The Human Medicines Regulations 2012

Conditions for holding a wholesale dealer's licence U.K.

Conditions for wholesale dealer's licence U.K.

42.—(1) Regulations 43 to 45 apply to the holder of a wholesale dealer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products).

[F1 (2) Those provisions are regulations 43(2) and (8) and 44.]

(3) The requirements in Part 2 of Schedule 6 apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.

Textual Amendments

F1 Reg. 42(2) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 13

Obligations of licence holder U.K.

43.—(1) The licence holder must comply with the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive.

(2) The licence holder must ensure, within the limits of the holder's responsibility, the continued supply of medicinal products to pharmacies, and other persons who may lawfully sell medicinal products by retail or supply them in circumstances corresponding to retail sale, so that the needs of patients in the United Kingdom are met.

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

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

(b) to ensure their proper distribution.

(4) 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.

(5) Subject to paragraph (6), the licence holder must not sell or supply a medicinal product, or offer it for sale or supply, unless—

(a) there is a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration (an “authorisation”) in force in relation to the product; and

(b) the sale or supply, or offer for sale or supply, is in accordance with the authorisation.

(6) The restriction in paragraph (5) does not apply to—

(a) the sale or supply, or offer for sale or supply, of a special medicinal product;

(b) the export to an EEA State, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that State without a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration by virtue of legislation adopted by that State under Article 5(1) of the 2001 Directive; or

(c) the sale or supply, or offer for sale or supply, of an unauthorised medicinal product where the Secretary of State has temporarily authorised the distribution of the product under regulation 174.

(7) The licence holder must—

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

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

(i) ordered by the licensing authority or by the competent authority of any EEA State, or

(ii) carried out in co-operation with the manufacturer of, or the holder of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for, the product; and

[F2 (c) keep records in relation to the receipt, dispatch or brokering of medicinal products, of—

(i) the date of receipt,

(ii) the date of despatch,

(iii) the date of brokering,

(iv) the name of the medicinal 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,

(vii) the batch number of medicinal products bearing safety features referred to in point (o) of Article 54 of the 2001 Directive.]

[F2 (8) A licence holder (“L”) who imports from another EEA State a medicinal product in relation to which L is not the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or a traditional herbal registration shall—

(a) notify the intention to import that product to the holder of the authorisation and—

(i) in the case of a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004, to the EMA; or

(ii) in any other case, the licensing authority; and

(b) pay a fee to the EMA in accordance with Article 76(4) of the 2001 Directive or the licensing authority as the case may be, in accordance with the Fees Regulations,

but this paragraph does not apply in relation to the wholesale distribution of medicinal products to a person in a third country.]

(9) 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).

[F3 (10) The holder (“L”) must verify in accordance with paragraph (11) that any medicinal products received by L that are required by Article 54a of the Directive to bear safety features are not falsified but this paragraph does not apply in relation to the distribution of medicinal products received from a third country by a person to a person in a third country.

(11) Verification under this paragraph is carried out by checking the safety features on the outer packaging, in accordance with the requirements laid down in the delegated acts adopted under Article 54a(2) of the 2001 Directive.

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

(13) The licence holder must immediately inform the licensing authority and, where applicable, the marketing authorisation holder, 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,

to be falsified.

(14) Where the medicinal product is obtained through brokering, the licence holder must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b).

(15) In this regulation, “marketing authorisation” means—

(a) a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; or

(b) an EU marketing authorisation.]

Textual Amendments

F2 Reg. 43(7)(c)(8) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 14(a)

F3 Reg. 43(10)-(15) substituted for reg. 43(10) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 14(b)

[F4 Requirement for wholesale dealers to deal only with specified persons U.K.

44.— (1) Unless paragraph (2) applies, the licence holder must not obtain supplies of medicinal products from anyone except—

(a) the holder of a manufacturer’s licence or wholesale dealer’s licence in relation to products of that description;

(b) the person who holds an authorisation granted by another EEA State authorising the manufacture of products of the description or their distribution by way of wholesale dealing; or

(c) where the supplier is not the holder of a manufacturer’s licence, where the supply is in accordance with the principles and guidelines of good distribution practice,

but this paragraph does not apply in relation to the distribution of medicinal products directly received from a third country but not imported into the EU.

(2) From 28th October 2013 the licence holder must not obtain supplies of medicinal products from anyone except—

(a) the holder of a manufacturer’s licence or wholesale dealer’s licence in relation to products of that description;

(b) the person who holds an authorisation granted by another EEA State authorising the manufacture of products of the description or their distribution by way of wholesale dealing;

(c) where the medicinal product is directly received from a third country (“A”) for export to a third country (“B”), the supplier of the medicinal product in country A is a person who is authorised or entitled to supply such medicinal products in accordance with the legal and administrative provisions in country A; or

(d) where the supplier is not the holder of a manufacturer’s licence, where the supply is in accordance with the principles and guidelines of good distribution practice.

(3) Where a medicinal product is obtained in accordance with paragraph (1), (2)(a) or (b), the licence holder must verify that—

(a) the wholesale dealer who supplies the product complies with the principles and guidelines of good distribution practices; or

(b) the manufacturer or importer who supplies the product holds a manufacturing authorisation.

(4) Unless paragraph (5) applies, the licence holder may distribute medicinal products by way of wholesale dealing only to—

(a) the holder of a wholesale dealer’s licence relating to those products;

(b) the holder of an authorisation granted by the competent authority of another EEA State authorising the supply of those products by way of wholesale dealing;

(c) a person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale; or

(d) a person who may lawfully administer those products,

but this paragraph does not apply in relation to medicinal products which are distributed by way of wholesale dealing to a person in a third country.

(5) From 28th October 2013, the licence holder may distribute medicinal products by way of wholesale dealing only to—

(a) the holder of a wholesale dealer’s licence relating to those products;

(b) the holder of an authorisation granted by the competent authority of another EEA State authorising the supply of those products by way of wholesale dealing;

(c) a person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale;

(d) a person who may lawfully administer those products; or

(e) in relation to supply to persons in third countries, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned.

(6) Where a medicinal product is supplied to a person who is authorised or entitled to supply medicinal products to the public in accordance with paragraph (4)(c), (5)(c) or (e), the licence holder must enclose with the product a document stating the—

(a) date on which the supply took place;

(b) name and pharmaceutical form of the product supplied;

(c) quantity of product supplied;

(d) name and address of the licence holder; and

(e) batch number of the medicinal products bearing the safety features referred to in point (o) of Article 54 of the 2001 Directive.

(7) The licence holder must—

(a) keep a record of information supplied in accordance with paragraph (6) for at least five years beginning immediately after the date on which the information is supplied; and

(b) ensure that the record is available to the licensing authority for inspection.]

Textual Amendments

F4 Reg. 44 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 15

Requirement as to responsible persons U.K.

45.—(1) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “ responsible person”) who in the opinion of the licensing authority—

(a) has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate to carry out the functions mentioned in paragraph (2); and

(b) has adequate experience relating to those activities and procedures.

(2) Those functions are—

(a) ensuring that the conditions under which the licence was granted have been, and are being, complied with; and

(b) ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of the marketing authorisations, Article 126a authorisations, certificates of registration or traditional herbal registrations applicable to those products.

(3) The licence holder must notify the licensing authority of—

(a) any change to the responsible person; and

(b) the name, address, qualifications and experience of the responsible person.

(4) The licence holder must not permit any person to act as a responsible person other than the person named in the licence or another person notified to the licensing authority under paragraph (3).

(5) Paragraph (6) applies if, after giving the licence holder and a person acting as a responsible person the opportunity to make representations (orally or in writing), the licensing authority thinks that the person—

(a) does not satisfy the requirements of paragraph (1) in relation to qualifications or experience; or

(b) is failing to carry out the functions referred to in paragraph (2) adequately or at all.

(6) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a responsible person.