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.