The Health Service Products (Provision and Disclosure of Information) Regulations 2018

Valid from 01/08/2018

Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers U.K.

13.—(1) A UK producer who is a medicines wholesaler or an importer must—

(a) record and keep the information mentioned in paragraph (2) for each presentation of imported special health service medicine—

(i) which the producer purchases for supply, and

(ii) which is, in the month in which the producer purchases it, listed in a Drug Tariff, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 14.

(2) The information for a presentation is—

(a) the number of packs purchased, and

(b) the net purchase amount paid, or a reasonable estimate of the net purchase amount paid, for that purchase.

(3) A UK producer who is a medicines wholesaler or an importer must also—

(a) record the information mentioned in paragraph (4) for each presentation of imported special health service medicine which—

(i) the producer supplies to any relevant person, and

(ii) is, in the month in which the producer supplies it, listed in a Drug Tariff, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 14.

(4) The information for a presentation is—

(a) the number of packs supplied to relevant persons, and

(b) the net sales income, or a reasonable estimate of the net sales income, for that supply.

(5) In this regulation, “relevant person”—

(a) in relation to a producer who is an importer, means—

(i) a UK primary medical services provider,

(ii) a Health Service chemist, or

(iii) a medicines wholesaler;

(b) in relation to a producer who is a medicines wholesaler, means—

(i) a UK primary medical services provider, or

(ii) a Health Service chemist.