Home » EMA Outlines the Regulatory Path for Combination Device Products
EMA Outlines the Regulatory Path for Combination Device Products
December 13, 2010
Sponsors of combination products in the EU are advised to have a pre-submission meeting with the relevant notified body at least six months before they expect to submit their application, a proposed guideline from the European Medicines Agency (EMA) says. Includes the full text of EMA’s Draft Procedures for Ancillary Products.
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