by In2Pharma | Jun 22, 2021 | News
The Netherlands The Medicines Evaluation Board (MEB) has amended its policy regarding the national implementation of ‘additional Risk Minimization Measures’ (aRMM) (MEB 45). This is still a draft version. The main changes are: 1. Clarification of the...
by In2Pharma | Jun 11, 2021 | News
The Netherlands The Medicines Evaluation Board (MEB) has amended its policy regarding the labeling of medicines for humans (MEB 6). The MEB recognizes the value that pictograms on the packaging can have to clarify the information. Pictograms on the packaging of...
by In2Pharma | Jun 11, 2021 | News
Europe The Commission has published a notice to stakeholders informing them that the mutual recognition and related trade facilitating effects for medical devices between the EU and Switzerland ceased to apply on 26 May. This is linked to the...
by In2Pharma | Jun 11, 2021 | News
Europe Regulation (EU) 2017/745 on medical devices is applicable in the European Union as of 26 May 2021. The Medical Device Regulation (MDR), was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and...
by In2Pharma | Jun 9, 2021 | News
Europe The Unique Device Identification (UDI) System has been introduced under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) which apply respectively as from 26 May 2021 and 26 May 2022. The...
by In2Pharma | Jun 2, 2021 | News
Europe Titanium dioxide (E 171) is currently authorized as a food additive in the EU according to Annex II of Regulation 1333/2008. EFSA has updated its safety assessment of the food additive titanium dioxide (E...
