Regulation 298 Free samples for persons qualified to prescribe or supply medicinal products

(1)

A person (“the supplier”) may not supply a free sample of a medicinal product to another person (“the recipient”) unless the following conditions are met.

(2)

Condition A is that the recipient—

(a)

is qualified to prescribe medicinal products; and

(b)

receives the sample for the purpose of acquiring experience in dealing with the product in question.

(3)

Condition B is that the sample is supplied to the recipient—

(a)

on an exceptional basis; and

(b)

in response to a request from, and signed and dated by, the recipient.

(4)

Condition C is that, taking the year in which the sample is supplied as a whole, only a limited number of samples of the product in question are supplied to the recipient in that year.

(5)

Condition D is that the sample—

F1(a)

is no larger than the smallest presentation of the product that is available for sale—

(i)

in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or

(ii)

in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;

(b)

is marked “free medical sample – not for resale” or bears a similar description; and

(c)

is accompanied by a copy of the summary of the product characteristics.

(6)

Condition E is that the sample does not contain—

(a)

a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or

(b)

a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).

(7)

Condition F is that the supplier maintains an adequate system of control and accountability in relation to the supply of free samples.

Annotations

Textual amendments

F1: Reg. 298(5)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 215A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 174)