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The European Medicines Agency (EMA) has issued guidance for pharmaceutical companies participating in a pilot programme that supports reliance-based submission of post-authorisation changes to multiple non-EU markets at the same time.

Source: https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/reliance-post-authorisation-changes-guidance-pharmaceutical-industry

Region: EU Harmonized (27 Markets)

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