The European Medicines Agency (EMA) is responsible for the scientific evaluation of. Voluntary sharing of market launch intentions: pilot project. ![]() European Commission decision on the marketing authorisation. Applicant’s information Regulatory information submitted by an applicant for, or to maintain, a marketing authorisation that falls within the scope of this guidance document. Steps prior to submitting an application (updated) Submission of the application. designated to modify or explore physiological systems or pathological states for the benefit of the. First, the FDA wants to see longer follow-up of trial participants, particularly at least six months of safety data (compared to the two months required for EUA submission). ![]() ![]() Any formulation is prepared for human use i.e. This page lists documents and forms applicants may need for the preparation of their marketing authorisation application with the European Medicines Agency (EMA). Definition Applicant A pharmaceutical company or its agent that is submitting information in support of an application. Dossier 1-4 The word 'Dossier' has the english meaning as a collection or file of documents on the particular subject, especially a file containing detailed information about a person or a topic.
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