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53 news items
Coronavirus: consequences for applications for production and distribution licences, GMP inspections and certificates
Unfortunately, the current coronavirus situation is also having consequences for applications for licences for the manufacture ...
Implementation of the Medical Device Regulation postponed until 26 May 2021
Due to the coronavirus crisis the European Commission has postponed the implementation of the new Medical Device Regulation (MDR, ...
Veterinary Medicinal Products Unit: submit your application digitally
The Veterinary Medicinal Products Unit (VMPU) requests marketing authorisation holders to submit their applications or reports ...
MEB Portal shut down permanently
For safety reasons, the MEB portal was provisionally taken offline in January this year. Unfortunately, the MEB has had to take ...
Request to take over the Fucidin marketing authorisation
The company Leo Pharma B.V. has informed the Medicines Evaluation Board (MEB) that the production of the antibiotic Fucidin ...
Request to take over the pyridoxine hydrochloride marketing authorisation
The company Pharmachemie B.V. has requested the Medicines Evaluation Board (MEB) to withdraw marketing authorisation for ...
Changes to product information policy
The Medicines Evaluation Board (MEB) recently revised a number of policy documents for pharmaceutical companies relating to the ...
Coronavirus - MEB employees work from home
Complying with the Dutch government guidelines regarding the coronavirus situation, MEB employees will be working from home as of ...
Regulatory Science Magazine 10: Reduction, replacement and refinement of animal studies
This week, the newest edition of the Regulatory Science Magazine was issued. This 10th edition of the online science magazine of ...
Amended policy on DHPCs
The Medicines Evaluation Board (MEB) has amended its policy on Direct Healthcare Professional Communications (DHPCs). This ...