Guidance on submission of Marketing Authorization/Extension, MA Variation and Renewal applications,

Guidance on submission of Marketing Authorization/Extension, MA Variation and Renewal applications, up to the end of the restrictions related to COVID-19 emergencyPlease be informed that, due to COVID-19 emergency and the difficulties that some MA holders are facing, as exception to the provisions given in the guidance published the 7th May 2019, the Marketing Authorizations Department will accept:1.the submission of MA variation and renewal applications/noifications through the relevant portals; the submission of what required in the above mentioned guidance can be postponed2.the submission through CESP of MA/extension applications (N,MR,DC); the submission of what required in the above mentioned guidance can be postponedThe provisions given above are also applicable to responses/additional documents

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