Directive 2001/83/EC of the European Parliament and of the CouncilDangos y teitl llawn

[F1 Article 21a U.K.

In addition to the provisions laid down in Article 19, a marketing authorisation for a medicinal product may be granted subject to one or more of the following conditions:

(a)

to take certain measures for ensuring the safe use of the medicinal product to be included in the risk management system;

(b)

to conduct post-authorisation safety studies;

(c)

to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Title IX;

(d)

any other conditions or restrictions with regard to the safe and effective use of the medicinal product;

(e)

the existence of an adequate pharmacovigilance system;

(f)

to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 22b while taking into account the scientific guidance referred to in Article 108a.

The marketing authorisation shall lay down deadlines for the fulfilment of these conditions where necessary.]

Textual Amendments

F1 Inserted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).