BlogEntering the EU MarketEU Product Registration Ep.10

EU Product Registration Ep.10

Which are the countries that are willing to inspect regardless of a product dossier? 

A product dossier is not required to obtain a new GMP inspection. However, having a product dossier certainly helps in prioritization. It is important to keep in mind the key concept of prioritization, especially considering the significant influx of inspection requests coming from various parts of the world. 

Is there is any time difference for having a European GMP certificate from different states?

Yes, actually, it depends on the backlog that inspectors from each competent authority have. So we have a variable situation in this case, and it’s quite complex. It is crucial to rely on the most up-to-date information from the market to be properly guided because this is a dynamic landscape that changes over time, influenced by the backlog and other factors such as shortages. For instance, if you are a manufacturer of an essential medicine and several European countries are experiencing a shortage of that medicine, you would be immediately prioritized over other manufacturers. 

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