Module 1 2021

30/06/2021

A Marketing Authorisation (MA) in the European Union

 License to sell a medicine  License granted by “Competent Authorities”  Assessment is benefit/risk balance based on:

● Quality; ● Safety; ● Efficacy;  Positive risk-benefit balance in favour of patients and users of products once they reach the market place.

The Organisation for Professionals in Regulatory Affairs

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 Know the Regulatory Landscape and its options; ● Competent Authorities ● Regulations, Guidelines  Know your product and organisation; ● What are the goals and capabilities of your organisation ● Are specific guidelines applicable to your product or indication  Be aware of the consequences of a choice for future development, and (post-)marketing; ● Is it possible to meet commitments made ● What are the marketing and manufacturing capabilities ● Have Health economics or reimbursement been taken into account Some considerations for Strategic Choices to obtain a Marketing Authorisation in the EU

The Organisation for Professionals in Regulatory Affairs

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