- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (09/02/2019)
- Gwreiddiol (a wnaed Fel)
Version Superseded: 31/12/2020
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The Human Medicines Regulations 2012, Section 298 is up to date with all changes known to be in force on or before 26 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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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.
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