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Clause 21.1 (17) Samples
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 21.
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 in Clause 1.21.
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.
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Clause 21.1 (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.
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Clause 21.3 (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.
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Clause 21.7 (17.7) Control and Accountability
Companies should ensure that their systems of control, quality 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 authorised to receive them on their behalf. The provision of medicines and samples in hospitals must comply with individual hospital requirements.
The supplementary information to Clause 21 defines a sample and what is not a sample.
