agenziafarmaco.gov.it Medical Product Registration Procedure Italy : Medicines Agency

Organisation : Italian Medicines Agency
Facility : Medical Product Registration Procedure
Country : Italy

Homepage : https://www.aifa.gov.it/en/
Details Here : https://www.aifa.gov.it/

Medical Product Registration Procedure

The registration of medicinal products is ensured by the Italian Medicines Agency through the procedures provided by the European set of laws :

Related : Ministry of Foreign Affairs & International Cooperation Italian Citizenship : www.statusin.org/9299.html

** national procedure
** community procedure

Through these procedures and supported by adequate software applications that ensure traceability, transparency and timeliness throughout the registration process, the Agency guarantees :

** homogeneity of the pharmaceutical assistance over the national territory
** access to innovative medicinal products and to drugs for rare diseases

The national procedure allows the marketing authorization of a medicinal product only in Italy, though assessment and registration process complies with the same criteria foreseen by the EU procedures, since the national legislation integrally implements the EU Directives.

The community procedures of marketing authorization of new medicinal products are divided into :
** Mutual Recognition Procedure, allowing the extension of a marketing authorization granted by a Member State to one or more other Countries of the European Union;

** Decentralized Procedure, allowing to obtain a single marketing authorization simultaneously valid in most countries of the European Union for a medicinal product which has been not yet authorized in Europe.

Activities :
AIFA, through the Assessment and Registration Unit, is responsible for the activities related to administrative and technical-scientific assessment of documentation submitted for :

** new Marketing Authorization requests
** variations to the terms of medicinal products already authorized.

In this context the Agency follows all the stages of the process, from the submission of the request to the final release of the marketing authorization (AIC), in accordance with the national procedures and with the Community ones in which Italy is the Reference or Concerned Member State (FORM_AIFA.RMS) – (Mod.309/2).

Such activities are performed for all categories of medicinal products for human use, included biologicals, human blood products, radiopharmaceuticals, medicinal gasses, herbals and homeopathic medicinal products.

Among the further activities related to national procedures, AIFA is competent for : Free Sale Certificates (Certificati di Libera Vendita – CLV or Certificati di Prodotto Farmaceutico – CPP), transfers of marketing authorization holder, depot and updating of DMF, import/export of plasma and human blood products, parallel imports of medicinal products, sale licenses, SIS code assignments.

Within the activities concerning the parallel import/export of medicinal products licensed according to the Mutual Recognition Procedure, AIFA provides the requesting Regulatory Authorities of the other Member States with information regarding some of the identification elements of the medicinal products authorized in Italy.

Aifa is also responsible for the application of the provisions related to the “sunset clause” for all medicinal products authorized in Italy.

Assessment :
Within the assessment process, the Agency deals with the administrative and technical-scientific assessment of the dossier submitted for marketing authorization or variations to the terms of medicinal products for human use under national or Community procedure.

The assessment aims at ensuring adequate standards of quality, safety and efficacy of all the medicinal products, through chemical, pharmaceutical, biological, pharma-toxicological and clinical assessments.

Such assessment is fulfilled with the assistance of the Technical Scientific Commission (CTS), with the co-operation of experts belonging to the National Institute of Health (ISS) and of other experts of well-known experience belonging to the Italian academic and health community.

Moreover, the assessment activities are carried out in close collaboration with the other European countries involved in the assessment process and in accordance with the guidelines issued by the European Medicines Agency and the International Conference on Harmonisation – ICH, that in turns are periodically revised according to the latest ongoing updates in the scientific community. For this purpose AIFA is represented in all the relevant European seats.