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 (c. 83)

TITLE XIII U.K. GENERAL PROVISIONS

Article 125 U.K.

Every decision referred to in this Directive which is taken by the competent authority of a Member State shall state in detail the reasons on which it is based.

Such decision shall be notified to the party concerned, together with information as to the redress available to him under the laws in force and of the time-limit allowed for access to such redress.

[F1 Decisions to grant or revoke a marketing authorisation shall be made publicly available.]

Textual Amendments

F1 Substituted 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.