Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (Text with EEA relevance) (c. 1235)

Article 3 U.K. Transitional provisions

1. The obligation on the part of the marketing authorisation holder to maintain and make available on request a pharmacovigilance system master file in respect of one or more medicinal products for human use provided for in Article 104(3)(b) of Directive 2001/83/EC as amended by Directive 2010/84/EU, which applies to medicinal products for human use authorised pursuant to Regulation (EC) No 726/2004 by virtue of Article 21 of Regulation (EC) No 726/2004 as amended by this Regulation, shall apply to marketing authorisations granted before 2 July 2012 as from either:

(a) the date on which those marketing authorisations are renewed; or

(b) the expiry of a period of 3 years starting from 2 July 2012,

whichever is the earlier.

2. The procedure provided for in Articles 107m to 107q of Directive 2001/83/EC as amended by Directive 2010/84/EU, which apply by virtue of Article 28b of Regulation (EC) No 726/2004 as amended by this Regulation, shall apply only to studies which have commenced after 2 July 2012.

3. The obligation of the Agency under the second subparagraph of Article 28c(1) of Regulation (EC) No 726/2004 as amended by this Regulation shall apply once the full functionality of Eudravigilance has been announced by the Management Board.