The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

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.

79

After regulation 101 (amendment of regulation 108 (application for renewal of certificate)) insert—

(101A) (1) Regulation 109 (failure to place on the market etc.) is amended as follows. (2) In paragraph (1) after “in the United Kingdom” insert “ (or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain) ”. (3) In paragraph (2) after “in the United Kingdom” insert “ (or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain) ”.

PART 5 — Amendment of Part 6 (amendment of Part 6 (certification of homoeopathic products))

80

In regulation 102 (amendment of regulation 110 (revocation, variation and suspension of certificate of registration))—

• (a) for paragraph (2) substitute—

(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.

• (b) after paragraph (2) insert—

(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.

81

For regulation 107 (amendment of regulation 116 (obligation in relation to product information)) substitute—

(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 6 — Amendment of Part 7 (amendment of Part 7 (Traditional Herbal Registrations))

82

In regulation 110 (amendment of regulation 125 (traditional herbal medicinal products)) for “125(5)(b)” to the end substitute—

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.

83

In regulation 112 (insertion of new italic heading and regulation 126A (list of herbal substances, preparations and combinations for use in traditional herbal medicinal products)), in the inserted regulation 126A(1), after “traditional herbal medicinal products” insert “ for which a THR(GB) may be granted ”.

84

For regulation 113 (amendment of regulation 127 (application for grant of traditional herbal registration)) substitute—

(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.

85

For regulation 114 (amendment of regulation 128 (accompanying material)) substitute—

(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) ”.

86

For regulation 115(3)(a) (amendment of Schedule 12 (material to accompany an application for a traditional herbal registration)) substitute—

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

87

In regulation 116 (amendment of regulation 130 (consideration of application))—

• (a) in paragraph (3) for “for “Article” to the end substitute—

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.

• (b) in paragraph (4) for “for “list referred to” to the end substitute—

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)

.”;

• (c) for paragraph (5) substitute—

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

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

for “in Article 16h(3)” to the end substitute— (i) in Article 16h(3) of the 2001 Directive, where the application is for a THR(NI) or THR(UK); (ii) in regulation 143A, where the application is for a THR(GB), that the authority thinks relevant to the application; or

• (e) for paragraph (7) substitute—

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

• (f) after paragraph (7) insert—

(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.

88

In regulation 117 (Insertion of regulation 130A (procedure where less than 15 years use of traditional herbal medicinal product)), in the inserted regulation 130A(1), for “traditional herbal registration” substitute “ THR(GB) (other than an application under the unfettered access route) ”.

89

In regulation 118 (amendment of regulation 133 (application for renewal of registration)) for “for “European Union”” to the end substitute—

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.

90

After regulation 118 amendment of regulation 133 (amendment of regulation 133 (application for renewal of registration)) insert—

(118A) (1) Regulation 134 (failure to place on the market etc.) is amended as follows. (2) In paragraph (1) after “in the United Kingdom” insert “ (or, in the case of a THR(GB) granted after an application under the unfettered access route, in Great Britain) ”. (3) In paragraph (2) after “in the United Kingdom” insert “ (or, in the case of a THR(GB) granted after an application under the unfettered access route, in Great Britain) ”.

91

In regulation 119 (amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration))—

• (a) after paragraph (1) insert—

(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.

• (b) in paragraph (2), for “for “from states” to the end substitute “after “states other than EEA states” insert “ / countries other than approved countries for import ”.”;

• (c) for paragraph (3) substitute—

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

• (d) in paragraph (4) for “omit sub-paragraph” to the end substitute “ in sub-paragraph (b), at the beginning insert “in the case of a THR(NI) or THR(UK),”. ”;

• (e) after paragraph (4) insert—

(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.

92

In regulation 120(2) (amendment of regulation 136 (revocation by licensing authority: further provisions)) for “for “list referred to in” to the end substitute—

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

93

In regulation 123 (amendment of regulation 140 (withdrawal of traditional herbal medicinal product from the market) for “140(1)(a)” to the end substitute “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

94

In regulation 125 (amendment of regulation 142 (obligation to notify placing on the market etc)) for “Omit regulation 142(5C)” substitute “In regulation 142(5C), for “traditional herbal registration” substitute “ THR(NI) or THR(UK) ”.

95

In regulation 126 (insertion of new regulation 143A (establishment of herbal monographs)), in the inserted regulation 143A(1), after “traditional herbal medicinal products” insert “ to be placed on the market in Great Britain ”.

96

For regulation 127 (amendment of regulation 144 (obligation following new herbal monograph)) substitute—

(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.

97

For regulation 129 (amendment of regulation 146 (obligation in relation to product information)) substitute—

(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).

98

In regulation 131 (amendment of regulation 149 (urgent safety restrictions)) substitute—

(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 7 — Amendment of Part 8 (omission of Part 8 (Article 126a authorisations))

99

For regulation 132 (omission of Part 8), substitute—

(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 ”. (132A) In regulation 157(1)— (a) in the heading for “other member States” substitute “ EU member States ”; and (b) in paragraph (1)— (i) after “where the licensing authority” insert “ , in relation to a UKMA(NI), ”; and (ii) for “another member State” substitute “ a member State ”.

PART 8 — Amendment of Part 9 (amendment of Part 9 (borderline products))

100

In regulation 133 (amendment of regulation 159 (provisional determination)) for paragraph (b) substitute—

(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, ”.

101

In regulation 134 (amendment of regulation 164 (effect of determination)) for paragraph (b) substitute—

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

102

Before regulation 135 (amendment of regulation 168 (use of non-prescription medicines in the course of a business) insert—

(135ZA) In regulation 167 (supply to fulfil special patient needs)— (a) in paragraph (6), for “or imported into the United Kingdom from a country other than an EEA State” substitute “ , imported into Northern Ireland from a country other than an EEA State or Great Britain, or imported into Great Britain from a country other than an approved country for import or Northern Ireland ”; (b) in paragraph (7)— (i) for “imported from an EEA State” substitute “ imported into Northern Ireland from an EEA State or imported into Great Britain from a country other than an approved country for import ”; (ii) for sub-paragraph (a) substitute— (a) it is manufactured or assembled in that State or country (as appropriate) by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with— (i) in the case of a product for sale or supply in Northern Ireland, the provisions of the 2001 Directive as implemented in that State, and (ii) in the case of a product for sale or supply in Great Britain, in accordance with the provisions applicable in that country; or (iii) for sub-paragraph (b) substitute— (b) it is manufactured or assembled as an investigational medicinal product in that State or country (as appropriate) by the holder of an authorisation in relation to its manufacture or assembly in accordance with— (i) in the case of a product for sale or supply in Northern Ireland, Article 13 of the Clinical Trials Directive as implemented in that State, and (ii) in the case of a product for sale or supply in Great Britain, regulations 13 and 43 of the Clinical Trials Regulations,

103

For regulation 135 (amendment of regulation 168 (use of non-prescription medicines in the course of a business)), substitute—

(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.

104

In regulation 136 (amendment of regulation 169 (mixing of general sale medicinal products)), for “insert “ UK ” before “marketing authorisation” ” substitute “for “marketing authorisation” substitute “ UK marketing authorisation or EU marketing authorisation ””.

105

In regulation 137 (amendment of regulation 171 (exempt advanced therapy medicinal products)), for “substitute “regulation 49(1)”.” substitute—

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).

106

In regulation 138 (amendment of regulation 173 (exemption for certain radiopharmaceuticals)), for “insert “ UK ” before “marketing authorisation” ” substitute “for “marketing authorisation” substitute “ UK marketing authorisation or EU marketing authorisation ””.

PART 10 — Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))

107

In regulation 139 (amendment of regulation 177 (application of part and interpretation))—

• (a) for paragraph (2) substitute—

(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).

'

• (b) in paragraph (3) omit sub-paragraphs (b) and (c);

• (c) in paragraph (4) omit sub-paragraphs (b) and (c);

• (d) omit paragraph (5);

• (e) for paragraph (6) substitute—

(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

108

After regulation 139 (amendment of regulation 177 (application of part and interpretation)) insert—

(139A) In regulation 179— (a) in paragraph (1), after “pharmacovigilance system” insert “ in relation to medicinal products for sale or supply in Great Britain ”; (b) after paragraph (1) insert— (1A) The licensing authority must operate a pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland. (c) in paragraph (2) for “The pharmacovigilance system” substitute “ Each pharmacovigilance system ”; and (d) in paragraph (3)(a) for “the pharmacovigilance system” substitute “ each pharmacovigilance system ”.

109

In regulation 140 (amendment of regulation 180 (obligation on licensing authority to audit pharmacovigilance system))—

• (a) in paragraph (2)—

• (i) before “omit” insert—

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

• (ii) from “omit” to the end becomes sub-paragraph (b);

• (b) after paragraph (2) insert—

(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.

• (c) after paragraph (3) insert—

(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.

110

For regulation 141 (omission of regulation 181 (delegation of obligations under Part 11)) substitute—

(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 ”.

111

In regulation 142 (amendment of regulation 182 (obligation on holder to operate a pharmacovigilance system))—

• (a) in paragraph (2) for “for “resides and operates” to the end substitute “after “in the EU” insert “ or United Kingdom ””;

• (b) after paragraph (2) insert—

(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.

; and

• (c) for paragraph (3) substitute—

(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.

112

In regulation 143 (amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)), in the inserted paragraph (3) after “The holder” insert “ of a UKMA(GB) or THR(GB) ”.

113

For regulation 145 (amendment of regulation 186 (reporting obligations on the licensing authority)) substitute—

(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).

114

In regulation 147 (amendment of regulation 187 (recording obligations on holders)) for paragraph (2) substitute—

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

115

In regulation 148 (amendment of regulation 188 (reporting obligations on holders))—

• (a) in paragraph (3), before sub-paragraph (a) insert—

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

• (b) after paragraph (3) insert—

(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.

• (c) for paragraph (4) substitute—

(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) ”.

• (d) after paragraph (5) insert—

(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).

116

In regulation 149 (amendment of regulation 189 (signal detection: licensing authority obligations)) for paragraph (3) substitute—

(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 ”.

117

For regulation 150 (amendment of regulation 190 (signal detection: holder obligation)) substitute—

(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.

118

In regulation 151 (amendment of regulation 191 (obligation on holder to submit periodic safety update reports: general requirements))—

• (a) in paragraph (2) for “for “EMA” substitute “ licensing authority ”” substitute “after “EMA” insert “ and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only, ”;

• (b) omit paragraph (4);

• (c) in paragraph (5), in the inserted paragraph (4A), after “A PSUR” insert “ in relation to a product authorised under a UKMA(GB) ”;

• (d) in paragraph (6), in the inserted paragraph (8A), after “conditional marketing authorisation” insert “ in relation to a product authorised under a UKMA(GB) ”;

• (e) for paragraph (7) substitute—

(7) In paragraph (10)— (a) for sub-paragraph (b) substitute— (b) where— (i) in relation to a product authorised under a UKMA(NI) or UKMA(UK), the product has not yet been placed on the market within the EEA or Northern Ireland, at least every six months following authorisation until the placing on the market within the EEA or Northern Ireland, or (ii) in relation to a product authorised under a UKMA(GB), the product has not yet been placed on the market in Great Britain, at least every six months following authorisation until the placing on the market within Great Britain; and (b) for sub-paragraph (c) substitute— (c) where— (i) in relation to a product authorised under a UKMA(NI) or UKMA(UK), the product has been placed on the market within the EEA or Northern Ireland— (aa) at least every six months during the first two years following the initial placing on the market, (bb) once a year for the following two years, and (cc) every three years after that; (ii) in relation to a product authorised under a UKMA(GB), the product has been placed on the market in Great Britain— (aa) at least every six months during the first two years following the initial placing on the market, (bb) once a year for the following two years, and (cc) every three years after that.

119

In regulation 152 (amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements))—

• (a) in paragraph (3), for “for “EMA” to the end substitute “after “EMA” insert “ and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only, ”;

• (b) for paragraph (4) substitute—

(4) In paragraph (9), after “paragraph (3)(a)” insert “ from the holder of a UKMA(UK), UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation ”.

120

In regulation 153 (amendment of regulation 193 (harmonisation of PSUR frequency or date of submission))—

• (a) for paragraph (2) substitute—

(2) In paragraph (1) substitute— (1) Where products that are subject to different authorisations or registrations contain the same active substance or the same combination of active substances, the frequency and dates of submission may be amended and harmonised in accordance with— (a) Article 107c(4) of the 2001 Directive, where— (i) any of the authorisations or registrations is a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation; and (ii) none of the authorisations or registrations is a UKMA(GB) or THR(GB); or (b) paragraphs (2A), (3) and (4A), where— (i) any of the authorisations or registrations is a UKMA(GB) or THR(GB); and (ii) none of the authorisations or registrations is a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation.

• (b) after paragraph (2) insert—

(2A) In paragraph (2), after “holder” insert “ of a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation ”.

• (c) in paragraph (3)—

• (i) for “For paragraph (2) substitute—” substitute “ After paragraph (2) insert— ”;

• (ii) the text to be inserted is renumbered as paragraph (2A);

• (iii) in the text to be inserted, after “the holder” insert “ of a UKMA(GB) or THR(GB) ”;

• (d) in paragraph (4)—

• (i) for “For paragraph (4) substitute—” substitute “ After paragraph (4) insert— ”;

• (ii) the text to be inserted is renumbered as paragraph (4A);

• (iii) in the text to be inserted, after “from a holder” insert “ of a UKMA(GB) or THR(GB) ”;

• (e) in paragraph (5)—

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

(a) after “of the 2001 Directive” insert “ or paragraph (2A) (as the case may be) ”

; and

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

(b) after “EMA” insert “ or licensing authority (as the case may be) ”

• (f) in paragraph (6)—

• (i) for “For paragraph (6) substitute” substitute “ After paragraph (6) insert ”; and

• (ii) the substituted paragraphs (6) and (6A) become paragraphs (6A) and (6B) respectively; and

• (iii) in the substituted paragraph (6A) for “(6A)” substitute “ (6B) ”; and

• (g) in paragraph (7) for “(6A)” substitute “ (6B) ”.

121

In regulation 154 (omission of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive))—

• (a) in the heading, for “omission” substitute “ amendment ”; and

• (b) for “Omit regulation 194.” substitute “In regulation 194(1) after “medicinal product” insert “ authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation ”.”.

122

In regulation 155 (amendment of regulation 195 (obligation on licensing authority to assess PSURs)—

• (a) after paragraph (2) insert—

(2A) Before paragraph (1) insert— (A1) This regulation applies in the circumstances specified in paragraphs (1) and (1A). (2B) In paragraph (1)— (a) after “relating to a medicinal product” insert “ authorised for sale or supply authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation ”; and (b) in sub-paragraph (a)(i) omit “other than the United Kingdom”.

• (b) in paragraph (3)—

• (i) for “For” substitute “ After ”;

• (ii) for “substitute” substitute “ insert ”;

• (iii) the inserted paragraph (1) becomes inserted paragraph (1A);

• (iv) in the inserted paragraph (1A), after “to a medicinal product” insert “ authorised for sale or supply under a UKMA(GB) or THR(GB) ”;

• (c) omit paragraph (5).

123

Before regulation 156 insert—

(156ZA) In regulation 196— (a) in the italic heading immediately preceding it, after “Urgent action” insert “ and major safety review ”; (b) in paragraph (1), for “The licensing authority must initiate the Section 4 procedure by informing” substitute “ In the case of a medicinal product authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority must inform ”; (c) omit sub-paragraph (2B); (d) omit paragraphs (4) to (7); (e) in paragraph (8), omit the definition of “EU urgent action procedure” and “Section 4 procedure”.

124

In regulation 156 (substitution of regulation 196 (urgent action))—

• (a) for the heading to the regulation, substitute “ Insertion of new regulation 196A (major safety review by the licensing authority) ”;

• (b) for “For regulation 196 and the italic heading immediately preceding it, substitute” substitute “ After regulation 196 insert ”;

• (c) in the text to be inserted by that regulation—

• (i) omit the italic heading “Major safety review”;

• (ii) renumber the regulation as regulation 196A.

125

In regulation 157 (omission of regulation 197 (EU urgent action procedure))—

• (a) in the heading for “Omission” substitute “ Amendment ”;

• (b) for “Omit” substitute “In;

• (c) after “regulation 197” insert “, in paragraph (1), after “ class of medicinal products ” insert “ authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation ””.

126

In regulation 158 (amendment of regulation 198 (post-authorisation safety studies: general provisions))—

• (a) in paragraph (2), for “for “competent authorities” to the end substitute—

(a) “the competent authorities” to the end becomes sub-paragraph (a); (b) in sub-paragraph (a), at the end insert “ and the licensing authority, where the product is subject to a marketing authorisation, traditional herbal registration or Article 126a authorisation for sale or supply in Northern Ireland; ” (c) after sub-paragraph (a) insert— (b) the licensing authority, where the product is subject to a marketing authorisation or traditional herbal registration for sale or supply in Great Britain only.

• (b) in paragraph (3)—

• (i) in sub-paragraph (a) for “for “relevant competent authorities” to the end substitute—

(i) “for “the relevant competent authorities” substitute— (i) the relevant competent authorities and the licensing authority, where paragraph (2)(a) applies; (ii) the licensing authority where paragraph (2)(b) applies, (ii) “any new information” to the end becomes full-out words;

; and

• (ii) in sub-paragraph (b) for “for “competent authorities” to the end substitute—

(i) “the competent authorities of the EEA States in which the study was conducted” becomes paragraph (i); (ii) in paragraph (i), after “the study was conducted” insert “ and the licensing authority, where paragraph (2)(a) applies; ” (iii) after paragraph (i) insert— (ii) the licensing authority, where paragraph (2)(b) applies, (iv) “before the end of the period” to the end becomes full-out words.

127

In regulation 159 (amendment of regulation 199 (submission of draft study protocols for required studies))—

• (a) for paragraph (2) substitute—

(2) In paragraph (2) for “to the body specified in paragraph (3)” to the end substitute— to— (a) the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation is a UKMA(NI) or UKMA(UK); (b) the licensing authority, where the authorisation is a UKMA(GB), before the study is commenced.

• (b) for paragraph (3) substitute—

(3) In paragraph (4)— (a) after “protocol is submitted” insert “ only ”; (b) after “paragraphs (2) and (3)(a)” insert “ (and is not submitted to the Pharmacovigilance Risk Assessment Committee) ”.

• (c) omit paragraphs (4) to (6).

128

In regulation 160 (amendment of regulation 200 (amendment to study protocols for required studies))—

• (a) for paragraph (2) substitute—

(2) In paragraph (2) for “to the body specified in paragraph (3)” to the end substitute— to— (a) the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or UKMA(UK); (b) the licensing authority, where the authorisation for the product is a UKMA(GB), before their implementation.

• (b) for paragraph (3) substitute—

(3) In paragraph (4)— (a) after “protocol is submitted” insert “ only ”; (b) after “paragraphs (2) and (3)(a)” insert “ (and is not submitted to the Pharmacovigilance Risk Assessment Committee) ”.

• (c) omit paragraphs (4) and (5).

129

In regulation 161 (amendment of regulation 201 (submission and evaluation of final study reports for required studies))—

• (a) for paragraph (2) substitute—

(2) In paragraph (2) for “to the body specified in paragraph (3)” to the end substitute— to— (a) the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or UKMA(UK); (b) the licensing authority, where the authorisation for the product is a UKMA(GB), a final study report and an abstract of the study results.

• (b) omit paragraph (3);

• (c) in paragraph (4) for “omit from” to the end substitute “omit “for reports falling under paragraph (3)(a)” and “for reports falling under paragraph (3)(b)”.

130

For regulation 162 (omission of regulation 202 (follow up of final study reports)) substitute—

(162) In regulation 202(1), after “This regulation applies” insert “ in respect of a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation ”.

131

For regulation 164(3) (amendment of regulation 203 (obligations on licensing authority in relation to national medicines web-portal)) substitute—

(3) In paragraph (2), after sub-paragraph (d) insert— (da) the list published by the licensing authority under, or which applies by virtue of, regulation 202A;

132

In regulation 165 (omission of regulation 204 (obligation on licensing authority in relation to public announcements))—

• (a) in the heading for “Omission” substitute “ Amendment ”;

• (b) for “Omit” substitute “ In ”;

• (c) after “regulation 204” insert “, in paragraph (1), after “ pharmacovigilance concerns ” insert “ which relate to products authorised under a UKMA(NI) or UKMA(UK) ”.

133

In regulation 166 (amendment of regulation 205 (obligations on holders in relation to public announcements))—

• (a) in paragraph (2) for “for “bodies listed” to the end substitute “after “bodies listed in paragraph (3)” insert “ where the product is subject to a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, or the licensing authority where the product is subject to a UKMA(GB) or THR(GB), ””;

• (b) omit paragraph (3).

134

In regulation 167 (insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)), in the inserted regulation 205A—

• (a) in paragraph (1), after “Schedule 12A” insert “ applies in relation to medicinal products for sale or supply under a UKMA(GB) or THR(GB) and ”;

• (b) in paragraph (2)—

• (i) for “The Ministers” substitute “ The Secretary of State ”;

• (ii) after “by regulations” insert “ in respect of Great Britain ”.

135

In regulation 170 (amendment of regulation 206 (infringement notices)) for paragraphs (2) and (3) substitute—

(2) In paragraph (3), after “paragraph (1)” insert “ in relation to a product authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI) or THR(UK) ”. (3) In paragraph (4) after sub-paragraph (a) insert— (aa) Schedule 12A;

136

Omit regulations 172 (amendment regulation 208 (false and misleading information)), 173 (amendment of regulation 209 (penalties)) and 174 (Omission of regulation 210 (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004)).

137

In regulation 175 (amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation))—

• (a) in paragraph (2)—

• (i) for “for” substitute “ after ”;

• (ii) for “substitute “Schedule 12A”” substitute “ insert “and Schedule 12A” ”;

• (b) in paragraph (3) for sub-paragraphs (a) and (b) substitute—

(a) in sub-paragraph (a), at the beginning insert “ in relation to a UKMA(NI), UKMA(UK), THR(NI) THR(UK) or Article 126a authorisation, ”; (b) after sub-paragraph (a) insert— (aa) in relation to a UKMA(GB) or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or

• (c) in paragraph (4)—

• (i) for “For paragraph (2) substitute” substitute “ After paragraph (2) insert ”;

• (ii) the inserted paragraph (2) becomes inserted paragraph (2A);

• (iii) omit the inserted paragraphs (3) and (4);

• (d) after paragraph (4) insert—

(5) In paragraph (4), after “Implementing Regulation” insert “ , or of paragraph 26(8) or 29(1) of Schedule 12A, ”.

138

Omit regulation 176 (amendment of regulation 211 (persons liable)).

139

For regulation 177 (amendment of regulation 212 (transitional amendments)) substitute—

(177) In regulation 212, omit “182, 186, 188, 191, 192”.

140

In regulation 178 (amendment of Schedule 33 (transitional arrangements: pharmacovigilance)) for “4” substitute “ 5 ”.

PART 11 — Amendment of Part 12 (amendment of Part 12 (dealings with medicinal products))

141

For regulation 187 (amendment of regulation 229 (exemption for supply by national health services bodies and local authorities)) substitute—

(187) In regulation 229(3), for sub-paragraph (f) substitute— (f) when the product is supplied— (i) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or (ii) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK), is in force in relation to it.

142

For regulation 188 (amendment of regulation 230 (exemption for supply etc under a PGD to assist doctors or dentists)) substitute—

(188) For regulation 230(8) substitute— (8) Condition G is that when the product is supplied or (as the case may be) administered — (a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or (b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK), is in force in relation to it.

143

For regulation 189 (amendment of regulation 231 (exemption for supply etc under a PGD by independent hospitals etc)) substitute—

(189) For regulation 231(8) substitute— (8) Condition G is that when the product is supplied— (a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or (b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK), is in force in relation to it.

144

For regulation 190 (amendment of regulation 232 (exemption for supply etc under a PGD by dental practices and clinics: England and Wales)) substitute—

(190) For regulation 232(8) substitute— (8) Condition F is that when the product is supplied, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK) is in force in relation to it.

145

For regulation 191 (amendment of regulation 233 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business)) substitute—

(191) For regulation 233(7) substitute— (7) Condition F is that when the prescription only medicine is supplied or (as the case may be) administered— (a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or (b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK), is in force in relation to it.

146

For regulation 192 (amendment of regulation 234 (exemption for supply etc of products under a PGD to assist the police etc)) substitute—

(192) For regulation 234(9) substitute— (9) Condition H is that when the product is supplied— (a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or (b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK), is in force in relation to it.

147

In regulation 193 (amendment of Schedule 17 (exemptions for sale, supply or administration by certain persons)—

• (a) in paragraph (2), for “insert “ UK ” before “marketing authorisations”.” substitute “for “marketing authorisations” substitute “ UK marketing authorisations, EU marketing authorisations ”;

• (b) in paragraph (3), for “insert “ UK ” before “marketing authorisation”.” substitute “for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation ”.

148

In regulation 194 (amendment of regulation 249 (restrictions on persons to be supplied with medicinal products)), for paragraphs (b) and (c) substitute—

(b) after sub-paragraph (a) insert— (aa) an EU marketing authorisation;

149

After regulation 194 (amendment of regulation 249 (restrictions on persons to be supplied with medicinal products) insert—

(194A) In regulation 251 (compliance with standards specified in certain publications), after paragraph (5) insert— (6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where— (a) the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and (b) the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph. (7) In paragraph (6), “relevant marketing authorisation” means— (a) an EU marketing authorisation; (b) an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or (c) a UKMA(GB) granted under the unfettered access route.

150

For regulation 196 (omission of regulation 255A to 255C (enforcement and offences relating to Commission Regulation 2016/161)) substitute—

(196) In regulation 255A(1), after “purpose of sale or supply,” insert “ in Northern Ireland, ”. (196A) In regulation 255B, after “medicinal products to the public” in the first place it occurs insert “ in Northern Ireland ”.

PART 12 — Amendment of Part 13 (omission of Part 12A (sale of medicines to the public at a distance))

151

For regulation 197 (omission of Part 12A) substitute—

(197) (1) Before regulation 256A (interpretation) insert— (256ZA) This part applies to Northern Ireland only. (2) In regulation 256A(1) (interpretation)— (a) in the definition of “the list”, for “competent authority of a member State in which the person named on the list is established” substitute “ licensing authority ”; (b) omit the definition of “relevant website of the member State”; (c) at the appropriate place in the alphabetical order insert— “website of the licensing authority” means a website of the licensing authority providing information on— (a) the national legislation applicable to the offering of medicinal products for sale at a distance to the public by information society services; (b) the differences between Northern Ireland and EEA States regarding classification of medicinal products and the conditions for their supply; (c) the purpose of the common logo; (d) the list of persons offering medicinal products for sale at a distance by means of information society services as well as their website addresses; (e) background information about the risks related to medicinal products supplied illegally to the public by means of information society services; (f) a hyperlink to the website of the EMA; (d) in the definition of “website of the EMA”— (i) in paragraph (a)— (aa) for “relevant website of the member State” substitute “ website of the licensing authority ”; (bb) for “that member State” substitute “ Northern Ireland ”; (ii) in paragraph (e), for “hyperlinks to the relevant website of the member State” substitute “ a hyperlink to the website of the licensing authority ”. (3) In regulation 256B (person who may sell medicinal products by information society services)— (a) before paragraph (1) insert— (A1) This regulation applies to a person who is an established service provider (as defined in regulation 2(1) of the Electronic Commerce (EC Directive) Regulations 2002 ) in Northern Ireland. (b) in paragraph (2), omit “of persons selling medicinal products at a distance that is published on the relevant website of the member State”; (c) for paragraph (3) substitute— (3) Condition B is that the product to be sold by information society services is covered by a UK marketing authorisation or an authorisation granted— (a) under Regulation (EC) No 726/2004; or (b) by a competent authority of the member State in which that product is destined to be sold. (3A) Condition B does not apply to— (a) a special medicinal product; (b) a medicinal product where the product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968 ; or (c) a medicinal product where— (i) the product is a result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15); (ii) regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968; (iii) the process of assembly results in a change in the presentation of the authorised medicinal product; and (iv) by reason of the change in paragraph (iii) the product does not comply with condition B. (d) in paragraph (4), omit “in the member State in which that person is established”; (e) in paragraphs (6), for “the competent authority in a member State in which the person is established” substitute “ the licensing authority ”; (f) in each of paragraphs (8)(b) and (c), for “the competent authority of a member State” substitute “ the licensing authority ”. (4) In regulations 256C (notification requirements for sellers of medicinal products at a distance) to 256M (offences: breach of regulations and false information), for “competent authority of a member State” in each place it occurs (including in the headings to regulations 256F and 256J) substitute “ licensing authority ”. (5) In regulation 256C (notification requirements for sellers of medicinal products at a distance), in paragraph (2)(b)(iv), for “informantion” substitute “ information ”. (6) In regulation 256D(3) (procedure for listing persons who may supply medicinal products at a distance), for “that competent authority” in both places substitute “ the licensing authority ”. (7) In regulation 256G (grant or refusal to list a person)— (a) in paragraph (2), for “that competent authority” substitute “ the licensing authority ”; (b) in paragraph (3)— (i) for “that competent authority” substitute “ the licensing authority ”; (ii) for “relevant website of the member State” substitute “ website of the licensing authority ”. (8) In regulation 256H(3) (conditions to be met by a person entered on the list)— (a) in sub-paragraph (a), omit “which is responsible for maintaining the list on which the person selling products at a distance is included”; (b) in sub-paragraph (b), for “relevant website of the Member State” substitute “ website of the licensing authority ”. (9) In regulation 256J (procedure where the licensing authority proposes to suspend, vary or remove a person's entry on the list), omit sub-paragraph (6)(b) (and the “and” at the end of sub-paragraph (a)). (10) In regulation 256K(1) (suspension of a person's entry on the list in cases of urgency), for “that competent authority” substitute “ the licensing authority ”. (11) In regulation 256L (variation of a person's entry on the list on the application of that person)— (a) in paragraph (3), for “that competent authority” substitute “ the licensing authority ”; (b) in paragraph (6)(b), for “that competent authority's” substitute “the licensing authority's”.

PART 13 — Amendment of Part 14 (amendment of Part 13 (packaging and leaflets))

152

In regulation 198 (amendment of regulation 257 (packaging requirements: general))—

• (a) in paragraph (2), after “257C” insert “ where the product is for sale or supply in Great Britain only ”;

• (b) in paragraph (3), in the inserted paragraph (8), after “product” insert “ for sale or supply in Great Britain only ”.

153

For regulation 199 (omission of regulations 257A and 257B (packaging requirements: medicinal products required to bear safety features and associated transitionals)) substitute—

(199) In regulation 257A, after “either fully or partially,” insert “ from a product to which Article 54a of the 2001 Directive applies ”. (199A) In regulation 257B, after “unless the product” insert “ is one to which Article 54a of the 2001 Directive applies and ”.

154

In regulation 200 (insertion of regulations 257C (packaging requirements: advanced therapy medicinal products) and 257D and 257E (guidance and regulations in relation to packing, leaflets and labelling))—

• (a) in the inserted regulation 257C(1)—

• (i) in sub-paragraph (a), after the first reference to “advanced therapy medicinal product” insert “ for sale or supply in Great Britain only ”;

• (ii) in sub-paragraph (b), for “of the product” substitute “ of that product ”

• (b) for the inserted regulation 257D substitute—

(257D) (1) The licensing authority may publish guidance on packaging and package leaflets applicable to products for sale or supply in the whole United Kingdom or parts of the United Kingdom, as appropriate. (2) Guidance published under paragraph (1) may, in particular, include— (a) the wording of certain special warnings for certain categories of medicinal products; (b) the particular information needs relating to products that are a pharmacy medicine; (c) the legibility of particulars on the labelling and package leaflet; (d) the methods of identification and authentication of medicinal products; (e) the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated. (3) Until such time as the licensing authority publishes guidance under paragraph (1), any guidance published by the Commission pursuant to Article 65 of the 2001 Directive , insofar as that guidance was in force immediately before IP completion day, continues to apply as if it had been published by the licensing authority under paragraph (1).

155

In regulation 201 (amendment of Schedule 24 (packaging information requirements))—

• (a) in paragraph (2), after “regulation 257D” insert “ in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products. ”;

• (b) in paragraph (3), for “for “marketing authorisation”” to the end substitute “for “ marketing authorisation, ” substitute “UK marketing authorisation, EU marketing authorisation”.”;

• (c) omit paragraph (4);

• (d) in paragraph (5)—

• (i) in the inserted Part 4 (outer and immediate packaging: advanced therapy medicinal products), in the heading, after “products” insert “ for sale or supply in Great Britain only ”;

• (ii) in the inserted Part 5 (immediate packaging: blister packs and small packaging (advanced therapy medicinal products)), in the heading, after “products” insert “ for sale or supply in Great Britain only ”.

156

In regulation 202 (amendment of regulation 259 (packaging requirements: information for blind and partially sighted patients)), for “for “marketing authorisation” to the end substitute “for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation ”.”.

157

In regulation 203 (amendment of regulation 260 (package leaflets))—

• (a) in paragraph (2), in the inserted paragraph (1A), after the first reference to “advanced therapy medicinal product” insert “ for sale or supply in Great Britain only ”;

• (b) in paragraph (3), in the inserted text, after “advanced therapy medicinal product,” insert “ for sale or supply in Great Britain only ”;

• (c) in paragraph (4)—

• (i) omit “, Article 126a authorisation”;

• (ii) after “UK marketing authorisation” insert “ , EU marketing authorisation, ”.

158

In regulation 204 (amendment of Schedule 27 (package leaflets))—

• (a) in paragraph (2), after “regulation 257D” insert “ in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products. ”;

• (b) in paragraph (3), for “for “marketing authorisation” to the end substitute “for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation ”.”;

• (c) in paragraph (4)—

• (i) for “Omit” substitute “ In ”;

• (ii) after “12” insert “after “ Where the product ” insert “ is authorised for sale or supply in Northern Ireland and ”.”;

• (d) in paragraph (5)(a)—

• (i) for “for” substitute “ after ”;

• (ii) for “substitute “regulation 202A”” substitute “ insert “in the case of products for sale or supply in Northern Ireland, or the list referred to in regulation 202A, in the case of products for sale or supply in Great Britain,”; ”;

• (e) in paragraph (6), in the inserted Part 3 (advanced therapy medicinal products), in the heading, after “products” insert “ for sale or supply in Great Britain only ”.

159

Omit regulation 205 (amendment of regulation 266 (language requirements etc)).

160

In regulation 206 (amendment of regulation 267 (submission of mock-ups of packaging and leaflets to licensing authority)) for “, in each place where it occurs” to the end substitute “before “ marketing authorisation ”, in each place where it occurs, insert “ UK ”.”.

161

In regulation 207 (amendment of regulation 268 (offence relating to packaging and package leaflets))

• (a) after paragraph (1) insert—

(1A) In the heading to the regulation, after “packaging and package leaflets” insert “ in Great Britain ”.

• (b) for paragraph (2) substitute—

(2) In paragraph (1)— (a) for “marketing authorisation, Article 126a authorisation” substitute “ UKMA(UK), UKMA(GB) ”; (b) after “the purpose of sale or supply” insert “ , in Northern Ireland ”.

162

After regulation 207 (amendment of regulation 268 (offence relating to packaging and package leaflets)) insert—

(207A) After regulation 268 insert— (268A) (1) This regulation applies to the holder of a UKMA(UK), UKMA(NI), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply, in Northern Ireland, a medicinal product to which the authorisation, certificate or registration relates. (2) A person to whom this regulation applies is guilty of an offence if— (a) a package or package leaflet relating to the product does not comply with the applicable requirements of this Part, Article 9 of Commission Regulation 2016/161 or Article 28 or 32 of the Paediatric Regulation; or (b) the product is not accompanied by a package leaflet when one is required by virtue of this Part.

163

In regulation 208 (amendment of regulation 269 (offences relating to packaging and package leaflets: other persons))—

• (a) after paragraph (1) insert—

(1A) In the heading to the regulation, after “packaging and package leaflets” insert “ in Great Britain ”.

• (b) for paragraph (2) substitute—

(2) In paragraph (1)— (a) for “marketing authorisation, Article 126a authorisation” substitute “ UKMA(UK), UKMA(GB) ”; (b) after “the purpose of sale or supply” insert “ , in Great Britain ”.

• (c) after paragraph (2) insert—

(2A) In paragraph (2), after “for the purpose of sale or supply,” insert “ in Great Britain ”.

164

After regulation 208 (amendment of regulation 269 (offences relating to packaging and package leaflets: other persons)) insert—

(208A) After regulation 269 insert— (269A) (1) This regulation applies to a person, other than the holder of a UKMA(UK), UKMA(NI), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business carried on by that person, sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply in Northern Ireland. (2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, in Northern Ireland knowing or having reasonable cause to believe— (a) that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part, Article 9 of Commission Regulation 2016/161 or Article 28 or 32 of the Paediatric Regulation; or (b) that the product is not accompanied by a package leaflet when one is required by virtue of this Part.

165