IE: IMB released the final version of their guide on electronic submissions for human medicines

Ireland now joined the significantly increasing group of EU Member States for which national requirements on electronic submissions have been published.

The Irish Medicines Board (IMB) published yesterday their rather short (6 pages) guide on electronic submissions (see link below). Whith that the IMB now accepts and strongly recommends electronic-only submissions, either in eCTD or NeeS format without paper copies or through the IMB’s online portal RIO.

This applies to new applications; responses to validation queries and review of assessment questions, supplementary information, variations, renewals, periodic safety update reports (PSURs), active substance master files (ASMFs) / drug master files (DMFs).

[Source: IMB website]

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