The Human Medicines Regulations 2012

[F1 PART 8 U.K. Transitional provision in respect of homoeopathic medicinal products

Textual Amendments

F1 Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)

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

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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)

a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or

(b)

an 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)

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; but

(b)

does not include a referral made under Article 107i of the 2001 Directive.]