Here what should be done by company wishing to import drugs from parallel markets
Parallel market (importation) is founded on the principle of free movement of goods inside the inner (European) market.
In the pharmaceutical sector, parallel importation benefits from the price differences, since Member States fix or control the price of the medicinal products sold in their respective markets.
Parallel importation is therefore a way to import drugs from a Member State of the European Union or of the European Economic Area, stocking good at cheaper prices than those of the national market.
Importation into Italy
The parallel importation medicines shall have the same therapeutic effects as well as the same use safety of the product authorised in Italy.
In order to carry out parallel importation, it is necessary to obtain a specific authorisation from the Italian Medicine Agency (AIFA), that controls the conformity of the imported drug with the one authorised in Italy.
The steps below should be followed to apply for a parallel importation authorisation (AIP):
- Submit an application to AIFA, including the documentation requested in “Check List” available on the AIFA website, such as regulatory information of the product to be imported and the relevant comparison vs. the reference product in Italy, the product information of the medicinal product to be imported to Italy (SmPC, Package Leaflet and labels), the re-packaging proposed for the Italian market, the manufacturing authorisations of the sites proposed for repackaging, the fee payment receipts, etc.;
- Wait for the outcome of the procedure from AIFA, that can be either positive, or negative, or subordinated to provisions or changes. In case of positive outcome, AIFA releases a parallel authorisation importation (AIP) with a validity if five years and that can be renewed on request of the MA holder. In case of negative or subordinated outcome, the applicant is allowed to submit comments or integrations;
- Meet the conditions and obligations provided for by the parallel importation authorisation, including the compliance with the regulations on pharmacovigilance and on batch traceability, the conformity of the package leaflet and labelling of the imported with the one authorised in Italy, quality assurance and safety of the imported product;
- Make the required changes in the imported product, such as the change of label or packaging, in compliance with the provisions of AIFA and of the competent authorities of the country of origin;
- Comply with the good manufacturing practice, good distribution and pharmacovigilance practice ensuring the quality, safety and efficacy of the imported products.
Di Renzo Regulatory Affairs can assist companies in all these steps, offering a regulatory advice, technical and scientific support, managing administrative procedures and monitoring all activities.
Di Renzo Regulatory Affairs has a team of qualified experts, up-to-date with the novelties of the regulations and with the needs of the pharmaceutical market. Contact us and see how we can help you to fulfil your projects of drug parallel importantion.
Written by Valeria Cardinale on 20/09/2023
Foto di Miguel Á. Padriñán da Pixabay
