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Commission Implementing Regulation (EU) No 520/2012Show full title

Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance)

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CHAPTER IX Final provisions

Article 39Data protection

This Regulation shall apply without prejudice to the obligations of national competent authorities and marketing authorisation holders relating to their processing of personal data under Directive 95/46/EC or the obligations of the Agency relating to its processing of personal data under Regulation (EC) No 45/2001.

Article 40Transitional provisions

1.The obligation on the part of marketing authorisation holders, national competent authorities and the Agency to use the terminology provided for in points (c) to (g) of Article 25 shall apply from 1 July 2016.

2.Article 26(2) shall apply from 1 July 2016.

3.The obligation on the part of the marketing authorisation holder to comply with the format and content as provided for in Articles 29 to 38 shall apply from 10 January 2013.

Article 41Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 10 July 2012.

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