Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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articles 4

Reform history JSON API

(5) Where the licensing authority requests that the pharmacovigilance system master file is made available under paragraph (2)(b), the holder must submit a copy of the pharmacovigilance system master file to the licensing authority before the end of the period of 7 days beginning on the day after the day when the request was made.

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

Exception to obligation to operate risk management system

183

(1) The holder is not required to operate a risk management system under regulation 182(2)(c) in relation to a medicinal product which has an authorisation or registration that was granted before 21st July 2012.

(2) The licensing authority may impose an obligation on the holder to operate a risk management system in relation to a medicinal product referred to in paragraph (1) if there are concerns about new or changed risks affecting the risk-benefit balance of that product.

(3) Paragraphs (4) to (6) apply where the licensing authority imposes an obligation to operate a risk management system on the holder under paragraph (2).

(4) The licensing authority must without delay notify the holder in writing of—

(a) the imposition of the obligation;

(b) the justification for the obligation;

(c) the timeframe for submission of the detailed description of the risk management system required under paragraph (8)(a); and

(d) the opportunity to present written observations in accordance with paragraph (5).

(5) Where the holder so requests before the end of the period of thirty days beginning on the day after the receipt by the holder of the notice referred to in paragraph (4), the licensing authority must provide the holder with an opportunity to present written observations in response to the imposition of the obligation within such a time limit as the licensing authority may specify.

(6) Where a holder presents written observations under paragraph (5), the licensing authority must withdraw or confirm the imposition of the obligation under paragraph (2), having regard to the written observations, as soon as is reasonably practicable.

(7) Paragraphs (8) and (9) apply where the licensing authority—

(a) imposes an obligation under paragraph (2) and the holder does not present written obligations under paragraph (5); or

(b) confirms the imposition of the obligation under paragraph (2) pursuant to paragraph (6).

(8) The holder must—

(a) submit to the licensing authority in writing a detailed description of the risk management system which it intends to introduce for the product in accordance with the timeframe set out in the notification under paragraph (4); and

(b) comply with the obligation to operate a risk management system.

(9) Where the imposition relates to a product with a UK marketing authorisation, the licensing authority must vary the authorisation to include the measures to be taken as part of the risk management system as conditions of the authorisation as if they were conditions imposed under regulation 59 (conditions of UK marketing authorisations: general).

Obligation on holder to audit pharmacovigilance system

184

(1) The holder must—

(a) perform a regular audit of its pharmacovigilance system;

(b) place a note concerning the main findings of each audit on the pharmacovigilance system master file on completion of each audit; and

(c) ensure that an appropriate corrective action plan is prepared and implemented as soon as is reasonably practicable after completion of each audit.

(2) The holder may remove the note placed on the pharmacovigilance system master file under paragraph (1)(b) when all the measures in the corrective action plan under paragraph (1)(c) have been fully implemented.

(3) The holder of a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB) must also comply with the requirements of paragraph 13 of Schedule 12A in relation to auditing the pharmacovigilance system.

Recording, reporting and assessment of pharmacovigilance data

Recording obligations on the licensing authority

185

The licensing authority must record all suspected adverse reactions to medicinal products that—

(a) occur in the United Kingdom; and

(b) are reported to it by a holder, a patient or a patient's carer, a health care professional, a coroner or a procurator fiscal.

Reporting obligations on the licensing authority

186

(1) The licensing authority must—

(a) when it receives a suspected adverse reaction report from a person mentioned in regulation 185(b), follow up the report with that person as appropriate;

(b) ensure that reports of suspected adverse reactions in the United Kingdom may be submitted to it, whether by the UK web-portal or by other means;

(c) collaborate with the EMA and the holders of authorisations or registrations in the detection of duplicates of suspected adverse reaction reports;

(d) submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i) a UKMA(NI),

(ii) a UKMA(UK)(Category 2),

(iii) a THR(NI),

(iv) a THR(UK), or

(v) an Article 126a authorisation,

to the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and

(e) submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i) a UKMA(NI),

(ii) a UKMA(UK)(Category 2),

(iii) a THR(NI),

(iv) a THR(UK), or

(v) an Article 126a authorisation,

to the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.

(2) Paragraph (3) applies where the licensing authority has received a report of a suspected adverse reaction arising from an error associated with the use of a medicinal product.

(3) The licensing authority must (in addition to meeting the requirements in paragraph (1) in respect of the report) ensure that the report is made available to any statutory body with functions in relation to patient safety within the United Kingdom.

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

Recording obligations on holders

187

(1) Subject to paragraph (2), the holder must record all suspected adverse reactions to the product (including listed NIMAR products in Northern Ireland) occurring in the United Kingdom or another country which are brought to its attention irrespective of whether the reaction—

(a) is reported spontaneously by patients or health care professionals; or

(b) occurred in the context of a post-authorisation study.

(2) Paragraph (1) does not apply where the suspected adverse reaction occurred in the context of a clinical trial within the meaning of the Clinical Trials Regulations.

(3) The holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

(4) The holder must ensure that reports recorded under paragraph (1) are accessible (electronically or physically) at a single point within the United Kingdom.

Reporting obligations on holders

188

(1) Subject to paragraphs (1B) and (1C), the holder of a UK marketing authorisation, traditional herbal registration or Article 126a authorisation must in relation to the product (including listed NIMAR products in Northern Ireland)—

(a) submit electronically to the licensing authority a report on all serious suspected adverse reactions that occur in the United Kingdom and countries other than the United Kingdom before the end of the period of 15 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(b) submit electronically to the licensing authority a report on all non-serious suspected adverse reactions that occur in the United Kingdom before the end of the period of 90 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(c) establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

(ca) in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;

(d) collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the licensing authority by way of an update to the original report within the specified time period; and

(e) collaborate with the licensing authority in the detection of duplicates of suspected adverse reaction reports.

(1A) Subject to paragraphs (1B) and (1C), the holder of a UKMA(UK)(Category 2), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation must, in relation to the product—

(a) submit electronically to the Eudravigilance database a report on all serious suspected adverse reactions that occur in the UK and other countries before the end of the period of 15 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(b) submit electronically to the Eudraviligance database a report on all non-serious suspected adverse reactions that occur in an EEA State or Northern Ireland before the end of the period of 90 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(ba) in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;

(c) collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the Eudravigilance database by way of an update to the original report within the specified time period; and

(d) collaborate with the EMA and the competent authorities of the EEA States in the detection of duplicates of suspected adverse reaction reports.

(1B) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.

(1C) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.

(2) The holder of a UKMA(NI), a UKMA(UK)(Category 2), a THR(NI), a THR(UK) or an Article 126a authorisation is not required to submit a report of a suspected adverse reaction to the product under paragraph (1A)(a) or (b), or to provide follow-up information under paragraph (1A)(c), where—

(a) the suspected adverse reaction relates to a medicinal product which contains a monitored active substance; and

(b) the suspected adverse reaction is recorded in a monitored publication.

(3) Paragraph (4A) applies to medicinal products containing a monitored active substance.

(4) The holder must—

(a) monitor medical literature ... for reports of suspected adverse reactions to the product; and

(b) report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1).

(4A) The holder of a UKMA(NI), a UKMA(UK)(Category 2), a THR(NI), a THR(UK) or an Article 126a authorisation must—

(a) monitor medical literature other than the monitored publications for reports of suspected adverse reactions to the product; and

(b) report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1A).

(5) In this regulation—

“the specified time period” means—in the case of serious adverse reactions, the period of 15 days beginning on the day following the day on which the follow up information became known to the holder; andin the case of non-serious adverse reactions, the period of 90 days beginning on the day following the day on which the follow up information became known to the holder.

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

Signal detection

Signal detection: licensing authority obligations

189

(1) The licensing authority must in relation to each medicinal product—

(a) monitor the data that it collects by virtue of operating its pharmacovigilance system under this Part to determine whether there are any relevant changes;

(b) assess updates to the risk management system for the product;

(d) monitor the outcome of conditions imposed under regulations 59, 60 and 61 (conditions of UK marketing authorisations) (if any).

(2) In relation to medicinal products subject to a UKMA(UK)(Category 2) , a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing authority must collaborate with the EMA in carrying out its functions under paragraph (1).

(3) In relation to medicinal products subject to a UKMA(UK)(Category 2) , a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing authority must inform the bodies specified in paragraph (4) without delay if it detects any relevant changes in relation to a medicinal product.

(4) The bodies specified in this paragraph are—

(a) the EMA; and

(b) the relevant competent authorities.

(5) In this regulation “relevant changes” in relation to a medicinal product means—

(a) new risks;

(b) risks that have changed; or

Signal detection: holder obligation

190

(1) The holder must inform—

(a) the licensing authority, and

(b) in respect of a UKMA(UK)(Category 2), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the EMA,

without delay if it detects any relevant changes in relation to the product.

(2) In this regulation, “relevant changes” has the meaning given in regulation 189(5).

Periodic Safety Update Reports

Obligation on holder to submit periodic safety update reports: general requirements

191

(1) The holder must submit reports known as periodic safety update reports (“PSURs”) in relation to the product to the EMA and the licensing authority in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2) or, in the case of a holder of a UKMA(GB) or a UKMA(UK)(Category 1), to the licensing authority only, in accordance with this regulation, or in a case where paragraph (2) applies, in accordance with regulation 192.

(2) This paragraph applies to—

(a) a UK marketing authorisation granted pursuant to regulations 51 (applications for UK marketing authorisations relating to generic medicinal products) or 54 (application relating to products in well-established medicinal use); or

(b) a traditional herbal registration.

(3) In the following paragraphs of this regulation—

“authorisation” means a UK marketing authorisation or an Article 126a authorisation;

“the holder” means the holder of a UK marketing authorisation or an Article 126a authorisation; and

“product” means a product to which a UK marketing authorisation or Article 126a authorisation relates.

(4) Each PSUR must contain—

(a) summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the authorisation for the product;

(b) a scientific evaluation of the risk-benefit balance of the product; and

(c) all data relating to the volume of sales of the product and any data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the product.

(4A) A PSUR in relation to a product authorised under a UKMA(GB) or a UKMA(UK)(Category 1) must also include the content, and be submitted in the format, specified in Part 8 of Schedule 12A.

(5) For the purposes of paragraph (4)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation for the product.

(6) Each PSUR must be submitted electronically.

(7) PSURs must be submitted to the EMA and the licensing authority in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2) or, in the case of a holder of a UKMA(GB) or a UKMA(UK)(Category 1), to the licensing authority only, with the frequency and on the dates as set out in paragraphs (8) to (10).

(8) In the case of an authorisation granted on or after 21st July 2012, the holder must submit PSURs with the frequency as specified in the authorisation for the product, with the dates of submission being calculated from the date of authorisation.

(8A) In the case of a conditional marketing authorisation in relation to a product authorised under a UKMA(GB) or a UKMA(UK)(Category 1), 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.

(9) In the case of an authorisation granted before 21st July 2012 which specifies the frequency and dates of submission of PSURs, the holder must submit PSURs with the frequency and on the dates as specified in the authorisation for the product.

(10) In the case of an authorisation granted before 21st July 2012 which does not specify the frequency and dates of submission of PSURs, the holder must submit a PSUR—

(a) immediately upon the request of the licensing authority;

(b) where—

(i) in relation to a product authorised under a UKMA(NI) or UKMA(UK)(Category 2), 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) or a UKMA(UK)(Category 1), the product has not yet been placed on the market in the United Kingdom, at least every six months following authorisation until the placing on the market within the United Kingdom; and

(i) in relation to a product authorised under a UKMA(NI) or UKMA(UK)(Category 2), 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) or a UKMA(UK)(Category 1), the product has been placed on the market in the United Kingdom—

(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.

(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Obligation on holder to submit periodic safety update reports: derogation from general requirements

192

(1) This regulation applies in relation to medicinal products granted—

(a) a UK marketing authorisation pursuant to regulations 51 (applications for UK marketing authorisations relating to generic medicinal products) or 54 (application relating to products in well-established medicinal use); or

(b) a traditional herbal registration.

(2) In the following paragraphs of this regulation—

“authorisation or registration” means a marketing authorisation to which paragraph (1)(a) applies or a traditional herbal registration;

“the holder” means the holder of a marketing authorisation to which paragraph (1)(a) applies or of a traditional herbal registration; and

“product” means a product to which a marketing authorisation referred to in paragraph (1)(a) or a traditional herbal registration relates.

(3) The holder must submit PSURs in relation to the product to the EMA and the licensing authority in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2) or, in the case of a holder of a UKMA(GB) or a UKMA(UK)(Category 1), to the licensing authority only, in accordance with paragraph (5)—

(a) where requested to do so by the licensing authority in accordance with paragraph (4); or

(b) in the case of a product to which paragraph (1)(a) applies, where it is a condition to which the marketing authorisation for the product is subject by virtue of regulations 59 (conditions of UK marketing authorisation: general) or 60 (conditions of UK marketing authorisation: exceptional circumstances) to do so.

(4) The licensing authority may request the holder to submit PSURs where—

(a) it has concerns relating to the product's pharmacovigilance data; or

(b) it considers there is a lack of PSUR data relating to an active substance of the product after the authorisation or registration is granted.

(5) The submission of PSURs under paragraph (3) must be in accordance with—

(a) where the PSUR is submitted pursuant to a request under paragraph (3)(a), the terms of the request; and

(b) where the PSUR is submitted pursuant to a condition under paragraph (3)(b), the terms of the condition.

(6) Each PSUR must contain—

(a) summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the authorisation or registration for the product;

(b) a scientific evaluation of the risk-benefit balance of the product; and

(c) all data relating to the volume of sales of the product and any data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the product.

(7) For the purposes of paragraph (6)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation or registration for the product.

(8) Each PSUR must be submitted electronically.

(9) Where the licensing authority requests submission of PSURs under paragraph (3)(a) from the holder of a UKMA(UK)(Category 2), UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation, it must communicate a PSUR assessment report to the EMA as soon as is reasonably practicable after each report is received.

(10) In this regulation “PSUR assessment report” means a report which evaluates the information provided in a PSUR.

(11) This regulation is subject to regulation 212 (transitional arrangements).

Harmonisation of PSUR frequency or date of submission

193

(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)(Category 2), THR(NI), THR(UK) or Article 126a authorisation; and

(ii) none of the authorisations or registrations is a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB); or

(b) paragraphs (2A), (3) and (4A), where—

(i) any of the authorisations or registrations is a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB); and

(ii) none of the authorisations or registrations is a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation.

(2) The holder of a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation may, where one or more of the grounds in paragraph (3) is met, submit a request in relation to the product to the EMA—

(a) to determine an EU reference date; or

(b) to change the frequency of submission of the PSUR.

(2A) Where one or more of the grounds in paragraph (3) is met, the holder of a UKMA(GB) , UKMA(UK)(Category 1) 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.

(3) The grounds in this paragraph are—

(a) reasons relating to public health;

(b) in order to avoid duplication of the assessment; or

(4) The second paragraph of Article 107c(6) of the 2001 Directive has effect in relation to the submission and determination of a request under paragraph (2).

(4A) Where the licensing authority makes a decision under paragraph (2) following a written request from a holder of a UKMA(GB) UKMA(UK)(Category 1) or THR(GB), it must notify that holder in writing of its decision to approve or refuse the request.

(5) Where the frequency or dates of submission of a PSUR are changed in accordance with Article 107c(4) or Article 107c(6) of the 2001 Directive or paragraph (2A) (as the case may be), the holder must apply to vary the product's authorisation or registration to reflect the new frequency or date of submission before the end of the period of six months beginning on the day after the change is made public by the EMA or licensing authority (as the case may be).

(6) In this regulation, “EU reference date” in relation to a product means—

(a) the date of the first marketing authorisation in the EEA of a medicinal product containing the same active substance or the same combination of active substances as that product; or

(b) if the date referred to in point (a) cannot be ascertained, the earliest of the known dates of the marketing authorisations in the EEA for a medicinal product containing the same active substance or the same combination of active substances as that product.

(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) 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).

Responding to a single assessment of PSUR under Article 107e of the 2001 Directive

194

(1) This regulation applies where PSURs relating to a medicinal product authorised under a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation have been assessed under the EU single assessment procedure.

(2) The licensing authority must implement—

(a) the necessary measures that are consequent upon any agreement reached under Article 107g(2) of the 2001 Directive as part of the EU single assessment process, in accordance with the implementation timetable determined in the agreement; or

(b) any decision adopted under Article 107g(4)(a) of the 2001 Directive before the end of the period of 30 days beginning on the day after the day on which the licensing authority received notification of the decision.

(3) Paragraph (4) applies where—

(a) an agreement reached under Article 107g(2) of the 2001 Directive requires a variation to be made to an authorisation or registration; and

(b) the terms of the agreement are known to the holder of that authorisation or registration.

(4) A holder of an authorisation or registration referred to in paragraph (3)(a) must submit to the licensing authority in accordance with the implementation timetable determined in the agreement an appropriate application for a variation, including—

(a) an updated summary of the product characteristics; and

(b) an updated package leaflet.

(5) In this regulation, “EU single assessment procedure” means the single assessment procedure laid down in Article 107e of the 2001 Directive, which covers—

(a) medicinal products that are authorised in more than one member State; and

(b) medicinal products that contain the same active substance or the same combination of active substances and for which a harmonised EU reference date and frequency of submission of PSURs have been established under Article 107c of the 2001 Directive.

Obligation on licensing authority to assess PSURs where EU single assessment procedure does not apply

195

(A1) This regulation applies in the circumstances specified in paragraphs (1) and (1A).

(1) This regulation applies where PSURs relating to a medicinal product authorised for sale or supply authorised under a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation have not been assessed under the EU single assessment procedure because—

(a) the medicinal product to which the PSUR relates—

(i) has not been authorised to be placed on the market in accordance with the 2001 Directive in an EEA State ...; and

(ii) a harmonised EU reference date and frequency of submission of PSURs have not been established for that product under Article 107c of the 2001 Directive; or

(b) the medicinal product is one that is imported into the UK under a parallel import licence.

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

(2) The licensing authority must assess the PSURs to determine whether there are any relevant changes.

(3) Where the licensing authority has assessed a PSUR under paragraph (2) it must—

(a) consider whether any action concerning the authorisation or registration of the product to which the PSUR relates is necessary; and

(b) vary, suspend, or revoke the authorisation or registration as appropriate.

(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.

(4) In this regulation—

“EU reference date” has the meaning given in regulation 193(6);

“EU single assessment procedure” has the meaning given in regulation 194(5); and

“relevant changes” in relation to a medicinal product means—new risks,risks that have changed, orchanges to the risk-benefit balance.

Urgent action and major safety review

Urgent action

196

(1) In the case of a medicinal product authorised for sale or supply under a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority must inform the specified bodies where, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities,—

(a) it considers suspending or revoking an authorisation or registration of a medicinal product or class of medicinal products;

(b) it considers prohibiting the supply of a medicinal product or class of medicinal products;

(d) 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,

(ii) taken action to have the product’s authorisation or registration cancelled or intends to do so, or

(iii) not applied for the renewal of the product’s authorisation or registration.

(2) The licensing authority must inform the specified bodies where, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, it considers it necessary to vary an authorisation or registration or a class of authorisations or registrations to include—

(a) a new contra-indication,

(b) a reduction to the recommended dose, or

(2A) The information provided under paragraph (2) must outline the action considered and the reasons for the action.

(2B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2C) The information required to be provided under paragraph (1) or (2) must be provided by the end of the day on which the consideration arose under paragraph (1)(a) to (c) or (2) or the information was received under paragraph (1)(d) (as the case may be).

(3) When informing the EMA under paragraph (1) or (2), the licensing authority must make available to the EMA in relation to the medicinal product or class of medicinal products—

(a) all relevant scientific information at its disposal; and

(b) any assessment it has carried out.

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

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

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

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) In this regulation—

“specified bodies” means—the competent authority of each EEA State other than the United Kingdom,the EMA, andthe European Commission.

EU urgent action procedure

197

(1) Where the EU urgent action procedure is initiated in relation to a medicinal product or class of medicinal products authorised for sale or supply under a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority—

(a) may publicly announce the initiation of the EU urgent action procedure on the UK web-portal; and

(b) must implement the measures set out in any agreement reached under Article 107k of the 2001 Directive in relation to the medicinal product or class of medicinal products in accordance with the implementation timetable determined in the agreement.

(2) Paragraph (3) applies where an agreement under Article 107k of the 2001 Directive in relation to a medicinal product or class of medicinal products requires a variation to be made to one or more authorisation or registration.

(3) Each holder of an authorisation or registration covered by the agreement referred to in paragraph (2) must submit to the licensing authority in accordance with the terms of the agreement (including its implementation timetable) an application for a variation in respect of the authorisation or registration including—

(a) an updated summary of the product characteristics; and

(b) an updated package leaflet.

(4) In this regulation, “EU urgent action procedure” has the same meaning as it is given in regulation 196(8).

Post-authorisation safety studies

Post-authorisation safety studies: general provisions

198

(1) A relevant post-authorisation safety study—

(a) may not be conducted where the act of conducting the study promotes the use of a medicinal product; and

(b) may not provide for payments to health care professionals for participating in the study except in compensation for time and expenses incurred.

(2) The licensing authority may require the holder for the product which is the subject of a relevant post-authorisation safety study to submit the protocol and progress reports for the study to

(a) the competent authorities of the EEA States in which the study is conducted and the licensing authority, where the product is subject to a UKMA(UK)(Category 2), UKMA(UK)(NI), traditional herbal registration or Article 126a authorisation for sale or supply in Northern Ireland;

(b) the licensing authority, where the product is subject to a UKMA(UK)(Category 1), a UKMA(GB) or traditional herbal registration for sale or supply in Great Britain only.

(3) The holder for the product which is the subject of a relevant post-authorisation safety study must—

(a) comply with a requirement imposed by the licensing authority under paragraph (2) (if any);

(b) while the study is being conducted—

(i) monitor the data generated, and

(ii) consider its implications for the risk-benefit balance of the product which is the subject of the study;

(i) the relevant competent authorities and the licensing authority, where paragraph (2)(a) applies;

(ii) the licensing authority where paragraph (2)(b) applies,

any new information that arises at any point during the study which might influence the evaluation of the risk-benefit balance for that product as soon as is reasonably practicable after it becomes known to the holder; and

(d) send the final report on the study to

(i) the competent authorities of the EEA States in which the study was conducted and the licensing authority, where paragraph (2)(a) applies;

(ii) the licensing authority, where paragraph (2)(b) applies,

before the end of the period of 12 months beginning on the day after the day on which data collection for the study ended.

(4) This regulation is subject to regulation 212 (transitional arrangements).

Submission of draft study protocols for required studies

199

(1) This regulation applies to a relevant post-authorisation safety study that is to be conducted pursuant to a condition of a UK marketing authorisation imposed under regulation 59 (conditions of a UK marketing authorisation: general) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).

(2) The holder for the product which is the intended subject of the study must submit a draft protocol for the study 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)(Category 2);

(b) the licensing authority, where the authorisation is a UKMA(GB) or UKMA(UK)(Category 1),

before the study is commenced.

(3) The body specified in this paragraph is—

(a) where the study is to be conducted in the United Kingdom only, the licensing authority; or

(b) in all other cases where the study is to be conducted in the EU or an EEA State, the Pharmacovigilance Risk Assessment Committee.

(4) Paragraph (5) applies where a draft protocol is submitted only to the licensing authority under paragraphs (2) and (3)(a) (and is not submitted to the Pharmacovigilance Risk Assessment Committee).

(5) Where this paragraph applies, the licensing authority, before the end of the period of 60 days beginning on the day after the day on which the draft protocol is submitted, must issue—

(a) a letter endorsing the draft protocol;

(b) a letter objecting to the draft protocol on the grounds that—

(i) it considers that the conduct of the study promotes the use of a medicinal product, or

(ii) it considers that the design of the study does not fulfil the study objectives; or

(c) a letter notifying the holder for the product which is the intended subject of the study that the study is a clinical trial within the meaning of the Clinical Trials Regulations.

(6) A study may not commence unless a letter endorsing the draft protocol has been issued by—

(a) the licensing authority under paragraph (5)(a); or

(b) the Pharmacovigilance Risk Assessment Committee under Article 107n(2) of the 2001 Directive.

(7) Paragraph (8) applies where a letter endorsing the draft protocol has been issued by the Pharmacovigilance Risk Assessment Committee under Article 107n(2) of the 2001 Directive.

(8) Where this paragraph applies, the holder for the product which is the intended subject of the study must forward the protocol to the competent authorities of the EEA States in which the study is to be conducted before commencing the study.

(9) In this regulation, “a letter” includes email correspondence.

(10) This regulation is subject to regulation 212 (transitional arrangements).

Amendment to study protocols for required studies

200

(1) This regulation applies where a study to which regulation 199 applies has been commenced.

(2) The holder for the product which is the subject of the study must submit any substantial amendments to the study protocol 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)(Category 2);

(b) the licensing authority, where the authorisation for the product is a UKMA(GB) or UKMA(UK)(Category 1),

before their implementation.

(3) The body specified in this paragraph is—

(a) where the study is being conducted in the United Kingdom only, the licensing authority; or

(b) where the study is being conducted in the EU or an EEA State, the Pharmacovigilance Risk Assessment Committee.

(4) Paragraph (5) applies where a proposed amendment to a study protocol is submitted only to the licensing authority under paragraphs (2) and (3)(a) (and is not submitted to the Pharmacovigilance Risk Assessment Committee).

(5) Where this paragraph applies, the licensing authority must as soon as is reasonably practicable—

(a) assess the amendment; and

(b) inform the holder of its endorsement of, or objection to, the proposed amendment.

(6) Paragraph (7) applies where the proposed amendment to a study protocol is submitted to the Pharmacovigilance Risk Assessment Committee under paragraphs (2) and (3)(b).

(7) Where this paragraph applies, the holder who submitted the amendment must inform the competent authorities of the EEA States in which the study is being conducted of any amendment to the study protocol approved by the Pharmacovigilance Risk Assessment Committee as soon as is reasonably practicable.

(8) This regulation is subject to regulation 212 (transitional arrangements).

Submission and evaluation of final study reports for required studies

201

(1) This regulation applies where a study to which regulation 199 applies has been completed.

(2) Subject to paragraph (4), the holder for the product which is the subject of the study must submit electronically, before the end of the period of 12 months beginning on the day after the day on which data collection for the study ended, 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)(Category 2);

(b) the licensing authority, where the authorisation for the product is a UKMA(GB) or UKMA(UK)(Category 1),

a final study report and an abstract of the study results.

(3) The body specified in this paragraph is—

(a) where the study was conducted in the United Kingdom only, the licensing authority; or

(b) where the study was conducted in the EU or an EEA State, the Pharmacovigilance Risk Assessment Committee.

(4) Paragraph (2) does not apply where a written waiver has been granted by the licensing authority ..., or by the Pharmacovigilance Risk Assessment Committee ....

(5) The holder must without delay—

(a) evaluate whether the results of a final study report submitted under paragraph (2) have an impact on the authorisation or registration of the medicinal product to which the report relates; and

(b) if necessary, submit an application to vary the authorisation or registration for the product.

(6) This regulation is subject to regulation 212 (transitional arrangements).

Follow-up of final study reports

202

(1) This regulation applies in respect of a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation where—

(a) the Pharmacovigilance Risk Assessment Committee has made recommendations concerning an authorisation or registration or a class of authorisations or registrations based on a final study report under Article 107q(1) of the 2001 Directive; and

(b) an agreement on the action to be taken in respect of the authorisation or registration or the class of authorisations or registrations has been reached by the co-ordination group under the procedure laid out in Article 107q(2) of the 2001 Directive (“the agreement”).

(2) The licensing authority must implement the measures set out in the agreement in accordance with the implementation timetable determined in the agreement.

(3) Paragraph (4) applies where—

(a) the agreement requires a variation to be made to one or more authorisation or registration; and

(b) the terms of the agreement are known to the holder or holders for the product or products which is, or which are, the subject of the agreement.

(4) Where this paragraph applies, each holder must submit to the licensing authority in accordance with the terms of the agreement (including its implementation timetable) an application for a variation including—

(a) an updated summary of the product characteristics; and

(b) an updated package leaflet.

(5) This regulation is subject to regulation 212 (transitional arrangements).

Transparency and communications

Obligations on licensing authority in relation to national medicines web-portal

203

(1) The licensing authority must set up and maintain a national medicines web-portal (“the UK web-portal”) ...

(2) The licensing authority must make available publicly by means of the UK web-portal the following (at a minimum)—

(a) the assessment reports prepared or revised by the licensing authority under regulation 64(5) and (6) (duties of licensing authority in connection with determination), each with a summary;

(b) the summary of the product characteristics for the medicinal products concerned;

(d) a summary of the risk management plan (if any) for the medicinal products concerned;

(da) the list published by the licensing authority under, or which applies by virtue of, regulation 202A;

(e) the list of medicinal products that are subject to additional monitoring referred to in Article 23 of Regulation (EC) No 726/2004; and

(f) information on the different ways of reporting suspected adverse reactions to medicinal products to the licensing authority by patients or their carers, health care professionals, coroners or procurators fiscal (including by way of the web-based structured forms referred to in Article 25 of Regulation (EC) No 726/2004).

Obligation on licensing authority in relation to public announcements

204

(1) This regulation applies where the licensing authority intends to make a public announcement relating to information on pharmacovigilance concerns which relate to products authorised under a UKMA(NI) or UKMA(UK)(Category 2).

(2) Subject to paragraph (4), the licensing authority must inform the bodies specified in paragraph (3) not less than 24 hours prior to making the public announcement.

(3) The bodies specified in this paragraph are—

(a) the EMA;

(b) the European Commission; and

(4) Paragraph (2) does not apply if the information in the announcement needs to be made public urgently for the protection of public health.

Obligations on holders in relation to public announcements

205

(1) This regulation applies where the holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product.

(2) The holder must inform the bodies listed in paragraph (3) where the product is subject to a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation, or the licensing authority where the product is subject to a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB), of its intention to make the public announcement—

(a) as soon as is practicable once it forms that intention; and

(b) in any event no later than at the same time as, or before, the public announcement is made.

(3) The bodies listed in this paragraph are—

(a) the licensing authority;

(b) the EMA; and

(4) The holder must ensure that the information in the public announcement—

(a) is presented objectively; and

(b) is not misleading.

Enforcement

Infringement notices

206

(1) If an enforcement authority has objective grounds for considering that any person (“P”) has contravened any relevant provision, it may serve upon P a notice in writing (referred to in this Part as an “infringement notice”)—

(a) informing P of the authority’s grounds for considering that P has contravened one or more relevant provision;

(b) specifying the relevant provision;

(c) specifying the measures which P must take in order to ensure that the contravention does not continue or, as the case may be, does not recur;

(d) requiring P to take those measures, within such period as may be specified in the notice;

(e) specifying the further action (if any) that the enforcement authority may take.

(2) An infringement notice may include directions as to the measures to be taken by P to ensure that the contravention does not continue or, as the case may be, does not recur, including the different ways of securing compliance.

(3) If an enforcement authority serves an infringement notice in accordance with paragraph (1) in relation to a product authorised for sale or supply under a UKMA(NI), UKMA(UK)(Category 2), THR(NI) or THR(UK), it shall as soon as is reasonably practicable inform—

(a) the EMA; and

(b) the European Commission.

(4) In this regulation “relevant provision” means a provision of—

(a) this Part;

(aa) Schedule 12A;

(b) Chapter 3 of Title II of Regulation (EC) No 726/2004; or

Offences

207

(1) A person is guilty of an offence if the person commits a breach of a provision in this Part, other than Schedule 12A (further requirements in respect of pharmacovigilance activities) and regulation 199(2) or (6) (submission of draft study protocols for required studies).

(2) A breach of a provision in this Part includes any—

(a) failure by a holder to comply with any requirement or obligation in this Part; or

(b) contravention by any person of any prohibition in this Part.

False and misleading information

208

A person is guilty of an offence if the person provides information to the licensing authority or the EMA, pursuant to an obligation in this Part, but that information is false or misleading in a material particular.

Penalties

209

(1) Subject to paragraph (2), a person guilty of an offence under regulation 207 or 208 is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.

(2) A person guilty of an offence under regulation 207 which relates to a breach of a provision listed in paragraph (3) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine.

(3) Those provisions are regulations—

(a) 182(2)(a) and (b), (3) and (5);

(b) 183(8)(a);

(d) 187(4);

(e) 188(1)(c) and (e);

(f) 193(5);

(g) 198(1) and (3)(a) and (d);

(h) 199(8); and

(i) 200(7).

Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004

210

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

Persons liable

211

If an offence under regulation 207(1) (offences) ... is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.

Transitional arrangements

212

Regulations ... 198, 199, 200, 201, 202 and 210 are subject to the transitional provisions set out in Schedule 33 (transitional arrangements: pharmacovigilance).

PART 12 — Dealings with medicinal products

CHAPTER 1 — Interpretation

Interpretation

213

(1) In this Part—

“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;

“the Common Services Agency” means the Common Services Agency for the Scottish Health Service established under section 10 of the National Health Service (Scotland) Act 1978 ;

“the dental care professionals register” means the register established and maintained under section 36B of the Dentists Act 1984 ;

“Council Directive 2005/36/EC” means Council Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications;

“food” includes—beverages;confectionery;articles and substances used as ingredients in the preparation of food; andany manufactured substance—to which there has been added any vitamin, andwhich is advertised as available and for sale to the general public as a dietary supplement;

“health authority” means—...in relation to Wales, a Local Health Board established under section 11 of the National Health Service (Wales) Act 2006 ;in relation to Scotland, a Health Board constituted under section 2(1)(a) of the National Health Service (Scotland) Act 1978 ; andin relation to Northern Ireland, the Department of Health in Northern Ireland;

“health care” means services for or in connection with the prevention, diagnosis or treatment of disease;

“health prescription” means a prescription issued by a doctor, dentist, supplementary prescriber, nurse independent prescriber, optometrist independent prescriber, pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber , paramedic independent prescriber or community practitioner nurse prescriber under—in England, the National Health Service Act 2006;in Wales, the National Health Service (Wales) Act 2006;in Scotland, the National Health Service (Scotland) Act 1978; andin Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972 ;

“independent clinic”—in relation to England, means an establishment of either of the following kinds—a walk-in centre, in which one or more medical practitioners provides services of a kind which, if provided in pursuance of the National Health Services Act 2006, would be provided as primary medical services under Part 4 of that Act, ora surgery or consulting room in which a medical practitioner who provides no services in pursuance of the National Health Services Act 2006 provides medical services of any kind (including psychiatric treatment), except where such medical services are provided only under arrangements made on behalf of the patients by—their employer,a government department or any executive agency of any government department,a prison or other establishment in which patients are held under custody, other than pursuant to any provision under the Mental Health Act 1983 , oran insurance provider with whom the patients hold an insurance policy, other than an insurance policy which is solely or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability or infirmity,and where two or more medical practitioners use different parts of the same premises as a surgery or consulting room, or use the same surgery or consulting room at different times, each of the medical practitioners shall be regarded as carrying on a separate independent clinic unless they practise together;in relation to Wales, has the meaning given by section 2(4) of the Care Standards Act 2000 ;in relation to Scotland, has the meaning given by section 10F(2) of the National Health Service (Scotland) Act 1978 ; andin relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 ;

“independent hospital”—in relation to England, means a hospital as defined by section 275 of the National Health Service Act 2006 that is not a health service hospital as defined by that section;in relation to Wales, has the meaning given by section 2(2) of the Care Standards Act 2000;in relation to Scotland, has the meaning given by section 10F(2) of the National Health Act 1978; andin relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;

“independent medical agency”—in relation to England, means an undertaking (not being an independent hospital) which consists of or includes the provision of services by medical practitioners, and the term “undertaking” in this definition includes any business or profession and—in relation to a public or local authority includes the exercise of any functions of that authority, andin relation to any other body of persons, whether corporate or unincorporated, includes any of the activities of that body;in relation to Wales, has the meaning given by section 2(5) of the Care Standards Act 2000;in relation to Scotland means an undertaking which is neither an independent clinic nor an undertaking comprised in a hospital and which consists of or includes the provision of services, other than in pursuance of the National Health Service (Scotland) Act 1978, by a medical practitioner; andin relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;

“integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the National Health Service Act 2006;

“local authority” has the same meaning as in section 2B of the National Health Service Act 2006;

“Maritime and Coastguard Agency” means the executive agency of that name of the Department for Transport;

“maximum daily dose” or “MDD”, in relation to a product for internal use, means the maximum quantity of the substance contained in the amount of the product that it is recommended should be taken or administered in any period of 24 hours;

“maximum dose” or “MD”, in relation to a product for internal use, means the maximum quantity of the substance contained in the amount of the product that it is recommended should be taken or administered at any one time;

“NHS body” means—the Common Services Agency;a health authority;a special health authority;an integrated care board; NHS England;...an NHS trust; oran NHS foundation trust;

“NHS foundation trust” has the meaning given by section 30(1) of the National Health Service Act 2006;

“NHS trust”—in relation to England, means an NHS trust established under section 25(1) of the National Health Service Act 2006;in relation to Wales, means an NHS trust established under section 18(1) of the National Health Service (Wales) Act 2006;in relation to Scotland, means an NHS trust established under section 12A of the National Health Service (Scotland) Act 1978 ; andin relation to Northern Ireland, means a Health and Social Care trust established under Article 10 of the Health and Personal Social Services (Northern Ireland) Order 1991 ;

“nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 ;

“parenteral administration” means administration by breach of the skin or mucous membrane;

“patient group direction” or “PGD” means a written direction that relates to the sale or supply and to the administration of a description or class of medicinal product and that—is signed—by a doctor or dentist and by a pharmacist, andby any other person who may be required to sign it in the circumstances specified for its use in any provision of this Part; andrelates to sale or supply and to administration to persons generally (subject to any exclusions that may be specified in the PGD);

“prison service” means—in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952 );in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989 ); andin relation to Northern Ireland, the Department of Justice exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953 );

“product subject to special medical prescription” means a prescription only medicine that has been designated as subject to special medical prescription in accordance with paragraph (3);

“Public Health Agency” means the Regional Agency for Public Health and Social Well-being established by section 12 of the Health and Social Care (Reform) Act (Northern Ireland) 2009;

“registered chiropodist” means a person who is registered in Part 2 of the Health and Care Professions Council register;

“registered dental hygienist” means a person registered under that title in the dental care professionals register;

“registered dental therapist” means a person registered under that title in the dental care professionals register;

“registered dispensing optician” means a person whose name is entered in the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989 or the register of visiting dispensing opticians from relevant European States maintained under section 8B(1)(b) of that Act;

“registered occupational therapist” means a person who is registered in Part 6 of the Health and Care Professions Council register;

“registered orthoptist” means a person who is registered in Part 7 of the Health and Care Professions Council register;

“registered orthotist and prosthetist” means a person who is registered in Part 10 of the Health and Care Professions Council register;

“registered pharmacy technician” means a person registered in Part 2 of the Register of pharmacists and pharmacy technicians established and maintained under article 19(1) and (2) of the Pharmacy Order 2010;

“registered provider”—in England, in relation to an independent hospital, independent clinic, an independent medical agency, a dental clinic or a dental practice means the person who is registered as a service provider under Chapter 2 of Part 1 of the Health and Social Care Act 2008 in respect of regulated activities (within the meaning of that Part) carried on in that hospital, clinic, agency, dental clinic or dental practice;in Wales, in relation to an independent hospital, an independent clinic or an independent medical agency, means the person who is registered under Part 2 of the Care Standards Act 2000 as the person who carries on the hospital, clinic or agency;in Scotland, in relation to an independent hospital, an independent clinic or an independent medical agency, means the person who is registered under section 10P of the National Health Service (Scotland) Act 1978 ; andin Northern Ireland, in relation to an independent hospital, an independent clinic, a nursing home or an independent medical agency, means the person who is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person who carries on the hospital, clinic, nursing home or agency;

“registered speech and language therapist” means a person who is registered in Part 12 of Health and Care Professions Council register;

“relevant manager”—in England, means—a person, other than the registered provider, who is registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 as the manager of an independent hospital, independent clinic, an independent medical agency, a dental clinic or a dental practice, orif there is no such person, but the registered provider has appointed a person to manage the hospital, clinic, agency, dental clinic or dental practice, that person;in Wales, means—a person, other than the registered provider, who is registered under Part 2 of the Care Standards Act 2000 as the manager of an independent hospital, an independent clinic or an independent medical agency, orif there is no such person, but the registered provider has appointed a person to manage the hospital, clinic or agency, that person;in Scotland, means a person, other than the registered provider, who was identified as an individual who is to manage an independent hospital, an independent clinic or an independent medical agency on the application for registration of that clinic, hospital or agency under section 10P of the National Health Service (Scotland) Act 1978; andin Northern Ireland, means—a person, other than the registered provider, who is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of an independent hospital, an independent clinic, a nursing home or an independent medical agency, orif there is no such person, but the registered provider has appointed a person to manage the hospital, clinic, nursing home or agency, that person;

“relevant prescriber” means any of the following—a doctor;a dentist;a supplementary prescriber;a nurse independent prescriber;a pharmacist independent prescriber;a community practitioner nurse prescriber; a physiotherapist independent prescriber; a podiatrist independent prescriber;a therapeutic radiographer independent prescriber; a paramedic independent prescriber;an optometrist independent prescriber; andan approved country health professional;

“repeatable prescription” means a prescription that contains a direction that it may be dispensed more than once;

“school” means—a maintained school (as defined in section 20(7) of the School Standards and Framework Act 1998);a maintained nursery school (as defined in section 22(9) of the School Standards and Framework Act 1998);an independent school (as defined in section 463 of the Education Act 1996) entered on a register of independent schools kept under section 158 of the Education Act 2002;an independent educational institution (as defined in section 92(1) of the Education and Skills Act 2008) entered on a register of independent educational institutions kept under section 95 of that Act;a school approved under section 342 of the Education Act 1996 (non-maintained special schools);a pupil referral unit (as defined in section 19 of the Education Act 1996);an alternative provision Academy (as defined in section 1C(3) of the Academies Act 2010);a school as defined in section 135(1) of the Education (Scotland) Act 1980; anda school as defined in Article 2(2) of the Education and Libraries (Northern Ireland) Order 1986.

“sell” means sell by retail (and “sale” has a corresponding meaning);

“special health authority” means—in relation to England, a Special Health Authority established under section 28 of the National Health Service Act 2006;in relation to Wales, a Special Health Authority established under section 22 of the National Health Service (Wales) Act 2006;in relation to Scotland, a Special Health Board constituted under section 2(1)(b) of the National Health Service (Scotland) Act 1978 ; andin relation to Northern Ireland, a special health and social care agency established under Article 3 of the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990 ;

“supply” means supply in circumstances corresponding to retail sale;

“unit preparation” means a preparation, including a mother tincture, that—is prepared by a process of—solution,extraction, ortrituration,with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert dilutent; andis used—in that diluted form, orwhere applicable, by impregnating tablets, granules, powders or other inert substances,for the purpose of being administered to human beings.

“vaccine group direction” means a written direction that relates to the supply and administration of a vaccine and that—is signed by any person who may be required to sign it in the circumstances specified for its use in regulation 235A; andrelates to supply and to administration to eligible persons in accordance with regulation 235A (subject to any exclusions that may be specified in the vaccine group direction).

“the United Kingdom Health Security Agency” means the executive agency of that name of the Department of Health and Social Care.

(2) In this Part—

(a) a reference to a product being sold or supplied for the purpose of being administered in accordance with the written directions of a doctor or dentist relating to a person includes a reference to it being supplied in accordance with such directions; and

(b) a reference to a product being sold or supplied for the purpose of being administered in accordance with a patient group direction includes a reference to it being supplied in accordance with a patient group direction.

(3) In this Part any substance or product for the time being specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002 is designated as a product subject to special medical prescription.

CHAPTER 2 — Sale and supply of medicines

Prescription only medicines

Sale or supply of prescription only medicines

214

(1) A person may not sell or supply a prescription only medicine except in accordance with a prescription given by an appropriate practitioner.

(2) A person may not parenterally administer (otherwise than to himself or herself) a prescription only medicine unless the person is—

(a) an appropriate practitioner other than an approved country health professional; or

(b) acting in accordance with the directions of such an appropriate practitioner.

(3) The following are appropriate practitioners in relation to any prescription only medicine—

(a) a doctor;

(b) a dentist;

(d) a nurse independent prescriber; and

(e) a pharmacist independent prescriber.

(4) A community practitioner nurse prescriber is an appropriate practitioner in relation to a prescription only medicine specified in Schedule 13.

(5) An optometrist independent prescriber is an appropriate practitioner in relation to any prescription only medicine other than—

(a) a medicinal product that is a product subject to special medical prescription; or

(b) a medicinal product that is for parenteral administration.

(5A) A podiatrist independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than—

(a) Dihydrocodeine: or

(b) Temazepam.

(5B) A physiotherapist independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than—

(a) Dihydrocodeine;

(b) Fentanyl;

(d) Oxycodone; or

(e) Temazepam.

(5C) A therapeutic radiographer independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than—

(a) Codeine;

(b) Fentanyl;

(d) Morphine;

(e) Oxycodone;

(f) Temazepam; or

(g) Tramadol.

(5D) A paramedic independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than—

(a) Codeine;

(b) Fentanyl;

(d) Morphine.

(6) An approved country health professional is an appropriate practitioner in relation to any prescription only medicine other than a product subject to special medical prescription.

(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;

(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.

(7) This regulation is subject to Chapter 3 (exemptions).

Prescribing and administration by supplementary prescribers

215

(1) A supplementary prescriber (“S”) may not give a prescription for a prescription only medicine unless S meets conditions A and C.

(2) A supplementary prescriber (“S”) may not—

(a) parenterally administer a prescription only medicine; or

(b) give directions for the parenteral administration of a prescription only medicine,

unless S meets conditions B and C.

(3) Condition A is that S is acting in accordance with the terms of a clinical management plan that—

(a) relates to the patient to whom the product is prescribed;

(b) has effect when the prescription is given; and

(4) Condition B is that S is acting in accordance with the terms of a clinical management plan that—

(a) relates to the patient to whom the product is, or is to be, administered;

(b) has effect when the product is administered or (as the case may be) the direction is given; and

(5) Condition C is that S has access to health records that—

(a) are the health records of the patient to whom the plan relates; and

(b) are used by any doctor or dentist who is a party to the plan.

(6) This regulation is subject to regulation 216.

(7) In this regulation—

“clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—the patient to whom the plan relates;the doctor or dentist who is a party to the plan; andany supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;

“health record” has the meaning given by section 68(2) of the Data Protection Act 1998 .

Exceptions to regulation 215

216

(1) Regulation 215 does not apply if—

(a) S is a community practitioner nurse prescriber; and

(b) the prescription only medicine prescribed or administered, or in respect of which S gives directions for administration, is specified in Schedule 13.

(2) Regulation 215(2) does not apply if S is acting in accordance with the directions of another person who is an appropriate practitioner (other than a supplementary prescriber or an approved country health professional) in relation to the prescription only medicine in question.

Requirements for prescriptions: general

217

(1) For the purposes of this Chapter, a prescription only medicine is not sold or supplied in accordance with a prescription given by an appropriate practitioner unless the following conditions are met.

(2) Condition A is that the prescription is signed in ink by the appropriate practitioner giving it.

(3) Condition B is that the prescription—

(a) is written in ink or otherwise so as to be indelible; or

(b) in the case of a health prescription which is not for a product subject to special medical prescription, is written as described in sub-paragraph (a) or by means of carbon paper or similar material.

(4) Condition C is that the prescription contains the following particulars—

(a) the address of the appropriate practitioner giving it;

(b) the appropriate date;

(d) the name and address of the person for whose treatment it is given; and

(e) if that person is under 12, that person's age.

(5) Condition D is that the prescription—

(a) is not dispensed after the end of the period of six months beginning with the appropriate date; or

(b) in the case of a repeatable prescription—

(i) it is not dispensed for the first time after the end of that period, and

(ii) it is dispensed in accordance with the directions contained in the prescription.

(6) Condition E is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed—

(a) it is not dispensed on more than two occasions, or

(b) in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the appropriate date.

(7) In this regulation “appropriate date” means, subject to paragraph (8)—

(a) in the case of a health prescription, whichever is the later of—

(i) the date on which it was signed by the appropriate practitioner giving it, or

(ii) a date indicated by the appropriate practitioner as the date before which it should not be dispensed; and

(b) otherwise, the date on which the prescription was signed by the appropriate practitioner giving it.

(8) This regulation—

(a) does not apply to a prescription given by an approved country health professional (as to which see regulation 218); and

(b) is subject to regulation 219 (electronic prescriptions).

Requirements for prescriptions: EEA health professionals

218

(1) For the purposes of this Chapter, a prescription only medicine is not sold or supplied in accordance with a prescription given by an appropriate practitioner who is an approved country health professional unless the following conditions are met.

(2) Condition A is that—

(a) the prescription is issued in a country included in the list published under regulation 214(6A); and

(b) the prescribing approved country health professional is legally entitled to issue a prescription of that kind in the country in which the prescription is issued.

(3) Condition B is that the prescription is signed in ink by the prescribing approved country health professional.

(4) Condition C is that the prescription is written in ink or otherwise so as to be indelible.

(5) Condition D is that the prescription contains—

(a) the patient’s—

(i) surname,

(ii) first names written out in full, and

(iii) date of birth;

(b) the issue date of the prescription;

(i) surname,

(ii) first names written out in full,

(iii) professional qualification,

(iv) direct contact details including—

(aa) email address, and

(bb) telephone or fax number with the appropriate international prefix,

(v) work address, and

(vi) name of the relevant member State in which that approved country health professional works; and

(d) details about the prescribed product, including where applicable the—

(i) common name of the product,

(ii) brand name if—

(aa) the prescribed product is a biological medicinal product, or

(bb) the prescribing approved country health professional deems it medically necessary for that product to be dispensed and the approved country health professional's reasons justifying the use of the branded product,

(iii) pharmaceutical formulation (tablet, solution, etc.),

(iv) quantity,

(v) strength of the medicinal product as defined in Article 1 of the 2001 Directive, and

(vi) dosage regimen.

(6) Condition E is that the prescription—

(a) is not dispensed after the end of the period of six months beginning with the date on which it is signed by the approved country health professional; or

(b) in the case of a repeatable prescription—

(i) it is not dispensed for the first time after the end of that period, and

(ii) it is dispensed in accordance with the directions contained in the prescription.

(7) Condition F is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed—

(a) it is not dispensed on more than two occasions; or

(b) in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the date on which it is signed by the approved country health professional.

(8) This regulation is subject to regulation 219A (electronic prescriptions: EEA health professionals).

Electronic prescriptions

219

(1) This regulation applies to a prescription that is not a health prescription for a substance or product for the time being specified in Schedule 1 to the Misuse of Drugs Regulations 2001 or in Schedule 1 to the Misuse of Drugs Regulations (Northern Ireland) 2002.

(2) A prescription only medicine is also sold or supplied in accordance with a prescription given by an appropriate practitioner other than an approved country health professional if—

(a) conditions A and B in regulation 217 are not met; but

(b) the conditions in paragraph (4) of this regulation and conditions C to E in regulation 217 are met.

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

(4) The conditions mentioned in paragraph (2)(b) are that the prescription is—

(a) created in electronic form;

(b) signed with an advanced electronic signature; and

(i) as an electronic communication (whether or not through one or more intermediaries), and

(ii) via the electronic prescription service, if it is for a substance or product for the time being specified in Schedule 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002.

(5) In this regulation—

“advanced electronic signature” has the meaning given within Article 3(11) of Regulation (EU) No 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market;

“electronic prescription service” means the service of that name which is managed by NHS England, the body corporate established under section 1H of the National Health Service Act 2006.

Medicines not subject to general sale

Sale or supply of medicinal products not subject to general sale

220

(1) Unless paragraph (2) applies, a person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is not subject to general sale.

(2) This paragraph applies if—

(a) P is a person lawfully conducting a retail pharmacy business;

(b) the product is sold, supplied, or offered for sale or supply, at or from premises that are a registered pharmacy; and

(i) is, or acts under the supervision of, a pharmacist, or

(ii) acts in accordance with regulation 220A or 220B.

(3) This regulation is subject to Chapter 3.

General sale medicines

Sale or supply of medicinal products subject to general sale

221

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