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EMA guidelines

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[2017.09.18]Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance 


[2017.09.04]Regulatory and procedural guideline: European Medicines Agency procedural advice on medicinal products intended exclusively for markets outside the Community under Article 58 of Regulation (EC) No 726/2004 in the context of cooperation with the World Health Organization 


[2017.08.30]Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure 


[2017.08.30]Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes 


[2017.08.30]Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes 


[2017.08.30]Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure 


[2017.08.24]Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes 




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