Generic and hybrid applications

The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). To help applicants, EMA has published questions and answers (Q&As) on its position on issues applicants preparing to request marketing authorisation for generic or hybrid medicines typically raise.

Theses Q&As complement the Agency's pre-authorisation guidance.

The Q&As are updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation. Revised topics are marked 'New' or 'Rev.' on publication.

These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

Marketing authorisation holders must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

1. Eligibility and reference product

2. Steps prior to submitting the application

3. Assessment of the application

4. Post-authorisation

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