European Medicines Agency reminds companies about arrangements before and during Olympic Games
The European Medicines Agency reminds pharmaceutical companies that its activities will be affected by the preparation for the Olympic Games taking place in London in July and August 2012.
Meetings held off-site
The Agency's committee meetings are being held in the offices of medicines regulatory agencies elsewhere in the European Economic Area in late June and July 2012. Companies invited for oral explanations during this period may have to travel to one of these venues instead of the Agency's offices in London.
Information on the meetings that are taking place off-site is available under 2012 Olympic Games. Companies invited to attend for oral explanations at these venues can obtain detailed information on meeting arrangements from the Agency.
Like the Agency, the host regulatory authorities have strict policies for allowing access to representatives of the pharmaceutical industry. Companies will need to supply lists of attendees in advance to the authority hosting the meeting, with only those representatives included on the list of attendees being permitted to enter the premises. Company representatives will need to be accompanied at all times.
Electronic submission of applications
The Agency encourages applicants to connect to the eSubmission Gateway during the Olympic period, to allow for efficient and timely submission of their dossiers.
Companies can use the eSubmission Gateway to send centralised procedure submissions to the Agency in electronic common technical document (eCTD) format instead of sending CDs or DVDs via courier mail.
More information on the eSubmission Gateway and how to get connected is available under eSubmission Gateway.
How useful is this page?
Average rating:Based on 6 ratings
Add your rating:
- See all ratings
1 ratings0 ratings0 ratings3 ratings2 ratings