Free Sale Certificate

This section refers to a category of certificates regarding different types of products, such as medicinal products for human and veterinary use, medical devices (MDs), in-vitro diagnostics (IVDs), food supplements and other foods, PMCs (presidi medico-chirurgici, medical surgical aids), and cosmetics.

Certificate of Pharmaceutical Product (CPP) for human medicinal products

As far as medicinal products for human use are concerned, it is possible to request a Certificate of Pharmaceutical Product (CPP). When referring to a medicinal product with an Italian MA, this certificate can be only requested by the MA holder or their representative, and it is intended for those extra-EU countries where the local authorisation is to be registered or renewed, or only to export a specific medicinal product. The CPP states that a medicinal product is registered in Italy and meets the prescriptions of the national legislation; it reports the MA number, the date of first registration, the pharmaceutical form, the route of administration, the composition, and the authorised manufacturing sites with the relevant manufacturing steps.

The certificate also states that the manufacturing sites where the medicinal product is manufactured comply with the norms on Good Manufacturing Practice (GMP). This certificate is released by AIFA, and it is in two languages (Italian/English).

Certificate of Pharmaceutical Product only for exportation (Export Certificate) for human medicinal products

When a medicinal product does not have an Italian MA and is consistent with the model recommended by the World Health Organization, it can be exported by submitting a request for an Export Certificate. A certificate for the sole exportation can be requested by either the manufacturer, the exporter, or the Authorities of the importing third country. AIFA certifies that the manufacturer has a license to manufacture medicinal products.

In order to receive the certificate, the reasons for the absence of the Italian MA shall be provided, along with either copy of the MA of the country of destination, or the authorisation application submitted to the Authorities of this country, or the documentation of the Authorities of this country stating that the product is under assessment for one of the following regulatory procedures: registration, renewal, extension, variation, review. 

The reasons for the non registration of the product could be the following: 

• the product was developed only to treat diseases that are not endemic in the exporting country (special tropical diseases);
• the product was reformulated in order to improve its stability under conditions of tropical climate;
• the product was reformulated in order to exclude an excipient that is not approved for pharmaceutical use in the importing country;
• the product was reformulated in order to obtain a different limit of maximum dosage for the active substance.

The Export Certificate is released for a single product, since the manufacturing conditions and the information authorised for the different pharmaceutical forms and dosages can vary.

Certificate of Pharmaceutical Product (CPP) for veterinary medicinal products

This CPP can be requested from the Ministry of Health by all subjects interested to the exportation of veterinary medicinal products, their legal representatives, people or companies delegated by them, including marketing authorisation holders of veterinary medicines. The certificate is released for a veterinary medicinal product even if it has no Italian marketing authorisation, justifying its lack. If referring to a veterinary medicinal product authorised in Italy, it is necessary to enclose the documentation demonstrating such MA.

• The CPP certifies that a manufacturer of veterinary medicinal products has the license to such manufacturing.
• Among other information, the CPP also includes the extra-EU country of destination.

Free sale certificate (CE marking certification) for MDs and IVDs

This is a declaration to be submitted at times to the Authorities of extra-EU countries for the exportation of medical devices (MDs) and in vitro diagnostics (IVDs). These Free Sale Certificates can be requested by the manufacturer or by the authorised representative located in Italy. They are released by the Italian Ministry of Health, either in Italian or in English or in double language (Italian and English), as requested by the company. If requested by the company, the free sale certificate can also specify the address of the manufacturing site.

Free Sale Certificates for PMCs

The FSCs referring to PMCs (presidi medico chirurgici, medical surgical aids) can be requested to the Ministry of Health by the marketing authorisation holders of these products intending to market them in the EU and in extra-EU countries.

In these certificates, released for a single product and indicating one single country of destination, the Ministry declares that the PMC is authorised in Italy according to the Italian Presidential Decree 6 October 1998, no. 392.

Certificate for food supplements, fortified foods, infant formulae, gluten-free foods, growing-up milks, food for special medical purposes

The request of these free sale certificates can be submitted by a food business operator (FBO) only after the product has been notified to the Ministry of Health, it has received a positive opinion, and it results as a “published product”.

• The request can only be submitted electronically.
• The Ministry releases a FSC for a single product.

This document states that the product is duly notified to the Competent Authority, and is therefore present on the Italian market. The FSC is not valid as export certificate.

Free Sale Certificates for cosmetics

The FSCs referring to cosmetic products can be requested from the Ministry of Health by companies intending to export their products outside the European Union.

These cosmetics, if marketed in Italy or in the EU, shall be preliminarily notified in the European portal CPNP. More cosmetic products can be included in the same FSC.

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