Marketing Authorisation Routes in the EU
Marketing Authorisation Routes in the EU
The EU medicines regulatory system and the European Medicines Agency: an introduction for international regulators and non-governmental organisations 18 September 2017
Presented by Maria Nieto-Gutierrez Procedure Management Department
An agency of the European Union
Contents
Who grants MA in the EU National procedures Mutual recognition and decentralised procedures Centralised procedures
Pricing and reimbursement
1 International Regulators ? Awareness Session
Contents
Who grants MA in the EU National procedures Mutual recognition and decentralised procedures Centralised procedures
Pricing and reimbursement
2 International Regulators ? Awareness Session
Who grants a MA in the EU?
? To protect public health and ensure the availability of high quality, safe and
effective medicines for European citizens, all medicines must be authorised before they can be placed on the market in the EU.
? 50 years of EU pharmaceutical legislation
In 1965 the first EU law on medicinal products was adopted Progressive harmonisation of requirements for the granting of marketing
authorisations and post-marketing monitoring has been implemented across the entire EU
? The data requirements and standards governing the authorisation of
medicines are the same in the EU.
3
Who grants a MA in the EU?
4 International Regulators ? Awareness Session
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