Regulatory information – adjustment of linguistic review timetable for opinions adopted at December CHMP meeting

2 December 2013

The European Medicines Agency (EMA) has adjusted the post-opinion linguistic review timetable for opinions adopted at the 16-19 December 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP), to take account of the Christmas break. The adjusted deadlines are as follows:

• Sending of draft translations to Member States (usually 5 days after opinion at the latest): the deadline of 24 December 2013 is unchanged. However, given that the EMA will be closed from 23 December this year, companies with opinions for initial authorisation applications and line extensions will exceptionally need to send their translation packages directly to the Member states contact points for translations review for linguistic review;
• Provision of comments by Member States to companies (usually 19 days after opinion at the latest): the deadline has been extended to 10 January 2014;
• Final provision of translations by companies to the EMA (usually 25 days after opinion at the latest): the deadline has been extended to 16 January 2014, excluding referrals. For referrals, for which final translations usually need to be provided 22 days after opinion at the latest, the deadline has been extended to 14 January 2014;
• Final provision of translations by the EMA to the European Commission (usually 27 days after opinion at the latest): the deadline has been extended to 17 January 2014.

Further information can be found in The linguistic review process of product information in the centralised procedure – human guidance document.

The EMA coordinates the linguistic review of product information in all EU languages after the adoption of CHMP opinions, to ensure high quality and consistent product information for centrally authorised products in all Member States.