EU Product Registration Ep.8

As we understood, you can either have or not have a product dossier when requesting a GMP inspection. However, the specific cases may vary depending on the location of the site. But which locations are we referring to? 

According to European law, if the product is manufactured outside of Europe, you must have a release site in Europe as well. This is a legal requirement.
Generally speaking, European authorities require them to come and inspect a foreign site only if it is linked to the supply of medicine to European patients. This is because their final goal, aim, and scope of their work is to ensure that European patients have therapeutic options and medicines available. Therefore, in order to trigger an inspection, the majority of European authorities require you to file for registration of a medicine for European citizens. Only some European authorities actually inspect foreign sites when the European batch release site is located on their territory. So, this is not something that is applied by all competent authorities. If you are a foreign manufacturer, you can be sure they will inspect you and they will be interested in routinely re-inspecting you if you are involved in manufacturing and supplying medicine to European citizens. In some cases, yes, we have some European authorities who come to inspect, but you must be linked to a European batch release site located on the territory of those few competent authorities. 

Can one request authority for GMP certification inspection without filling a product to the EU? 

Yes, there are only a few European authorities who may be interested in inspecting companies that have not filed. However, this is becoming increasingly difficult. In this case, you should expect that you will not be prioritized as a site, so there may be delays in being inspected by European authorities.

It’s important to note, that this is not relevant for companies that wish to register for the European market, as those companies require a European GMP inspection. However, for companies that are not interested in the European market, there is always the option, if their medicine is eligible, to apply for the pre-qualification program at the World Health Organization. This serves as an alternative option where they can have an alternative approach.