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

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.

Amendment of regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)

151

• (1) Regulation 191 is amended as follows.

• (2) In paragraphs (1) and (7), after “EMA” insert “and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,".

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

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) After paragraph (4) insert—

(4A) A PSUR in relation to a product authorised under a UKMA(GB) must also include the content, and be submitted in the format, specified in Part 8 of Schedule 12A.

• (6) After paragraph (8), insert—

(8A) In the case of a conditional marketing authorisation in relation to a product authorised under a UKMA(GB), the holder must submit PSURs immediately upon the request of the licensing authority and at least every six months beginning with the date on which the authorisation for the medicinal product is granted or renewed by the licensing authority.

• (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.

• (8) Omit paragraph (11).

Amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements)

152

• (1) Regulation 192 is amended as follows.

• (2) In paragraph (1)(a), insert “ UK ” before “marketing authorisation”.

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

• (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”.

Amendment of regulation 193 (harmonisation of PSUR frequency or date of submission)

153

• (1) Regulation 193 is amended as follows.

• (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.

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

• (3) After paragraph (2) insert—

(2A) Where one or more of the grounds in paragraph (3) is met, the holder of a UKMA(GB) or THR(GB) may submit a request in writing to the licensing authority, or the licensing authority may in any event decide, to— (a) determine a UK reference date from which submission dates are calculated in respect of products that fall under paragraph (1); or (b) change the frequency and date of submission of the PSUR.

• (4) After paragraph (4) insert—

(4A) Where the licensing authority makes a decision under paragraph (2) following a written request from a holder of a UKMA(GB) or THR(GB), it must notify that holder in writing of its decision to approve or refuse the request.

• (5) In paragraph (5)—

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

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

• (6) After paragraph (6) insert—

(6A) Subject to paragraph (6B), in this regulation, “UK reference date” means a date determined by the licensing authority under paragraph (2)(a) in respect of medicinal products containing the same active substance or the same combination of active substances. (6B) Until the licensing authority makes a decision under paragraph (2), any— (a) Union reference date in respect of medicinal products containing the same active substance or the same combination of active substances; or (b) date of submission and frequency of periodic safety reports in respect of such products, published by the EMA under Article 107c(7) of the 2001 Directive, is deemed to be the UK reference date or, as the case may be, the required date or frequency of PSUR submission, in respect of those medicinal products.

• (7) After paragraph (6B) insert—

(7) The licensing authority must publish a list of— (a) UK reference dates it determines under paragraph (2); and (b) the required date of submission and frequency for PSURs in respect of medicinal products containing the same active substance or the same combination of active substances. (8) Any change to the date of submission and frequency of PSURs as a result of the application of this regulation is to take effect after a 6 month period, such period beginning with the day after the licensing authority publishes that change under paragraph (7).

Omission of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive)

154

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

Amendment of regulation 195 (obligation on licensing authority to assess PSURs)

155

• (1) Regulation 195 is amended as follows.

• (2) In the heading, omit “where EU single assessment procedure does not apply”.

• (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”.

• (3) After paragraph (1) insert—

(1A) This regulation applies where PSURs relating to a medicinal product authorised for sale or supply under a UKMA(GB) or THR(GB) have been submitted to the licensing authority under regulations 191 to 192.

• (4) After paragraph (3) insert—

(3A) If the licensing authority considers under paragraph (3)(b) that an authorisation or registration needs to be varied, it may require the holder to submit to the licensing authority, within a time period that the licensing authority specifies, an application for a variation, including— (a) an updated summary of the product characteristics; and (b) an updated package leaflet.

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

Substitution of regulation 196 (urgent action)

156

After regulation 196 insert substitute—

(196A) (1) The licensing authority may conduct a major safety review where— (a) on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities it considers— (i) suspending or revoking a UK marketing authorisation or traditional herbal registration of a medicinal product or in respect of a class of medicinal products, (ii) prohibiting the supply of a medicinal product or a class of medicinal products, (iii) refusing the renewal of a UK marketing authorisation or traditional herbal registration, or (iv) action is necessary to vary a UK marketing authorisation or traditional herbal registration or a class of such authorisations or registrations, including to impose new conditions; or (b) it is informed by a holder that, on the basis of safety concerns, the holder has— (i) interrupted the sale or supply, or offer of sale or supply, of the product to which a UK marketing authorisation or traditional herbal registration relates, (ii) taken action to have that product's authorisation or registration cancelled or intends to do so, or (iii) not applied for the renewal of that product's authorisation or registration. (2) If the licensing authority conducts a review under paragraph (1), it must— (a) announce the initiation of that review on the UK web-portal as soon as reasonably practicable; (b) include in that announcement— (i) an outline of its reasons for conducting a major safety review, the medicinal products concerned and, where applicable, the active substances concerned, and (ii) the proposed structure and time-scale of the review; (c) notify a holder if the product to which that holder's authorisation or registration relates is within the scope of the review; and (d) publish the outcome of that review, including any recommendations it is making, or action it is proposing to take, as soon as reasonably practicable after the conclusion of that review. (3) A holder who is notified under paragraph (2)(c)— (a) must provide to the licensing authority such information as the licensing authority notifies that holder it requires, within such time period as the licensing authority specifies; and (b) may, where such information contains confidential data relevant to the subject matter of the review, because the data relates to a manufacturing process or trade secret, notify the licensing authority that that data is provided in confidence. (4) Where the licensing authority proposes that action should be taken in respect of any UK marketing authorisation or traditional herbal registration— (a) during the conduct of the major safety review, because urgent action is necessary to protect public health; or (b) upon the conclusion of such a review, it may exercise its powers under Part 5 or 7 (as the case may be) in relation to that authorisation or registration.

Omission of regulation 197 (EU urgent action procedure)

157

In regulation 197 , 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” .

Amendment of regulation 198 (post-authorisation safety studies: general provisions)

158

• (1) Regulation 198 is amended as follows.

• (2) In paragraph (2),

• (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.

• (3) In paragraph (3)—

• (a) in sub-paragraph (c),

• (i) “for “the relevant competent authorities” 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;

• (b) in sub-paragraph (d),

• (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.

Amendment of regulation 199 (submission of draft study protocols for required studies)

159

• (1) Regulation 199 is amended as follows.

• (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.

• (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)”.

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 200 (amendment to study protocols for required studies)

160

• (1) Regulation 200 is amended as follows.

• (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.

• (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)”.

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Amendment of regulation 201 (submission and evaluation of final study reports for required studies)

161

• (1) Regulation 201 is amended as follows.

• (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.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) In paragraph (4), omit “for reports falling under paragraph (3)(a)” and “for reports falling under paragraph (3)(b)

Omission of regulation 202 (follow up of final study reports)

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”.

Insertion of new regulation 202A (medicinal products subject to additional monitoring)

163

After regulation 202 insert—

(202A) (1) The licensing authority may establish a list of medicinal products that are subject to additional monitoring. (2) The list referred to in paragraph (1) is to include the names and active substances of— (a) medicinal products authorised in the United Kingdom that contain a new active substance which, on 1st January 2011, was not contained in any medicinal product authorised in the United Kingdom; (b) any biological medicinal product not covered by sub-paragraph (a) that was authorised in the United Kingdom after 1st January 2011; (c) medicinal products that are authorised pursuant to these Regulations, subject to the conditions referred to in regulation 50I, 59(2)(b) or (c), 60 or 61(4). (3) If the licensing authority considers it appropriate, medicinal products that are authorised pursuant to these Regulations, subject to the conditions referred to in regulation 59(2)(a), (d), (e) or (f), 61(5) or 183(2), may also be included in the list referred to in paragraph (1). (4) For medicinal products included in the list referred to in paragraph (1)— (a) the summary of product characteristics and the package leaflet must include a symbol and statement as follows: “▼ This medicinal product is subject to additional monitoring”; and (b) that symbol must be proportional to the font of the subsequent standardised text, and each side of the triangle must have a minimum length of 5 millimetres. (5) In the cases referred to in paragraph (2)(a) and (b), the licensing authority must, unless paragraph (6) applies, remove a medicinal product from the list after five years, beginning with the day after the UK reference date referred to in regulation 193. (6) In the cases referred to in paragraph (2)(c) and (3), the licensing authority must remove a medicinal product from the list once the condition or obligation under a provision specified in those paragraphs has been fulfilled. (7) Until the licensing authority publishes a list of medicinal products under paragraph (1), the reference to that list is instead to be read as a reference to the list referred to in Article 23 of Regulation (EC) No 726/2004, as that list may be amended from time to time.

Amendment of regulation 203 (obligations on licensing authority in relation to national medicines web-portal)

164

• (1) Regulation 203 is amended as follows.

• (2) In paragraph (1), omit from “linked” to the end.

• (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;

Omission of regulation 204 (obligation on licensing authority in relation to public announcements)

165

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

Amendment of regulation 205 (obligations on holders in relation to public announcements)

166

• (1) Regulation 205 is amended as follows.

• (2) In paragraph (2), 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),”

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)

167

After regulation 205 insert—

(205A) (1) Schedule 12A applies in relation to medicinal products for sale or supply under a UKMA(GB) or THR(GB) and makes further provision as to the obligations of a holder and the licensing authority in respect of the performance of pharmacovigilance activities under this Part. (2) The Secretary of State may by regulations in respect of Great Britain amend Schedule 12A. (3) Regulations under paragraph (2) may make provision regarding the performance of pharmacovigilance activities under this Part as to— (a) the content and maintenance of the pharmacovigilance system master file kept by the holder; (b) the minimum requirements for the quality system for the performance of pharmacovigilance activities by the holder and the licensing authority; (c) the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities; (d) the minimum requirements for the monitoring of data recorded by the licensing authority pursuant to regulation 185 (recording obligations on the licensing authority) to determine whether there are new risks or whether risks have changed; (e) the format and content of electronic transmission of suspected adverse reactions by a holder; (f) the format and content of electronic periodic safety reports and risk management plans; and (g) the format of protocols, abstracts and final study reports for the post-authorisation safety studies.

Insertion of new Schedule 12A (further provision as to performance of pharmacovigilance activities)

168

Schedule 6 inserts a new Schedule 12A after Schedule 12 to the 2012 Regulations.

Insertion of regulation 205B (guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies)

169

After new regulation 205A insert—

(205B) (1) The licensing authority may publish— (a) guidance on good pharmacovigilance practices for both the licensing authority and UK marketing authorisation holders; (b) scientific guidance on post authorisation efficacy studies. (2) Subject to paragraph (3), the guidance issued by the Commission under Article 108a of the 2001 Directive on the matters specified in paragraph (1)(a) and (b) continues to apply until the date on which the licensing authority publishes guidance under paragraph (1). (3) The licensing authority— (a) may determine that provisions of the guidance specified in paragraph (2) no longer apply, or apply subject to specified modifications, from a date that it specifies; and (b) must, if it so determines, publish its determination. (4) Guidance published under paragraph (1), or which applies by virtue of paragraph (2) (as modified by any determination under paragraph (3), as the case may be), is to be taken into account in consideration of whether there has been any failure to comply with a provision in this Part, or Schedule 12A, to which the guidance is relevant.

Amendment of regulation 206 (infringement notices)

170

• (1) Regulation 206 is amended as follows.

• (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;

Amendment of regulation 207 (offences)

171

In regulation 207(1), after “other than” insert “ Schedule 12A (further requirements in respect of pharmacovigilance activities) and ”.

Amendment of regulation 208 (false and misleading information)

172

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

Amendment of regulation 209 (penalties)

173

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

Omission of regulation 210 (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004)

174

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

Amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation)

175

• (1) Regulation 210A is amended as follows.

• (2) In the heading, after “the Implementing Regulation insert “and Schedule 12A”.

• (3) In paragraph (1)—

• (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

• (4) After paragraph (2) insert—

(2A) The provisions of Schedule 12A mentioned in paragraph (1)(a) are— (a) Part 1 (pharmacovigilance system master file); (b) Parts 2 and 3 (minimum requirements for the quality systems in the performance of pharmacovigilance activities); (c) Part 6 (transmission of reports of suspected adverse reactions); (d) paragraph 24 (update of risk management plans); (e) Part 8 (periodic safety update reports); and (f) Part 9 (post-authorisation safety studies). (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Amendment of regulation 211 (persons liable)

176

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

Amendment of regulation 212 (transitional arrangements)

177

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

Amendment of Schedule 33 (transitional arrangements: pharmacovigilance)

178

In Schedule 33, omit paragraphs 1, 2 and 5 to 10.

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

Amendment of regulation 213 (interpretation of Part 12)

179

In regulation 213(1) —

• (a) insert at the appropriate place—

“approved country health professional” means a person who is practising in a profession included in the list published under regulation 214(6A) in a country that is included in that list in relation to that profession;

• (b) omit the definition of “EEA health professional”; and

• (c) in the definition of “relevant prescriber”, for “EEA health professional” substitute “ approved country health professional ”.

Amendment of regulation 214 (sale or supply of prescription only medicines)

180

• (1) Regulation 214 is amended as follows.

• (2) In paragraph (2)(a), for “EEA health professional” substitute “ approved country health professional ”.

• (3) In paragraph (6), for “EEA health professional” substitute “ approved country health professional ”.

• (4) After paragraph (6) insert—

(6A) The licensing authority must publish a list of approved countries and professions for the purposes of the definition of “approved country health professional”. (6B) In order to determine whether a country or profession should be included in the list published under paragraph (6A), the licensing authority may, in particular, take into account— (a) the country's standards of professional qualification; (b) the country's system for ensuring that qualified professionals have undergone training which meets the requirements that apply in that country; (c) the effectiveness of enforcement of professional standards; (d) the mechanisms the country has in place to assist members of the public in obtaining information in respect of a qualified professional who is established there; and (e) the regularity and rapidity of information provided by that country relating to non-compliant professionals. (6C) The licensing authority must— (a) review a country or profession it has included in the list published under paragraph (6A) to determine if it is still satisfied that they should remain on the list, and if it is not so satisfied, remove it from that list; and (b) undertake such a review at least every 3 years beginning with the date on which that country or profession was included in that list.

Amendment of regulation 216 (exceptions to regulation 215)

181

In regulation 216(2), for “EEA health professional” substitute “ approved country health professional ”.

Amendment of regulation 217 (requirements for prescriptions: general)

182

In regulation 217(8)(a) , for “EEA health professional” substitute “ approved country health professional ”.

Amendment of regulation 217A (requirements for prescriptions to be dispensed in an EEA State)

183

• (1) Regulation 217A is amended as follows.

• (2) In the heading, omit “other than the UK”.

• (3) In paragraph (2)(a), omit “other than the UK”.

Amendment of regulation 218 (requirements for prescriptions: EEA health professionals)

184

• (1) Regulation 218 is amended as follows.

• (2) In the heading, and each place where it subsequently occurs, for “EEA health professional” substitute “ approved country health professional ”.

• (3) In paragraph (5)(c) and (d)(ii)(bb), for “EEA health professional's” substitute “approved country health professional's”.

• (4) In paragraph (2)(a), for “relevant European State except the United Kingdom” substitute “ country included in the list published under regulation 214(6A) ”.

Amendment of regulation 219 (electronic prescriptions)

185

In regulation 219(2) , for “EEA health professional” substitute “ approved country health professional ”.

Amendment of regulation 219A (electronic prescriptions: EEA health professionals)

186

• (1) Regulation 219A is amended as follows.

• (2) In the heading, for “EEA health professionals” substitute “ approved country health professionals ”.