by In2Pharma | Jul 5, 2022 | News
Europe All Marketing authorisation holders (MAHs) should register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’...
by In2Pharma | Jul 5, 2022 | News
Europe The Commission Regulation (EU) 2022/860 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice has been published on 2nd June 2022. This Regulation entered into force on 22nd...
by In2Pharma | Jun 21, 2022 | News
Luxembourg Since 1st of May 2022 the notification of food supplements in Luxembourg should be done electronically. Since that date, the platform MyGuichet.lu is available without authentication and therefore accessible to all companies. No file submitted on paper or...
by In2Pharma | Jun 21, 2022 | News
Europe EMA published 2 updates of guidelines related to (traditional) herbal medicinal products: Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products:...
by In2Pharma | Jun 21, 2022 | News
Europe At the end of January, EU Regulation 536/014 “Clinical trials” went into force. The entry into force of this Regulation resulted in the parallel updating of some international guidelines. In particular, a new version of the GMP Guide PE016 was...
