Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
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1.Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions:
(a)the number of samples for each medicinal product each year on prescription shall be limited;
(b)any supply of samples shall be in response to a written request, signed and dated, from the prescribing agent;
(c)those supplying samples shall maintain an adequate system of control and accountability;
[F1(d) each sample shall be no larger than the smallest presentation on the market;]
(e)each sample shall be marked ‘free medical sample — not for sale’ or shall show some other wording having the same meaning;
(f)each sample shall be accompanied by a copy of the summary of product characteristics;
(g)no samples of medicinal products containing psychotropic or narcotic substances within the meaning of international conventions, such as the United Nations Conventions of 1961 and 1971, may be supplied.
2.Member States may also place further restrictions on the distribution of samples of certain medicinal products.
Textual Amendments
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