The Human Medicines Regulations 2012

Free samples for persons qualified to prescribe or supply medicinal products U.K.

298.—(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—

(a) is no larger than the smallest presentation of the product that is available for sale in the United Kingdom;

(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.