The Health Service Products (Provision and Disclosure of Information) Regulations 2018 No. 677

PART 2 U.K. Quarterly information about unbranded generic health service medicines

Information to be recorded and kept about supply of unbranded generic health service medicines: medicines wholesalers U.K.

8.—(1) A UK producer who is a medicines wholesaler must—

(a) record the information mentioned in paragraph (2) for each presentation of unbranded generic health service medicine which the producer purchases for supply (including any purchase which requires the presentation to be imported into the United Kingdom) and—

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

(ii) if it is a liquid or a topical preparation, or is in tablet or capsule form, which is in a pack not exceeding the maximum pack size, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 9.

(2) The information is—

(a) the number of packs purchased, and

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

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

(a) record the information mentioned in paragraph (4) for each presentation of unbranded generic health service medicine (other than a presentation which the wholesaler has manufactured) which—

(i) the producer supplies to any UK primary medical services provider or Health Service chemist,

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

(iii) if it is a liquid or a topical preparation, or is in tablet or capsule form, is in a pack which does not exceed the maximum pack size, and

(b) keep that information until it is provided to the Secretary of State in accordance with regulation 9.

(4) The information is—

(a) the number of packs supplied to persons mentioned in paragraph (3)(a)(i), and

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