Baker McKenzie’s Global Compliance News Blog published “Italy: Publication of Annex 21 to the Good Manufacturing Practice Guidelines on the import of medicinal products,” which can be viewed here.
Baker McKenzie’s Global Compliance News Blog published “Italy: AIFA (Agenzia Italiana del Farmaco) – clarifications on the renewal procedure of parallel import licenses” which can be viewed here.
Baker McKenzie’s Global Compliance News Blog published “Italy: Medical Device Coordination Group published a new document on the obligations applicable to importers and distributors,” which can be viewed here.
Baker McKenzie’s Global Compliance News Blog published “Italy: New document on relabeling and repackaging of medical devices” which can be viewed here.
Baker McKenzie’s Global Compliance News Blog published “Italy: New Guidance on translation of labels and repackaging of medical devices,” which can be viewed here.
The Italian Government has blocked the export of 250,700 doses of COVID-19 vaccine to Australia. This decision represents the first application of the newly enacted EU transparency and authorization mechanism for exports of COVID-19 vaccines provided for by Implementing Regulation (EU) 2021/111 of January 29, 2021. This mechanism establishes that, until March 31, 2021, exports of COVID-19 vaccines are subject to the prior authorization by the Member State where products are manufactured with the purpose…