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

Type Statutory-Instrument

Publication 2020-12-08

Last updated 2021-08-03

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(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 ”.

(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) ”;

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 ”;

(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) ”.

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) ”.

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

(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”.”;

(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 ”;

(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 ”.”;

(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 ”.

(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

In regulation 209 (amendment of regulation 270 (non-compliance with requirements of this Part)) for “for “marketing authorisation” to the end substitute “for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation, ”.

166

After regulation 209 (amendment of regulation 270 (non-compliance with requirements of this Part)) insert—

(209A) In regulation 271 for “268, 269” substitute “ 268, 268A, 269, 269A ”.

PART 14 — Amendment of Part 15 (amendment of Part 14 (advertising))

167

For regulation 211 (amendment of regulation 279 (products without a marketing authorisation)) substitute—

(211) For regulation 279 substitute— (279) (1) A person may not publish an advertisement in Great Britain for a medicinal product unless one of the following is in force for the product— (a) a UKMA(GB) or UKMA(UK); (b) a COR(GB) or COR(UK); or (c) a THR(GB) or THR(UK). (2) A person may not publish an advertisement in Northern Ireland for a medicinal product unless one of the following is in force for the product— (a) a UKMA(NI) or UKMA(UK); (b) a COR(NI) or COR(UK); (c) a THR(NI) or THR(UK); (d) an EU marketing authorisation; or (e) an Article 126a authorisation. (3) A person may not publish an advertisement in the whole United Kingdom for a medicinal product unless, in relation to that product— (a) one of the authorisations or registrations specified in paragraph (1) is in force in Great Britain; and (b) one of the authorisations or registrations specified in paragraph (2) is in force in Northern Ireland.

168

In regulation 212 (amendment of regulation 280 (general principles))—

(a) for “280(1)” substitute “ 280 ”;

(b) in paragraph (a)—

(i) at the beginning, insert “ in paragraph (1) ”;

(ii) for “UK marketing authorisation or” substitute “ UK marketing authorisation, EU marketing authorisation, ”;

(b) after paragraph (1) insert— (1A) Where an advertisement mentioned in paragraph (1) relates to a product in relation to which there is a separate authorisation or registration in force in Great Britain and in Northern Ireland, it may not be published in the whole United Kingdom unless it complies with the particulars listed in the summary of the product characteristics in each of those authorisations or registrations (as the case may be).

169

In regulation 213 (amendment of regulation 281 (duties of authorisation holders and registration holders)) for paragraphs (b) and (c) substitute—

(b) omit “or” at the end of sub-paragraph (c); and (c) in sub-paragraph (d), after “for a medicinal product” insert— ; or (e) an EU marketing authorisation for a medicinal product.

170

After regulation 213 (amendment of regulation 281 (duties of authorisation holders and registration holders)) insert—

(213A) After regulation 284, insert— (284A) In the case of a medicinal product for sale or supply in Great Britain where the product concerned is not a prescription only medicine in Great Britain but is either— (a) a prescription only medicine in Northern Ireland; or (b) not authorised for sale or supply in Northern Ireland, any advertisement to the public must include a statement that the medicinal product is not available without a prescription, or is not available for sale or supply, in Northern Ireland (as the case may be).

171

For regulation 214 (amendment of regulation 293 (prohibition of supply to the public for promotional purposes) substitute—

(214) For regulation 293(1) substitute— (1) The holder of— (a) in the case of a medicinal product for sale or supply in Great Britain, a UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK); or (b) in the case of a medicinal product for sale or supply in Northern Ireland, a UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation or Article 126a authorisation, may not sell or supply a medicinal product for a promotional purpose to a person who is not qualified to prescribe medicinal products.

172

After regulation 214 (amendment of regulation 293 (prohibition of supply to the public for promotional purposes) insert—

(214A) In regulation 294, after paragraph (4) insert— (5) In the case of an advertisement which relates to a medicinal product for sale or supply— (a) in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland, (b) in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and (c) in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both— (i) the product for sale or supply in Great Britain, and (ii) the product for sale or supply in Northern Ireland.

173

For regulation 215 (amendment of regulation 295 (abbreviated advertisements)) substitute—

(215) In regulation 295— (a) for paragraph (2)(d) substitute— (d) the name and address of the holder— (i) in the case of a medicinal product for sale or supply in Great Britain, of the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK) for the medicinal product, or (ii) in the case of a medicinal product for sale or supply in Northern Ireland, the name and address of the holder of the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation, or Article 126a authorisation for the medicinal product, or the business name and address of the part of the holder's business that is responsible for the sale or supply of the medicinal product. (b) after paragraph (4) insert— (4A) In the application of this regulation to a medicinal product for sale or supply— (a) in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland, (b) in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and (c) in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both— (i) the product for sale or supply in Great Britain, and (ii) the product for sale or supply in Northern Ireland.

174

After regulation 215 (amendment of regulation 295 (abbreviated advertisements)) insert—

(215A) In regulation 298, for paragraph (5)(a) substitute— (a) is no larger than the smallest presentation of the product that is available for sale— (i) in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or (ii) in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;

175

For regulation 216 (amendment of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply)) substitute—

(216) In Schedule 30— (a) in paragraphs 1, 2 and 6, for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation ”; (b) after paragraph 2 insert— (2A) In relation to an advertisement in Great Britain (other than an advertisement falling within the exception in regulation 296) where the medicinal product concerned is authorised under a UKMA(GB), a statement that the product concerned is authorised under a UKMA(GB).

176

In regulation 217 (amendment of regulation 299 (medical sales representatives)), for “for “marketing authorisation” to the end substitute “for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation ”.”.

177

After regulation 217 (amendment of regulation 299 (medical sales representatives)) insert—

(217A) In regulation 305— (a) for paragraph (3)(a) substitute— (a) state that the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2 and specify whether the incompatibility is insofar as the advertisement is for publication— (i) in Great Britain; (ii) in Northern Ireland; or (iii) in both Great Britain and Northern Ireland; (b) in paragraph (4), after “the advertisement” insert— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland (217B) In regulation 306— (a) in paragraph (2), after “Chapter 2” insert— and specify whether the incompatibility is insofar as the advertisement is for publication— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland (b) in paragraph (4)— (i) in sub-paragraph (a), after “Chapter 2” insert— insofar as the advertisement is for publication— (i) in Great Britain; (ii) in Northern Ireland; or (iii) in both Great Britain and Northern Ireland (ii) after “no longer applies” insert “ in Great Britain, Northern Ireland, or both Great Britain and Northern Ireland (as appropriate) ”; (c) in paragraph (5), after “Chapter 2” insert— insofar as the advertisement is for publication— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland (d) in paragraph (7)(b), after “no longer applies” insert— , and where that original notice related to both Great Britain and Northern Ireland, the new notice may be expressed to apply in relation to either of or both Great Britain and Northern Ireland (e) in paragraph (8), after “the advertisement” insert— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland (217C) In regulation 307— (a) in paragraph (1)(a), after “subject of the notice” insert— in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland (b) in paragraph (1)(b), after “that advertisement” insert— in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland (c) in paragraph (2)(a), for “, either in full or in part; and” substitute— in respect of— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland, either in full or in part; and (217D) In regulation 311— (a) in paragraph (1)(a), for “Chapter 2; and” substitute— Chapter 2 in respect of— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland; and (b) in paragraph (3), after “ the advertisement” insert— in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland, as the case may be.

PART 15 — Amendment of Part 16 (amendment of Part 15 (British Pharmacopoeia))

178

In regulation 218 (amendment of regulation 321 (specified publications)), for paragraph (b) substitute—

(b) after sub-paragraph (c) insert— (ca) an EU marketing authorisation;

PART 16 — Amendment of Part 17 (amendment of Part 16 (enforcement))

179

Omit regulation 219 (amendment of regulation 322 (validity of proceedings)).

180

In regulation 221 (amendment of regulation 327 (powers of inspection, sampling and seizure))—

(a) in paragraph (2), for sub-paragraphs (b) and (c) substitute—

(b) after paragraph (v), insert— (va) an EU marketing authorisation;

(b) for paragraph (3) substitute—

(3) In paragraph (2)(g), after paragraph (iv) insert— (iva) the requirements of Schedule 12A (further provision as to the performance of pharmacovigilance activities);

181

In regulation 222 (amendment of regulation 331 (findings and reports of inspections))—

(a) for paragraph (2) substitute—

(2) In paragraph (1)— (a) for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation ”; (b) in sub-paragraph (c), at the beginning, insert “ in the case of a product authorised under a UKMA(NI) or UKMA(UK), ”.

(b) for paragraph (3) substitute—

(3) In paragraph (4)— (a) for sub-paragraph (b) substitute— (b) the guidelines on good distribution practice— (i) in the case of Great Britain, published under, or that apply by virtue of, regulation C17; (ii) in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive; (b) after sub-paragraph (c) insert— (d) Schedule 12A; and (e) the Implementing Regulation (as defined in regulation 177(5)).

182

In regulation 223 (insertion of regulation 331A (guidelines on inspections)), in the inserted regulation 331A(3), for “exit day” substitute “ IP completion day ”.

PART 17 — Amendment of Part 18 (amendment of Part 17 (miscellaneous and general))

183

Before regulation 224 (amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)) insert—

(224ZA) In regulation 335(6)(b) for “268 and 269” substitute “ 268, 268A, 269 and 269A ”. (224ZB) In regulation 336(3)(b) for “268 and 269” substitute “ 268, 268A, 269 and 269A ”. (224ZC) In regulation 340(5) for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “ 268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons) ”. (224ZD) In paragraph 3(10) of Schedule 32 for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “ 268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons) ”.

184

For regulation 224 (amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)) substitute—

(224) In regulation 341(4)— (a) in paragraph (a), insert “ UK ” before “marketing authorisation”; (b) after paragraph (a), insert— (aa) a decision to grant or revoke an EU marketing authorisation;

185

In regulation 225 (insertion of regulation 344A (modifications to deal with serious shortages) and 344B (regulation making powers)), in the inserted regulation 344A(5) for “exit day” substitute “ IP completion day ”.

186

For regulation 226 (amendment of regulation 345 (immunity from civil liability)) substitute—

(226) In regulation 345(5), for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation ”.

187

In regulation 227 (amendment of regulation 346 (Secretary of State to carry out a review of certain provisions))—

(a) in paragraph (a), for “paragraphs (iia)” to “(xxviiij)” substitute “ paragraph (xixa) ”;

(b) in paragraph (b), for “paragraphs (ia) and (ivab)” substitute “ paragraph (ia) ”.

PART 18 — Amendment of Schedule 1 (amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016)

188

In Schedule 1 (amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016)—

(a) before paragraph 1 insert—

(1ZA) After regulation 10 insert— (10A) (1) The fee payable in connection with a meeting mentioned in any of regulations 4 to 10 is waived where the person by whom the fee would otherwise be payable is established in the United Kingdom and is— (a) a small company, or (b) a medium-sized company. (2) In this regulation, “small company” and “medium-sized company” have the same meanings as in sections 382 and 465 of the Companies Act 2006 respectively.

(b) in paragraph 1 (amendment of regulation 19 (capital fees for applications for variations of authorisations)), after sub-paragraph (a) insert—

(aa) after paragraph (1)(d), insert— (e) under Commission Regulation (EC) No 1234/2008 for the variation of a UKMA(UK) or UKMA(NI).

(c) in paragraph 2 (insertion of regulations 19A–19F (fees for plasma master files, vaccine antigen master files, post-authorisation safety studies, major safety reviews, periodic safety update reports and batch testing))—

(i) in the inserted regulation 19C (fees for assessment of post-authorisation safety studies)—

(aa) for paragraph (2) substitute—

(2) The fee payable by the holder of a marketing authorisation upon submission of the draft protocol for a post-authorisation safety study in accordance with regulation 199(2) of the Human Medicines Regulations— (a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding draft protocol has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £734; (b) where sub-paragraph (a) does not apply and— (i) the study is to be conducted in the United Kingdom only; or (ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only, is £8,309; and (c) in any other case, is £734.

(bb) for paragraph (3) substitute—

(3) The fee payable by the holder of a marketing authorisation upon submission of the final study report for a post-authorisation safety study in accordance with regulation 201(2) of the Human Medicines Regulations— (a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding final study report has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £734; (b) where sub-paragraph (a) does not apply and— (i) the study is to be conducted in the United Kingdom only; or (ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only, is £8,309; and (c) in any other case, is £734.

(ii) in new regulation 19D (fee for carrying out a major safety review), in paragraph (1)—

(aa) before “marketing authorisation” insert “ United Kingdom ”;

(bb) after “a set of” insert “ such ”;

(d) in paragraph 3 (amendment of regulation 23 (applications for multiple variations)), for sub-paragraphs (2) to (4) substitute—

(2) For paragraph (3)(b)(i) substitute— (i) have agreed— (aa) in the case of a UKMA(NI) or UKMA(UK), in consultation with member States concerned and in accordance with Article 7(2)(c) of Commission Regulation (EC) No 1234/2008, should be subject to the procedure for grouping of variations within the meaning of that Article; (bb) in the case of a UKMA(GB), should be subject to the procedure for grouping of variations within the meaning of paragraph 5(2)(c) of Schedule 10A to the Human Medicines Regulations; and (3) For paragraph (6) substitute— (6) In a case where a recommendation on the classification of a variation is made in accordance with— (a) in the case of a UKMA(NI) or UKMA(UK), Article 5 of Commission Regulation (EC) No 1234/2008; or (b) in the case of a UKMA(GB), paragraph 3 of Schedule 10A to the Human Medicines Regulations, the fee payable for the application made in respect of that variation is the appropriate fee for the classification given to the variation or, as the case may be, the appropriate fee which arises as a consequence of the classification given to the variation. (4) In paragraph (7)— (a) in the definition of “Major Variation (Type II) Group Application”— (i) for sub-paragraph (b) substitute— (b) subject to sub-paragraph (c), the variations fall— (i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations; (ii) for sub-paragraph (c)(i) substitute— (i) of a kind referred to— (aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008; (bb) in the case of UKMA(GB), in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations; (b) in the definition of “Major Variation (Type II) Complex Group Application”— (i) for sub-paragraph (b) substitute— (b) subject to sub-paragraph (c), the variations fall— (i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations; (ii) for sub-paragraph (c)(i) substitute— (i) of a kind referred to— (aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008; (bb) in the case of a UKMA(GB), in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations; (c) in the definition of “Major Variation (Type II) Extended Complex Group Application”— (i) for sub-paragraph (b) substitute— (b) subject to sub-paragraph (c), the variations fall— (i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations; (ii) for sub-paragraph (c) substitute— (c) the variations do not include a variation of a kind referred to— (i) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 of Annex III to Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), in paragraph 5(3)(a) of Schedule 10A to the Human Medicines Regulations; and (d) for the definition of “major variation of type II” substitute— “major variation of type II”— (a) in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(3) of Commission Regulation (EC) No 1234/2008; and (b) in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; (e) in the definition of “Minor Variation (Type IB) Group Application”— (i) for sub-paragraph (b) substitute— (b) subject to sub-paragraph (c), the variations fall— (i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations; (ii) for sub-paragraph (c)(i) substitute— (i) a variation of a kind referred to— (aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 or paragraph 2 of Annex III of Commission Regulation (EC) No 1234/2008; (bb) in the case of a UKMA(GB), in paragraph 5(3)(a) or (b) of Schedule 10A to the Human Medicines Regulations; or (f) for the definition of “minor variation of type IA” substitute— “minor variation of type IA”— (a) in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(2) of Commission Regulation (EC) No 1234/2008; and (b) in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; (g) for the definition of “minor variation of type IB” substitute— “minor variation of type IB”— (a) in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(5) of Commission Regulation (EC) No 1234/2008; and (b) in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and (h) in the definition of “work sharing”, after “means” insert “ , in the case of a UKMA(NI) or UKMA(UK), ”.

(e) in paragraph 4 (insertion of regulation 27A (fee for renewals of a marketing authorisation)), in the inserted regulation 27A, after “renewal of a marketing authorisation” insert “ in the case of a product for sale or supply in Great Britain ”;

(f) in paragraph 6 (amendment of Schedule 1 (general interpretation provisions)), in sub-paragraph (a)—

(i) before paragraph (i) insert—

(ai) in the definition of “marketing authorisation”, in paragraph (a) after “Human Medicines Regulations” insert “ (and a reference to a UKMA(GB), UKMA(NI) or UKMA(UK) should be construed in accordance with those Regulations) ”;

(ii) in paragraph (iv), after the definition of “the EMA” insert—

“under the unfettered access route” has the meaning given by regulation 8(1) of the Human Medicines Regulations;

(g) in paragraph 7 (amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates))—

(i) for sub-paragraph (2) substitute—

(2) For paragraph 4(a) substitute— (a) for an extension of a marketing authorisation— (i) in the case of a UKMA(NI) or UKMA(UK), within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008; or (ii) in the case of a UKMA(GB), within the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and

(ii) in sub-paragraph (3)—

(aa) in paragraph (a), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute—

(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(5) of Commission Regulation (EC) No 1234/2008; (b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

(bb) in paragraph (b), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute—

(i) in the case of a UKMA(NI) or UKMA(UK), Article 2(4) of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

(cc) in paragraph (c), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute—

(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(2) of Commission Regulation (EC) No 1234/2008; (b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

(iii) in sub-paragraph (4)—

(aa) in paragraph (a), for “substitute” to the end, substitute “substitute in the case of a UKMA(NI) or UKMA(UK), paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to Commission Regulation (EC) No 1234/2008 applies or, in the case of a UKMA(GB), sub-paragraph (a) (changes to active substances) or sub-paragraph (b) (changes to strength, pharmaceutical form and route of administration) of the definition of “extension of a UK marketing authorisation” in paragraph 1 of Schedule 10A to the Human Medicines Regulations applies ”;

(bb) in paragraph (b), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute “ in the case of a UKMA(NI) or UKMA(UK), Article 2(3) of Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations ”;

(cc) in paragraph (c), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute “ in the case of a UKMA(NI) or UKMA(UK), Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations ”;

(iv) in sub-paragraph (5), for the table substituted in paragraph 24, substitute—

Column 1Kind of application	Column 1Kind of application	Column 2Fee payable
1. Major Application	1. Major Application
(a)	in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies	£29,732
(b)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£62,421
(c)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£62,421
(d)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for UKMA(GB)	£62,421
(e)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£18,437
(f)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£62,421
(g)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£18,437
(h)	in any other case	£92,753
2. Complex application	2. Complex application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£17,330
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£17,330
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£17,330
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£10,443
(e)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£17,330
(f)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£10,443
(g)	in any other case	£25,643
3. Standard application	3. Standard application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£6,350
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£6,350
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£6,350
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£5,783
(e)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£6,350
(f)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£5,783
(g)	in any other case	£9,402
4. Simple application	4. Simple application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£2,564
(b)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£2,564
(c)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£2,564
(d)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive	£2,564
(e)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£2,564
(f)	in any other case	£2,564
5. Parallel import licence applications	5. Parallel import licence applications
(a)	in respect of a simple parallel import licence	£1,792
(b)	in respect of a standard parallel import licence	£6,663
(c)	in respect of a complex parallel import licence	£18,180
6. Change of ownership application	6. Change of ownership application	£442

(v) in sub-paragraph (6), in the inserted paragraph 24A—

(aa) in the heading, for “exit day” substitute “ IP completion day ”;

(bb) in sub-paragraph (1), for “exit day” substitute “ IP completion day ”;

(vi) after paragraph (8) insert—

(8A) After paragraph 28 (application for multiple authorisations) insert— (28A) (1) Where an applicant for a United Kingdom marketing authorisation submits material in accordance with regulation 50(5) of the Human Medicines Regulations for pre-assessment by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is— (a) £23,188.25 in respect of Module 3 (chemical, pharmaceutical and biological information); (b) £23,188.25 in respect of Module 4 (non-clinical reports); (c) £23,188.25 in respect of Module 5 (clinical study reports). (2) Where an applicant for a United Kingdom marketing authorisation for a similar biological medicinal product submits material in accordance with regulations 53, 53A or 53B of the Human Medicines Regulations for pre-assessment of a complex abridged application by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is— (a) £4,332.50 in respect of Module 3 (chemical, pharmaceutical and biological information); (b) £4,332.50 in respect of Module 4 (non-clinical reports); (c) £4,332.50 in respect of Module 5 (clinical study reports). (3) The fee payable under sub-paragraphs (1) and (2) must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of the fee. (4) Where a fee has been paid under this paragraph, any fee payable under regulation 12(1) in connection with an application for the grant of a United Kingdom marketing authorisation in respect of the same product is reduced by the amount paid under this paragraph provided that no further assessment of the Module concerned is required.

(vii) for sub-paragraph (9) substitute—

(9) In paragraph 38— (a) in sub-paragraph (4)(b), after “Commission Regulation (EC) 1234/2008” insert “ and of marketing authorisations in force in Great Britain ”; (b) after sub-paragraph (6)— (i) for Table 1 substitute—

Column 1Kind of variation	Column 1Kind of variation	Column 2Fee payable
1. Application for a single kind variation	1. Application for a single kind variation
(a)	Type IB Application	£277
(b)	Type II Application	£277
(c)	Type II Complex Variation Application	£2,493
(d)	Extended Type II Complex Variation Application	£7,693
2. Applications for a Group	2. Applications for a Group
(a)	Minor Variation (Type IB) Group Application	£277
(b)	Major Variation (Type II) Group Application	£496
(c)	Major Variation (Type II) Complex Group Application	£2,703
(d)	Major Variation (Type II) Extended Complex Group Application	£7,883

(ii) in Table 2—
  (aa) in the heading to the table, after “Commission Regulation [(EC) No 1234/2008](https://www.legislation.gov.uk/european/regulation/2008/1234)” insert “ and of marketing authorisations in force in Great Britain ”;
  (bb) after row 8 insert—

9 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related UKMA(NI) for the same product	£nil
10 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related European Union marketing authorisation for the same product	Apply fees and fee categories in Table 1
11 Variation of a UKMA(UK) or a UKMA(GB) which was granted following an application other than an application made under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive, provided a corresponding variation has been approved to the related marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in Table 1
12 Variation of a UKMA(GB) which was granted following an application where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), provided a corresponding variation has been approved to the related European Union marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in table 1

(viii) in sub-paragraph (12), in the inserted paragraph 40A—

(aa) in the heading for “exit day” substitute “ IP completion day ”;

(bb) in subparagraph (1) for “exit day” substitute “ IP completion day ”;

(ix) in sub-paragraph (13)—

(aa) for the inserted paragraph 56 substitute—

(56) Unless paragraph 57 applies, the fee payable under regulation 27A in connection with an application for the renewal of a United Kingdom marketing authorisation is— (a) in respect of an application for renewal of a UKMA(GB) granted under the unfettered access route, £747; (b) in respect of an application for renewal of a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), £747; (c) in all other cases, £9,682.

(bb) for the inserted paragraph 57(2) substitute—

(2) The fee payable under regulation 27A for applications to which sub-paragraph (1) applies is— (a) in respect of applications for renewal of more than one UKMA(GB) granted under the unfettered access route or UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding renewal application has been made to the related European Union marketing authorisation or UKMA(NI) for the same product— (i) £747 for the first application considered by the licensing authority; and (ii) £747 for each other application; (b) in all other cases— (i) £9,682 for the first application considered by the licensing authority; and (ii) £747 for each other application.

(h) after paragraph 8 insert—

(8A) In Schedule 6, in paragraph 2, for “entry 1(f)” substitute “ entry 1(h) ”.

189

In Schedule 2 (insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)), in the inserted Schedule 8B—

(a) in the entry in the table for “Part I, paragraph 5.2(a)”, in the corresponding modification, for “regulations 51 to 56” substitute “ regulations 51A, 52A, 53A and 54 to 56 ”;

(b) in the entry in the table for “Part I, paragraph 5.2.1, second paragraph”, in the corresponding modification, for “regulation 51” substitute “ regulation 51A ”;

(c) in the entry in the table for “Part II, paragraph 2(b)”, in the corresponding modification, for “regulation 51” substitute “ regulation 51A ”;

(d) in the entry in the table for “Part II, paragraph 4, first paragraph”, in the corresponding modification, for “regulation 53” substitute “ regulation 53A ”.

PART 19 — Insertion of Schedule 2A (insertion of new Schedule 8C (material to accompany an application for a UK marketing authorisation under the unfettered access route))

190

After Schedule 2 (insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)) insert—

SCHEDULE 2A (1) After Schedule 8B to the Human Medicines Regulations 2012, insert— SCHEDULE 8C (1) A copy of the application submitted in connection with the granting of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland. (2) A copy of all material submitted in support of the application for the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland. (3) A copy of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.

PART 20 — Amendment of Schedule 4 (insertion of new Schedule 9A)

191

In Schedule 4 (insertion of new Schedule 9A), in the inserted Schedule 9A, for “the United Kingdom”, in each place it occurs (including the heading to paragraph 1) other than in paragraph 2(3), substitute “ Great Britain ”.

PART 21 — Amendment of Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities))

192

In Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities)), in the inserted Schedule 12A—

(a) in paragraphs 1(3), 12(5), 16(3), 22(1)(d) and 30(g), for “UK marketing authorisation” substitute “ UKMA(GB) ”;

(b) in paragraph 2(a)—

(i) at the end of paragraph (iii) omit “and”;

(ii) in paragraph (iv), for “pharmacovigilance;” substitute “ pharmacovigilance, and ”;

(iii) after paragraph (iv) insert—

(v) responsibilities and contact details of the nominated person (where a person is nominated under regulation 182(2A));

(d) omit paragraph 4(4);

(e) in paragraph 7—

(i) omit sub-paragraph (1);

(ii) in sub-paragraph (2)—

(aa) after “qualified person” insert “ and nominated person (where a person is nominated under regulation 182(2A)) ”;

(bb) for “has” substitute “ have ”.

PART 22 — Amendment of Schedule 7 (insertion of new Schedule 33A (Transitional Provision))

193

In Schedule 7 (insertion of new Schedule 33A (Transitional Provision)), in the inserted Schedule 33A—

(a) for “exit day”, in each place it occurs, including in headings, substitute “ IP completion day ”;

(b) for “21 months”, in each place it occurs, substitute “ 24 months ”;

(d) for paragraph 6(2)(a) substitute—

(a) insofar as it authorises sale or supply of a medicinal product in Great Britain, has effect on and after IP completion day as a UKMA(GB) granted under regulation 49(1) of these Regulations (but, insofar as it authorises sale or supply of a medicinal product in Northern Ireland, continues to operate in Northern Ireland as an EU marketing authorisation); and

(e) in paragraph 6(4)(f), for “regulation 51(1) and (2)” substitute “ regulation 51A(1) and (6) ”;

(f) before paragraph 26 insert—

(26ZA) (1) This paragraph applies in relation to a UK marketing authorisation granted by the licensing authority under Chapter 4 of Title III to the 2001 Directive that was in force immediately before IP completion day. (2) A UK marketing authorisation to which this paragraph applies— (a) has effect on and after IP completion day as a UKMA(UK) granted under regulation 49(1) of these Regulations; and (b) is treated as including a statement that it is in force in the whole United Kingdom for the purposes of regulation 49(1C).

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