Licensing Guidelines and Regulations

Enfoque por país/Italy | Posted 16/05/2012 post-comment0 Post your comment

First posted: 16 May 2012 

Concerning a concept paper on biosimilars published by the Italian Medicines Agency (AIFA), view the following related article:

Italian Medicines Agency publishes concept paper on biosimilars

Italy has a governmental medical service. In 1970, Italy still had approximately 100 different health insurances, which were abolished in 1978. At that time the National Health Service (Servicio Sanitario Nazionale, SSN) was introduced, which covers the entire population [1]. The system is based on the UK NHS model and provides uniform and comprehensive care and delivers the majority of care free of charge [2].

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) is the national authority responsible for drugs regulation in Italy. AIFA is a public body operating autonomously, under the direction of the Ministry of Health and under the vigilance of the Ministry of Health and the Ministry of Economy [3].

The average time for generics to obtain marketing authorisation in Italy is approximately 6.5 months, which is below the EU average of a 7 month delay [4].

AIFA cooperates with the Regional Authorities, the National Institute of Health (Istituto Superiore di Sanità, ISS), research institutes, patients’ associations, health professionals, scientific associations the pharmaceutical industry and the distributor [3].

The registration of medicinal products is ensured by AIFA through the procedures provided by the European Commission laws for both national and community procedures [5].

National procedure
The national procedure allows the marketing authorisation 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 [5].

The activities related to the marketing authorisation of drugs with the national procedure, are aimed at ensuring the unity of medicines availability throughout the country, and access to innovative medicines for rare diseases [6].

With the support of a pool of experts inside and outside the Institute of Health (ISS) and the Scientific-Technical Committee (Comitato Tecnico Scientifico, CTS), for each drug intended to be placed on the Italian market, evaluations of chemical, pharmaceutical, biological and pharmaco-toxicological properties, along with evaluation of clinical trials are carried out in order to ensure safety and efficacy requirements [6].

These evaluations, starting with the first marketing authorisation, are spread over the entire life cycle of the drug and, in particular, for any subsequent amendment to the same (line extensions, extensions of therapeutic indications, etc.) [6].

Community procedure
The community procedures for marketing authorisation of new medicinal products are divided into:

  • Mutual Recognition Procedure, allowing the extension of a marketing authorisation granted by a member state to one or more other countries of the EU
  • Decentralised Procedure, allowing single marketing authorisation to be obtained, which is simultaneously valid in most countries of the EU for a medicinal product which has not yet been authorised in Europe [5]

For generics applications bioequivalence studies are necessary according to the European guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) [7].

Generics may be marketed in Italy once patent protection has lapsed. Patent protection on medicines was only introduced in Italy as late as 1978 [8].

Since October 2010, the AIFA also publishes a list of active substances for which it has started the evaluation procedure for marketing approval. The list only refers to applications submitted under Articles 10(1) and 10(3) of Directive 2001/83/EC (generics pure and hybrid), according to national procedures, decentralised, and mutual recognition, or, for centralised procedures, following the request for grading and price for the same products [9].

Intellectual property
In addition to patent coverage for a period of 20 years, a Supplementary Certificate of Protection was introduced in 1991, which can extend patent protection for a further 18 years. The supplementary term of protection is calculated as the number of years that have elapsed from the date of filing the patent application to the date of the initial marketing authorisation [8]. This prolongation of patent coverage was granted to around 400 active substances between 19 October 1991 and 2 January 1993, prior to the enforcement of European patent supplementary certificates [10].

Over time, the system of the Supplementary Certificate of Protection is being abolished. From 2003 onwards, the supplementary term of protection has been reduced every two years by one year [8].

Data Exclusivity
Under Directive 2001/83/EC, data exclusivity extending for 10 years after European marketing authorisation was granted in Italy. This however was changed to the 8+2+1-year system, which was adopted in 2004. The first generic medicines applications under the 8+2+1-year data exclusivity period will not occur until late 2013 [11].


1. Health service/health insurance in Italy [monograph on the Internet]. c2005 [cited 2012 May 11]. Available from:

2.  Italian Medicines Agency (Agenzia Italiana del Farmaco [AIFA]). PPRI Pharma Profile Italy. October 2007.

3.  AIFA. The Italian Medicines Agency [monograph on the Internet]. AIFA [cited 2012 May 11]. Available from:

4.  European Commission. Pharmaceutical Sector Inquiry Preliminary Report (DG Competition Staff Working Paper). 28 November 2008.

5.  AIFA. Registration [monograph on the Internet]. AIFA [cited 2012 May 11]. Available from:

6.  AIFA. Procedura nazionale (AIC) [monograph on the Internet]. AIFA [cited 2012 May 11]. Italian. Available from:

7.  EMA, Committee for Proprietary Medicinal Products (CPMP), Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) 24 July 2008 [monograph on the Internet] London, UK, EMA [cited 2012 May 11]. Available from:

8.  Simoens S, De Coster S. Sustaining Generic Medicines Markets in Europe. April 2006. [monograph on the Internet]. Brussels, Belgium, European Generic medicines Association (EGA) [cited 2012 May 11]. Available from:

9.  AIFA. Comunicazione AIFA su rilascio AIC di farmaci generici e inserimento nelle liste di trasparenza [monograph on the Internet]. AIFA [cited 2012 May 11]. Italian. Available from:

10.  Espicom. Italy Generics Market Intelligence Report. March 2006.

11.  European Generic medicines Association [EGA]. Data Exclusivity. [page on the Internet]. Brussels, Belgium, EGA c2004 [cited 2012 May 11]. Available from:

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