F2TITLE VIIIaINFORMATION AND ADVERTISING
Article 96
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;
F1d
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.
Inserted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.