Certification of Conformity to the Good Manufacturing Practice (cNBF)

The high quality of the active substances and pharmaceutical products is assured by the manufacturers’ compliance with the guidelines on the good manufacturing practice (GMP), as expressly provided for by Directive 2001/83/EC, and as amended by Directive 2004/27/EC. Per

For veterinary medicinal products, the meticulous compliance with these norms is duly verified by the Italian Ministry of Health, that is the official body entrusted by the European Authority with the task of inspecting manufacturing sites of active substances and medicinal products for veterinary use.

Copy of Certificate of Conformity to the Good Manufacturing Practice (cNBF) is released by the Ministry on request of manufacturing sites of veterinary medicinal products and those manufacturing pharmacologically active substances for veterinary use.

Thanks to the presence of several regulatory experts among its staff, Di Renzo Regulatory Affairs can assist companies in applying for GMP certificates, but also in audits of active pharmaceutical ingredients (APIs) and finished products, in Italy and in other EU and extra-EU countries.

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