Entering the EU Market
Deep dive in medicine's registration road map
This webinar took place on May 15th. Click the button below to view it on demand!
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speaker
Managing Director PQE Malta / Quintian Pharma & Global Business Development Manager
speaker
Regulatory Affairs Operations Manager
Senior Associate Partner
moderator
Marketing and Communication Director
What will I learn?
The European Market is the second largest market in the world for pharmaceuticals.
The EU has developed one single market where same rules and harmonized procedures for authorization of medicines apply in all the 27 Member States. Despite this, the European regulatory environment remains one of the most regulated and most complex markets in the world.
Indeed, the EU Market is characterized by several regulatory requirements which can be divided into two groups: licensing and registration requirements and manufacturing requirements.
Licensing requirements covers the registration of the product in one or more EU countries through the presentation of a Technical Dossier.
Manufacturing Requirements concerns the sites where the medicinal product is produced, tested and released for the EU market, and which all need to be according to EU legislation.
Ensuring that all the requirements for the EU are fulfilled is a daunting task and having the right partner is essential to ensure that the business comes to fruition. Together, we are happy to guide you on this journey!
