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

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

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Amendment of regulation 209 (penalties)

173

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

174

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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

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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 ”.

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

Amendment of regulation 229 (exemption for supply by national health services bodies and local authorities)

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.

Amendment of regulation 230 (exemption for supply etc under a PGD to assist doctors or dentists)

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.

Amendment of regulation 231 (exemption for supply etc under a PGD by independent hospitals etc.)

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.

Amendment of regulation 232 (exemption for supply etc under a PGD by dental practices and clinics: England and Wales)

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.

Amendment of regulation 233 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business)

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.

Amendment of regulation 234 (exemption for supply etc of products under a PGD to assist the police etc)

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.

Amendment of Schedule 17 (exemptions for sale, supply or administration by certain persons)

193

• (1) Schedule 17 is amended as follows.

• (2) In the table in Part 1, in column 1 in entry 10, for “marketing authorisations” substitute “UK marketing authorisations, EU marketing authorisations.

• (3) In the table in Part 4, in columns 1 and 2 in entry 9, for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation.

Amendment of regulation 249 (restrictions on persons to be supplied with medicinal products)

194

In regulation 249(2)—

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

• (b) after sub-paragraph (a) insert—

(aa) an EU marketing authorisation;

Amendment of regulation 254 (prohibitions concerning traceability of treatment with advanced therapy medicinal products)

195

In regulation 254(2)(a), for the words from “laid down in” to the end, substitute—

imposed pursuant to— (a) as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990 ; (b) as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005 ; and (c) as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ;

Omission of regulation 255A to 255C (enforcement and offences relating to Commission Regulation 2016/161)

196

In regulation 255A(1), after “purpose of sale or supply,” insert “in Northern Ireland,”.

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

Omission of Part 12A

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—the national legislation applicable to the offering of medicinal products for sale at a distance to the public by information society services;the differences between Northern Ireland and EEA States regarding classification of medicinal products and the conditions for their supply;the purpose of the common logo;the list of persons offering medicinal products for sale at a distance by means of information society services as well as their website addresses;background information about the risks related to medicinal products supplied illegally to the public by means of information society services;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 14 — Amendment of Part 13 (packaging and leaflets)

Amendment of regulation 257 (packaging requirements: general)

198

• (1) Regulation 257 is amended as follows.

• (2) In paragraph (6), after “this regulation,” insert “ regulation 257C where the product is for sale or supply in Great Britain only,”.

• (3) After paragraph (7) insert—

(8) Nothing in this regulation applies to the outer or immediate packaging of an advanced therapy medicinal product for sale or supply in Great Britain only.

Omission of regulations 257A and 257B (packaging requirements: medicinal products required to bear safety features and associated transitionals)

199

In regulation 257A, after “either fully or partially,” insert “from a product to which Article 54a of the 2001 Directive applies”.

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

200

After regulation 257, insert—

(257C) (1) The information specified in Part 4 of Schedule 24 must appear— (a) on the outer packaging of an advanced therapy medicinal product for sale or supply in Great Britain only (other than an exempt advanced therapy medicinal product); and (b) on the immediate packaging of that product, unless paragraph (2) or (3) applies to the packaging. (2) This paragraph applies to the immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 4 of Schedule 24. (3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 4 of Schedule 24. (4) The information specified in Part 5 of Schedule 24 must appear on immediate packaging to which paragraph (2) or (3) applies. (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). (257E) The Ministers may by regulations require the use of certain forms of labelling of a medicinal product in order to make it possible to ascertain— (a) the price of the medicinal product; (b) any reimbursement conditions of the National Health Service; (c) the legal status for supply to the patient in accordance with regulation 5 (classification), insofar as not already provided for in Schedule 25; (d) authenticity and identification of the medicinal product in accordance with Article 54a(5) of the 2001 Directive.

Amendment of Schedule 24 (packaging information requirements)

201

• (1) Schedule 24 is amended as follows.

• (2) In paragraph 7(b), for “published pursuant to Article 65 of the 2001 Directive” substitute “ published under regulation 257D 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.”.

• (3) In paragraphs 15, 16 and 23, for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”..

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

• (5) After Part 3 insert—

(34) The name of the advanced therapy medicinal product which is the international non-proprietary name, or if none, the common name. (35) Where appropriate, whether the product is intended for babies, children or adults. (36) The expiry date in clear terms including the year and month and, if applicable, day. (37) A description of the active substance, expressed qualitatively and quantitatively. (38) Where the product contains tissues and cells of human or animal origin— (a) a statement that the product contains such cells or tissues; and (b) a short description of the cells or tissues and of their specific origin, including the species of animal in cases on non-human origin. (39) The pharmaceutical form and the contents by weight, volume or number of doses of the product. (40) A list of excipients, including preservative systems. (41) The method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated. (42) A special warning that the product is to be stored out of the sight and reach and children. (43) Any special warning necessary for the particular product. (44) Any special storage precautions. (45) Specific precautions relating to the disposal of the unused product or of waste derived from the product and, where appropriate, reference to any appropriate collection system. (46) The name and address of the holder of the UK marketing authorisation and, where applicable, the name of the representative appointed by the holder to represent him. (47) The UK marketing authorisation number. (48) The manufacturer's batch number. (49) The unique donation code assigned by a tissue establishment pursuant to— (a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 , as regards human gametes and embryos; and (b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 , as regards other human tissues and cells. (50) Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”. (51) The information specified in Part 2. (52) The unique donation code assigned by a tissue establishment pursuant to— (a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and (b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells. (53) Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

Amendment of regulation 259 (packaging requirements: information for blind and partially sighted patients)

202

In regulation 259(2), for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”.

Amendment of regulation 260 (package leaflets)

203

• (1) Regulation 260 is amended as follows.

• (2) After paragraph (1) insert—

(1A) If the medicinal product is an advanced therapy medicinal product for sale or supply in Great Britain only (other than an exempt advanced therapy medicinal product), the package leaflet must contain the information specified in Part 3 of Schedule 27 in the order specified in that Part.

• (3) In paragraph (2), after “Part 2 of that Schedule)” insert “ , or where the product is an advanced therapy medicinal product for sale or supply in Great Britain only, the information specified in Part 3 of that Schedule, ”.

• (4) In paragraph (3), for “marketing authorisation...” substitute “ UK marketing authorisation , EU marketing authorisation, ”.

Amendment of Schedule 27 (package leaflets)

204

• (1) Schedule 27 is amended as follows.

• (2) In paragraph 8(c)(ii), for “Article 65 of the 2001 Directive”, substitute “ published under regulation 257D 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. ”.

• (3) In paragraph 11(f), for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”.

• (4) In paragraph 12 after “ Where the product ” insert "is authorised for sale or supply in Northern Ireland and”. .

• (5) In paragraph 13—

• (a) after “Article 23 of Regulation (EC) No 726/2004" 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,”; ;

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

• (c) before “This”, insert “ ▼ ”.

• (6) At the end insert—

(18) The name of the advanced therapy medicinal product. (19) Where appropriate, whether the product is intended for babies, children or adults. (20) The common name of the advanced therapy medicinal product. (21) The therapeutic group, or type of activity, of the product, in terms easily comprehensible for the patient. (22) Where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin. (23) Where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin. (24) The product's therapeutic indications. (25) A list of information which is necessary before the medicinal product is taken or used, including— (a) contra-indications; (b) appropriate precautions for use; (c) interactions with other medicinal products which may affect the action of the product; (d) interactions with other substances, including alcohol, tobacco and foodstuffs which may affect the action of the product; (e) special warnings; if any, relating to the product. (26) The list mentioned in paragraph 25 must— (a) take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions); (b) mention, if appropriate, possible effects on the ability to drive vehicles or operate machinery; and (c) list any excipients— (i) if knowledge of the excipients is important for the safe and effective use of the product; and (ii) the excipients are included in the guidance published under regulation 257D. (27) Instructions for proper use of the product including in particular— (a) the dosage; (b) the method of use, application, administration or implantation and, if necessary, the route of administration; (c) the frequency of administration (including, if necessary, specifying the times at which the product may or must be administered); (d) the duration of treatment if this is to be time limited; (e) symptoms of an overdose and the action, if any, to be taken in the case of an overdose; (f) what to do if one or more doses have not been taken; (g) a specific recommendation to consult a doctor or pharmacist, as appropriate, for further explanation of the use of the product. (28) A description of the adverse reactions which may occur in normal use of the medicinal product and, if necessary, the action to be taken in such a case. (29) A reference to the expiry date printed on the packaging of the product with— (a) a warning against using the product after that date; (b) if appropriate, details of special storage precautions to be taken; (c) if necessary, a warning concerning visible signs of deterioration; (d) the full qualitative and quantitative composition; (e) the name and address of the UK marketing authorisation holder and, if applicable, the name of the holder's appointed representative; and (f) the name and address of the manufacturer. (30) The date on which the package leaflet was last revised.

Amendment of regulation 266 (language requirements etc)

205

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

Amendment of regulation 267 (submission of mock-ups of packaging and leaflets to licensing authority)

206

In regulation 267 before “marketing authorisation”, in each place where it occurs, insert “UK”.

Amendment of regulation 268 (offence relating to packaging and package leaflets)

207

• (1) Regulation 268 is amended as follows.

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

• (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”.

• (3) In paragraph (2)(a)—

• (a) for “Article 28 or 32 of the Paediatric Regulation” substitute “ regulation 50C(4), 50D(8) or 58A(2)(b) ”; and

• (b) omit “, Article 9 of Commission Regulation 2016/161”.

Amendment of regulation 269 (offences relating to packaging and package leaflets: other persons)

208

• (1) Regulation 269 is amended as follows.

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

• (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”.

• (3) In paragraph (2)(a)—

• (a) for “Article 28 or 32 of the Paediatric Regulation” substitute “ regulation 50C(4), 50D(8) or 58A(2)(b) ”; and

• (b) omit “, Article 9 of Commission Regulation 2016/161”.

Amendment of regulation 270 (non-compliance with requirements of this Part)

209

In regulation 270(1) and (2), for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation,.

Amendment of regulation 273 (child resistant containers for regulated medicinal products)

210

• (1) Regulation 273 is amended as follows.

• (2) In paragraph (2), for sub-paragraph (b) substitute—

(b) any specification for non-reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).

• (3) In paragraph (3), for sub-paragraph (b) substitute—

(b) any specification for reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).

PART 15 — Amendment of Part 14 (advertising)

Amendment of regulation 279 (products without a marketing authorisation)

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.

Amendment of regulation 280 (general principles)

212

In regulation 280 —

• (a) in paragraph (1) for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation, ”; and

• (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).

Amendment of regulation 281 (duties of authorisation holders and registration holders)

213

In regulation 281(1)—

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

• (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.

Amendment of regulation 293 (prohibition of supply to the public for promotional purposes)

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.

Amendment of regulation 295 (abbreviated advertisements)

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.

Amendment of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply)

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).

Amendment of regulation 299 (medical sales representatives)

217

In regulation 299(3), for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”.

PART 16 — Amendment of Part 15 (British Pharmacopoeia)

Amendment of regulation 321 (specified publications)

218

In regulation 321(5)—

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

• (b) after sub-paragraph (c) insert—

(ca) an EU marketing authorisation;

PART 17 — Amendment of Part 16 (enforcement)

Amendment of regulation 322 (validity of proceedings)

219

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

Amendment of regulation 323 (enforcement in England, Wales and Scotland)

220

• (1) Regulation 323 is amended as follows.

• (2) In paragraph (1) omit “and the relevant EU provisions”.

• (3) In paragraph (3)—

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

• (b) omit sub-paragraph (d).

• (4) Omit paragraph (4A).

Amendment of regulation 327 (powers of inspection, sampling and seizure)

221

• (1) Regulation 327 is amended as follows.

• (2) In paragraph (1)(c)—

• (a) in paragraph (v), insert “ UK ” before “marketing authorisation”;

• (b) after paragraph (v), insert—

(va) an EU marketing authorisation;

• (3) In paragraph (2)(g), after paragraph (iv) insert—

(iva) the requirements of Schedule 12A (further provision as to the performance of pharmacovigilance activities);

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

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

Amendment of regulation 331 (findings and reports of inspections)

222

• (1) Regulation 331 is amended as follows.

• (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),”.

• (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)).

Insertion of regulation 331A (guidelines on inspections)

223

After regulation 331 (finding and reports of inspections) insert—

(331A) (1) The licensing authority may publish guidelines specifying the principles applicable to inspections referred to in this Part. (2) Guidelines under paragraph (1) may include the form and content of reports under regulation 331 and of certificates of good manufacturing practice or good distribution practice. (3) Until the licensing authority exercises its power under paragraph (1), the guidelines adopted by the European Commission under Article 111a of the 2001 Directive, as they had effect immediately before IP completion day , are to continue to apply.

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

Amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)

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;

Insertion of regulation 344A (modifications to deal with serious shortages) and 344B (regulation making powers)

225

After regulation 344 insert—

(344A) (1) The Ministers may by regulations modify the application of any of the specified provisions in circumstances where the United Kingdom, or any part of the United Kingdom, is experiencing or may experience a serious shortage of medicinal products, or of medicinal products of a specified description, arising from the withdrawal of the United Kingdom from the European Union. (2) Regulations may only be made under paragraph (1) for the purposes of preventing, remedying or mitigating the serious shortage that is being or may be experienced. (3) For the purposes of paragraph (1), the “specified provisions” are the provisions of Parts 1, 3 to 5, 10 to 13 and 16, and of the associated Schedules. (4) The reference in paragraph (1) to a serious shortage arising from the withdrawal of the United Kingdom from the European Union includes reference to a serious shortage where the withdrawal of the United Kingdom from the European Union is one but not the only significant factor contributing to the shortage. (5) No regulations under paragraph (1) may be made, or have effect, after the end of the period of two years beginning with IP completion day. (344B) (1) Regulations made under a power in the regulations listed in paragraph (2)— (a) are to be made by statutory instrument; (b) may make different provision for different purposes and different areas; and (c) may include incidental, supplemental, consequential, transitional, transitory or saving provisions, including consequential amendments to these Regulations. (2) The regulations referred to in paragraph (1) are— (a) regulation B17(1) and (4) (good manufacturing practice); (b) regulation 50(5A) (Annex I to the 2001 Directive); (c) regulation 50G(5) (orphan criteria etc); (d) regulations 59(3A) and 61(7A) (post-authorisation efficacy studies); (e) regulation 65C(7) (variations of UK marketing authorisations); (f) regulation 102(7) (homoeopathic medicinal products); (g) regulation 205A(2) (further obligations in respect of pharmacovigilance activities); (h) regulation 257E (certain forms of labelling); and (i) regulation 344A (modifications to deal with serious shortages). (3) A statutory instrument containing regulations made under the powers listed in paragraph (2) is subject to annulment in pursuance of a resolution of either House of Parliament.

Amendment of regulation 345 (immunity from civil liability)

226

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

Amendment of regulation 346 (Secretary of State to carry out a review of certain provisions)

227

In regulation 346 —

• (a) in sub-paragraph (c), omit paragraph (xixa); and

• (b) in sub-paragraph (d), omit paragraph (ia).

PART 19 — Transitional and consequential provision and revocations

Transitional provision in relation to EU exit

228

• (1) After regulation 347 insert—

(347A) Schedule 33A contains transitional provision in relation to the EU Exit Regulations.

• (2) Schedule 7 inserts a new Schedule 33A after Schedule 33.

Consequential amendments

229

Schedule 8 contains consequential amendments.

Revocations of retained direct EU law

230

Schedule 9 contains revocations of retained direct EU law.

SCHEDULE 1 — Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

Amendment of regulation 19 (capital fees for applications for variations of authorisations)

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In regulation 19—

• (a) in paragraph (1)(a), for paragraph (ii) substitute—

(ii) 65C (variation of a UK marketing authorisation)

; and

• (aa) after paragraph (1)(d), insert—

(e) under Commission Regulation (EC) No 1234/2008 for the variation of a UKMA(UK) or UKMA(NI).

• (b) after paragraph (3) insert—

(4) The reference in paragraph (1)(a)(ii) to an application under regulation 65C of the Human Medicines Regulations includes a reference to an application or notification submitted under paragraph 11(7) or 12(3) of Schedule 33A to the Human Medicines Regulations, or an application or notification which would have been submitted under those paragraphs but for its earlier submission in accordance with paragraph 13(1)(a) of that Schedule.

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)

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After regulation 19, insert—

(19A) (1) The fee payable by a person who submits a plasma master file to the licensing authority for scientific and technical evaluation in accordance with paragraph 1.1(c), second indent, of Part III of Annex I to the 2001 Directive, is £8,309. (2) The fee payable by a person who submits a plasma master file to the licensing authority for re-certification in accordance with paragraph 1.1(c), third indent, of Part III of Annex I to the 2001 Directive is— (a) £277, where there are no changes to the plasma master file other than an update to epidemiological data; or (b) £734, in any other case. (19B) The fee payable by a person who submits a vaccine antigen master file to the licensing authority for scientific and technical evaluation in accordance with paragraph 1.2(c), first indent, of Part III of Annex I to the 2001 Directive, is £8,309. (19C) (1) This regulation applies to post-authorisation safety studies initiated, managed or financed by the holder of a marketing authorisation in compliance with obligations imposed under regulation 59 or 61 of the Human Medicines Regulations. (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. (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. (19D) (1) Where the licensing authority conducts a major safety review of a United Kingdom marketing authorisation or traditional herbal registration, or a set of such marketing authorisations or traditional herbal registrations, under regulation 196 of the Human Medicines Regulations, a fee is payable in accordance with Part 6A of Schedule 2. (2) Unless paragraph (3) applies, the fee referred to in paragraph (1) is payable by the holder of the marketing authorisation or registration to which the review relates. (3) Where the review relates to two or more authorisations or registrations the fee referred to in paragraph (1) is to be divided by the number of authorisations or registrations forming part of the review (“relevant authorisation or registration”) and each holder of a relevant authorisation or registration must pay that reduced fee in respect of each relevant authorisation or registration it holds. (19E) (1) This regulation applies where— (a) a periodic safety update report has been submitted to the licensing authority under regulation 191 or 192 of the Human Medicines Regulations; and (b) that periodic safety update report relates to a medicinal product which has a UK reference date within the meaning of regulation 193 of the Human Medicines Regulations. (2) Where this regulation applies, the fee payable by the holder of a marketing authorisation or traditional herbal registration to which the periodic safety update report relates is— (a) £890, in the case where no other periodic safety update reports relating to medicinal products with the same UK reference date are submitted; and (b) £445, in any other case. (19F) (1) Where a sample from a batch of a medicinal product is submitted to the appropriate authority in accordance with a batch testing condition imposed under regulation 60A of the Human Medicines Regulations, the fee payable by the holder of the marketing authorisation to which the medicinal product relates is the fee prescribed in Part 6B of Schedule 2 in connection with that submission. (2) The fee payable by an applicant for a certified copy of a certificate confirming that the appropriate authority is satisfied that the batch is in conformity with the approved specifications is £50. (3) In this regulation, and in Part 6B of Schedule 2, “appropriate authority” and “batch testing condition” have the same meaning as in regulation 60A of the Human Medicines Regulations. (19G) All sums payable by way of fees under regulations 19A to 19F are payable on invoice.

Amendment of regulation 23 (applications for multiple variations)

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• (1) Regulation 23 is amended as follows.

• (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”—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; andin 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”—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; andin 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”—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; andin 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),”.

Insertion of regulation 27A (fee for renewals of a marketing authorisation)

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After regulation 27, insert—