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Focus On Regulation

Insights, analysis, and news about regulatory issues affecting a broad array of industries.

Blog Post

EMA updates guidance concerning medicinal products intended exclusively for non-EU countries

13 September 17

The European Medicines Agency (“EMA”) has updated its guidance (Guidance) regarding procedural advice for medicinal products intended exclusively for markets outside the...

Blog Post

EMA launches new submission form facilitating submission of post-authorisation data

13 September 17

The European Medicines Agency (“EMA”) has issued a new submission form in order to help marketing authorisation holders to submit the post-approval data that is generated to...

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