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

(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

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

86

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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

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

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

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

Amendment of regulation 99 (penalties)

96

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

Amendment of regulation 101 (defences)

97

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

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

Amendment of regulation 102 (regulation-making power to amend regulation 102(4) to (6))

98

In regulation 102 (application of Part 6), at the end insert—

(7) The Secretary of State may make regulations in respect of Great Britain to amend paragraphs (4) to (6). (8) The Secretary of State may only exercise the power in paragraph (7) if the Secretary of State considers that it is necessary to do so because of new scientific evidence.

Amendment of regulation 103 (application for certificate of registration)

99

• (1) Regulation 103 is amended as follows.

• (1A) After paragraph (1) insert—

(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 COR(GB) only where— (a) there is already in place, or will be at the time the COR(GB) is granted, a certificate of registration in respect of the product authorising sale or supply in Northern Ireland, (b) the applicant complies with the requirements in paragraph (5B), and (c) the registrable homoeopathic medicinal product satisfies the definition of qualifying Northern Ireland goods. (1B) A certificate of registration 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 certificate of registration being “in force” is limited to that territory.

• (2) In paragraph (4), for “must be established in the European Union” substitute—

, where it is applying for—

• (a) a COR(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 COR(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 COR(UK), must be established in the United Kingdom.

• (2A) After paragraph (5) insert—

(5A) The application must include a statement indicating whether the certificate sought is for sale or supply of the product in— (a) the whole United Kingdom; (b) Great Britain only; or (c) Northern Ireland only. (5B) The applicant for the grant of a COR(GB) under the unfettered access route must provide— (a) the application form submitted in connection with the granting of the COR(NI) which authorises the sale or supply of the product in Northern Ireland; (b) a copy of all material submitted in support of the application for the COR(NI) which authorises the sale or supply of the product in Northern Ireland; and (c) a copy of the COR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland, together with any material specified in paragraph (8) which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.

• (3) In paragraph (8)—

• (a) in sub-paragraph (e)—

• (i) omit “or another EEA State”, and

• (ii) for “that EEA State” substitute “ a country other than the United Kingdom ”; and

• (b) in sub-paragraph (f), for “another member state” substitute “ a country other than the United Kingdom ”.

Amendment of regulation 104 (consideration of application)

100

• (1) Regulation 104 (consideration of application) is amended as follows.

• (2) After paragraph (6) insert—

(7) In the case of an application under the unfettered access route, the licensing authority may grant a COR(GB) (notwithstanding paragraph (3)) where the licensing authority— (a) has considered the application under the unfettered access route and the accompanying material, (b) is satisfied that the applicant has complied with the application requirements, and (c) is satisfied that the conditions in regulation 103(1A) will continue to be met. (8) The licensing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.

Amendment of regulation 108 (application for renewal of certificate)

101

In regulation 108(2), for “must be established in the European Union” substitute—

, where it is applying for renewal of— (a) a COR(NI) and originally granted— (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 COR(GB) and originally granted— (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) in the whole United Kingdom, must be established in the United Kingdom.

Amendment of regulation 110 (revocation, variation and suspension of certificate of registration)

102

• (1) Regulation 110 is amended as follows.

• (2) In paragraph (7) for “established in the European Union” substitute—

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

• (2A) After paragraph (8A) insert—

(8B) Condition I 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.

• (3) Omit paragraph (10).

Omission of regulation 111 (certificates granted under Chapter 4 of Title III of the 2001 Directive)

103

Omit regulation 111.

Amendment of regulation 112 (withdrawal of homoeopathic medicinal product from the market)

104

In regulation 112(1), omit “or regulation 111(2)”.

Amendment of regulation 113 (obligation to notify placing on the market etc)

105

In regulation 113(3A) , omit “in accordance with article 123(2) of the 2001 Directive”.

Amendment of regulation 115 (obligation to provide information relating to safety etc)

106

In regulation 115(5)(a) for “which is not an EEA State” substitute “ other than the United Kingdom ”.

Amendment of regulation 116 (obligation in relation to product information)

107

For regulation 116(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 by a COR(NI) or COR(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 by a COR(GB), the UK web-portal established in accordance with regulation 203(1).

PART 7 — Amendment of Part 7 (Traditional Herbal Registrations)

Amendment of italic heading above regulation 125 (traditional herbal medicinal products)

108

For the italic heading “Application of Part”, substitute “ Interpretation and application of Part ”.

Insertion of regulation 124A (interpretation)

109

Before regulation 125 (traditional herbal medicinal products), insert—

(124A) In this Part, “relevant list” means— (a) the list referred to in Article 16f(1) of the 2001 Directive, as that list may be amended from time to time; or (b) if the licensing authority publishes a list under regulation 126A(1), that list.

Amendment of regulation 125 (traditional herbal medicinal products)

110

In regulation 125(5) for sub-paragraph (b) substitute—

• (b) in relation to—

• (i) a THR(NI) or THR(UK), the product has been in medicinal use in the European Union for a continuous period of at least 15 years;

• (ii) a THR(GB), the product has been in medicinal use in the United Kingdom or a country included in the list published under regulation 125A(1) for a continuous period of at least 15 years.

Insertion of regulation 125A (list of approved countries for herbal medicinal products)

111

After regulation 125 insert—

(125A) (1) The licensing authority may publish a list of countries for the purposes of regulation 125(5)(b) (condition D). (2) In establishing the list under paragraph (1), the licensing authority may only include a country in that list if it is satisfied that— (a) continuous use evidence in respect of that country can be sufficiently validated by the licensing authority; and (b) the country has a level of pharmacovigilance that is equivalent to that in the United Kingdom to ensure that any safety issues in respect of the herbal medicinal product have been properly identified. (3) The licensing authority must— (a) review any list it publishes under paragraph (1) to determine if a country still satisfies the criteria for inclusion in the list specified in paragraph (2), and if it is not so satisfied, remove that country from the list; and (b) undertake such a review at least every three years beginning with the date on which the country is included in that list.

Insertion of new italic heading and regulation 126A (list of herbal substances, preparations and combinations for use in traditional herbal medicinal products)

112

After regulation 126 (addition of vitamins or minerals) insert—

(126A) (1) The licensing authority may establish, and publish a list of, herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products for which a THR(GB) may be granted. (2) A list established under paragraph (1) must contain, with regard to each herbal substance— (a) the indication; (b) the specified strength and posology; (c) the route of administration; and (d) any other information necessary for the safe use of the herbal substance as a traditional medicinal product. (3) The licensing authority may review and amend any list it publishes under paragraph (1) at such intervals as it considers appropriate.

Amendment of regulation 127 (application for grant of traditional herbal registration)

113

• (1) Regulation 127 (application for grant of traditional herbal registration) is amended as follows.

• (2) After paragraph (1) insert—

(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 THR(GB) only where— (a) there is already in place, or will be at the time the THR(GB) is granted, a traditional herbal registration in respect of the product authorising sale or supply in Northern Ireland, (b) the applicant complies with the requirements in regulation 128(1A), and (c) the traditional herbal medicinal product satisfies the definition of qualifying Northern Ireland goods. (1B) A traditional herbal registration 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 traditional herbal registration being “in force” is limited to that territory.

• (3) In paragraph (3) for “must be established in the European Union” substitute—

, where it is applying for— (a) a THR(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 THR (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 THR(UK), must be established in the United Kingdom.

• (4) After paragraph (4) insert—

(4A) The application must include a statement indicating whether the traditional herbal registration sought is for sale or supply of the product in— (a) the whole United Kingdom; (b) Great Britain only; or (c) Northern Ireland only.

Amendment of regulation 128 (accompanying material)

114

• (1) Regulation 128 (accompanying material) is amended as follows.

• (2) For paragraph (1) substitute—

(128) (1) The applicant for the grant of a traditional herbal registration other than a THR(GB) under the unfettered access route must provide the material specified in Schedule 12 in relation to the product. (1A) The applicant for the grant of a THR(GB) under the unfettered access route must provide— (a) the application form submitted in connection with the granting of the THR(NI) which authorises the sale or supply of the product in Northern Ireland; (b) a copy of all material submitted in support of the application for the THR(NI) which authorises the sale or supply of the product in Northern Ireland; and (c) a copy of the THR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland, together with any material specified in Schedule 12 which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.

• (3) In paragraph (3), after “of the 2001 Directive” insert “where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)”.

Amendment of Schedule 12 (material to accompany an application for a traditional herbal registration)

115

• (1) Schedule 12 is amended as follows.

• (2) In paragraphs 16 and 17, for “another member State or a third country” substitute “ a country other than the United Kingdom ”.

• (3) In paragraph 21—

• (a) after “Article 23 of Regulation (EC) No 726/2004” insert “or regulation 202A, as the case may be”;

• (b) before “statement”, insert “ symbol and ”; and

• (c) before “This”, insert “ ▼ ”.

Amendment of regulation 130 (consideration of application)

116

• (1) Regulation 130 is amended as follows.

• (2) In paragraph (6), insert “ UK ” before “marketing authorisation”.

• (3) In paragraph (7), for “is subject to” to the end substitute—

(a) where the application is for a THR(NI) or THR(UK), is subject to Article 16c(4) of the 2001 Directive (procedure where product has been used in the European Union for less than 15 years); (b) where the application is for a THR(GB), is subject to regulation 130A.

• (4) In paragraph (8), after “of the 2001 Directive” insert “where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)

• (5) In paragraph (9), after “Where” insert “, in relation to an application for a THR(NI) or THR(UK),”.

• (6) In paragraph (10)(a) for “in Article 16h(3)” to the end substitute—

—iin Article 16h(3) of the 2001 Directive, where the application is for a THR(NI) or THR(UK);iiin regulation 143A, where the application is for a THR(GB),

that the authority thinks relevant to the application; or

• (7) In paragraph (12), after “This regulation does not apply where” insert “, in relation to an application for a THR(NI) or THR(UK),”.

• (8) After paragraph (13) insert—

(14) In the case of an application under the unfettered access route, the licensing authority may grant a THR(GB) (notwithstanding paragraph (4)) where the licensing authority— (a) has considered the application under the unfettered access route and the accompanying material, (b) is satisfied that the applicant has complied with the application requirements, and (c) is satisfied that the conditions in regulation 127(1A) will continue to be met. (15) The licencing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.

Insertion of regulation 130A (procedure where less than 15 years use of traditional herbal medicinal product)

117

After regulation 130 (consideration of application) insert—

(130A) the licensing authority may refer the matter to the appropriate committee for relevant advice, and the procedure in Part 3 of Schedule 11 applies (referral to the appropriate committee for traditional herbal registrations). (1) Where an application for a THR(GB) (other than an application under the unfettered access route) has been made and the licensing authority considers that— (a) the traditional herbal medicinal product does not satisfy regulation 125(5)(b) (Condition D); but (b) otherwise satisfies the conditions in regulation 125, (2) In this regulation— - “appropriate committee” has the same meaning as in paragraph 2(4) of Schedule 11; - “relevant advice” means advice as to whether— 1. the conditions in regulation 125, other than condition D, are met in relation to the application; and 2. the licensing authority should exercise its powers under regulation 143A to establish a herbal monograph.

Amendment of regulation 133 (application for renewal of registration)

118

In regulation 133(2), for “must be established in the European Union” substitute—

, where it is applying for renewal of— (a) a THR(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 THR(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 THR(UK), must be established in the United Kingdom.

Amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration)

119

• (1) Regulation 135 is amended as follows.

• (1A) For paragraph (6) substitute—

(6) Condition E is that the holder of the registration has ceased to be established in— (a) the United Kingdom; or (b) in relation to a THR(NI), either the United Kingdom or the European Union, in accordance with the requirements of these Regulations.

• (2) In paragraph (7)(b), after “states other than EEA states” insert “/ countries other than approved countries for import”.

• (3) In paragraph (8)(a) omit “other than the United Kingdom”.

• (4) In paragraph (9), in sub-paragraph (b), at the beginning insert “in the case of a THR(NI) or THR(UK),”.

• (4A) After paragraph (10A) insert—

(10B) Condition K 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.

• (5) Omit paragraph (11).

Amendment of regulation 136 (revocation by licensing authority: further provisions)

120

• (1) Regulation 136 is amended as follows.

• (2) In paragraph (1)(a), for “the list referred to in” to the end substitute—

(i) the list referred to in Article 16f(1) of the 2001 Directive, in the case of a THR(NI) or THR(UK); (ii) the list established under regulation 126A where the application is for a THR(GB); and

• (3) Omit paragraph (3).

Amendment of regulation 138 (suspension of use etc of traditional herbal medicinal product)

121

Omit regulation 138(10).

Omission of regulation 139 (registrations granted under Chapter 4 of Title III of the 2001 Directive)

122

Omit regulation 139.

Amendment of regulation 140 (withdrawal of traditional herbal medicinal product from the market)

123

In regulation 140(1) for sub-paragraph (a) substitute—

(a) under— (i) regulation 135 or 136, in the case of a THR(GB); (ii) regulation 135 or 136 or Article 34(3) of the 2001 Directive, in the case of a THR(NI) or THR(UK), the licensing authority revokes or suspends the registration; or

Amendment of regulation 141 (sale etc of suspended traditional herbal medicinal product)

124

In regulation 141(1), omit “or 139(2)”.

Amendment of regulation 142 (obligation to notify placing on the market etc)

125

In regulation 142(5C), for “traditional herbal registration” substitute “THR(NI) or THR(UK) .

Insertion of new regulation 143A (establishment of herbal monographs)

126

After regulation 143 (obligation to take account of scientific or technical progress) insert—

(143A) (1) The licensing authority may establish herbal monographs for herbal medicinal products and traditional herbal medicinal products to be placed on the market in Great Britain. (2) Subject to paragraph (3), the licensing authority must— (a) consult the appropriate committee, within the meaning of paragraph 2(4) of Schedule 11, on a proposal to establish herbal monographs under paragraph (1); and (b) take the advice of the appropriate committee into account in determining whether to proceed with that proposal. (3) Where an application for a traditional herbal registration has been referred to the appropriate committee by the licensing authority under regulation 130A, the licensing authority must consider whether to exercise its powers under paragraph (1), taking into account any relevant advice of the appropriate committee given under Part 3 of Schedule 11 in relation to that application. (4) The licensing authority must publish a list of any herbal monographs established under this regulation. (5) Until the licensing authority exercises the power under paragraph (1), the Community herbal monographs published from time to time under Article 16h(3) of the 2001 Directive continue to apply, and holders of a traditional herbal registration and the licensing authority must continue to take them into account in exercising any function or in relation to any obligation to which they are relevant under this Part.

Amendment of regulation 144 (obligation following new herbal monograph)

127

For regulation 144 substitute—

(144) (1) Paragraph (2) applies where a new herbal monograph of the kind referred to— (a) in the case of a THR (NI) or THR (UK), in Article 16h(3) of the 2001 Directive, or (b) in the case of a THR (GB), in regulation 143A, is established. (2) Where this paragraph applies, the holder of the THR(GB), THR(NI) or THR(UK) to which the monograph relates must as soon as is reasonably practicable— (a) consider whether to modify the registration dossier; and (b) notify any modification to the licensing authority.

Amendment of regulation 145 (obligation to provide information relating to safety etc)

128

In regulation 145(5)(a), for “which is not an EEA State” substitute “ other than the United Kingdom ”.

Amendment of regulation 146 (obligation in relation to product information)

129

For regulation 146(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 for sale or supply in Northern Ireland— (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 for sale or supply in Great Britain only, the UK web-portal established in accordance with regulation 203(1).

Insertion of regulation 148A (urgent safety restrictions)

130

After regulation 148 (obligation to ensure appropriate and continued supplies) insert—

(148A) (1) Where, in the event of a risk to public health, the holder of a traditional herbal registration takes urgent safety restrictions on its own initiative, it must inform the licensing authority immediately. (2) If the licensing authority has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions are deemed to be accepted by the licensing authority. (3) In the event of a risk to public health, the licensing authority may impose urgent safety restrictions. (4) Where an urgent safety restriction is taken by the holder of a traditional herbal registration, or imposed by the licensing authority, the holder must submit an application for variation of that registration in relation to that restriction within 15 days beginning with the date of the initiation of that restriction.

Amendment of regulation 149 (urgent safety restrictions)

131

For regulation 149 substitute—

(149) (1) The holder of a THR(NI) or a THR(UK) is guilty of an offence if the holder— (a) fails to inform the licensing authority or 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; (b) fails to implement an urgent safety restriction imposed on the holder by the licensing authority or the European Commission under Article 22(2) of that Regulation; or (c) fails to submit an application for variation of the traditional herbal registration to the licensing authority or the European Commission in accordance with Article 22(3) of that Regulation before the end of a period of fifteen days beginning on the day after— (i) the taking under Article 22(1) or, as the case may be, (ii) the imposition under Article 22(2), of that Regulation of an urgent safety restriction; (2) The holder of a THR(GB) is guilty of an offence if the holder— (a) fails to inform the licensing authority in accordance with regulation 148A(1) that the holder has taken urgent safety restrictions on the holder’s own initiative; (b) fails to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with regulation 148A(2); or (c) fails to submit an application for variation of the traditional herbal registration to the licensing authority in accordance with regulation 148A(4) before the end of the period of 15 days beginning with the day after— (i) the taking under regulation 148A(1), or (ii) the imposition under regulation 148A(2), of an urgent safety restriction.

PART 8 — Omission of Part 8 (Article 126a authorisations)

Omission of Part 8

132

In regulation 156—

• (a) in paragraph (1)—

• (i) after “126a authorisation for” insert “sale or supply of”;

• (ii) after “medicinal product” insert “in Northern Ireland only,”;

• (b) in paragraph (2), after “is in force” insert “in Northern Ireland”;

• (c) in paragraph (3), after “traditional herbal registration” insert “to be in force in Northern Ireland”;

• (d) in paragraph (4) for “the United Kingdom” substitute “Northern Ireland”; and

• (e) in paragraph (5) for “another member State” substitute “an EU member State”.

PART 9 — Amendment of Part 9 (borderline products)

Amendment of regulation 159 (provisional determination)

133

In regulation 159(1)—

• (a) insert “ UK ” before “marketing authorisation”; and

• (b) for “Article 126a authorisation” insert “, only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation,”.

Amendment of regulation 164 (effect of determination)

134

In regulation 164(2)(a) and (b)—

• (a) insert “ UK ” before “marketing authorisation”; and

• (b) for “Article 126a authorisation” insert “, only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation,”.

PART 10 — Amendment of Part 10 (exceptions to requirement for marketing authorisations etc)

Amendment of regulation 168 (use of non-prescription medicines in the course of a business)

135

In regulation 168 (use of non-prescription medicines in the course of a business), for paragraph (8) substitute—

(8) Condition G is that if the medicinal product is— (a) manufactured or assembled in the United Kingdom or imported into the United Kingdom from— (i) in the case of a product for sale or supply in Northern Ireland, a country other than an EEA State, or (ii) in the case of a product for sale or supply in Great Britain, a country other than an approved country for import, it is manufactured, assembled or imported by the holder of a manufacturer’s licence that relates specifically to the manufacture, assembly or importation of special medicinal products, or (b) imported into— (i) Northern Ireland from an EEA State, it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State, or (ii) Great Britain from an approved country for import— (aa) it is manufactured or assembled in that country by a person who is the holder of an authorisation in that country in relation to its manufacture or assembly, and (bb) it is imported by the holder of a wholesale dealer’s licence under Part 3 that includes the import of a medicinal product from such a country.

Amendment of regulation 169 (mixing of general sale medicinal products)

136

In regulation 169(9)(a), for “marketing authorisation” substitute “UK marketing authorisation or EU marketing authorisation” .

Amendment of regulation 171 (exempt advanced therapy medicinal products)

137

In regulation 171(2)(c) for “Regulation (EC) No 726/2004 substitute—

— (i) in the case of a product for sale or supply in Northern Ireland, Regulation (EC) No 726/2004, and (ii) in the case of a product for sale or supply in Great Britain, regulation 49(1).

Amendment of regulation 173 (exemption for certain radiopharmaceuticals)

138

In regulation 173(c), for “marketing authorisation” substitute “UK marketing authorisation or EU marketing authorisation” .

PART 11 — Amendment of Part 11 (Pharmacovigilance)

Amendment of regulation 177 (application of Part and interpretation)

139

• (1) Regulation 177 is amended as follows.

• (2) After paragraph (1) insert—

(1A) Schedule 12A applies in relation to medicinal products that are the subject of a UKMA(GB) ora THR(GB).

• (3) In paragraph (2)—

• (a) after “this Part” insert “ and Schedule 12A ”;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) In paragraph (3)—

• (a) for “Schedule 33” substitute “ Schedules 12A and 33 ”;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) In paragraph (5)—

• (a) for “Schedule 33” substitute “Schedules 33 and 33A”;

• (b) in paragraph (c) of the definition of “relevant post-authorisation safety study”, omit “and”; and

• (c) after that definition, insert—

• “signal” means, in relation to a UKMA(GB) or THR(GB), information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and

Amendment of regulation 180 (obligation on licensing authority to audit pharmacovigilance system)

140

• (1) Regulation 180 is amended as follows.

• (2) In paragraph (1),

• (a) after “its pharmacovigilance system” insert “relating to medicinal products for sale or supply in Great Britain” and

• (b) omit “and report the results of that audit to the European Commission”.

• (2A) After paragraph (1) insert—

(1A) The licensing authority must perform a regular audit of its pharmacovigilance system relating to medicinal products for sale or supply in Northern Ireland and report the results of that audit to the European Commission.

• (3) In paragraph (2)—

• (a) omit “results of the”; and

• (b) for “reported to the European Commission” substitute “ performed ”.

• (4) After paragraph (2) insert—

(3) The results of the audit referred to in paragraph (1A) must be reported to the European Commission— (a) on the first occasion no later than 21st September 2021; (b) every two years after the first occasion.

Omission of regulation 181 (delegation of obligations under Part 11)

141

In regulation 181(1), for “to another EEA State” substitute “in connection with its pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland to an EEA State”.

Amendment of regulation 182 (obligation on holder to operate a pharmacovigilance system)

142

• (1) Regulation 182 is amended as follows.

• (2) In paragraph (2)(a), after “in the EU” insert “or United Kingdom” .

• (2A) In paragraph (2)(b), after “pharmacovigilance system master file” insert “and ensure it is permanently and immediately available for inspection electronically in the United Kingdom at the single point from which the reports referred to in regulation 187(4) are accessible”.

• (2B) After paragraph (2) insert—

(2A) Where the person the holder has permanently and continuously at its disposal under paragraph (2)(a) (“the qualified person”) does not reside and operate in the United Kingdom, the holder must nominate a contact person for pharmacovigilance at a national level who reports to the qualified person, resides and operates in the United Kingdom and has permanent access to the pharmacovigilance system master file. (2B) Paragraph (2A) has effect from the day twelve months after IP completion day.

• (3) For paragraph (3) substitute—

(3) Without prejudice to the requirements set out in regulation 65C and Schedule 10A (variations to a UK marketing authorisation) the holder must keep the licensing authority informed at all times of the name and contact details of— (a) the appropriately qualified person mentioned in paragraph (2)(a); and (b) the nominated person mentioned in paragraph (2A). (3A) The holder must— (a) ensure that the pharmacovigilance system master file is accessible electronically from the single point within the United Kingdom from which the reports referred to in regulation 187(4) are accessible; and (b) immediately notify the licensing authority of any change to the single point where the pharmacovigilance system master file may be accessed electronically.

• (4) Omit paragraph (6).

Amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)

143

In regulation 184, after paragraph (2) insert—

(3) The holder of a UKMA(GB) or THR(GB) must also comply with the requirements of paragraph 13 of Schedule 12A in relation to auditing the pharmacovigilance system.

Amendment of regulation 185 (recording obligations on the licensing authority)

144

In regulation 185(b), after “by” insert “ a holder, ”.

Amendment of regulation 186 (reporting obligations on the licensing authority)

145

In regulation 186—

• (a) in paragraph (1), for sub-paragraphs (d) and (e) substitute—

(d) submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to— (i) a UKMA(NI), (ii) a UKMA(UK), (iii) a THR(NI), (iv) a THR(UK), or (v) an Article 126a authorisation, to the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and (e) submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to— (i) a UKMA(NI), (ii) a UKMA(UK), (iii) a THR(NI), (iv) a THR(UK), or (v) an Article 126a authorisation, to the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.

• (b) omit paragraph (4).

Insertion of new regulation 187A (collaboration with the World Health Organisation)

146

After regulation 186 insert—

(186A) The licensing authority must collaborate with the World Health Organisation in matters of pharmacovigilance, and must in particular— (a) take the necessary steps to promptly submit to the World Health Organisation appropriate and adequate information regarding the measures taken in the United Kingdom which may have a bearing on public health protection in other countries; and (b) make available promptly all suspected adverse reaction reports occurring in the United Kingdom to the World Health Organisation.

Amendment of regulation 187 (recording obligations on holders)

147

• (1) Regulation 187 is amended as follows.

• (2) In paragraph (1) for “in the EEA or in third countries” substitute “in the United Kingdom or another country”.

• (3) In paragraph (4), for “EEA” substitute “ United Kingdom ”.

Amendment of regulation 188 (reporting obligations on holders)

148

• (1) Regulation 188 is amended as follows.

• (2) In each place where it occurs, for “Eudravigilance database” substitute “ licensing authority ”.

• (3) In paragraph (1)—

• (za) for “Subject to paragraph (2), the holder” substitute “The holder of a UK marketing authorisation, traditional herbal registration or Article 126a authorisation”;

• (a) in sub-paragraph (a)—

• (i) for “EEA” substitute “ United Kingdom ”, and

• (ii) for “third countries” substitute “ countries other than the United Kingdom ”;

• (b) in sub-paragraph (b), for “EEA” substitute “ United Kingdom ”;

• (c) in sub-paragraph (e), for “EMA and the competent authorities of the EEA States” substitute “ licensing authority ”.

• (3A) After paragraph (1) insert—

(1A) The holder of a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation must, in relation to the product— (a) submit electronically to the Eudravigilance database a report on all serious suspected adverse reactions that occur in the UK and other countries before the end of the period of 15 days beginning on the day on which the holder gained knowledge of the reaction; (b) submit electronically to the Eudraviligance database a report on all non-serious suspected adverse reactions that occur in an EEA State or Northern Ireland before the end of the period of 90 days beginning on the day on which the holder gained knowledge of the reaction; (c) collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the Eudravigilance database by way of an update to the original report within the specified time period; and (d) collaborate with the EMA and the competent authorities of the EEA States in the detection of duplicates of suspected adverse reaction reports.

• (4) In paragraph (2)—

• (a) after “holder” insert “of a UKMA(NI), a UKMA(UK), a THR(NI), a THR(UK) or an Article 126a authorisation”;

• (b) for “paragraph (1)(a) or (b)” substitute “paragraph (1A)(a) or (b)”; and

• (c) for “paragraph (1)(d)” substitute “paragraph (1A)(c)”.

• (4A) In paragraph (3) for “paragraph (4)” substitute “paragraph (4A)”.

• (5) In paragraph (4)(a), omit “other than monitored publications”.

• (5A) After paragraph (4) insert—

(4A) The holder of a UKMA(NI), a UKMA(UK), a THR(NI), a THR(UK) or an Article 126a authorisation must— (a) monitor medical literature other than the monitored publications for reports of suspected adverse reactions to the product; and (b) report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1A).

• (6) In paragraph (5), omit the definitions of “monitored active substance” and “monitored publication”.

• (7) Omit paragraph (6).

Amendment of regulation 189 (signal detection: licensing authority obligations)

149

• (1) Regulation 189 is amended as follows.

• (2) In paragraph (1)—

• (a) in sub-paragraph (a), for “in the Eudravigilance database” substitute “ that it collects by virtue of operating its pharmacovigilance system under this Part ”; and

• (b) in sub-paragraph (d), for “regulations 59 to 61” substitute “ regulations 59, 60 and 61 ”.

• (3) In paragraphs (2) and (3), for “The licensing” insert “In relation to medicinal products subject to a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing”.

Amendment of regulation 190 (signal detection: holder obligation)

150

For regulation 190(1) substitute—

(1) The holder must inform— (a) the licensing authority, and (b) in respect of a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the EMA, without delay if it detects any relevant changes in relation to the product.