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Regulatory Focus™ > News Articles > Regulatory Advice

Regulatory Advice

Posted 01 August 2009 | By

Question: My company is planning to apply for authorization under the repeat-use Mutual Recognition Procedure (MRP) in Europe of a product that was registered in the Reference Member State (RMS) before 26 July 2008. Does Article 7 of the EU Paediatric Regulation apply in our case?

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