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Tag: procedures

1. ISSUES RELATED TO MARKETING AUTHORISATIONS, MARKETING AUTHORISATION PROCEDURES

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC 1.1. Can medicinal products intended for use in COVID-19 patients be marketed in the absence of a marketing authorisation? A marketing authorisation is required before medicinal products can be marketed in the EU. A marketing authorisation granted by the […]