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

PDF Download

articles 4

Reform history JSON API

(a) regulation 130(12) and (13) (applications to be determined under Chapter 4 of Title III of the 2001 Directive) applied to that application before IP completion day; but

(b) a decision as specified in Article 28(5) of the 2001 Directive has not been adopted by the licensing authority before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a) where the procedure specified in Article 28(4) of the 2001 Directive has concluded before IP completion day in relation to that application, grant a traditional herbal registration in respect of that application as soon as reasonably practicable, and in any event before the end of the period of 30 days, beginning with IP completion day; or

(b) where the procedure specified in Article 28(4) of the 2001 Directive has not concluded before IP completion day, determine that application in accordance with Part 7 of these Regulations as soon as reasonably practicable, unless the applicant notifies the licensing authority in writing that they no longer want the application to proceed.

(3) In making a determination under sub-paragraph (2)(b), the licensing authority must have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the application as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a reference member state or concerned member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(c) any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) In making a determination under sub-paragraph (2)(b), the licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a traditional herbal registration in the time period specified in regulation 130(1) as if it had applied to that application on the date on which the application was submitted.

Suspensions of traditional herbal registrations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive

53

Where, immediately before IP completion day, a traditional herbal registration in force in Great Britain only has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive, the suspension—

(a) continues to have effect on and after IP completion day in accordance with the terms on which it was imposed; and

(b) is to be treated as if it had been imposed by the licensing authority under Part 7 of these Regulations (traditional herbal registrations).

Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a traditional herbal registration that have not concluded before IP completion day

54

(1) Sub-paragraph (2) applies where—

(a) a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day; but

(b) the procedure has not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 135 (revocation, variation and suspension of traditional herbal registration) as soon as reasonably practicable.

(3) In making a decision under regulation 135 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(c) any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 135 of these Regulations in accordance with sub-paragraph (2) in a case where the Co-ordination Group for Mutual Recognition and Decentralised procedures has given an opinion in relation to the matter under Article 31 of the Directive.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11.

(6) Sub-paragraph (7) applies where—

(a) a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day;

(b) the referral has concluded before IP completion day; but

(c) the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(7) Where this sub-paragraph applies, the licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the traditional herbal registration within the time period specified in Article 34(3) of the 2001 Directive where the decision or opinion requires steps to be taken in relation to a traditional herbal registration.

(8) In this paragraph—

“concluded before IP completion day”, in relation to an Article 31 referral, means—a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; oran opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day; and

“specified matter” means—a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a traditional herbal registration; butdoes not include a referral made under Article 107i of the 2001 Directive.

Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion day

55

(1) This paragraph applies where—

(a) the licensing authority has proposed to refer an application for a traditional herbal registration to be in force in Great Britain only to the Committee on Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive before IP completion day; but

(b) that application has not been determined in accordance with Part 7 of these Regulations before IP completion day.

(2) Where the licensing authority has received an opinion of the Committee for Herbal Medicinal Products before IP completion day in relation to the application, it must take that decision in to account and determine that application.

(3) Where the licensing authority has not received an opinion of the Committee for Herbal Medicinal Products before IP completion day, notwithstanding the amendments made to Part 3 of Schedule 11 by the EU Exit Regulations, it may—

(a) proceed to determine the application, taking into account any proceedings that took place before IP completion day under Part 3 of Schedule 11 (prior to its amendment by the EU Exit Regulations), or any opinion of the Committee on Herbal Medicinal Products in relation to the application that is given on or after IP completion day; or

(b) it may refer the matter under regulation 130A in order to obtain the findings and advice of the appropriate committee before determining the application.

PART 10 — Transitional provision in respect of pharmacovigilance

Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion day

58

(1) Sub-paragraph (2) applies where—

(a) a specified matter in relation to a UKMA(GB) or a THR(GB) has been referred under Article 107i of the 2001 Directive (urgent Union procedure) before IP completion day; but

(b) that procedure has not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 68 or 135 (revocation, variation and suspension of UKMA(GB) or THR(GB)) as soon as reasonably practicable.

(3) In making a decision under regulation 68 or 135 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for by, or referred to in, Section 4 of Chapter 3 of the 2001 Directive;

(b) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for by, or referred to in, Section 4 of Chapter 3 of the 2001 Directive; and

(c) any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 or 135 in accordance with sub-paragraph (2) in a case where the Committee for Medicinal Products for Human Use or the Co-ordination Group for Mutual Recognition and Decentralised Procedures (as the case may be) has given a final opinion in relation to the matter.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11 (advice and representations).

(6) In making a determination under regulation 68 or 135 in accordance with sub-paragraph (2), the licensing authority may adopt or have regard to any decision made, or agreement reached, in relation to the specified matter under Section 4 of Chapter 3 of the 2001 Directive on or after IP completion day, notwithstanding that the United Kingdom did not participate in the making of that decision or agreement.

(7) Sub-paragraph (8) applies where—

(a) a specified matter in relation to a UKMA(GB) or a THR(GB) has been referred under Article 107i of the 2001 Directive before IP completion day; and

(b) that referral has concluded before IP completion day; but

(c) the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(8) Where this sub-paragraph applies, the licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the UK marketing authorisation or traditional herbal registration—

(a) as soon as reasonably practicable, and, where relevant, within the time period specified in Article 34(3) of the 2001 Directive where a Commission decision requires steps to be taken in relation to a UK marketing authorisation that is not a converted EU marketing authorisation, or traditional herbal registration; or

(b) as soon as reasonably practicable, where a Commission decision or opinion requires steps to be taken in respect of a UK marketing authorisation that is a converted EU marketing authorisation.

(9) In this paragraph—

“concluded before IP completion day”, in relation to an Article 107i referral, means—a Commission decision as provided for in Article 107k of the 2001 Directive has been taken before IP completion day; oran opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 107i referral procedure in accordance with Article 107k(2), has been given before IP completion day;

“specified matter” means a referral made under Article 107i of the 2001 Directive on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities.

Matters on-going at IP completion day in respect of periodic safety update reports

59

(1) Sub-paragraph (2) applies where—

(a) a holder of a UKMA(GB) or a THR(GB) has submitted a periodic safety update report under regulation 191 before IP completion day;

(b) that periodic safety report is, immediately before IP completion day, to be assessed in accordance with the single assessment procedure in Article 107e of the 2001 Directive;

(d) the licensing authority has not yet taken the steps described in regulation 194 before IP completion day.

(2) Where this sub-paragraph applies, notwithstanding the amendment of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive) by the EU Exit Regulations, the licensing authority must take the steps specified in regulation 194 in respect of the UKMA(GB) or THR(GB) as soon as reasonably practicable.

(3) Sub-paragraph (4) applies where—

(a) a holder of a UKMA(GB) or a THR(GB) has submitted a periodic safety update report under regulation 191 before IP completion day;

(b) that periodic safety report is, immediately before IP completion day, to be assessed in accordance with the single assessment procedure in Article 107e of the 2001 Directive; and

(4) Where this sub-paragraph applies, the licensing authority—

(a) may notify a holder falling within sub-paragraph (3)(a) of the need to provide to it such further information that the licensing authority specifies; and

(b) must, subject to sub-paragraph (5), assess the periodic safety update report in accordance with regulation 195 (obligations on licensing authority to assess PSURs) (as amended by the EU Exit Regulations) as soon as reasonably practicable.

(5) Information required under sub-paragraph (4)(a) must be provided before the end of whatever period the licensing authority may specify.

(6) In making a determination under regulation 195, where sub-paragraph (4) applies, the licensing authority may adopt or have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the periodic safety report and the assessment of that report as a consequence of its involvement in any procedure provided for in Section 2 of Chapter III of the 2001 Directive;

(b) any relevant decision made, or agreement reached, in relation to the periodic safety update report or its assessment before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Section 2 of Chapter III of the 2001 Directive;

(c) any decision made, or agreement reached, in relation to that marketing authorisation or certificate of registration under Section 2 of Chapter III of the 2001 Directive on or after IP completion day, notwithstanding that the United Kingdom did not participate in the making of that decision or agreement.

Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies)

60

(1) Where the Pharmacovigilance Risk Assessment Committee has, before IP completion day—

(a) issued a letter endorsing a draft study protocol under Article 107n(2)(a) of the 2001 Directive;

(b) informed a holder of a UKMA(GB) or a THR(GB) that the study is a clinical trial under Article 107n(2)(c) of the 2001 Directive; or

(c) informed a holder of its endorsement of a substantial amendment to that protocol under Article 107o of the 2001 Directive,

the licensing authority is deemed to have accepted the draft study protocol, or the amended draft study protocol, or made that decision (as the case may be) under regulation 199(5) (submission of draft study protocols for required studies) or 200(5)(b) (amendment to study protocols for required studies).

(2) Where sub-paragraph (1) applies, the licensing authority may request the holder of a UKMA(GB) or a THR(GB) to provide to it any information in relation to the procedures under Article 107n or 107o of the 2001 Directive within a specified time period, and that holder must provide that information within that time period.

(3) Sub-paragraph (4) applies where, before IP completion day—

(a) a holder of a UKMA(GB) or a THR(GB) is proposing to, or, pursuant to Article 21a or 22a of the 2001 Directive, is under a duty to, undertake a non-interventional post-authorisation safety study; and

(b) the procedure specified in Article 107n or 107o of the 2001 Directive has not concluded before IP completion day.

(4) Where this sub-paragraph applies, on and after IP completion day, the holder must—

(a) submit any further information that has been required of it by the Pharmacovigilance Risk Assessment Committee to the licensing authority; and

(b) submit to the licensing authority such further information that it may request in relation to the procedures under Article 107n or 107o of the 2001 Directive within a time period specified by the licensing authority, whether or not that information has already been submitted to, or received from, that Committee before IP completion day,

and the licensing authority must assess that information in accordance with regulation 199 or 200 (as the case may be).

(5) In this paragraph, “not concluded before IP completion day” means that—

(a) a holder of a UKMA(GB) or a THR(GB) is proposing to, or, pursuant to Article 21a or 22a of the 2001 Directive, is under a duty to, undertake a non-interventional post-authorisation safety study;

(b) the Pharmacovigilance Risk Assessment Committee has not taken any of the steps specified in sub-paragraph (1)(a) to (c).

Matters on-going at IP completion day in respect of the follow up of final study reports

61

(1) Sub-paragraph (2) applies where—

(a) a final study report has been submitted to the Pharmacovigilance Risk Assessment Committee under Article 107p of the 2001 Directive; but

(b) that committee has not, before IP completion day, made recommendations under Article 107q(1) of the 2001 Directive.

(2) Where this sub-paragraph applies—

(a) the licensing authority may, on or after IP completion day, request the holder of a UKMA(GB) or a THR(GB) to submit to it the information specified in regulation 201(2) (submission and evaluation of final study reports for required studies), and such further information relating to the final study report, or the procedure provided for in Chapter 4 of Title IX of the 2001 Directive, as the licensing authority may require; and

(b) that holder of a UKMA(GB) or a THR(GB) must, in any event, undertake the steps specified in regulation 201(5) in respect of that final study report.

(3) Sub-paragraph (4) applies where—

(a) regulation 202(1) (follow-up of final study reports) applied before IP completion day in respect of a final study report; but

(b) the licensing authority has not, before IP completion day, taken the steps specified in regulation 202(2).

(4) Where this paragraph applies, notwithstanding the amendment of regulation 202 by the EU Exit Regulations, the licensing authority must take the steps specified in regulation 202(2) in accordance with the time period specified in that paragraph.

(5) Sub-paragraph (6) applies where—

(a) regulation 202(3) applied before IP completion day; but

(b) the holder of a UKMA(GB) or a THR(GB) has not taken the steps specified in regulation 202(4) before IP completion day.

(6) Where this sub-paragraph applies, notwithstanding the amendment of regulation 202—

(a) the holder of a UKMA(GB) or a THR(GB) must take the steps specified in regulation 202(4); and

(b) the licensing authority must determine that application for a variation in accordance with Part 5 (marketing authorisations) or 7 (traditional herbal registrations).

PART 11 — Transitional provision in respect of Part 12

Approved country health professional list on IP completion day (regulation 214(6A))

62

(1) For the purposes of regulation 214(6A), for the transitional period, the licensing authority must include on the list published under that paragraph, professions of equivalent professional status to an appropriate practitioner under regulation 214(3) to (5D) in each EEA State.

(2) In this paragraph, “transitional period” is the period of one year beginning with IP completion day.

PART 12 — General provision in relation to transitional provisions

Licensing authority power to require information

63

(1) Notwithstanding any other power to require information under this Schedule, the licensing authority may require in writing that a holder of, or an applicant for, a UK marketing authorisation, parallel import licence, manufacturing licence, wholesale dealing licence, certificate of registration or traditional herbal registration provides it with any information which—

(a) is relevant to the exercise of the licensing authority's functions under this Schedule; and

(b) is either in the holder's or applicant's possession or is information which the holder or applicant may reasonably access,

within such time period as the licensing authority specifies in that written request.

(2) If the holder of an authorisation, licence, certificate or registration mentioned in sub-paragraph (1) fails to comply with a request made pursuant to that sub-paragraph, the licensing authority may suspend the authorisation, licence, certificate or registration until the holder complies with the obligation.

(3) Nothing in this Schedule requires a person to supply information in contravention of requirements imposed under the data protection legislation (within the meaning of Part 1 of the Data Protection Act 2018).

Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland

43ZA

(1) This regulation applies only to licence holders in Great Britain supplying listed NIMAR products to Northern Ireland.

(2) A licence holder must comply with the guidelines on good distribution practice, published under, or that apply by virtue of, regulation C17.

(3) So that the needs of patients in Northern Ireland are met, the licence holder must ensure, within the limits of the holder’s responsibility, the continued supply of listed NIMAR products to—

(a) registered pharmacies in Northern Ireland;

(b) any person who may lawfully sell those products by retail sale or may lawfully supply them in circumstances corresponding to retail sale in Northern Ireland;

(4) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of listed NIMAR products under the licence as are necessary—

(a) to maintain the quality of the products; and

(b) to ensure their proper distribution.

(5) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.

(6) The licence holder must not sell or supply, or offer for sale or supply, listed NIMAR products to a person in Northern Ireland, unless—

(a) there is a UKMA(UK) or UKMA(GB) in force in relation to that product; and

(b) the sale or supply is in accordance with that authorisation (except for the fact the product will be in Northern Ireland).

(7) The licence holder must—

(a) keep documents relating to the sale or supply of listed NIMAR products under the licence which may facilitate the withdrawal or recall from sale of such products in accordance with paragraph (b);

(b) maintain an emergency plan to ensure effective implementation of the recall from the market of a listed NIMAR product where recall is—

(i) ordered by the licensing authority or

(ii) carried out in co-operation with the manufacturer of, or the holder of the corresponding UKMA(GB) or UKMA(UK) for the product; and

(i) the date of receipt,

(ii) the date of despatch,

(iii) the date of brokering,

(iv) the name of the listed NIMAR product,

(v) the quantity of the product received, dispatched or brokered,

(vi) the name and address of the person from whom the products were received or to whom they are dispatched; and

(d) provide the records in sub-paragraph (c) to the licensing authority on request.

(8) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any samples or copies, which an inspector could carry out or take under Part 16 (enforcement).

(9) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.

(10) The licence holder must immediately inform the licensing authority of medicinal products which the licence holder receives or is offered which the licence holder—

(a) knows or suspects; or

(b) has reasonable grounds for knowing or suspecting,

Requirement for wholesale dealers to decommission the unique identifier

Requirement for wholesale dealers to deal only with specified persons

Requirement as to responsible persons

Requirement as to responsible persons where licence holder imports from an approved country for import

Register for responsible persons (import)

NIMAR supply to Northern Ireland

167A

(1) If the following conditions are met—

(a) the prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product sold or supplied, or offered for sale or supply, in Northern Ireland, and

(b) that product is classified in Northern Ireland as a prescription only medicine.

(2) Condition A is that a UK marketing authorisation of a following type is in force for the product—

(a) a UKMA(UK);

(b) a UKMA(GB).

(3) Condition B is that the product is classified as a prescription only medicine in accordance with regulation 5(3) for the purposes of sale and supply in Great Britain.

(4) Condition C is that the product is a listed NIMAR product.

(5) Condition D is that if the product is to be distributed by wholesale dealing by a person (“P”) in Northern Ireland, P must be a holder of a wholesale dealer’s licence.

(6) Condition E is that if the product is manufactured or assembled in Great Britain, it is supplied to Northern Ireland—

(a) by the holder of a manufacturer’s licence in respect of that product; or

(b) by the holder of a wholesale dealer’s licence.

(7) Condition F is that if the product is manufactured outside of the UK and imported into Great Britain, it is supplied to Northern Ireland—

(a) by a holder of a manufacturer’s licence in respect of that product; or

(b) by the holder of a wholesale dealer’s licence.

List of NIMAR products

167B

(1) The licensing authority must maintain a list for the purposes of regulation 167A(4).

(2) In relation to each listed NIMAR product, the list must specify the date the NIMAR product was added to the list.

(3) The licensing authority must publish the list and keep it up to date.

(4) A product may only be included on the list if the following conditions are satisfied—

(a) Condition A is that the Secretary of State has in relation to Northern Ireland been provided with at least one of the following—

(i) information requested under regulation 28 (provision of information about availability of health service medicines) of the 2018 Regulations;

(ii) information under regulation 29 (requirement to provide information about discontinuation or anticipated supply shortage of certain health service medicines) of the 2018 Regulations;

(b) Condition B is that the holder of a UK marketing authorisation, has notified the Secretary of State that—

(i) in relation to a medicinal product to which a UKMA(UK) relates, the qualified person who is at the disposal of the holder of a manufacturer’s licence is unable to secure the matters mentioned in paragraph 12A of Schedule 7 for the purpose of supplying the product into Northern Ireland from Great Britain; or

(ii) in relation to a medicinal product to which a UKMA(GB) relates, the inability of a qualified person who is at the disposal of the holder of a manufacturer’s licence to secure the matters mentioned in paragraph 12A of Schedule 7 prevents the holder of the UKMA(GB) from converting it into a UKMA(UK);

(c) Condition C is that the licensing authority considers that clinical needs in Northern Ireland for the product may be unmet.

(5) The licensing authority must remove a product from the list if the licensing authority considers that medicinal products, not including listed NIMAR products, available in Northern Ireland are capable of meeting clinical need.

Use of non-prescription medicines in the course of a business

Mixing of general sale medicinal products

Record-keeping requirements

Exempt advanced therapy medicinal products

Parallel import licences

Exemption for certain radiopharmaceuticals

Supply in response to spread of pathogenic agents etc

Conditions of temporary authorisations under regulation 174

15A

The provisions of this Part are standard provisions of a manufacturer’s licence relating to the supply of a listed NIMAR product from Great Britain to Northern Ireland.

23ZA

The licence holder in Great Britain must take all reasonable precautions and exercise due diligence to ensure that any information provided to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a product for human use which is supplied from Great Britain into Northern Ireland by virtue of regulation 167A handled, stored or distributed under the licence is not false or misleading in a material particular.

Early Access to Medicines Scheme: establishment and licensing authority functions

167C

(1) The licensing authority must establish and operate a scheme, to be known as the Early Access to Medicines Scheme—

(a) the purpose of which is to give patients with life threatening or seriously debilitating conditions access to medicinal products that may be used for preventing, diagnosing or treating those conditions but which are either not authorised or not authorised for that use; and

(b) which is to include arrangements to support the collection of data about EAMS medicinal products.

(2) The licensing authority has the following functions with regard to the Early Access to Medicines Scheme—

(a) issuing, where appropriate, a designation (“Promising Innovative Medicines designation”) in respect of a product under consideration for inclusion in the Scheme to the person who is or may in due course be responsible for placing the product on the market, after concluding based on early clinical and non-clinical data that the medicinal product may be eligible for inclusion in the Scheme because—

(i) there is a life threatening or seriously debilitating condition and a high unmet need,

(ii) the medicinal product is likely to offer a major advantage over methods of preventing, diagnosing or treating the condition already in use in the United Kingdom, and

(iii) the potential adverse effects of the medicinal product are likely to be outweighed by the potential benefits, allowing for a reasonable expectation of a positive risk-benefit balance;

(b) issuing, where appropriate, an opinion (“EAMS scientific opinion”) to a holder of a Promising Innovative Medicines designation to the effect that the holder is able—

(i) to demonstrate that there is a life threatening or seriously debilitating condition and a high unmet need,

(ii) to demonstrate that the medicinal product offers a major advantage over methods of preventing, diagnosing or treating the condition already in use in the United Kingdom,

(iii) to demonstrate that the potential adverse effects of the medicinal product are outweighed by the potential benefits, allowing for a reasonable expectation of a positive risk-benefit balance,

(iv) to supply the product to or within the United Kingdom (or a part thereof) for use as part of the Scheme, and

(v) to manufacture, or secure the manufacturing of, the product to a consistent quality standard and in compliance with good manufacturing practice,

as a consequence of which the product is included in and may be supplied as part of the Scheme;

(c) where it issues an opinion under sub-paragraph (b), attaching where appropriate conditions, which may be varied from time to time, to the access to the Scheme that the opinion gives (which may include conditions that are equivalent to requirements of Part 13);

(d) revoking, pursuant to paragraph (3), opinions issued in accordance with sub-paragraph (b); and

(e) renewing opinions issued in accordance with sub-paragraph (b) that would otherwise cease to have effect in accordance with regulation 167D(1).

(3) The licensing authority may, if it is reasonable to do so, revoke an EAMS scientific opinion at any time (as a consequence of which, subject to regulation 167D(2), the product can no longer be supplied as part of the Scheme) if—

(a) there is a breach of the conditions referred to in paragraph (2)(c);

(b) there is a breach of regulation 167E to 167G; or

(4) For the purposes of this regulation and regulations 167E and 167G, “authorised” has the meaning given in regulation 3(15), and (including the purposes of regulation 43(6)(aa)) “unauthorised” is to be construed accordingly.

EAMS scientific opinions ceasing to have effect

167D

(1) Subject to paragraph (2), an EAMS scientific opinion ceases to have effect—

(a) at the end of a period of one year beginning with the date on which it is issued;

(b) on the granting of a marketing authorisation in respect of the product to which the opinion relates (but if the marketing authorisation is to apply in Great Britain only, the opinion can continue to have effect in Northern Ireland and vice versa);

(c) on a variation of an existing marketing authorisation to take account of the advantage, identified in the opinion, because of which the product was included in the Early Access to Medicines Scheme (but if the variation is of a marketing authorisation that applies in Great Britain only, the opinion can continue to have effect in Northern Ireland and vice versa); or

(d) if it is revoked by the licensing authority pursuant to regulation 167C(3).

(2) The licensing authority may provide, in conditions attached in accordance with regulation 167C(2)(c), for a winding down period during which an EAMS scientific opinion is to continue to have effect in specified circumstances or for specified purposes (or both), notwithstanding that it has otherwise ceased to have effect by virtue of paragraph (1).

EAMS medicinal products: manufacture, assembly, importation, distribution and supply

167E

(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to an EAMS medicinal product if—

(a) the medicinal product is supplied in response to an unsolicited order;

(b) the medicinal product is manufactured and assembled in accordance with the specification (of the EAMS medicinal product) of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;

(c) the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient that relate to the advantage identified in the EAMS scientific opinion in respect of the product;

(d) the EAMS scientific opinion issued in respect of the product and has not ceased to have effect in respect of it in accordance with regulation 167D; and

(e) the conditions in paragraphs (2) to (4) are met.

(2) If the EAMS medicinal product is—

(a) manufactured or assembled (wholly or partly) in the United Kingdom, that manufacture or assembly must be—

(i) by the holder of a manufacturer’s licence (which need not relate specifically to the manufacture of special medicinal products) or, if the licensing authority agrees, a manufacturing authorisation (within the meaning given in regulation 36(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004) that relates to the manufacture or assembly of investigational medicinal products, and

(ii) a function permitted by that manufacturer’s licence or manufacturing authorisation;

(b) manufactured or assembled (wholly or partly) in an EEA State and imported into Northern Ireland (whether it is for sale or supply in Northern Ireland or Great Britain), that manufacture or assembly must be—

(i) by a holder of a relevant authorisation in relation to the manufacture or assembly of medicinal products that has effect in accordance with the provisions of the 2001 Directive as implemented in that State, or

(ii) if the medicinal product was manufactured or assembled as an investigational medicinal product in that State, by the holder of a relevant authorisation in relation to the manufacture or assembly of investigational medicinal products that has effect in accordance with the provisions of the EU Clinical Trials Regulation;

(c) manufactured or assembled (wholly or partly) in an approved country for import and imported into Great Britain, that manufacture or assembly must be—

(i) by a holder of a relevant authorisation in relation to the manufacture or assembly of medicinal products that has effect in accordance with the provisions applicable in that country, or

(ii) if the medicinal product was manufactured or assembled as an investigational medicinal product in that country, by the holder of a relevant authorisation in relation to the manufacture or assembly of investigational medicinal products that has effect in accordance with the provisions applicable in that country,

and that importation must be by the holder of a wholesale dealer’s licence that permits importation into Great Britain of the product in question; or

(d) manufactured or assembled (wholly or partly) outside the United Kingdom but sub-paragraph (b) or (c) does not apply to the importation of that product, the importation of that product must be—

(i) by the holder of a manufacturer’s licence that relates to the importation of special medicinal products or, if the licensing authority agrees, investigational medicinal products, and

(ii) a function permitted by that licence.

(3) Written records of the manufacture or assembly of the EAMS medicinal product must be maintained by the manufacturer or assembler and be available to the licensing authority or to the enforcement authority on request.

(4) If the EAMS medicinal product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product as mentioned in paragraph (2), P must be the holder of a wholesale dealer’s licence that permits distribution of the product in question.

(5) Where, with the agreement of the licensing authority, to ensure the ongoing availability of an EAMS medicinal product, an authorised product is assembled as that EAMS medicinal product and is supplied as part of the Scheme—

(a) that authorised product is to be treated—

(i) as an unauthorised product for the purposes of Part 13, and

(ii) as that EAMS product for the purposes regulations 167G and 167H and Part 11; and

(b) in any circumstances where that supply would not be an off label supply to which the prohibitions in regulation 46(2) did not apply (by operation of the common law), that supply is to be treated as an off label supply to which those prohibitions do not apply.

Advertising of EAMS medicinal products

167F

(1) No advertisement relating to an EAMS medicinal product may be published by any person in respect of an advantage identified in the EAMS scientific opinion in respect of the product (although this does not preclude a person promoting the Early Access to Medicine Scheme itself).

(2) In this regulation, “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

EAMS medicinal products: pharmacovigilance

167G

(1) Subject to paragraphs (1A) and (1B), the EAMS scientific opinion holder must comply with the following pharmacovigilance requirements in respect of an EAMS medicinal product—

(a) a risk management system must be agreed with the licensing authority and operated by the EAMS scientific opinion holder in accordance with the risk management plan;

(b) the EAMS scientific opinion holder must record and maintain adverse reaction reports in respect of the EAMS medicinal product and must ensure that these reports are accessible (electronically or physically) at a single point within the United Kingdom;

(i) a report on all serious suspected adverse reactions that occur within 15 days of receipt, and

(ii) a report on all non-serious suspected adverse reactions that occur in the United Kingdom within 90 days of receipt,

and must ensure that the reports referred to in sub-paragraphs (i) and (ii) are in the format and content specified by Part 6 of Schedule 12A and, in the case of an MM medicinal product or a POC medicinal product, include the product’s batch number or other product identifier if no batch number is available;

(d) the EAMS scientific opinion holder must—

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

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

(e) the EAMS scientific opinion holder must submit periodic reports, in the manner specified in conditions attached under regulation 167C(2)(c), on the use of the EAMS medicinal product to the licensing authority, and where reasonably practicable, these reports must contain—

(i) details of any suspected adverse drug reaction to the medicinal product,

(ii) a summary of any significant new data on the quality, safety or efficacy of the medicinal product concerned,

(iii) any proposed updates to the medicinal product information,

(iv) all data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the medicinal product in the United Kingdom, and

(v) a scientific evaluation of the risk-benefit balance of the medicinal product;

(f) the EAMS scientific opinion holder must notify the licensing authority without delay if it detects any relevant changes in relation to the EAMS medicinal product, and for these purposes, “relevant changes” means—

(i) new risks,

(ii) risks that have changed, and

(iii) changes to the risk-benefit balance; and

(g) the EAMS scientific opinion holder must—

(i) record all pharmacovigilance information required under this regulation,

(ii) maintain those records for at least five years beginning on the date on which the EAMS scientific opinion ceases to have effect in accordance with regulation 167D(1) (subject to any winding down period provided for in accordance with regulation 167D(2)), and

(iii) make those records available to the licensing authority or to the enforcement authority on request.

(1A) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction.

(1B) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction.

(2) Nothing in paragraph (1) precludes the meeting of the requirements of that paragraph within systems or other arrangements established for other medicinal products (including for an authorised product the marketing authorisation of which may, in due course, be varied to take account of the advantage identified in the EAMS scientific opinion in respect of the EAMS medicinal product).

Early Access to Medicines Scheme: data collection

167H

(1) Data may be collected and handled in respect of patients for the purposes of assessing the quality, safety and efficacy of an EAMS medicine as part of the Early Access to Medicines Scheme without the need for an authorisation granted by the licensing authority under the Clinical Trials Regulations, if—

(a) informed consent is obtained from the patient and such consent is evidenced in writing, dated and signed, or otherwise marked by the patient as to indicate their consent; and

(b) the licensing authority has consented to the data collection.

(2) This is without prejudice to—

(a) the need for the EAMS scientific opinion holder to obtain other approvals in respect of the handling of patient data, where appropriate; and

(b) the powers that the EAMS scientific opinion holder and the licensing authority have to handle patient data (in accordance with the requirements of the Data Protection Act 2018) without the patient’s consent.

(3) For the avoidance of doubt, patient consent to data collection or handling is not, and must not be made, a condition of the supply of an EAMS medicinal product to a patient as part of the Early Access to Medicines Scheme.

Use of non-prescription medicines in the course of a business

Mixing of general sale medicinal products

Record-keeping requirements

Exempt advanced therapy medicinal products

Parallel import licences

Exemption for certain radiopharmaceuticals

Supply in response to spread of pathogenic agents etc

Conditions of temporary authorisations under regulation 174

14B

A licence holder may only manufacture or assemble EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.

23B

A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.

33A

A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.

Obligation on licensing authority to maintain list of medicinal products to which derogations have applied

345A

(1) The licensing authority must publish a list of medicinal products to which the derogations described in Articles 5a, 8(2a) and (2b), 18a, 20 (second paragraph), 40(1a) and (3a), 48(3) and 104(3) of the 2001 Directive have applied.

(2) The licensing authority must update the list referred to in paragraph (1) at least every six months.

Original pack dispensing

217B

(1) Subject to paragraphs (2) to (4) and regulation 217C, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where—

(a) a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and

(b) the sale or supply is otherwise in accordance with the prescription.

(2) Paragraph (1) does not apply—

(a) to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or

(b) in circumstances where—

(i) a pharmacist is carrying out, supervising or authorising (under regulation 220B) the carrying out of the sale or supply and the pharmacist considers, or

(ii) in Great Britian, a registered pharmacy technician is carrying out or supervising the sale or supply, pursuant to an authorisation (under regulation 220A) given by a pharmacist, and the registered pharmacy technician considers,

in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen intended by the prescriber.

(3) Paragraph (2) does not apply to—

(a) a medicine in a form that makes it not practicable to dispense in the exact quantity ordered;

(b) a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity;

(4) Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to—

(a) in England, paragraph 8(1)(b) of Schedule 4, or paragraph 6(1)(b) of Schedule 7, to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013,

(b) in Wales, paragraph 9(1)(b) of Schedule 5 to the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020,

until those Regulations expressly apply paragraphs (1) to (3) to those supplies.

Original pack dispensing: medicinal products containing a relevant substance

217C

(1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

(a) it is sold or supplied in its manufacturer’s original outer packaging; and

(b) if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

(2) Paragraph (1) does not apply where—

(a) the sale or supply is—

(i) by or under the supervision of or pursuant to an authorisation (under regulation 220B) given by a pharmacist, or

(ii) in Great Britain, by or under the supervision of a registered pharmacy technician, pursuant to an authorisation (under regulation 220A) given by a pharmacist; and

(b) the pharmacist (in a case to which paragraph (a)(i) applies) or registered pharmacy technician (in a case to which paragraph (a)(ii) applies) is satisfied that—

(i) a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

(ii) unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

(3) In this regulation, “relevant substance” means any of the following—

(a) sodium valproate;

(b) valproic acid;

Requirements for prescriptions: approved country health professional

Electronic prescriptions

Electronic Prescriptions: approved country health professionals

Original pack dispensing: Northern Ireland

217BA

(1) Subject to paragraphs (2) to (4) and regulation 217CA, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where—

(a) a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and

(b) the sale or supply is otherwise in accordance with the prescription.

(2) Paragraph (1) does not apply—

(a) to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or

(b) in circumstances where a pharmacist is carrying out , supervising or authorising (under regulation 220B) the carrying out of the sale or supply and the pharmacist considers, in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

(3) Paragraph (2) does not apply to—

(a) a medicine in a form that makes it not practicable to dispense in the exact quantity ordered;

(b) a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity;

(4) Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to paragraphs 2(1) and (1A) of Schedule 2 to the Pharmaceutical Services Regulations (Northern Ireland) 1997,

until those Regulations expressly apply paragraphs (1) to (3) to those supplies.

Original pack dispensing: medicinal products containing a relevant substance

Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland

217CA

(1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

(a) it is sold or supplied in its manufacturer’s original outer packaging; and

(b) if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

(2) Paragraph (1) does not apply where—

(a) the sale or supply is by or under the supervision of or pursuant to an authorisation (under regulation 220B) given by a pharmacist; and

(b) the pharmacist is satisfied that—

(i) a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

(ii) unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

(3) In this regulation, “relevant substance” means any of the following—

(a) sodium valproate;

(b) valproic acid;

Requirements for prescriptions: approved country health professional

Electronic prescriptions

Electronic Prescriptions: approved country health professionals

Appropriate suppliers of naloxone products

237A

(1) Regulations 214(1) and 220 do not apply to the supply of a naloxone product by an individual who is an appropriate supplier of naloxone products, if it is for an appropriate purpose.

(2) For the purposes of paragraph (1), the following are appropriate suppliers of naloxone products—

(a) a person employed or engaged in the provision of drug treatment services provided by or on behalf of, or under arrangements with, one of the following—

(i) an NHS body,

(ii) a local authority,

(iii) the Secretary of State, or

(iv) the Public Health Agency;

(b) a person employed or engaged in the provision of services as part of the medical services of His Majesty’s forces;

(c) a person employed or engaged by, or by an entity commissioned to provide drug treatment services by or on behalf of, one of the bodies listed below, if the listed body is satisfied that the person has undergone appropriate training in the storage and supply of naloxone products—

(i) a police force in England, Wales or Scotland,

(ii) the Police Service of Northern Ireland,

(iii) a prison service,

(iv) a provider of probation services, or

(v) a provider of youth justice services;

(d) a person who is one of the following—

(i) a pharmacist,

(ii) in England, Wales or Scotland, a registered pharmacy technician,

(iii) a registered nurse,

(iv) a registered midwife, or

(v) a registered paramedic,

if that person has undergone appropriate training in the storage and supply of naloxone products; and

(e) a person employed or engaged by a local naloxone provider, if that local naloxone provider is satisfied that the person has undergone appropriate training in the storage and supply of naloxone products.

(3) For the purposes of this regulation, a local naloxone provider is an entity that has valid arrangements in place (“local naloxone arrangements”) with a naloxone supply network co-ordinator for the supply of naloxone products for an appropriate purpose.

(4) For the purposes of this regulation, a naloxone supply network co-ordinator is an entity that has valid arrangements in place (“network creation arrangements”) with an appropriate national body as part of which the naloxone supply network co-ordinator creates and maintains a network of local naloxone providers that are willing to supply naloxone products for an appropriate purpose.

(5) For—

(a) local naloxone arrangements to be valid, a naloxone supply network co-ordinator must ensure that any putative local naloxone arrangements that it has contain arrangements that ensure; and

(b) network creation arrangements to be valid, the appropriate national body must ensure that any putative network creation arrangements that it has contain arrangements that ensure,

the outcomes listed in paragraph (6).

(6) Those outcomes are—

(a) that only persons who are employed or engaged by the putative local naloxone provider and who have undergone appropriate training in the storage and supply of naloxone products are able to supply them under the putative local naloxone arrangements;

(b) that any requirements that the appropriate national body has in respect of training in the storage and supply of naloxone products which are relevant to supply in accordance with this regulation are included in the putative local naloxone arrangements, and any such requirements are appropriate training for the purposes of paragraph (2)(e) (but see paragraph (8));

(c) that a record is kept by the putative local naloxone provider of all the persons employed or engaged by them who are able to supply naloxone products under the putative local naloxone arrangements, and of their relevant training;

(d) that the putative local naloxone provider has a named individual responsible at all times for—

(i) the storage, any handling relating to storage and any handling relating to supply of naloxone products by or on behalf of the putative local naloxone provider under their putative local naloxone arrangements, and

(ii) the maintenance of appropriate records of those activities by the putative local naloxone provider;

(e) that any requirements that the appropriate national body has in respect of storage and any handling relating to supply of naloxone products by local naloxone providers, which arise out of or relate to supply in accordance with this regulation, are included in the putative local naloxone arrangements; and

(f) that any requirements that the appropriate national body has in respect of the processing of information by local naloxone providers, including in respect of—

(i) the records to be kept as part of local naloxone arrangements,

(ii) the information to be derived from those records, and

(iii) the provision of information to naloxone supply network co-ordinators, and the occasions on which and the frequency with which to do so,

which arise out of or relate to supply in accordance with this regulation, are included in the putative local naloxone arrangements.

(7) For network creation arrangements to be valid, the appropriate national body must also ensure that any putative network creation arrangements that it has contain arrangements that ensure the following outcomes—

(a) that any requirements that the appropriate national body has in respect of the processing of information by naloxone supply network co-ordinators, including in respect of—

(i) the records to be kept as part of the network creation arrangements,

(ii) the information to be derived from those records, and

(iii) the provision of information to the appropriate national body, and the occasions on which and the frequency with which to do so,

which arise out of or relate to supply in accordance with this regulation, are included in the putative network creation arrangements; and

(b) that any requirements that the appropriate national body has in respect of who may be a local naloxone provider, and how their status as such is recorded or advertised, are included in the putative network creation arrangements.

(8) In order for training in the storage and supply of naloxone products to be appropriate for the purposes of this regulation, its outcome must be that a person completing the training successfully (T) has the following competencies—

(a) understanding of the legal framework for supply in accordance with this regulation which is sufficient for the purposes of ensuring that T is able to administer naloxone products lawfully and where appropriate to supply them to another person for that other person to administer them lawfully, having been trained to do so by T;

(b) understanding of the safe storage and safe handling of naloxone products which is sufficient for the purposes of ensuring—

(i) that T is able to store and handle naloxone products safely and without compromising their efficacy, and

(ii) if T is to supply those products to another person for that other person to store and handle them, that the other person is able to store and handle them safely, and without compromising their efficacy, having been trained to do so by T; and

(i) that T is able to do so safely, effectively and when appropriate, and

(ii) if T is to supply those products to another person for that other person to administer them, that the other person is able to administer them safely, effectively and when appropriate, having been trained to do so by T,

and if the appropriate national body for where a supply takes place has determined that that is the outcome of particular training for a particular (or any) category of person, then for where that supply takes place that determination is conclusive evidence, or in Scotland sufficient evidence, that the training is appropriate training for that category of person.

(9) The following are appropriate purposes for the purposes of this regulation—

(a) the naloxone product is needed by the person to whom or for whom it is supplied for the purpose of saving life in an emergency;

(b) in the reasonable expectation of the appropriate supplier of naloxone, the supply of the naloxone product is to enable it to be kept at a place where a person resides or which they frequent, in circumstances where that person may need, at that place—

(i) to administer it to themselves in an emergency for the purposes of saving their own life, or

(ii) to administer it to another person, or to have it administered to them, in accordance with regulation 238; or

(c) in the reasonable expectation of the appropriate supplier of naloxone, the supply of the naloxone product is to enable it to be carried about by the person to or for whom it is supplied, that person being a person who may need it—

(i) to administer it to themselves in an emergency for the purposes of saving their own life, or

(ii) to administer it to another person, or to have it administered to them, in accordance with regulation 238.

(10) Where, pursuant to this regulation, an appropriate supplier of naloxone mentioned in paragraph (2)(a) to (d) supplies a naloxone product—

(a) that appropriate supplier of naloxone;

(b) a provider of drug treatment services, medical services or other health care services that employs or engages the appropriate supplier of naloxone, if it is the entity that supplied the supplier with the naloxone product; or

(c) a body listed in paragraph (2)(a) or (c), where that body provided or commissioned the drug treatment services or other health care services as part of which the appropriate supplier of naloxone supplied the naloxone product,

may provide an appropriate national body with any information about that supply, if that type of information, or information derived from that type of information, is information that a naloxone supply network co-ordinator would be required to supply to that body under network creation arrangements, it (or the information derived from it) being information included in requirements that the appropriate national body has as mentioned in paragraph (7)(a)(iii).

(11) For the purposes of section 8(c) of the Data Protection Act 2018 (lawfulness of processing: public interest etc), provision of information in the circumstances described in paragraph (10) is to be considered necessary for the performance of a task carried out in the public interest.

(12) For the purposes of this regulation, the following are appropriate national bodies—

(a) in England, the Secretary of State;

(b) in Scotland, the Scottish Ministers;

(d) in Northern Ireland, the Public Health Agency or the Department of Health in Northern Ireland.

(13) For the purposes of this regulation and regulation 238, any use of a naloxone product that is indicated in a marketing authorisation for the product is to be treated as being for the purpose of saving life, even if the use is for, or partially for, diagnosis.

Administration of certain medicines in an emergency

Administration of smallpox vaccine

Radioactive medicinal products

Exemptions in respect of certain herbal remedies

Exemption for medicinal products at high dilution

Exemption for certain homoeopathic medicinal products

Variation of a UKMA(GB) or a UKMA(UK)(Category 1)

Application of regulations 89 to 94

Packaging requirements: variation in accordance with regulation 68(11I)

257AA

(1) This regulation applies where, in accordance with regulation 68(11I), the licensing authority thinks that a variation is necessary so that a UKMA(UK)(Category 2) is treated as a UKMA(GB) and separate UKMA(NI).

(2) Where this regulation applies, the licensing authority may require that, in relation to the UKMA(GB), the information specified in paragraph 18B of Schedule 24 is replaced with a statement that the medicinal product is for sale or supply in Great Britain only.

257AB

The information specified in paragraph 18B of Schedule 24 is not required to appear on the packaging of a medicinal product released for sale or distribution before 1st January 2025, unless the product has been re-packaged or relabelled after that date.

Packaging Requirements: medicinal products required to bear safety features

Transitional Arrangements

Packaging requirements: advanced therapy medicinal products

Guidance as to packaging and package leaflets

Regulation-making power as to certain forms of labelling

Packaging requirements: specific provisions

Package leaflets

Use of pictures and symbols etc

Labelling requirements for radionuclides

Leaflets relating to radionuclides

Homoeopathic medicines

Additional requirements for traditional herbal medicinal products

Language requirements etc

Submission of mock-ups of packaging and leaflets to licensing authority

Transitional provision relating to the Windsor Framework

347B

(1) Schedule 33B contains transitional provision in relation to the implementation of the Windsor Framework.

(2) In paragraph (1), “the Windsor Framework” means the part of the withdrawal agreement known as the Windsor Framework by virtue of Joint Declaration No. 1/2023 of 24 March 2023 made between the European Union and the United Kingdom in the Joint Committee established by the withdrawal agreement.

Amendments to existing law

Repeals and revocations

Prevalence of a condition in the United Kingdom

18B

The words “UK only”.

SCHEDULE33B — Transitional Provision in relation to the Windsor Framework

Existing marketing authorisations

1

(1) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a medicinal product in respect of which there is or has been in force an EU marketing authorisation, or which belongs to a category of medicinal product referred to in Article 3(1) or (2) of Regulation (EC) No 726/2004, has effect on and after that date as a UKMA(UK)(Category 1).

(2) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a generic medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product.

(3) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a hybrid medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product.

(4) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) granted in accordance with regulation 53A or Article 10(4) and (6) of the 2001 Directive and in force immediately before 1st January 2025 for a biological medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product.

(5) Subject to sub-paragraphs (6), (13) and (14), any other UKMA(GB) in force immediately before 1st January 2025 has effect on and after that date as a UKMA(UK)(Category 2).

(6) If the holder of a UKMA(GB) to which any of sub-paragraphs (1) to (5) applies notifies the licensing authority in writing before 1st January 2025 that it does not wish to be a holder of a UKMA(UK), the licensing authority must revoke the UKMA(GB) with effect from 1st January 2025.

(7) A UKMA(UK) which has effect by virtue of any of sub-paragraphs (1) to (5) is treated as if it had been granted by the licensing authority on the same terms as those on which the UKMA(GB) was granted, including any conditions or restrictions subject to which, and retaining any benefits with which, the UKMA(GB) was granted and which remain in force immediately before 1st January 2025.

(8) A UKMA(UK) in force immediately before 1st January 2025 for a generic medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product.

(9) A UKMA(UK) in force immediately before 1st January 2025 for a hybrid medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product.

(10) A UKMA(UK) granted in accordance with regulation 53B or Article 10(4) and (6) of the 2001 Directive and in force immediately before 1st January 2025 for a biological medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product.

(11) Any other UKMA(UK) in force immediately before 1st January 2025 has effect on and after that date as a UKMA(UK)(Category 2).

(12) A UKMA(UK) which has effect by virtue of sub-paragraph (8) to (10) is treated as if it had been granted by the licensing authority on the same terms as those on which the UKMA(UK) in force before 1st January 2025 was granted, including any conditions or restrictions subject to which, and retaining any benefits with which, the UKMA(UK) was granted and which remain in force immediately before 1st January 2025.

(13) Subject to sub-paragraph (14), a UKMA(GB) in force immediately before 1st January 2025 ceases to have effect on 1st January 2025 if—

(a) there is a UKMA(NI) in force on 1st January 2025 in relation to the same medicinal product and with the same marketing authorisation holder, and

(b) the holder of that UKMA(NI) has not made a request in writing to the licensing authority for the revocation of that UKMA(NI) before 30th September 2024.

(14) However, where the holder of the UKMA(NI) referred to in sub-paragraph (13) has made a request in writing to the licensing authority for the revocation of that UKMA(NI) on or after 30th September and before 1st January 2025 and the licensing authority thinks that it is in the interest of patients’ health in the United Kingdom, the UKMA(GB) continues to have effect on 1st January 2025.

(15) For the purposes of this paragraph, a medicinal product is a “hybrid medicinal product” if one or more of the circumstances set out in regulation 52B(1)(a) to (c) applied to the application for the UKMA for that product.

Existing applications for marketing authorisation

2

(1) An application for a UKMA(GB) made before 1st January 2025 which has not been determined immediately before that date is to be treated on and after that date as an application for a UKMA(UK).

(2) Sub-paragraph (3) applies where—

(a) an application for a UKMA(UK) was made before 1st January 2025,

(b) the application has not been determined immediately before that date,

(d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

(3) Where this sub-paragraph applies, regulations 48 and 51B apply in respect of the application as they had effect immediately before 1st January 2025.

(4) Sub-paragraph (5) applies where—

(a) an application for a UKMA(UK) was made before 1st January 2025,

(b) the application has not been determined immediately before that date,

(d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

(5) Where this sub-paragraph applies, regulations 48 and 52B apply in respect of the application as they had effect immediately before 1st January 2025.

(6) Sub-paragraph (7) applies where—

(a) an application for a UKMA(UK) was made before 1st January 2025,

(b) the application has not been determined immediately before that date,

(d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

(7) Where this sub-paragraph applies, regulations 48 and 53B apply in respect of the application as they had effect immediately before 1st January 2025.

Post-authorisation processes

3

(1) Where an application is made before 1st January 2025 for variation of a UKMA(GB) and that application has not been determined immediately before that date, if the authorisation has effect as a UKMA(UK)(Category 2) by virtue of paragraph 1(2), the application must be determined by the licensing authority as if it were an application for a variation of a UKMA(UK)(Category 1).

(2) Where a holder of a UKMA(GB) has submitted a draft protocol under regulation 199(2) before 1st January 2025, if the authorisation has effect as a UKMA(Category 2) by virtue of paragraph 1(2), the obligations applied by regulations 198 to 202 apply in relation to the medicinal product concerned on and after 1st January 2025 as if the authorisation were a UKMA(UK)(Category 1).

Manufacturing of MM medicinal products

17A

A person may not manufacture or assemble an MM medicinal product unless—

(a) it is specified in a manufacturer’s licence (MM); and

(b) there is an MM master file relating to that product and it is manufactured or assembled in accordance with that master file.

Manufacturing of POC medicinal products

17B

A person may not manufacture or assemble a POC medicinal product unless—

(a) it is specified in a manufacturer’s licence (POC); and

(b) there is a POC master file relating to that product and it is manufactured or assembled in accordance with that master file.

Wholesale dealing in medicinal products

Approved country for import

Exemptions from requirement for wholesale dealer's licence

Mixing of medicines

Application for manufacturer's or wholesale dealer's licence

Factors relevant to determination of application for manufacturer's or wholesale dealer's licence

Grant or refusal of licence

Standard provisions of licences

Duration of licence

General power to suspend, revoke or vary licences

Procedure where licensing authority proposes to suspend, revoke or vary licence

Effect of suspension or variation relating to modular unit or POC site

27A

(1) If the licensing authority suspends or varies a manufacturer’s licence (MM) in accordance with regulation 26(2)(d) so that manufacturing or assembly is suspended, or no longer authorised, at a modular unit, the licence holder may not approve that unit for the purpose of manufacturing or assembly of the MM medicinal product other than by way of an application under regulation 29.

(2) If the licensing authority suspends or varies a manufacturer’s licence (POC) in accordance with regulation 26(2)(e) so that manufacturing or assembly is suspended, or no longer authorised, at a POC site, the licence holder may not approve that site for the purpose of manufacturing or assembly of the POC medicinal product other than by way of an application under regulation 29.

Suspension of licence in cases of urgency

Variation of licence on the application of the holder

Variation of MM master file

29A

Except where regulation 27A(1) applies, the holder of a manufacturer’s licence (MM) may amend the information in the MM master file provided in accordance with paragraph 1A(2)(a), (c) and (h) to (k) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.

Variation of POC master file

29B

Except where regulation 27A(2) applies, the holder of a manufacturer’s licence (POC) may amend the information in the POC master file provided in accordance with paragraph 1B(2)(a), (b) and (g) to (j) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.

Provision of information

Manufacturing and assembly of MM medicinal products: additional requirements

37A

In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (MM) must ensure that—

(a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the modular units specified in the MM master file; and

(b) only the MM medicinal products specified in the licence are manufactured or assembled at the modular units specified in the MM master file.

Manufacturing and assembly of POC medicinal products: additional requirements

37B

In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (POC) must ensure that—

(a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the POC sites specified in the POC master file;

(b) only the POC medicinal products specified in the licence are manufactured or assembled at the POC sites specified in the POC master file; and

(c) a POC medicinal product specified in the licence is only manufactured at a POC site specified in the POC master file.

Imports from states other than EEA States / countries other than approved countries for import

Further requirements for manufacturer's licence

Obligation to provide information relating to control methods

Requirements as to qualified persons

Applications relating to POC medicinal products

50K

(1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product that is a POC medicinal product.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority information about the measures the applicant envisages putting in place to ensure the follow up of the efficacy of the product and of any adverse reactions to it.

Application for UKMA(NI) relating to generic medicinal products

Application for UKMA(GB) relating to generic medicinal products

Application for UKMA(UK) relating to generic medicinal products

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.