Find out why the updated EMA-Guideline allows the submission of Art. 13 TPA applications in Switzerland again without restrictions

In December of last year EMA published an updated guideline regarding the transfer of EMA Assessment Reports (AR) to regulatory authorities outside the EU (i.e. also to Swissmedic). In this version of the guideline, only final EMA ARs (which must also comply with EU data protection regulations) would be possible to share with regulatory authorities outside of the EU. In addition, EMA wished to be informed by e-mail which documents have been shared with which authority.

This development would have immensely impacted Swissmedic’s Art. 13 TPA procedure, as draft- or preliminary ARs must also be submitted in addition to the final AR.

The EMA guideline was revised again in March of this year. In this version, EMA states that applicants are allowed to share EMA ARs or inspection documents with non-EU regulatory authorities. The applicants must ensure compliance with EU data protection laws and are responsible for redacting personal sensitive data. The shared documents must clearly recognize the EMA as the source. Applicants are encouraged to notify the EMA by emailing reliance@ema.europa.eu about the sharing, detailing the documents and recipients.

Artikel 13 TPA (HMG): A glimpse at new developments in the EU

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