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What is m a r c?
m a r c stands for Marketing Authorisation of Regenerated Cell Therapy. It is a regulatory process for the approval of cell therapy products in the European Union.
Who is required to file m a r c?
Manufacturers of cell therapy products seeking approval to market their products in the EU are required to file for m a r c.
How to fill out m a r c?
m a r c application must be filled out in accordance with the guidelines provided by the European Medicines Agency (EMA). It involves submitting data on product quality, safety, and efficacy.
What is the purpose of m a r c?
The purpose of m a r c is to ensure that cell therapy products marketed in the EU meet the necessary standards for quality, safety, and efficacy.
What information must be reported on m a r c?
m a r c requires manufacturers to report data on product characterization, manufacturing process, quality control, preclinical and clinical data, and risk management.
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