Module232025

07/05/2025

Global Marketing Authorisation

When a medicinal product has been granted an initial marketing authorisation, any additional strengths, pharmaceutical forms, administration routes, presentations as well as any variations and extensions shall be viewed as part of the same Global Marketing Authorisation

PIP required for marketed products on patent (article 8), if further developments are being done or planned: New pharmaceutical form/New indication/New route of administration

The Organisation for Professionals in Regulatory Affairs

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What should the PIP cover?

Article 8 applications for authorised products should cover all existing and new indications, pharmaceutical forms and routes of administration with a view to agreement on a single comprehensive PIP.

A single application should cover the proposed research and development programme for a future single marketing authorisation application.

Where the product is developed in stages and for different conditions, the applicant may apply for separate PIPs (one PIP for each condition!!).

The Organisation for Professionals in Regulatory Affairs

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