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The EMA serves as the governing authority for the centralized procedure. The European Medicines Agency (EMA) Committee for Medicinal Products is responsible for issuing a single license that is valid in all member states of the European Union. This committee has representatives from each of the EU’s member states. Certain categories of medications, such as those used to treat HIV/AIDS, oncology, diabetes, neurodegenerative disorders, autoimmune disease, and viral diseases, are required to go through this method of gaining regulatory approval.
When it comes to the approval of drugs that don’t have to go through the centralized process, individual EU states are free to develop their own systems and protocols.
It is possible for drugs that have been given marketing authorization in one member state of the EU to get that same authorization in another member state of the EU.
When it comes to products that have not yet been authorized in any EU state and that do not fall under the mandatory centralized process, manufacturers have the ability to submit applications for simultaneous approval in more than one EU state.
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum of information you can provide.
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CEBIS Interantional
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