Changes in Sending Decisions/Notifications/Notices to Physical Entities and Foreign Legal Entities without a Data Box

The State Institute for Drug Control (hereinafter referred to only as the “Institute”) informs marketing authorisation holders about the new method of sending the decisions/notifications/notices concerning applications for marketing authorisation, renewal, variation, transfer of marketing authorisation as well as applications for parallel import authorisation, etc. to physical entities and foreign legal entities without a data box, with effect from November 6, 2013.

In view of the fact that in all of the above specified cases the original of the decision/notification/notice is generated electronically, from November 6, 2013 the Institute will send to physical entities and foreign legal entities without a data box the decisions/resolutions/notifications/notices by postal service in paper form, which the electronic original was transferred to applying the authorised conversion.

This authorised conversion will be carried out in compliance with Act No. 300/2008 Coll., on Electronic Acts and Authorised Document Conversion, as amended by subsequent regulations. It will be possible to check the authenticity of the converted document using the identification number sent together with the converted document on the Czech Point website – https://www.czechpoint.cz/overovacidolozky/search.do;jsessionid=7E772682EFFBC80DE403622F8033C976.

If concurrently with the relevant decision/notification/notice product information (SmPC, PIL, labelling) or possibly the identification sheet are to be sent, these documents will be attached to the converted document. 

 

Marketing Authorisation Branch
5. 11. 2013