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      • Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.
      www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines

      Scientific guidelines | European Medicines Agency (EMA)

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  4. www.who.int › guidelinesGuidelines: Norms and Standards for Pharmaceuticals

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  8. www.ema.europa.eu › scientific-guidelinesScientific guidelines | European Medicines Agency (EMA)

    The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines.

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