Can I read Serbia Medical Device Registration Guide on EtoBox?

Serbia Medical Device Registration Guide by Mario Basic is a document available to read on EtoBox.

What is Serbia Medical Device Registration Guide about?

The document outlines the registration requirements for medicinal products in Serbia using the national procedure. It lists 25 documents that must be provided for submission, including GMP certificates, manufacturing licenses, CPP, worldwide registration status, SmPC, PIL, and samples of the finished product with CoA. All documentation in modules 2-5 must be identical to what was approved in the EU via DCP, MRP or CP.

Author

Mario Basic

Language

EN