Summary of comments received during the public consultationĮnhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME).(comments are listed by the number assigned to each stakeholder) Overview of comments received on the reflection paper.Draft reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME).Was published for public consultation between October and December 2015.
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PRIME was developed in consultation with the Agency's scientific committees, the European Commission and its expert group on Safe and Timely Access to Medicines for Patients (STAMP) as well as the European medicines regulatory network. Guidance for applicants seeking access to PRIME scheme.Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME).When preparing their request, applicants should refer to: Applicant's justification template to provide evidence supporting the request (this should be submitted in MS Word format).To report any technical issues with the form, please use the EMA Service Desk portal.) Pre-submission request form - PRIME (select 'Human medicinal products', then 'Eligibility' and 'PRIME') ( Note: The form should be downloaded and saved before being completed, using for example “Save target as” function.PRIME eligibility requests: 2023 deadlines for submission and timetable for assessment.
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