Greetings from
Freyr Italy
With a mixed public-private healthcare system, Italy attracts medicinal products or device manufacturers from across the globe. At the same time, the requirement for controlled drug / device releases in the market necessitates foreign manufacturers to be more vigilant on the regulations imposed by the Ministry of Health. While Agenzia Italiana del Farmaco, AIFA - the Italian Medicines Agency - is responsible for drug regulations, medical devices are regulated by European Union’s competent authorities.
Freyr, as a global regulatory partner, assists foreign manufacturers in interpreting the Italian regulations and advises them on Regulatory strategies to be implemented for the region for compliant market authorizations. With streamlined and quicker submission procedures, Freyr provides Regulatory support and consulting services in Italy for:
Industries We Serve in Italy
Italy is a prominent EU nation with steady demand for drug and biological products. Italian Medicines Agency is responsible to grant approval for the medicinal products before they are marketed in the country which can be obtained by submitting a Marketing Authorization Application (MAA). As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
Italy is the first market for food supplements in the European Union (EU), and companies operating in the sector find it highly attractive. Food supplements in Italy are regulated by Legislative Decree No. 169/2004, implementing Directive 2002/46/EC. However, it is important to note that a product's classification as a food supplement, dietary supplement, nutraceutical, Natural Health Product (NHP), complementary medicine, health food, health functional food, or health supplement in other markets does not automatically qualify it as such in the EU or Italy.
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence
- End to end support for CE Marking Process
- Redaction of EU CTD dossiers, including preparation of NeeS and eCTD dossiers
- Lifecycle management of medicinal products: updates, variations and renewals
- IDMP
- Pharmacovigilance
- National and European registration and maintenance procedures (MRP and Centralized)
- In-country representation
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase - with Italian Ministry of Health
- Expert Regulatory team with proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines