The Human Medicines (Amendment) Regulations 2013

Amendment of regulation 43

14.  In regulation 43 (obligations of licence holder)—

(a) for paragraphs (7)(c) and (8) substitute—

“(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(1) of the 2001 Directive.

(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)(2) 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.”;

(b) for paragraph (10) substitute—

“(10) The holder (“L”) must verify in accordance with paragraph (11) that any medicinal products received by L that are required by Article 54a(3) 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.”

(1)

Point (o) of Article 54 was inserted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

(2)

Article 76(4) was inserted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

(3)

Article 54a was inserted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).