Agenzia Italiana del Farmaco Authorisation of medicinal products
Authorisation of medicinal products
In order to be marketed in Italy, a medicinal product must be granted a Marketing Authorisation (MA) by AIFA or the European Commission. The MA is issued following a scientific assessment of the quality, safety and efficacy requirements of the medicinal product.
In order to obtain the MA, the applicant is obliged to submit an application consisting of a dossier containing information on chemical-pharmaceutical, preclinical and clinical aspects, structured according to a standardised format (CTD – Common Technical Document). The data and studies submitted to support the application for MAs shall comply with guidelines defined at European level.
The authorisation procedures provided for in European legislation are:
- national procedure
- Mutual recognition procedure and decentralised procedure
- centralised procedure
- parallel import
Except in certain specific cases, the MA has a 5-year validity and is renewable for a further five years or indefinitely.
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Access to medicinal products
- Early access and off-label use
- Authorisation of medicinal products
- National authorisation procedure
- Mutual recognition and decentralised authorisation procedure
- Certificates of pharmaceutical product with AIC
- Concessionari di vendita di medicinali registrati con procedura nazionale, di mutuo riconoscimento o decentrata
- Centralised authorisation procedure
- Parallel import and distribution
- Summary of product characteristics and Patient leaflet
- Medicinal product supply regime
- Amendments, renewals and expirations of AIC
- Medicine shortages
- Antibiotic medicinal products
- Biological medicinal products
- Vaccines
- Blood derivatives
- Generic medicinal products
- Biosimilar medicinal products
- Orphan medicinal products
- Advanced therapies
- Homeopathic medicinal products
- Allergens
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Nested Applications
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