CERTIFICATES OF PHARMACEUTICAL PRODUCT (CPP)
These certificates can only be requested by the Marketing Authorisation Holders (MAH) for those countries where there is the intention to register or renew the authorisation or only to export a specific pharmaceutical product.
CPPs state that the medicinal package is registered in Italy and it is in accordance with the national legislation. It contains the Marketing Authorisation number (AIC number), the date of first registration, the pharmaceutical form, the methods and the routes of administration, the outer packaging, the shelf-life, the authorised manufacturers and the production phases, and the composition.
Furthermore, it states that the manufacturers producing the medical products are in accordance with Good Manufacturing Practice (GMP) norms recommended by the World Health Organization (WHO) and the Directive 2003/94/EC.
When a medicinal product does not have the Marketing Authorisation (AIC) in Italy, but is consistent with the model recommended by the World Health Organization (WHO), it can be exported by presenting a request for an Export Certificate, in accordance with and for the purposes set out in Article 156 of the Legislative Decree of the 24th of April 2006 n. 219 and the €œGuidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce.
This type of certificate is only prepared for a single product as the production and the authorised information for the different pharmaceutical forms and the various dosages can vary.
An export certificate for a non-registered product may be requested for different reasons such as, for example:
- the product has been developed exclusively for the treatment of non-endemic pathologies (particular tropical diseases) in the exporting country;
- the product has been reformulated in order to enhance its stability in tropical climate condition;
- the product has been reformulated in order to eliminate an excipien not approved for pharmaceutical use in the importing country,
- the product has been reformulated in order to obtain a different maximum dose limit for the active substance.
MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVD)
CE marking certification (commonly indicated as CFS)
This consists of a declaration that is sometimes requested for the exportation of medical devices and in vitro diagnostic medical devices to Extra EU countries. Certificates of Free Sale for medical devices can be requested by the manufacturer or by the agent, the distributor or the importer. CFSs are issued by the Ministry of Health both in English and in Italian, according to the requirements of the company. If requested by the company, the address of the production site can be specified on the certificate of free sale.
Specific types of certificates of free sale can also be requested for food supplements, medical surgical aids, cosmetics and medicinal products for veterinary use.
The high quality of active ingredients and pharmaceutical products is guaranteed by compliance with the guidelines of Good Manufacturing Practice (GMP), as expressly provided for in Article 46 letter F) of the Directive 2001/83/EC of the European Parliament and of the Council of the 6th of November 2001, as amended by the Directive 2004/27/EC of the European Parliament and of the Council of the 31st of March 2004.
The strict observance of these rules are duly verified by the AIFA Italian Medicines Agency, the institutional body that has been given the task by the Community in Italy to make inspections at production sites of active substances, intermediaries or medicinal products for human use. Following an inspection, the AIFA issues a certificate of suitability, known as a GMP Certificate.