Menu +

Tag: issues

2. MANUFACTURING, IMPORTATION OF FINISHED PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS AND GMP AND GDP ISSUES

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC 2.1. How can changes in the manufacturing/supply chain be implemented swiftly to ensure continuity of supplies to the EU of crucial medicines for treatment of COVID-19 patients? MAHs may experience supply chain/manufacturing disruptions due to manufacturing, distribution and trade […]

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 […]

Coronavirus: EU Commission issues guidelines on testing

Today, as part of the European Roadmap towards lifting coronavirus containment measures, the Commission is presenting guidelines on coronavirus testing methodologies. The guidance aims to support Member States in effectively using testing tools in the context of their national strategies and during the different stages of the pandemic, including when phasing out confinement measures. The […]