The Human Medicines Regulations 2012

• (ii) the number of the marketing authorisation, or

• (iii) the name and address of the manufacturer of the product; and

• (b) the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

• (i) the number of the marketing authorisation is the number of the EU marketing authorisation to which the application for the EU marketing authorisation related, or

• (ii) the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and the information specified in paragraph (a)(i) or (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

• (2) Sub-paragraph (1) only applies if—

• (a) the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

• (b) the UK marketing authorisation holder, being aware of the number of the UK marketing authorisation and having established in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

• (3) In this paragraph, “the transitional period” means the period beginning with the date on which the licensing authority grants a UK marketing authorisation as described in paragraph 31(4) and ending 36 months after IP completion day.

Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied

34

• (1) Sub-paragraph (2) applies where an application for a UK marketing authorisation has been made before IP completion day and—

• (a) regulation 58(6) and (7) of the 2012 Regulations (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 UK marketing authorisation 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 5 of these Regulations (marketing authorisations) 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; and

• (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 UK marketing authorisation in the time period specified in regulation 58(1) (consideration of application) as if it had applied to that application on the date on which the application was submitted.

Transitional provision in respect of Plasma Master Files

35

• (1) This paragraph applies in relation to a UK marketing authorisation or EU marketing authorisation—

• (a) which was granted before IP completion day;

• (b) the application for which made reference to a Plasma Master File within the meaning of paragraph 1.1(a), first indent, of Part III of Annex I to the 2001 Directive which was certified by the EMA in accordance with paragraph 1.1(c) of that Part of the Annex; and

• (c) which remains in force as a UK marketing authorisation on and after IP completion day.

• (2) A holder of the UK marketing authorisation to which this paragraph applies may, subject to complying with the obligations in sub-paragraph (3), continue to refer to the Plasma Master File as certified by the EMA, notwithstanding the modifications to paragraph 1.1(c) of Part III of Annex I to the 2001 Directive in Schedule 8B, subject which that paragraph is to be read on and after IP completion day.

• (3) The holder of a UK marketing authorisation to which this paragraph applies must notify the licensing authority of—

• (a) the outcome of the annual update and recertification of the Plasma Master File by the EMA within 4 weeks beginning with the completion of that update and recertification;

• (b) any application for changes to the terms of the Plasma Master File which the holder seeks from the EMA, within 4 weeks beginning with the date of the application; and

• (c) the outcome of any application referred to in paragraph (b), within 4 weeks beginning with the date on which the holder is notified of that outcome.

• (4) The licensing authority may at any time review the terms of a Plasma Master File to which reference is made in accordance with sub-paragraph (2), with a view to exercising its powers under these Regulations in relation to the UK marketing authorisation.

Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004

36

Where, immediately before IP completion day, a marketing authorisation, which is a UK marketing authorisation on IP completion day, has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive or Regulation (EC) No 726/2004, 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 5 (marketing authorisations).

Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion day

37

• (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) 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 (revocation, variation and suspension of UK marketing authorisation) as soon as reasonably practicable.

• (3) In making a decision under regulation 68 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; and

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

• (4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 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 referred under Article 31 of the 2001 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 (advice and representations).

• (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) 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).

• (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 UK marketing authorisation—

• (a) as soon as reasonably practicable; and

• (b) in the case of a UK marketing authorisation that is not a converted EU marketing authorisation, within the period specified in Article 34(3) of the 2001 Directive (if relevant).

• (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 UK marketing authorisation or an EU marketing authorisation; butdoes not include a referral made under Article 107i of the 2001 Directive.

PART 5 — Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations

Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations)

38

• (1) Sub-paragraph (2) applies where—

• (a) an application or notification in respect of a variation to a UK marketing authorisation has been submitted to the licensing authority under Chapter IIa of Regulation (EC) No 1234/2008 before IP completion day; but

• (b) the procedures specified in Article 13e of that Regulation (measures to close the variation procedures in Chapter IIa of that Regulation) have not concluded before IP completion day.

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

• (a) determine which of the provisions specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the steps that have already been undertaken under Chapter IIa of Regulation (EC) No 1234/2008 before IP completion day;

• (b) assess the application or notification in accordance with the provisions of that Schedule the authority has determined are relevant to the application, as if the application or notification had been made under them; and

• (c) take all reasonable steps to ensure that it assesses the notification or application in accordance with any relevant time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

• (3) Paragraphs 15 and 16 of Schedule 10A apply to any variation that falls under sub-paragraph (1)(a) or (b).

Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive)

39

• (1) This paragraph applies where an application or notification in respect of a variation to a marketing authorisation has been submitted to the licensing authority, as a relevant authority, under Chapter II of Regulation (EC) No 1234/2008 before IP completion day.

• (2) If the procedures specified in Article 11(1) of Regulation (EC) No 1234/2008 have not concluded before IP completion day, the licensing authority must—

• (a) assess the application or notification in accordance with regulation 65C and Schedule 10A to these Regulations, as if the application or notification had been made under those provisions; and

• (b) make such an assessment having regard to the matters specified in sub-paragraph (5).

• (3) If the procedures specified in Article 11(1) of Regulation (EC) No 1234/2008 have concluded before IP completion day—

• (a) the licensing authority must take the steps specified in Article 11(2) of Regulation (EC) No 1234/2008 within the time limit specified in Article 23(1) of that Regulation; and

• (b) paragraphs 15 and 16 of Schedule 10A apply to the variation.

• (4) In making a determination under sub-paragraph (2), the licensing authority must—

• (a) determine which steps of the procedures specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the matters specified in sub-paragraph (5); and

• (b) take all reasonable steps to ensure that it assesses the notification or application in accordance with any time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

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

• (a) any recommendation in relation to that application or notification given before IP completion day pursuant to Article 5 of Regulation (EC) No 1234/2008;

• (b) any relevant information obtained by it before IP completion day, as a relevant authority, in relation to the application or notification by virtue of any procedure provided for in Chapter II of that Regulation; and

• (c) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a relevant authority, including any matter referred under the procedure specified in Article 13 of that Regulation.

Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure)

40

• (1) Sub-paragraph (2) applies where—

• (a) an application or notification in respect of a variation to a UK marketing authorisation has been submitted to the licensing authority, as a relevant authority or the reference authority, under Article 20 of Regulation (EC) No 1234/2008;

• (b) the marketing authorisation is one to which Chapter II or IIa of that Regulation applied; and

• (c) the procedure in Article 20(8) has not been completed before IP completion day.

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

• (a) determine which of the provisions specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the steps that have already been undertaken under Article 20 of Regulation (EC) No 1234/2008 before IP completion day;

• (b) assess the application or notification in accordance with the relevant provisions in that Schedule, as if the application or notification had been made under them; and

• (c) take all reasonable steps to ensure that it assesses the notification or application in accordance with any relevant time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

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

• (a) any opinion given by the reference authority before IP completion day in relation to that application;

• (b) any relevant information obtained by it before IP completion day, as a reference authority or relevant authority, in relation to the application or notification by virtue of any procedure provided for in regulation 20 of Regulation (EC) No 1234/2008; and

• (c) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a relevant authority.

• (4) Paragraphs 15 and 16 of Schedule 10A apply to any variation that falls under sub-paragraph (1).

PART 6 — Transitional provision in relation to the Paediatric Regulation

Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation

41

• (1) Where a paediatric investigation plan has been agreed by the EMA in accordance with the Paediatric Regulation before IP completion day, that plan, including any modifications agreed by the EMA before IP completion day, has effect on and after IP completion day as an agreed paediatric investigation plan.

• (2) Sub-paragraph (3) applies where—

• (a) a paediatric investigation plan has been submitted to the EMA with a request for agreement before IP completion day;

• (b) the proposed paediatric plan is valid in accordance with the provisions of Article 15(2) of the Paediatric Regulation; but

• (c) the EMA has not adopted a decision to agree the plan before IP completion day.

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

• (a) where an opinion favourable to agreeing the paediatric investigation plan has been given by the Paediatric Committee before IP completion day, treat the plan as an agreed paediatric investigation plan;

• (b) where an opinion against agreeing the paediatric investigation plan has been given by the Paediatric Committee before IP completion day, decide that it cannot agree the plan under regulation 50B(5) (agreement and modification of paediatric investigation plan); or

• (c) where before IP completion day no opinion in relation to the paediatric investigation plan has been given by the Paediatric Committee treat it as a request for agreement under regulation 50B(1) and determine that request as soon as reasonably practicable, unless the applicant notifies the licensing authority in writing that they do not want the application to proceed as a request for agreement of a paediatric investigation plan under these Regulations.

• (4) Sub-paragraph (5) applies where—

• (a) a paediatric investigation plan has been agreed by the EMA in accordance with the Paediatric Regulation before IP completion day;

• (b) the person to whom the EMA's decision to agree the plan was addressed has, before IP completion day, made a proposal under Article 22 of the Paediatric Regulation to modify the plan, or to request a waiver; but

• (c) the EMA has not adopted a decision to agree to the modification or waiver before IP completion day.

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

• (a) where an opinion favourable to agreeing the modification or waiver has been given by the Paediatric Committee before IP completion day, agree to the modification or waiver as if it had been requested under regulation 50B(6);

• (b) where an opinion against agreeing the modification or waiver has been given by the Paediatric Committee before IP completion day, decide that it cannot agree to the modification or waiver as if it had been requested under regulation 50B(6); or

• (c) where before IP completion day no opinion in relation to the modification or waiver has been given by the Paediatric Committee treat the proposal as one made under regulation 50B(6) and consider it accordingly, unless the applicant notifies the licensing authority in writing that they do not want the proposal to proceed as a proposal under regulation 50B(6).

• (6) Where the EMA has adopted a decision to grant, and has not revoked, a waiver of the obligation to produce the information in Article 7(1)(a) of the Paediatric Regulation before IP completion day, that waiver has effect on and after IP completion day as a waiver granted by the licensing authority under regulation 50D (waiver of production of information in a paediatric investigation plan).

• (7) Sub-paragraph (8) applies where—

• (a) an application has been made to the EMA for a waiver of the obligation to produce the information in Article 7(1)(a) of the Paediatric Regulation before IP completion day;

• (b) the application has been accepted as valid by the EMA; but

• (c) the EMA has not adopted a decision to grant the waiver before IP completion day.

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

• (a) where an opinion favourable to agreeing the waiver has been given by the Paediatric Committee before IP completion day, grant the waiver under regulation 50D(2);

• (b) where an opinion against agreeing the waiver has been given by the Paediatric Committee before IP completion day, decide that it cannot grant the waiver under regulation 50D(2); or

• (c) where before IP completion day no opinion in relation to the waiver has been given by the Paediatric Committee treat the proposal as one made under regulation 50D and consider it accordingly, unless the applicant notifies the licensing authority in writing that they do not want the proposal to proceed as a proposal under regulation 50D.

Transitional provision in relation to global marketing authorisations under the 2001 Directive

41A

Where a relevant medicinal product is subject to a global marketing authorisation as described in Article 6 of the 2001 Directive before IP completion day, a paediatric investigation plan does not need to be carried out in relation to that product.

PART 8 — Transitional provision in respect of homoeopathic medicinal products

List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day

43

• (1) For the purposes of the definition of “homoeopathic medicinal product” in regulation 8 (general interpretation: accepted Pharmacopoeias for homoeopathic manufacturing procedures), during the transitional period, the licensing authority must publish a list of countries that includes each EEA State in it.

• (2) The licensing authority must not, before the end of the transitional period, remove an EEA State from the list described in sub-paragraph (1).

• (3) In this paragraph, “the transitional period” is the period of two years beginning with IP completion day.

Place of establishment for holders of certificates of registration established in EEA before IP completion day

44

• (1) Subject to sub-paragraph (2), any person—

• (a) who—

• (i) holds a certificate of registration immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

• (ii) has made an application for, or to renew, a certificate of registration before IP completion day, which has not been determined by the licensing authority before that date, or

• (iii) makes such an application on or after IP completion day but before the end of the transitional period; and

• (b) who was, immediately before IP completion day, established in an EEA State and who remains there on and after that day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 103(4) or 108(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

• (2) But sub-paragraph (1) continues to apply to a person, in relation to a certificate of registration in force in Great Britain, only if the person has notified the licensing authority in writing of—

• (a) a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the certificate of registration, or application for a certificate of registration, during the transitional period; and

• (b) that individual's address, telephone number and email address.

• (3) A person must notify the licensing authority under sub-paragraph (2)—

• (a) where sub-paragraph (1)(a)(i) or (ii) applies, within the period of 4 weeks beginning with IP completion day; or

• (b) where sub-paragraph (1)(a)(iii) applies, at the time of making the application.

• (4) In this paragraph “the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements: change of place of establishment

45

• (1) Subject to sub-paragraph (2), a person to whom paragraph 44 applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain) during the transitional period in relation to a product to the extent that—

• (a) the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet (as the case may be), do not include the correct information as to—

• (i) the name and address of the holder of the certificate of registration,

• (ii) the number of the certificate of registration, or

• (iii) the name and address of the manufacturer of the product if different from the holder of the certificate of registration; and

• (b) the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

• (i) the holder of the certificate of registration has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 103(4) or 108(2), and

• (ii) the information specified in paragraph (a)(i) to (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

• (2) Sub-paragraph (1) only applies if—

• (a) the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

• (b) the certificate of registration holder, having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

• (3) In this paragraph “the transitional period” means the period of 36 months beginning with IP completion day.

Applications made for a certificate of registration for a registrable homoeopathic product before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied

46

• (1) Sub-paragraph (2) applies where an application for a certificate of registration has been made before IP completion day and—

• (a) regulation 104(5) and (6) (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 certificate of 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 6 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; and

• (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.

• (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 certificate of registration in the time period specified in regulation 104(1) as if it had applied to that application on the date on which the application was submitted.

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

47

Where, immediately before IP completion day, a certificate of registration 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 6 of these Regulations (certification of homoeopathic medicinal products).

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

48

• (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 110 (revocation, variation and suspension of certificate of registration) as soon as reasonably practicable.

• (3) In making a decision under regulation 110 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 110 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) The licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the certificate of 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 certificate of 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;

• “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 certificate of registration; butdoes not include a referral made under Article 107i of the 2001 Directive.

PART 9 — Transitional provision in respect of traditional herbal registrations

Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day

49

• (1) Subject to sub-paragraph (2), any person—

• (a) who—

• (i) holds a traditional herbal registration immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

• (ii) has made an application for, or to renew, a traditional herbal registration before IP completion day, which has not been determined by the licensing authority before that date, or

• (iii) makes such an application on or after IP completion day but before the end of the transitional period; and

• (b) who was, immediately before IP completion day, established in an EEA State and who remains there on and after that day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 127(3) or 133(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

• (2) But sub-paragraph (1) continues to apply to a person, only in relation to a registration in force in Great Britain, and only if the person notifies the licensing authority in writing of—

• (a) a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the traditional herbal registration, or application for a traditional herbal registration, during the transitional period; and

• (b) that individual's address, telephone number and email address.

• (3) A person must notify the licensing authority under sub-paragraph (2)—

• (a) where sub-paragraph (1)(a)(i) or (ii) applies, within the period of 4 weeks beginning with IP completion day; or

• (b) where sub-paragraph (1)(a)(iii) applies, at the time of making the application.

• (4) In this paragraph “the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements: change of place of establishment

50

• (1) Subject to sub-paragraph (2), a person to whom paragraph 49 applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain) during the transitional period in relation to a product to the extent that—

• (a) the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet (as the case may be), do not include the correct information as to—

• (i) the name and address of the holder of the traditional herbal registration, or, if applicable, the holder's representative,

• (ii) the number of the traditional herbal registration, or

• (iii) the name and address of the manufacturer of the product; and

• (b) the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

• (i) the holder of the traditional herbal registration has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 127(3) or 133(2), and

• (ii) the information specified in paragraph (a)(i) to (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

• (2) Sub-paragraph (1) only applies if—

• (a) the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

• (b) the holder of the traditional herbal registration, having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

• (3) In this paragraph “the transitional period” means the period of 36 months beginning with IP completion day.

List of approved countries for traditional use of a herbal medicinal product on IP completion day

51

• (1) For the purpose of regulation 125A (list of approved countries for traditional use of a herbal medicinal product), the licensing authority must, for the transitional period, include each EEA State in the list it publishes under regulation 125A(1).

• (2) The licensing authority must not, before the end of the transitional period, exercise its power under regulation 125A(3) to remove an EEA State from the list.

• (3) In this paragraph, the transitional period is two years beginning with IP completion day.

Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied

52

• (1) Sub-paragraph (2) applies where an application for a traditional herbal registration to be in force in Great Britain only has been made before IP completion day and—

• (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;

• (c) the procedure described in Article 107e(3) of the 2001 Directive has been completed before IP completion day; but

• (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

• (c) the procedure described in Article 107e(3) of the 2001 Directive has not been completed before IP completion day.

• (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;

• (c) any person who may lawfully administer prescription only medicines 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

• (c) keep records in relation to the receipt, dispatch or brokering of listed NIMAR products, of—

• (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—