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GenderSensitive Remittances and AssetBuilding in the PhilippinesThis project is funded by the European Union. ABOUT UN WOMEN UN Women is the UN organization dedicated to gender equality and the empowerment
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UN and EU launch refers to the regulatory submission process for the marketing authorization of pharmaceuticals in the United Nations and European Union markets, respectively.
Companies seeking marketing authorization for their pharmaceutical products in the UN and EU markets are required to file UN and EU launch applications.
To fill out UN and EU launch applications, companies must provide detailed information about the product, including formulation, manufacturing processes, clinical trial data, and compliance with regulatory guidelines.
The purpose of UN and EU launch is to ensure that pharmaceutical products meet safety, efficacy, and quality standards before they are introduced to these markets.
Information that must be reported includes product identity, clinical trial results, safety and efficacy data, manufacturing information, and labeling details.
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