Pharmaceutical exports to Italy, ready for AIFA authorisation

Yes. Progene Pharma manufactures generic medicines in an EU-GMP and WHO-GMP certified facility and supplies them to marketing authorisation holders, importers, wholesalers and tender suppliers in Italy.

Yes. Progene Pharma prepares the manufacturing and quality documents an application needs: the CTD dossier, stability data, the GMP certificate and the manufacturing details. Your Italian company files the application, and we answer AIFA's questions with you.

Yes. The authorisation is held by a company established in the EU or EEA, usually the importer or distributor. Check the current requirements with AIFA.

Italy can authorise a generic nationally, or through the decentralised or mutual recognition procedures that let one assessment serve several EU countries. The right route depends on the product and on where else you plan to sell. Tell us the product and the countries and we will say which fits.

The usual set is the CTD dossier, stability data at European conditions, the manufacturer's GMP certificate and manufacturing details, bioequivalence data for most generics, the active substance master file details and product information. AIFA updates its requirements from time to time, so confirm the current list with AIFA or your regulatory consultant. We tell you what we can provide with your quotation.

A Qualified Person at an authorised importing site in the EU or EEA tests and certifies each batch before it goes on sale. Your importer normally holds that authorisation, and we supply the batch documents the Qualified Person needs. Check the current rules with AIFA.

Health care is organised by region, so each region or local health authority buys its own medicines through tenders. A manufacturer who can meet the document and supply requirements can sell across several regions.

Yes. Labels and leaflets for the Italian market are in Italian, following the EU templates. We prepare the artwork to match your authorisation, and you approve a proof before printing.

Italian text following the EU product information template, the authorisation number, batch number, expiry date, storage conditions, Braille on the carton and the safety features prescription medicines carry. We prepare the artwork to match your authorisation and you approve a proof before printing.

Yes. Progene Pharma tests products at 25 °C and 60% relative humidity (climate Zone II), the condition European authorities ask for, and packs them in moisture-resistant blisters or bottles, so the shelf life on the pack is valid.

Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.

Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Genoa or La Spezia, or by air to Milan for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.

It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.