CPPs, FSCs, GMPs: starting economic recovery from exportations
In this moment of uncertainty, linked to the unknown evolution of the COVID-19 pandemic, and to the stop to all activities that this caused in March and April, many Italian companies decided to bet everything on exportations to re-start the economic engine of our country.
This also applies to health and hygiene products, from medicines to supplements, from medical devices to cosmetics. Even before the lock-down, the exportation of drugs and other products to European and extra-European countries represented an important profit for our economy, made easier by the use of the certifications acknowledged at international level, ensuring the quality and compliance of the exported products with the norms of the country where they are manufactured.
Such certification is different depending on the type of product, but it works based on the same principle: a competent authority of the state of origin of the product officially certifies that the product is marketed in that country according to the applicable regulations, and that it can therefore be sold freely in the country of destination. Such certification is therefore generally known as “free sale certificate”.
Actually, in the case of (human or veterinary) medicinal products, the more appropriate term is Certificate of Pharmaceutical Product (CPP). CPPs can be requested by marketing authorisation holders directly to the competent authority (usually filling in a dedicated form) to register, to renew the authorisation or simply export a specific product to another country.
In CPPs, our competent authorities (the Italian Medicine Agency for the medicinal products for human use, the Ministry of Health for veterinary drugs) state that the medicine is manufactured in compliance with the legal provisions, and report its details, including the pharmaceutical form, route of administration, immediate container, shelf-life, composition, and even the sites authorised to its manufacturing including the specific manufacturing steps.
In the case of medical devices, the function of the CPP is performed by the Free Sale Certificate (FSC) certifying the CE marking required to export these products in the Countries outside the European Union. A FSC is required also for the exportation of food supplements, PMCs (presidi medico chirurgici, medical surgical aids), and cosmetics. In the case of devices, it can be requested by the manufacturer or by the authorised representative.
A different case is that of GMP certificates, issued to certify that active substances, intermediates, or medicinal products for human use are manufactured in compliance with the guidelines on the Good Manufacturing Practice (GMP), as provided for by the Community regulations. Such certification is issued only following appropriate controls (inspections) at the manufacturing site, to verify that all provisions are met.
Therefore, it can be concluded that the Italian, European and international legislations are able to ensure quality, safety and compliance with the regulations also when marketing products abroad, promoting the exportations that are so good for economy.
Written by: Maria Pia Felici
Foto di Arek Socha da Pixabay
