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European Medicines Agency Guidance for Applicants …
www.ema.europa.euEuropean Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance . This guidance document addresses a number of questions that users of the s cientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific advice or protocol assistance and gives
Guidance to applicants (Q&A) - European Medicines Agency
www.ema.europa.euEuropean Medicines Agency Guidance for applicants seeking access to PRIME scheme EMA/191104/2015 Page 5/10 PRIME is not the right support tool for you if: You are already in the MAA pre-submission phase (i.e. you have submitted a letter of intent for a MAA). In this case, you should consider alternative tools (e.g. pre-submission meeting request,