The Human Medicines Regulations 2012

[F1 PART 2 U.K. Manufacturing, wholesale dealing and brokering

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)

Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day U.K.

2.— (1) Subject to sub-paragraphs (2) and (3), a person (“P”) who is the holder of a wholesale dealer's licence which—

(a) was granted before IP completion day by the licensing authority;

(b) was in force immediately before IP completion day and remains in force on IP completion day (whether or not it is suspended); and

(c) was used by P to distribute a medicinal product, which was imported from an EEA State, by way of wholesale dealing, or to possess a medicinal product imported from an EEA State for such a purpose,

is deemed on and after IP completion day to hold a wholesale dealing licence granted under Part 3 (manufacture and distribution of medicinal products and active substances) that permits the operation of importing medicinal products from an approved country for import for the purposes specified in paragraph (c).

(2) After the end of the period of 6 months beginning with IP completion day, P is deemed to continue hold a wholesale dealer's licence that permits the operation of importing medicinal products from an approved country for import by virtue of sub-paragraph (1) only if, before the end of that period, P has notified the licensing authority in writing of—

(a) P's intention to continue to import medicinal products from an approved country for import; and

(b) either—

(i) P's intention to appoint a responsible person (import) who will carry out the functions under regulation 45AA(4) (requirement as to responsible persons where licence holder imports from an approved country for import) in respect of the licence, or

(ii) that P will only import medicinal products from an approved country for import to which an exemption in regulation 45AA(2) applies.

(3) Unless P has notified the licensing authority as provided for in sub-paragraph (2)(b)(ii), after the end of the period of 2 years beginning with IP completion day, P is deemed to continue to hold a wholesale dealer's licence that permits the operation of importing medicinal products from an approved country for import by virtue of sub-paragraph (1) only if, before the end of that period, P has notified the licensing authority in writing of the name, address and qualifications of a person who—

(a) is included in the register under regulation 45AB(1); and

(b) will carry out the functions under regulation 45AA(4) in respect of the licence.

(4) From IP completion day, until the date on which P notifies the licensing authority of the information specified in sub-paragraph (3), the responsible person in respect of that licence under regulation 45 must carry out the functions under regulation 45AA(4).

(5) As soon as reasonably practicable after receipt of the information specified in paragraph (3), the licensing authority must provide P with written notice that the responsible person (import) is named on the licence.

(6) Where P has notified the licensing authority as provided for in sub-paragraph (2)(b)(ii), the licensing authority must, as soon as reasonably practicable, notify P in writing that the wholesale dealer's licence includes import of a medicinal product from an approved country for import limited to medicinal products to which an exemption in regulation 45AA(2) applies.

Approved country for import list on IP completion day (regulation 18A) U.K.

3.— (1) For the purposes of regulation 18A(1) (approved country for import), during the transitional period, the licensing authority must publish an approved country for import list that includes each EEA State in it.

(2) The licensing authority must not, before the end of the transitional period, exercise its power under regulation 18A(3) to remove an EEA State from the approved country for import list.

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

Qualified persons and approved country for batch testing list on IP completion day (Schedule 7) U.K.

4.— (1) Sub-paragraph (2) applies to a person who—

(a) is acting as a qualified person immediately before IP completion day; and

(b) satisfies the requirements of Part 1 of Schedule 7 (qualification requirements for qualified persons) immediately before IP completion day as they had effect at that time.

(2) The person is to be treated on and after IP completion day as continuing to satisfy the requirements of Part 1 of Schedule 7 if the person would otherwise fail to do so as a result of amendments made to that Part by the EU Exit Regulations.

(3) For the purposes of paragraph 14(1)(b) of Schedule 7 (obligations of qualified person), for the transitional period, the licensing authority is deemed to have made appropriate arrangements with—

(a) each EEA State;

(b) Australia;

(c) Canada;

(d) Israel;

(e) Japan;

(f) New Zealand;

(g) Switzerland; and

(h) the United States of America,

and the licensing authority must, on IP completion day, publish a list that includes those countries under paragraph 14(3) of Schedule 7.

(4) The licensing authority may, in respect of any country specified in sub-paragraph (3)(b) to (h), include that country in the list subject to a condition or restriction as provided for in paragraph 14(4) of Schedule 7, insofar as that condition or restriction was reflected in the appropriate arrangements that existed immediately before IP completion day under Article 51(2) of the 2001 Directive.

(5) The licensing authority must not, before the end of the transitional period, exercise its powers under paragraph 14(6) of Schedule 7 to remove an EEA State from the list it publishes.

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

List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9)) U.K.

5.— (1) For the purposes of regulation 45O(6) (requirements for registration as an importer, manufacturer or distributor of active substances), for the transitional period, the licensing authority must publish a list that includes the following countries—

(a) each EEA State;

(b) Australia;

(c) Brazil;

(d) Israel;

(e) Japan;

(ea) Republic of Korea;

(f) Switzerland; and

(g) the United States of America.

(2) The licensing authority must not, before the end of the transitional period, exercise its power under regulation 45O(9) to remove an EEA State from the list it publishes.

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