Clause 21 Provision of Medicines and Samples
(17.1) Samples of a product may be provided only to a health professional qualified to prescribe that product. They must not be provided to other relevant decision makers.
(17.2) No more than four samples of a particular medicine may be provided to an individual health professional during the course of a year.
Samples of a particular medicine may be provided to a health professional for no longer than two years after that health professional first requested samples of it.
Notwithstanding the above, when a new medicine is marketed which is an extension of an existing product, samples of that new medicine can be provided as above. A ‘new medicine’ in this context is a product for which a new marketing authorisation has been granted, either following the initial application or following an extension application for a new indication that includes new strengths and/or dosage forms. Extension of a marketing authorisation to include additional strengths and/or dosage forms for existing indications or to include additional pack sizes is not regarded as leading to a new medicine.
(17.3) Samples may only be supplied in response to written requests which have been signed and dated. An electronic signature is acceptable. All signed and dated written requests for samples should be retained for not less than one year.
(17.4) A sample of a medicine must be no larger than the smallest presentation of the medicine on the market in the UK.
(17.5) Each sample must be marked ‘free medical sample – not for resale’ or words to that effect and must be accompanied by a copy of the summary of product characteristics.
(17.6) The provision of samples is not permitted for any medicine which contains a substance listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the medicine is not a preparation listed in Schedule III to that Convention) or a substance listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the medicine 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).
(17.7) Companies must have adequate systems of control and accountability for samples which they distribute and for all medicines handled by representatives. Systems must clearly establish, for each health professional, the number of samples supplied in accordance with Clause 21.2.
(17.8) Medicines which are sent by post must be packed so as to be reasonably secure against being opened by young children. No unsolicited medicine must be sent through the post.
(17.9) Medicines may not be sold or supplied to members of the public for promotional purposes.
(17.10) Samples must not be provided simply as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. Samples must not be given for the sole purpose of treating patients.