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The European Medicines Agency's scientific guidelines on the hybrid approach for veterinary medicines help applicants to prepare marketing authorisation applications under Article 19. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements set in Regulation (EU) 2019/6.
The European Medicines Agency (EMA) publishes the opinions of medical device expert panels on Class III implantable devices and Class IIb devices intended to administer or remove medicinal products.