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In what format should the submitted documentation be since the Amendment to the Act on Pharmaceuticals? If documentation is not in the eCTD format, should an exemption still be applied for?

The obligation to submit documentation in the eCTD format is stipulated in the Decree No. 228/2008 Coll., on the Marketing Authorisation of Medicinal Products, not on the Act on Pharmaceuticals. Therefore, an application for exemption from the eCTD format shall be submitted pursuant to REG-84, as has been the case so far.