Belupo has been recertified for EU GMP to demonstrate our compliance with the international GMP standards and guidelines relating to the development, manufacturing and marketing of medicinal products.
Belupo has been recertified for EU GMP to demonstrate our compliance with the international GMP standards and guidelines relating to the development, manufacturing and marketing of medicinal products.
Recently, after the Agency for Medicinal Products and Medical Devices completed its audit, Belupo was issued a new EU GMP Certificate for its Danica 5 site, which covers Medicinal Products for Human Use and Investigational Medicinal Products for Human Use.
Such EU GMP Certificate shows that Belupo complies with the GMP requirements applicable to the manufacturing and importation of medicinal products and investigational medicinal products and satisfies all legal requirements necessary for its continued operation.
Having obtained this EU GMP Certificate, we will be able to continue to participate in EU markets and markets of other countries accepting our EU GMP Certificate.
Until the next audit, which is scheduled to be performed in three years, Belupo may continue to work on improving and further developing its Pharmaceutical Quality System and Belupo as a whole.
Our EU GMP Certificate is publicly available on the Eudra GMP – Public Layot website.