No guidance for revised Variations Regulation…

Sweden 7-9 October – Revision of the Variations Regulation comes into effect 1 January 2010, and with guidelines not yet ready, concern was raised by industry and regulators at The TOPRA Annual Symposium this week.

New variations regulation EC 1234/2008 will apply from 1-Jan-2010. Initially this will cover mutual recognition/decentralised and centralised procedures, for which the latest version of the draft guidelines was circulated to trade associations only last week.

Hilde Boone from the EMEA updated delegates on the status of the guideline. “Commission guidelines have been sent for ‘Interservice Consultation’ with feedback expected mid-October. The finalisation will depend on the amount and nature of comments received. The aim is to publish the final draft guideline(s) in English on the Commission’s website in November 2009 and the publication in the Official Journal in all EU Languages, hopefully in December 2009…”

Zena Smith, Pfizer Ltd reflected on the new regulation and draft guidance. “Industry supports the objectives of the new variations regulations and we are awaiting implementation to assess the effectiveness. However, the lack of final guidelines will make it challenging for industry to meet timelines for the implementation.”

Ms Boone concluded that better regulation, with ‘key-items’ put in place, will allow the handling of variations to become a more efficient and flexible harmonised system in the EU, with the reassurance that regulation foresees regular updating of the guidelines to take account of scientific & technical progress (Art 4(2)).

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