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Instructions for MAHs for the submission of aRMM and DHPC in Luxembourg
Luxembourg The Luxembourg national competent authority Division de la Pharmacie et des Médicaments de la Direction de la Santé has published 2 new documents. Instructions for marketing authorization holders for preparation and submission of additional risk...
Notifying a change of marketing status for centralized procedures
Europe On 26 July 2021, EMA has launched the IRIS platform, a secure online platform to report marketing status changes and withdrawn product notifications of centrally authorised medicinal products (CAPs) to EMA.The marketing status overview will provide to EMA and...
Quality documentation for medicinal products when used with a medical device
Europe EMA published a guideline, effective from 1 January 2022, on quality documentation for medicinal products when used with a medical device (first version). The guideline describes the information that should be presented in the Quality part of a MA dossier for a...
Compliance and Ethics: new guidelines help companies partner with patient organisations (EU)
Europe On 3 June, MedTech Europe published a Guidance on the Interactions between the Medical Technology Industry and Patient Organisations (PO). The aim of this Guidance is to explain the rationale underpinning current interactions between the MedTech industry and PO...
Nitrosamines – step 2 (confirmatory testing)
Europe Marketing authorisation holders should review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine...
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...
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