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Notifying a change of marketing status for centralized procedures

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On 26 July 2021, EMA has launched the IRIS platform, a secure online platform to report marketing status changes and withdrawn product notifications of centrally authorised medicinal products (CAPs) to EMA.The marketing status overview will provide to EMA and...

Nitrosamines – step 2 (confirmatory testing)

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

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

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

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 Device Regulation comes into application

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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We are looking to expand our team with a Regulatory Affairs or Medical Affairs colleague who has the ambition and potential to grow in our organization. All projects within IN2Pharma are worked on in small teams of 2-5 people and for some projects, you also work on site at the clients’ offices for (max.) 1 or 2 days per week.

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