Clause 17 - Provision of Medicines and Samples
Clause 17 Definition of a Sample
A sample is a small supply of a medicine provided to health professionals so that they may familiarise themselves with it and acquire experience in dealing with it. A sample of a medicine may be provided only to a health professional qualified to prescribe that particular medicine.
A small sample which is provided only for identification or similar purposes and which is not intended to be used in treatment may be provided to any health professional but is otherwise subject to the requirements of Clause 17.
Titration packs, free goods and bonus stock provided to pharmacists and others are not samples. This is because they are not for the purposes described above.
Titration packs are packs containing various strengths of a medicine for the purpose of establishing a patient on an effective dose.
The supply of a product which is not a medicine because it does not contain the active ingredient normally present is not regarded as the supply of a sample.
Clause 17 Starter Packs
The provision of starter packs is not permitted. Starter packs were small packs designed to provide sufficient medicine for a primary care prescriber to initiate treatment in such circumstances as a call out in the night.
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 requests 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 authorization 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 authorization to include additional strengths and/or dosage forms for existing indications or to include additional pack sizes is not regarded as leading to new medicines.
17.3 Samples may only be supplied in response to written requests which have been signed and dated. An electronic signature is acceptable.
Clause 17.3 Sample Requests
This clause does not preclude the provision of a pre-printed sample request form bearing the name of the product for signing and dating by the applicant.
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 17.2.
Clause 17.7 Control and Accountability
Companies should ensure that their systems of control and accountability relating to medicines held by representatives cover such matters as the security of delivery to them, the security of medicines held by them, the audit of stocks held by them, including expiry dates, and the return to the companies of medicines no longer to be held by representatives.
Samples distributed by representatives must be handed direct to the health professionals requesting them or persons authorized to receive them on their behalf. The provision of medicines and samples in hospitals must comply with individual hospital requirements.
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