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EMA guidelines

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[2018.06.19]Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors 


[2018.06.19]Regulatory and procedural guideline: IRIS quick guide to registration  


[2018.06.19]Regulatory and procedural guideline: Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure 


[2018.06.19]Regulatory and procedural guideline: Committee for orphan medicinal products rules of procedure  


[2018.06.15]Regulatory and procedural guideline: EudraVigilance release notes v.1.15 


[2018.06.11]Regulatory and procedural guideline: Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities 


[2018.06.01]Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) 


[2018.05.25]Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes 




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