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New online reporting form for adverse events in animals
Belgium The FAMHP has developed a new online form for reporting suspected adverse events of treatments in animals. In this way the safety profile of the medicines can be improved. At www.eenbijwerkingmelden-dieren.be or...
Public consultation on aRMM policy
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 assessment...
Public consultation on labeling policy
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...
Medical devices: Mutual Recognition Agreement (MRA) Switzerland not signed
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...
Medical Device Regulation comes into application
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...
Launch of Unique Device Identification (UDI) Helpdesk
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...
Titanium dioxide (E171) no longer considered safe when used as a food additive
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...
Structured Dialogue with the EU commission to prevent shortages
Europe An important piece of the new Pharmaceutical Strategy adopted in November 2020 by the von der Leyen Commission is represented by the structured dialogue with the actors of the pharmaceuticals manufacturing chain in order to better identify causes and drivers of...
Sartan Medicinal Products: EMA’s Assesment Report defines Nitrosamine Limits and Reporting Deadlines
Europe In a final assessment report, the EMA has published important information for marketing authorisation holders of angiotensin II receptor antagonists (sartans) regarding nitrosamine contamination limits and deadlines for risk mitigation measures. On 2 April...
Release of FarmaStatus 2.0 by FAMHP
Belgium FarmaStatus is the online application that collects information about the availability of medicines in Belgium. The application shows when medicines are temporarily unavailable, when the commercialization was temporarily or permanently stopped and when...
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