Compassionate Use

#PreApprovalPrograms #CompassionateUse #EarlyAccess

Cevidra offers services for compassionate use for your medicinal products in France before the commercial launch.

How to provide products on a named patient basis?

Cevidra acts as local representative in France for companies located outside the country. In this context, Cevidra offers these companies the supply chain needed to deliver products under compassionate access to French patients.

After signing a contract with product “owner”, Cevidra’s role is to facilitate access to these products for hospitals, offering:

  • French speakers

  • Importation of products into France

  • Qualified storage room (ambient and cold room)

  • Dematerialized ordering process

  • Product delivery in 24/48 hours

  • Invoicing & cash collection

What are the obligations before delivering products under compassionate use?

As the access to these treatments is regulated by the ANSM, delivery to hospitals is subject to a pharmaceutical control of the product access form. This assessment is based on:

  • Verification of the validity period

  • Patient anonymisation

  • Product identification

  • Approval of the request by the French Health Agency (ANSM)

Cevidra has all the processes and the operational procedures in place to ensure the full compliance of these activities with regulations in force.

How to manage Medical Information requests for these products?

For products under compassionate use, medical information requests can raised by hospitals. Cevidra ensures the reception and treatment of all MedInfo requests and liaises with the Marketing Authorization Holder (MAH) to provide the adequate answer to the hospital in a timely manner.

Are the products subject to public tenders under compassionate use?

Products under compassionate use are delivered to hospitals only. Some of these products can be included in public tenders for the hospital reserve. They are usually part of a specific catalogue which groups together all the products with compassionate use status. Demands for public tenders are periodically published and renewed, which requires continuous monitoring to avoid missing an offer.

Cevidra has a strong expertise in hospital reserve that are subject to public tenders. Cevidra closely monitors all the tender publications related to products on its portfolio and liaises with the MAH to validate the participation to each tender.

Key takeaways