EMA Legalizations
The EMA (European Medicines Agency) is the European body that issues Certificates of Pharmaceutical Product (CPPs) to pharmaceutical companies. The aim of the EMA is to approve medicinal products for humans and animals for marketing authorization in European member states and whether pharmaceutical companies adhere to required manufacturing guidelines.
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What is a CPP export document?
The pharmaceutical companies that apply for a CPP are often manufacturers, but they can also only be exporters of medicinal products. With the help of a CPP export certificate, authorities of an importing country outside the EU are more easily informed.
The certificate declares:
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In which country the product is registered
That the producer mentioned on the certificate has the necessary manufacturer's licenses to make the pharmaceutical product
An EMA export document (CPP) stating that a pharmaceutical product is registered in the Netherlands means that:
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The drug is authorized on the Dutch market
There is a manufacturer's license that shows the company that they can make the medical products
The pharmaceutical company adheres to GMP (Good Manufacturing Practices) during the preparation of the pharmaceutical product
How does an ema legalization work?
EMA documents are now digitally certified. For use abroad, this CPP must be printed and legalized by the Ministry of Foreign Affairs and the embassy of the destination country.
EMA
The European Medicines Agency approves a company's submitted application for a pharma product and issues a CPP certificate
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Ministry of Foreign Affairs
The Ministry of Foreign Affairs can then continue to legalize a document issued by the EMA
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Embassy
Legalization of the embassy is the last step of the process.
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The certificate is officially recognized in the destination country
Enable KES Legalization?
At KES Legalization we can help you to apply for EMA certificates. We therefore have authorization for various companies to directly receive CPPs for pharmaceutical companies. This way we can immediately process the required legalization process and it is not necessary to wait.
Would you like to know what the possibilities are for your organization? Request a no-obligation quote to calculate the duration and costs of an EMA legalization.
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