the paediatric use marketing authorisation relates may retain the name of any medicinal product which contains the same active substance and in respect of which the holder of the paediatric use marketing authorisation has been granted a UK marketing authorisation for use in adults. (8) Where this paragraph applies, the holder of the paediatric use marketing authorisation is entitled to benefit from the periods of data and marketing exclusivity referred to in regulation 51A(1) and (6) in relation to the material supplied pursuant to regulation 50E(2). (58B) (1) The licensing authority must publish a register of UK marketing authorisations— (a) which include a paediatric indication following completion of an agreed paediatric investigation plan; and (b) in relation to which the medicinal product was placed on the market for other indications before the holder obtained that paediatric indication. (2) The register referred to in paragraph (1) must include the date by which the product must be placed on the market taking account of the paediatric indication in accordance with regulation 78A(4) (post-authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply). (3) The licensing authority must publish a list of the marketing authorisation holders which have— (a) benefitted from any of the rewards in regulation 58A; or (b) failed to comply with any of the obligations in regulation 78A. (4) The licensing authority must publish decisions made under— (a) regulation 50B(5) or (7) (agreement and modification of paediatric investigation plan); (b) regulation 50C(2) (deferral of the initiation or completion of measures in a paediatric investigation plan); and (c) regulation 50D(2) (waiver of production of information in a paediatric investigation plan) in relation to a specific medicinal product. (5) The decisions referred to in paragraph (4) must be published, with the omission of information of a commercially confidential nature, as soon as reasonably practicable after the decision has been made. (58C) (1) If the licensing authority is satisfied in relation to an application for a UK marketing authorisation (including an application under the unfettered access route)— (a) the orphan criteria are met in relation to all of the therapeutic indications to which the application relates; and (b) it is otherwise appropriate to grant a UK marketing authorisation in respect of the application under regulation 49(1)(a), it may grant a UK marketing authorisation which is known as an orphan marketing authorisation. (2) The licensing authority must publish and keep up to date a list of orphan marketing authorisations. (3) Schedule 11 makes provision about advice and representations in relation to proposals to grant a UK marketing authorisation in respect of which the applicant intended to demonstrate that the orphan criteria were met, in cases where the licensing authority considers that those criteria are not met. (58D) in relation to a medicinal product which is similar to the medicinal product to which the orphan marketing authorisation relates and in respect of the therapeutic indications which are covered by the orphan marketing authorisation. (1) Subject to the following provisions of this regulation, for the period of ten years beginning with the date on which the licensing authority grants an orphan marketing authorisation, the licensing authority must not— (a) grant an application for a UK marketing authorisation; or (b) grant an application to vary a UK marketing authorisation; (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) The period of ten years referred to in paragraph (1) may be reduced to six years if, at the end of the fifth year beginning on the date referred to in paragraph (1), the licensing authority is satisfied that the orphan criteria are no longer met in relation to the medicinal product. (5) The period of ten years referred to in paragraph (1) is extended to twelve years if regulation 58A(2) (paediatric rewards) applies to the orphan marketing authorisation. (6) Paragraph (1) does not apply if— (a) the holder of the orphan marketing authorisation consents to the grant or variation of a UK marketing authorisation in relation to a similar medicinal product; (b) the licensing authority is satisfied that the holder of the orphan marketing authorisation is unable to supply sufficient quantities of the medicinal product to which the orphan marketing authorisation relates; or (c) a subsequent applicant can establish to the satisfaction of the licensing authority that the medicinal product to which the application relates, although similar to the medicinal product to which the orphan marketing authorisation relates, is safer or more effective than, or clinically superior to, that product. (58E) (1) When determining an application to which regulation 50H(3) (applications relating to combined advance therapy medicinal products) applies, the licensing authority must— (a) assess the entire combined advanced therapy medicinal product in accordance with these Regulations; and (b) recognise the results of the assessment of the notified body, if supplied. (2) The licensing authority may request the notified body, if relevant, to provide it with information related to the results of the assessment. (3) Paragraph (4) applies if an application to which regulation 50H(3) applies does not include the results of the assessment of a notified body, or if the notified body fails to supply information related to the results of the assessment when requested by the licensing authority. (4) Where this paragraph applies, the licensing authority must seek an opinion on the conformity of the device part in accordance with the Medical Devices Regulations 2002 from a notified body identified in conjunction with the applicant, unless the licensing authority decides that the involvement of a notified body is not required. (58F) it may grant a UK marketing authorisation which is known as a conditional marketing authorisation. (1) If the licensing authority is satisfied in relation to an application to which regulation 50I (applications relating to conditional marketing authorisations) applies that— (a) the criteria in regulation 50I(3)(b) are met; and (b) it is otherwise appropriate to grant a UKMA(GB) in respect of the application in accordance with regulation 49(1)(a), (2) Where regulation 50I(2)(b) (applications relating to conditional marketing authorisations) applies, the licensing authority may grant a conditional marketing authorisation if, in addition to comprehensive clinical data, comprehensive pre-clinical or pharmaceutical data have not been supplied. (3) The licensing authority may, of its own motion, propose that a conditional marketing authorisation be granted if, having consulted the applicant for a UK marketing authorisation, it considers that the criteria in regulation 50I(3)(b) are met. (4) If the licensing authority grants a conditional marketing authorisation in relation to a medicinal product, it may at any time decide that it is appropriate to grant a UK marketing authorisation in relation to that product which is not a conditional marketing authorisation. (5) If the licensing authority grants a conditional marketing authorisation, the product's summary of product characteristics and package leaflet must include a statement to that effect, and the summary of product characteristics must include the date on which the conditional marketing authorisation is due for renewal. (58G) (1) When determining an application for a UK marketing authorisation in relation to which regulation 50J (applications relating to medicinal products containing or consisting of genetically modified organisms) applies, the licensing authority must be satisfied that the application respects the environmental safety requirements laid down by Directive 2001/18/EC. (2) In reaching its view under paragraph (1), the licensing authority must consult the bodies responsible for the giving of consent pursuant to the legislation referred to in regulation 50J(2)(a).

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

65

• (1) Regulation 59 is amended as follows.

• (1A) In paragraph (3) for “An obligation” substitute “In relation to a UKMA(NI) or UKMA(UK), an obligation”.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) After paragraph (3), insert—

(3A) In relation to a UKMA(GB), an obligation to conduct such studies as are referred to in paragraph (2)(f) must— (a) be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive; and (b) take into account the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies. (3B) The Secretary of State may by regulations make provision in respect of Great Britain specifying the situations in which post-authorisation efficacy studies may be required by virtue of the condition referred to in paragraph (2)(f). (3C) Paragraph (3A)(a) ceases to apply on the coming into force of regulations made under paragraph (3B).

• (4) In paragraph (4), insert “ UK ” before “marketing authorisation”.

• (5) After paragraph (4), insert—

(4A) Where the application is one to which regulation 50A, 50E or 50F (applications to which paediatric-specific provisions apply) applies, the licensing authority must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that— (a) a risk management system be set up comprising a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions; or (b) specific post-marketing studies be performed and submitted for review. (4B) The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A (post-authorisation safety studies), a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4A). (4C) If the licensing authority grants a conditional marketing authorisation— (a) it must impose, as a condition of the conditional marketing authorisation, an obligation on the holder of the authorisation to complete ongoing studies, or to conduct new studies, with a view to confirming the that the positive therapeutic effects of the product outweigh the risks to the health of patients or the public associated with the product, and to provide the additional data referred to in regulation 50I(3)(a); (b) it may impose, as a condition of the conditional marketing authorisation, an obligation on the holder of that authorisation in relation to collection of pharmacovigilance data. (4D) If the licensing authority grants a UK marketing authorisation in relation to an advanced therapy medicinal product, it must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that— (a) a risk management system be set up which is designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system; or (b) that specific post-marketing studies be carried out and submitted for review by the licensing authority. (4E) The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A, a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4D).

• (6) In paragraph (5) for “marketing authorisation” substitute “UKMA(NI) or UKMA(UK).

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

66

In regulation 60—

• (a) after “UK marketing authorisation” in each place it occurs (including the heading to the regulation) insert “or parallel import licence”;

• (b) after “the authorisation” in each place it occurs insert “or licence”;

• (c) in paragraph (3), after “an authorisation” insert “or licence”;

• (d) for paragraph (9) substitute—

(9) The licensing authority must notify the EMA of any UKMA(NI) or UKMA(UK) that it has granted subject to a condition included in accordance with this regulation.

• (e) in paragraph (10), after “a marketing authorisation” insert “or licence”.

Insertion of new regulations 60A (condition as to the submitting of samples and other information to the appropriate authority)

67

After regulation 60, insert—

(60A) (1) In this regulation— - “the appropriate authority” is to be construed in accordance with section 57(7) of the Health and Social Care Act 2012 ; - “appropriate documentation”, in relation to a sample of a batch submitted to the appropriate authority in accordance with the batch testing condition or pursuant to a notification under paragraph (12), means— 1. any certificate issued by a laboratory in an approved country for batch testing and certification of biological medicinal products that relates to the sample of the batch submitted to the appropriate authority with that certificate; and 2. such other documentation as the appropriate authority notifies the holder of the UK marketing authorisation to which the sample relates that it requires; - “approved country list for batch testing and certification of biological medicinal products” means the list described in paragraph (5), and “approved country for batch testing and certification of biological medicinal products” means a country included in that list; - “the batch testing condition”, in respect of a UK marketing authorisation, is a condition to the effect that, unless the batch testing exemption applies, the holder of the UK marketing authorisation— 1. must submit a sample from each batch of the medicinal product that is the subject of that authorisation to the appropriate authority, together with appropriate documentation; and 2. must not sell or supply, or offer to sell or supply, a medicinal product that forms part of that batch in the United Kingdom until the appropriate authority has examined— 1. the sample from that batch, 2. the appropriate documentation, or 3. both that sample and that documentation, - “the batch testing exemption” means that— 1. in the case of a medicinal product for sale or supply in Northern Ireland only—a certificate has been issued by a laboratory in an EEA State, andin relation to a product of a kind listed in Article 114(1) of the 2001 Directive, the certificate was issued in the same EEA State as that in which the batch was manufactured, or 1. a certificate has been issued by a laboratory in a country other than the United Kingdom, 2. an agreement has been made between that country and the United Kingdom (whether or not the agreement is solely with that country, a group of countries or an organisation of which that country is a part), and 3. that agreement is to the effect that the appropriate authority will recognise that certificate in respect of the batch of the medicinal product, in place of the appropriate authority’s own examination of a sample from the batch, the appropriate documentation or both. (2) The licensing authority may impose the batch testing condition in respect of a UK marketing authorisation for a medicinal product that is— (a) a live vaccine; (b) an immunological ... product used in the primary immunisation of infants or other groups at risk; (c) an immunological product used in public health immunisation programmes; (d) subject to paragraph (3), a new immunological product manufactured using new or altered kinds of technology or new for a particular manufacturer; or (e) derived from human blood or human plasma. (3) If the licensing authority imposes a condition in respect of a UK marketing authorisation for a medicinal product of a kind mentioned in paragraph (2)(d), it must, in imposing that condition, specify a period of time for the duration of the condition. (4) The appropriate authority must complete its examination of the sample for testing, the appropriate documentation or both (as the case may be) within the period of 60 days, beginning with the date on which the appropriate authority is in receipt of both the sample for testing, and the appropriate documentation. (5) The appropriate authority must publish a list, to be known as the approved country list for batch testing and certification of biological medicinal products, specifying the countries that are approved for the purposes of the appropriate authority's assessment under paragraph (6) and regulation 60B(5). (6) Where a holder of a UK marketing authorisation, in order to comply with the batch testing condition, submits appropriate documentation that includes a certificate issued by a laboratory in an approved country for batch testing and certification of biological medicinal products in respect of the batch, the appropriate authority must, in addition to any other factors it considers relevant, take that into account in determining whether the appropriate authority needs to undertake any further testing of the medicinal product submitted to it. (7) In order to determine whether a country should be included in the approved country list for batch testing and certification of biological medicinal products, the appropriate authority may, in particular, take into account whether the relevant certification process in that country is based on testing performed under a quality assurance system that undergoes regular external assessment to ensure it meets an appropriate standard of competence for testing biological medicines. (8) The appropriate authority must— (a) review the countries it has included in the approved country list for batch testing and certification of biological medicinal products to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; and (b) undertake that review at least every three years beginning with the date on which that country is included in the list. (9) The appropriate authority must— (a) publish a list of countries, or organisations, with whom the United Kingdom has an agreement for the purposes of the application of the batch testing exemption under this regulation or regulation 60B; (b) include in that list any conditions or restrictions in that agreement that affect the applicability of the batch testing exemption under this regulation or regulation 60B; and (c) update that list as soon as reasonably practicable if— (i) the United Kingdom no longer has an agreement with a country or organisation included in the list, (ii) any such agreement is amended, or (iii) the United Kingdom enters in to a new agreement with a country or organisation. (10) Where a holder of a UK marketing authorisation relies on the batch testing exemption in relation to a batch of a medicinal product, that holder must submit the certificate in respect of that batch to the licensing authority and the appropriate authority, and such other documentation as those authorities may notify that holder they require, before it sells or supplies, or offers to sell or supply, a medicinal product that forms part of that batch in the United Kingdom. (11) Paragraph (12) applies where the appropriate authority considers that there are public health concerns in respect of a batch of a medicinal product (“the relevant batch”) in relation to which the batch testing exemption would otherwise apply. (12) Where this paragraph applies, the appropriate authority must, subject to paragraph (13), notify the holder of the UK marketing authorisation in respect of the relevant batch that it nevertheless requires that holder— (a) to submit a sample from the relevant batch to the appropriate authority, together with appropriate documentation; and (b) not to sell or supply, or to offer to sell or supply, a medicinal product that forms part of that batch in the United Kingdom until the appropriate authority has examined— (i) the sample from that batch, (ii) the appropriate documentation, or (iii) both that sample and that documentation, and confirmed that it is satisfied that the relevant batch is in conformity with the approved specifications in the UK marketing authorisation. (13) The appropriate authority may only exercise its powers under paragraph (12) if the agreement made between the country in which the certificate was issued, and the United Kingdom (whether the agreement is solely with that country, a group of countries or an organisation of which that country is a part) provides for the relevant batch to be re-examined by the appropriate authority in the circumstances described in paragraph (11). (14) The appropriate authority may, in any particular case, apply this regulation to a medicinal product imported into the United Kingdom pursuant to a parallel import licence and accordingly any reference in this regulation to— (a) a UK marketing authorisation should be read as a reference to a parallel import licence for a medicinal product, (b) the holder of a UK marketing authorisation should be read as a reference to the holder of a parallel import licence, and (c) the approved specifications in a UK marketing authorisation should be read as a reference to the approved specifications in the UK reference product specified for the purposes of the parallel import licence in accordance with paragraph 4 of Schedule 8A. (15) Where, pursuant to paragraph (14), this regulation is applied to a medicinal product imported into the United Kingdom pursuant to a parallel import licence, sub-paragraph (a) of the definition of “the batch testing exemption” does not apply. (16) In the application of this regulation to a medicinal product for sale or supply in Northern Ireland only to which Article 114 of the 2001 Directive applies, a reference in this regulation to a laboratory is to an Official Medicines Control Laboratory or a laboratory referred to in that Article. (60B) (1) In this regulation— - “the appropriate authority” is to be construed in accordance with section 57(7) of the Health and Social Care Act 2012; - “appropriate documentation”, in relation to a sample of a batch submitted to the appropriate authority in accordance with the batch testing requirement or pursuant to a notification under paragraph (8), means such documentation as the appropriate authority notifies the holder of the EU marketing authorisation to which the sample relates that it requires; - “approved country list for batch testing and certification of biological medicinal products” means the list described in regulation 60A(5), and “approved country for batch testing and certification of biological medicinal products” means a country included in that list; - “the batch testing exemption” means that—a certificate has been issued by a laboratory in an EEA State, andin relation to a product of a kind listed in Article 114(1) of the 2001 Directive, the certificate was issued in the same EEA State as that in which the batch was manufactured, ora certificate has been issued by a laboratory in a country other than the United Kingdom,an agreement has been made between that country and the United Kingdom (whether or not the agreement is solely with that country, a group of countries or an organisation of which that country is a part), andthat agreement is to the effect that the appropriate authority will recognise that certificate in respect of the batch of the medicinal product, in place of the appropriate authority’s own examination of a sample from the batch, the appropriate documentation or both; - “the batch testing requirement”, in respect of an EU marketing authorisation, is a requirement that, unless the batch testing exemption applies, the holder of the EU marketing authorisation—must submit a sample from each batch of the medicinal product that is the subject of that authorisation to the appropriate authority, together with appropriate documentation; andmust not sell or supply, or offer to sell or supply, a medicinal product that forms part of that batch in Northern Ireland until the appropriate authority has examined—the sample from that batch,the appropriate documentation, orboth that sample and that documentation,and confirmed that it is satisfied that the batch is in conformity with the approved specifications in the EU marketing authorisation. (2) The licensing authority may impose the batch testing requirement on the holder of an EU marketing authorisation for a medicinal product— (a) that is— (i) a live vaccine; (ii) an immunological product used in the primary immunisation of infants or other groups at risk; (iii) an immunological product used in public health immunisation programmes; (iv) subject to paragraph (3), a new immunological product manufactured using new or altered kinds of technology or new for a particular manufacturer; or (v) derived from human blood or human plasma, and (b) which is intended for sale or supply in Northern Ireland. (3) If the licensing authority imposes the batch testing requirement in respect of an EU marketing authorisation for a medicinal product of a kind mentioned in paragraph (2)(a)(iv), it must, in imposing that requirement, specify a period of time for the duration of the requirement. (4) The appropriate authority must complete its examination of the sample for testing, the appropriate documentation or both (as the case may be) within the period of 60 days, beginning with the date on which the appropriate authority is in receipt of both the sample for testing, and the appropriate documentation. (5) Where a holder of an EU marketing authorisation, in order to comply with the batch testing requirement, submits appropriate documentation that includes a certificate issued by a laboratory in an approved country for batch testing and certification of biological medicinal products in respect of the batch, the appropriate authority must, in addition to any other factors it considers relevant, take that into account in determining whether the appropriate authority needs to undertake any further testing of the medicinal product submitted to it. (6) Where a holder of an EU marketing authorisation relies on the batch testing exemption in relation to a batch of a medicinal product, that holder must submit the certificate in respect of that batch to the licensing authority and the appropriate authority, and such other documentation as those authorities may notify that holder they require, before it sells or supplies, or offers to sell or supply, a medicinal product that forms part of that batch in Northern Ireland. (7) Paragraph (8) applies where the appropriate authority considers that there are public health concerns in respect of a batch of a medicinal product (“the relevant batch”) in relation to which the batch testing exemption would otherwise apply. (8) Where this paragraph applies, the appropriate authority must, subject to paragraph (9), notify the holder of the EU marketing authorisation in respect of the relevant batch that it nevertheless requires that holder— (a) to submit a sample from the relevant batch to the appropriate authority, together with appropriate documentation; and (b) not to sell or supply, or to offer to sell or supply, a medicinal product that forms part of that batch in Northern Ireland until the appropriate authority has examined— (i) the sample from that batch, (ii) the appropriate documentation, or (iii) both that sample and that documentation, and confirmed that it is satisfied that the relevant batch is in conformity with the approved specifications in the EU marketing authorisation. (9) The appropriate authority may only exercise its powers under paragraph (8) if the agreement made between the country in which the certificate was issued, and the United Kingdom (whether the agreement is solely with that country, a group of countries or an organisation of which that country is a part) provides for the relevant batch to be re-examined by the appropriate authority in the circumstances described in paragraph (7). (10) A reference in this regulation to a laboratory (other than in paragraph (b) of the definition of “the batch testing exemption” in paragraph (1)) is to an Official Medicines Control Laboratory or a laboratory referred to in Article 114 of the 2001 Directive.

Amendment of regulation 61 (conditions of UK marketing authorisation)

68

• (1) Regulation 61 is amended as follows.

• (2) For paragraph (4), substitute—

(4) The obligation in this paragraph is— (a) to conduct a post-authorisation safety study; or (b) in relation to a UKMA(GB), to comply with such other conditions or restrictions as the licensing authority considers essential for the safe and effective use of the medicinal product.

• (2A) In paragraph (6), after “one medicinal product” insert “authorised by a UKMA(NI) or UKMA(UK)”.

• (3) After paragraph (6) insert—

(6A) If concerns as described in paragraph (2) apply to more than one medicinal product authorised by a UKMA(GB), the licensing authority— (a) must, where the obligation is to conduct a post-authorisation safety study, encourage the UK marketing authorisation holders concerned to conduct a joint study, and (b) may, where the obligation is to comply with any other conditions or restrictions, encourage the UK marketing authorisation holders concerned to take co-ordinated action to comply with the conditions or restrictions.

• (3A) In paragraph (7) for “The obligation under paragraph (5) shall” substitute “In relation to a UKMA(NI) or UKMA(UK), the obligation under paragraph (5) must”.

• (4) After paragraph (7) insert—

(7A) In relation to a UKMA(GB), the obligation under paragraph (5) must— (a) be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive; and (b) take into account the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies. (7B) The Secretary of State may by regulations make provision in respect of Great Britain specifying the situations in which post-authorisation efficacy studies may be required by virtue of the obligation under paragraph (5). (7C) Paragraph (7A)(a) ceases to apply on the coming into force of regulations made under paragraph (7B).

• (5) In paragraph (13), after “notify the EMA” insert “, in relation to a UKMA(NI) or UKMA(UK),”.

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

69

For regulation 64(4)(d) substitute—

(d) any conditions— (i) in the case of a UKMA(NI) or UKMA(UK), established in accordance with Articles 21a, 22 and 22a of the 2001 Directive; (ii) in the case of UKMA(GB), imposed under regulations 59 to 61; and

Obligation of licensing authority in case of change of classification

70

After regulation 64, insert—

(64A) (1) In this regulation, “classification”, in relation to a medicinal product, means the term of the product's UK marketing authorisation which determines the way in which the product is to be made available, as described in regulation 62(1). (2) This regulation applies where— (a) the licensing authority grants or varies— (i) a UK marketing authorisation; (ii) an Article 126a authorisation; (iii) a traditional herbal registration; or (iv) a certificate of registration of a homoeopathic medicinal product; (b) the grant or variation of the UK marketing authorisation involves a change of the classification of the medicinal product to which the authorisation relates; and (c) the application for the UK marketing authorisation or variation was supported by the results of significant pre-clinical tests or clinical trials relating to the proposed classification. (3) Where this regulation applies, the licensing authority may not, for the period of one year beginning with the date on which the UK marketing authorisation was granted or varied, refer to the results of the tests or trials referred to in paragraph (2)(c) when examining an application by another applicant or UK marketing authorisation holder for a change of classification of the same kind as that to which the tests or trials relate.

Amendment of regulation 65 (validity of UK marketing authorisation)

71

In regulation 65(5) before sub-paragraph (a) insert—

(za) regulation 65B;

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

72

After regulation 65A , insert—

(65B) (1) A conditional marketing authorisation remains in force— (a) for an initial period of one year beginning with the date on which it is granted; and (b) if it is renewed in accordance with regulation 66B, for further periods of one year beginning with the date on which the renewal is granted. (2) If an application for the renewal or further renewal of a conditional marketing authorisation is made in accordance with regulation 66B the authorisation remains in force until the licensing authority notifies the applicant of its decision on the application. (65C) (1) A UKMA(GB) holder may apply to vary the authorisation. (2) Any such application must be made in accordance with Schedule 10A. (3) Schedule 10A does not apply to the transfer of a UKMA(GB) from one person to another. (4) The licensing authority may publish guidance on the details of the various categories of variations, on the operation of the procedures laid down in Schedule 10A, and on the documentation to be submitted pursuant to those procedures. (5) Any guidance referred to in paragraph (4) must be regularly reviewed and, when necessary, updated. (6) Unless replaced by guidelines published under paragraph (4), the guidelines published by the Commission under Article 4 of Regulation (EC) No 1234/2008 which applied immediately before IP completion day, insofar only as they concern applications under Chapter IIa of that Regulation, continue to apply to— (a) applications made under regulation 65C on or after IP completion day; or (b) applications made before IP completion day to which regulation 65C and Schedule 10A apply by virtue of Parts 3 and 5 of Schedule 33A. (7) The Ministers may by regulations amend Schedule 10A.

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

73

Schedule 5 inserts a new Schedule 10A after Schedule 10.

Amendment of regulation 66 (application for renewal of authorisation)

74

In regulation 66, for paragraph (2) substitute—

(2) The applicant, where it is applying for renewal of— (a) a UKMA(NI)— (i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union; (ii) on any other basis, must be established in the United Kingdom; (b) a UKMA(GB)— (i) under the unfettered access route, must be established in Northern Ireland; (ii) other than under the unfettered access route, must be established in the United Kingdom; (c) a UKMA(UK), must be established in the United Kingdom.

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

75

In regulation 66A(2) , for “European Union” substitute “ United Kingdom ”.

Renewal of conditional marketing authorisation

76

After regulation 66A, insert—

(66B) (1) The licensing authority may renew a conditional marketing authorisation in relation to an application made to it by the holder of the authorisation. (2) The application must be made at least six months before the date on which the conditional marketing authorisation is due to expire. (3) The application must include an interim report on the fulfilment of the obligations to which the conditional marketing authorisation is subject. (4) When considering an application under paragraph (1), the licensing authority must consider whether— (a) the positive therapeutic effects of the product continue to outweigh the risks to the health of patients and the public associated with the product; and (b) the obligations referred to in regulation 59(4C) and any time limits for their fulfilment remain appropriate, modifying or removing them if necessary. (5) The provisions of regulation 66(2), (3), (4), (6) and (8) apply to an application for renewal of a conditional marketing authorisation.

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

77

• (1) Regulation 68 is amended as follows.

• (2) In paragraph (5), after “exceptional circumstances)”, insert “ , regulation 60A (conditions as to testing of samples by the appropriate authority) ”.

• (3) In paragraph (7)—

• (a) after “authorisation” insert “ or licence ”; and

• (b) for “established in the European Union” substitute—

established in— (a) the United Kingdom; or (b) in relation to a UKMA(NI), either the United Kingdom or the European Union, in accordance with the requirements of these Regulations.

• (4) In paragraph (8)(b), for “states other than EEA states” substitute “ countries other than approved countries for import ”.

• (5) In paragraph (9)(a) omit “other than the United Kingdom”.

• (6) In paragraph (10)—

• (a) in sub-paragraph (a) for “authorisation; or” substitute “ authorisation or licence. ”; and

• (b) omit sub-paragraph (b).

• (7) In paragraph (11)(a), after authorisation insert “ or licence ”.

• (8) After paragraph (11A), insert—

(11B) Condition L is that the licensing authority thinks that the term of the authorisation which specifies the way in which the product is to be made available, as described in regulation 62(1), is incorrect. (11C) Condition M is that, in respect of a parallel import licence, the UK marketing authorisation in respect of the medicinal product that was specified in the application for that licence under paragraph 4 of Schedule 8A, has been varied, suspended or revoked by the licensing authority under this regulation. (11D) Condition N is that, in respect of a parallel import licence, the licensing authority is no longer satisfied that the product is essentially similar to a product that has been granted a UK marketing authorisation. (11E) The licensing authority may not exercise its powers under paragraph (1) by virtue of the condition in paragraph (11D)— (a) before the end of the period of one year beginning with IP completion day; and (b) in any event, in a way that prevents the import of any medicinal product in respect of which a qualified person undertook the certification referred to in Article 51(3) of the 2001 Directive before IP completion day. (11F) Condition O is that the licensing authority thinks that a variation of a UK marketing authorisation is necessary as a result of the submission of the results of a study by the holder of that authorisation under regulation 78A(14). (11G) Condition P is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.

• (9) In paragraph (12)—

• (a) after “UK marketing authorisation”, insert “ or parallel import licence ”; and

• (b) after “an authorisation” insert “ or licence ”.

• (10) Omit paragraph (13).

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

78

In regulation 69 , omit paragraph (10).

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

79

Omit regulation 70.

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

80

• (1) Regulation 71 is amended as follows.

• (2) In paragraph (1)—

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

(a) under regulation 68 the licensing authority revokes or suspends a UK marketing authorisation or parallel import licence; or

; and

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

(b) under— (i) regulation 69 the licensing authority suspends the use, sale, supply or offer for sale or supply within Great Britain of a product to which a UKMA(GB) relates; or (ii) regulation 69 or Article 20(4) of Regulation (EC) No 726/2004 the licensing authority suspends the use, sale, supply or offer for sale or supply within Northern Ireland of a product to which a UKMA(NI) or UKMA(UK) relates.

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

81

In regulation 72(1), for “regulation 69 or 70(2) or Article 20(4) of Regulation (EC) No 726/2004” substitute—

— (a) in the case of a medicinal product authorised for sale or supply by a UKMA(GB), regulation 69; (b) in the case of a medicinal product authorised for sale or supply by a UKMA(NI) or UKMA(UK), regulation 69 or Article 20(4) of Regulation (EC) No 726/2004.

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

82

• (1) Regulation 73 is amended as follows.

• (2) In paragraph (5A)(c), for “third country” substitute “ country other than the United Kingdom ”.

• (3) In paragraph (5C), for “UK marketing authorisation” insert “UKMA(NI) or UKMA(UK)”.

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

83

In regulation 75(5) —

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

(a) in a country other than the United Kingdom;

and

• (b) in sub-paragraph (b), insert “ UK ” before “marketing authorisation”.

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

84

For regulation 76(2), substitute—

(2) In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of— (a) in the case of a medicinal product authorised for sale or supply by a UKMA(NI) or a UKMA(UK)— (i) the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and (ii) the UK web-portal established in accordance with regulation 203(1); (b) in the case of a medicinal product authorised for sale or supply by a UKMA(GB), the UK web-portal established in accordance with regulation 203(1).

Amendment of regulation 77 (record-keeping obligations)

85

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

86

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

87

After regulation 78, insert—

(78A) (1) Paragraph (2) applies where— (a) a holder of a UK marketing authorisation intends to discontinue supply of the product to which that authorisation relates; (b) the holder of the authorisation benefited from a reward or incentive under regulation 58A(3) or (8) or 58D(5) in relation to the product; and (c) the period of protection provided pursuant to those regulations has expired. (2) Where this paragraph applies, the holder of the UK marketing authorisation must— (a) either— (i) transfer the UK marketing authorisation to another person who has declared an intention to continue to supply the product; or (ii) allow such a person to use the pharmaceutical, pre-clinical and clinical documentation contained in the file on that product in accordance with regulation 56; and (b) notify the licensing authority of its intention to cease to supply the product before the beginning of the period of six months ending immediately before the day on which the holder does so. (3) Paragraph (4) applies to the holder of a UK marketing authorisation if— (a) that authorisation includes a paediatric indication following completion of an agreed paediatric investigation plan; and (b) the product was placed on the market for other indications before that holder obtained that paediatric indication. (4) Where this paragraph applies, the holder of the UK marketing authorisation must place the product on the market taking account of the paediatric indication before the end of the period of two years beginning immediately after the day on which the paediatric indication is authorised. (5) Paragraph (6) applies if— (a) a decision by the licensing authority in respect of a paediatric investigation plan is addressed to a person (“PIP sponsor”); and (b) the plan refers to clinical trials carried out in a country other than the United Kingdom (“non-UK clinical trials”). (6) Where this paragraph applies, the PIP sponsor must send to the licensing authority the details set out in Article 11 of the Clinical Trials Directive in relation to the non-UK clinical trials within whichever is the later of— (a) the period of one month beginning after the day on which the decision was received; or (b) the period of one month beginning after the day on which the necessary permission to conduct the clinical trial was received from the competent authorities in the country where the clinical trial is to take place. (7) Where paragraph (6) applies, the PIP sponsor must submit the results of those clinical trials to the licensing authority within the period of twelve months beginning with the day on which the last of those trials ended, subject to paragraph (8). (8) Paragraph (7) does not apply in the case of a clinical trial which forms part of a paediatric study to which paragraph (12) applies. (9) Paragraph (10) applies in relation to the sponsor of a paediatric clinical trial in the United Kingdom in respect of a medicinal product if— (a) the product has a UK marketing authorisation but the sponsor is not the holder of the authorisation; or (b) the product does not have a UK marketing authorisation. (10) Where this paragraph applies, the sponsor of the clinical trial must submit the results of the trial to the licensing authority within the period of twelve months beginning with the day on which the trial ended. (11) Paragraph (12) applies in relation to the holder of a UK marketing authorisation who sponsors a paediatric clinical trial in respect of the medicinal product to which that authorisation relates. (12) Where this paragraph applies, the holder of the UK marketing authorisation must submit the results of the trial to the licensing authority within the period of six months beginning with the day on which the trial ended. (13) Paragraph (14) applies in relation to the holder of a UK marketing authorisation who sponsors a study which involves the use in the paediatric population of a medicinal product to which that UK marketing authorisation relates, irrespective of whether or not— (a) the studies are conducted in accordance with an agreed paediatric investigation plan; or (b) the marketing authorisation holder intends to apply for a marketing authorisation for a paediatric indication in relation to the product. (14) Where this paragraph applies, the holder of the UK marketing authorisation must submit the results of the study to the licensing authority within the period of six months beginning with the day on which the study ended. (15) Where the licensing authority has granted a deferral of the initiation or completion of some or all of the measures set out in a paediatric investigation plan, in accordance with regulation 50C, the person to whom that decision was addressed must submit to the licensing authority an annual report providing an update on progress with the paediatric studies to which the deferral relates. (16) The first report referred to in paragraph (15) must be submitted within the period of twelve months beginning with the date on which the licensing authority granted the deferral. (78B) (1) The holder of a UKMA(GB) in respect of an advanced therapy medicinal product must— (a) establish and maintain a system ensuring that the individual product and its starting raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used; (b) where the product contains human tissues or cells, ensure that the traceability system is complementary to and compatible with requirements imposed pursuant to— (i) as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990 , (ii) as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005 , and (iii) as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ; (c) keep the data referred to in paragraph (a) for a minimum of 30 years after the expiry of the date of the product, or longer if required by the licensing authority as a term of the UKMA(GB); and (d) in the event of the UKMA(GB) holder's bankruptcy or liquidation occurring within the period of time for which that holder is required to keep the data referred to in paragraph (a), transfer that data to another person or the licensing authority. (2) The holder of a UKMA(GB) who is subject to the obligations in paragraph (1) remains subject to them even if the UKMA(GB) is suspended or revoked.

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

88

In regulation 79 (failure to provide information on marketing authorisations to EMA)—

• (a) in paragraph (1), for the first reference to “a marketing authorisation” substitute “a UKMA(NI) or UKMA(UK)”;

• (b) in paragraph (2), for the first reference to “a marketing authorisation” substitute “UKMA(NI) or UKMA(UK)”.

Amendment of regulation 80 (urgent safety restrictions)

89

• (1) Regulation 80 is amended as follows.

• (2) In the introductory words, insert “ UK ” before “marketing authorisation”.

• (3) For paragraph (a) substitute—

(a) fails— (i) in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or (ii) in respect of a UKMA(NI), UKMA(UK) or EU marketing authorisation, to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008, that the holder has taken urgent safety restrictions on the holder’s own initiative;

• (4) For paragraph (b) substitute—

(b) fails— (i) in respect of a UKMA(GB), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or (ii) in respect of a UKMA(NI) or UKMA(UK), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or

• (4A) In paragraph (c) after “fails” insert “in respect of a UKMA(NI)”.

• (5) After paragraph (c) insert —

(d) fails in respect of a UKMA(GB) to submit an application for variation of the UK marketing authorisation to the licensing authority in accordance with paragraph 14(4) of Schedule 10A before the end of the period of fifteen days beginning with the day after— (i) the taking under paragraph 14(1) of Schedule 10A or, as the case may be, (ii) the imposition under paragraph 14(3) of that Schedule, of an urgent safety restriction.

Omission of regulations 81 to 94 (offences relation to EU marketing authorisations)

90

Before regulation 81 (obligation to update information supplied in connection with EU application), insert—

(A81) Regulations 81 to 94 apply in relation to medicinal products for sale or supply in Northern Ireland.

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

91

In regulation 94A—

• (a) for paragraph (1) substitute—

(1) A person who is— (a) the holder of a UKMA(NI), UKMA(UK) or parallel import licence, or (b) a parallel distributor, is guilty of an offence if the holder fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).

• (b) for paragraph (3) substitute—

(3) In this regulation “parallel distributor” means a person who imports into Northern Ireland from an EEA state a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004 and in relation to which that person is not the holder of a UKMA(NI), UKMA(UK), Article 126a authorisation, COR(NI), COR(UK), THR(NI) or THR(UK).

Amendment of regulation 95 (offences in connection with application)

92

In regulation 95—

• (a) in sub-paragraph (c), before “fails” insert “, in relation to an EU marketing authorisation for a product for sale or supply in Northern Ireland,”;

• (b) in sub-paragraph (d), before “provides” insert “, in relation to an EU marketing authorisation for a product for sale or supply in Northern Ireland,”.

Amendment of regulation 96 (provision of misleading information)

93

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Amendment of regulation 97 (breach of pharmacovigilance condition)

94

• (1) Regulation 97 , is amended as follows.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) In paragraph (2), after “exceptional circumstances)” insert “ , regulation 60A (condition as to the testing of samples by the appropriate authority) ”.

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

95

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Amendment of regulation 99 (penalties)

96

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 101 (defences)

97

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PART 6 — Amendment of Part 6 (certification of homoeopathic products)