by In2Pharma | Mar 29, 2023 | News
Europe Due to lack of Notified Body (NB) capacity, lack of access to NB for SMEs, supply chain disruptions (Covid-19, Ukraine war,…),…the MDR implementation is creating bottlenecks in product certification. A new regulation ((EU) 2023/607) has been published, amending...
by In2Pharma | Mar 3, 2023 | News
Europe In January 2023 EMA published a new Q&A with a clarification of Day 0 in the context of local literature review when it concerns physical copies of journals. Marketing authorisation holders (MAH) must review and assess reports of suspected adverse...
by In2Pharma | Dec 15, 2022 | News
Europe EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of...
by In2Pharma | Dec 12, 2022 | News
Europe The Commission Regulation (EU) 2022/2340 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards green tea extracts containing (-)-epigallocatechin-3-gallate has been published on 30 November 2022. This...
by In2Pharma | Dec 2, 2022 | News
Europe A new questions and answers concerning titanium dioxide was published by the EMA. The Q&A, including five questions, gives guidance about the replacement or removal of titanium dioxide in medicines. Titanium dioxide (E 171) is commonly used in the...
