On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
French sunshine regulations: publication of the governmental order on the unique public website managed by the French authorities
The governmental order on the unique public website set up under the French sunshine regulations was published today. The order provides details on this website, managed by the French authorities, which will make available to the public the information to be reported by the industry under the sunshine regulations.
As a reminder, under the sunshine regulations, companies were expected to publish on their own website such information pending the set up and go live of the unique public website.
The key points to bear in mind regarding this order are the following:
- the unique website will be accessible to the public at the latest on 1 April 2014. Accordingly, the next publication round required under the sunshine regulations will take place on that website. This means that companies will no longer need to publish on their websites information collected as from second semester 2013 nor to transmit this information to the competent professional bodies;
- companies should be able to access the website as from 20 December 2013 (the day following publication of the order). Practical access details are still to be confirmed, but this should enable companies to start very shortly to provide to the authorities the information to be published;
- the responsible authority for managing the website is the French Health Ministry;
- the governmental order sets out details on how companies will access and manage reporting of their information to the authorities, for publication on the website (e.g. data can be transmitted by sending files, inputting the data directly on the website or using a webservice);
- the format for the transmission of the data to the authorities is detailed in the governmental order.
Please click here to access to the governmental order (in French).
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