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EMA guidelines

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[2018.04.19]Regulatory and procedural guideline: Qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD), adopted 


[2018.04.18]Regulatory and procedural guideline: Q&A - European Medicines Agency guidance for companies requesting classification as minor uses minor species (MUMS) / limited markets, adopted 


[2018.04.13]Regulatory and procedural guideline: EudraVigilance release notes v.1.12 


[2018.04.09]Regulatory and procedural guideline: Public Hearing - Guidance for participants 


[2018.03.28]Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes 


[2018.03.26]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) 




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