Pharmacovigilance system master file

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Master file

— a detailed description of the pharmacovigilance system applied by the holder of the registration certificate in relation to data on one or more registered medicinal products (Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 N 87 On Approval of the Good Practice Rules for Pharmacovigilance of the Eurasian Economic Union)

Our experts will conduct a detailed analysis of the existing pharmacovigilance system of the applicant, give recommendations on making the necessary changes to the standard operating procedures, develop a master file in full compliance with the norms and requirements

All the nuances and suggestions are discussed. To clarify the details or order a service, you can use the form.

Familiarization with the structure and basics of the master file

You can familiarize yourself with the description, structure of the master file and the requirements for it on the basis of the Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 N 87 On Approval of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union