Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to 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 usenote, and in particular Article 23b(2a) thereof,Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agencynote, and in particular Article 16a(3) thereof,Whereas:
(1)The Bulgarian, Dutch, Estonian, Greek, Lithuanian and Polish language versions of Commission Regulation (EC) No 1234/2008note contain an error in Article 20(1), as regards the legal obligation of the marketing authorisation holder to follow the worksharing procedure laid down in paragraphs 3 to 9 of that Article. The error alters the meaning of the provision, affecting its substance.
(2)The Bulgarian, Dutch, Estonian, Greek, Lithuanian and Polish language versions of Regulation (EC) No 1234/2008 should therefore be corrected accordingly. The other language versions are not affected,
HAS ADOPTED THIS REGULATION:
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.