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REG-84 version 1 Electronically submitted applications regarding marketing authorisation.

This guideline supersedes guideline REG – 84, as of October 1. 2008.

Decree No 228/2008 Coll., on the marketing authorisation of medicinal products in its Section 3,paragraph 1 stipulates as follows: “Applications and other documentation submitted to the Institute,where products for human use are concerned, or to the Veterinary Institute, where products for veterinary use are concerned, must be submitted in electronic format, unless in special cases agreed otherwise with the Institute where products for human use are concerned or with the Veterinary Institute where products for veterinary use are concerned. Where products for human use are concerned, the applications and other documentation shall be processed in the eCTD electronic format as advised by the Institute; this format shall be also used for information and reports to be submitted in compliance with this Decree in electronic format to the Institute.”

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11 Feb 2009

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Rita Krezo

File Date:

11 Feb 2009

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