Healthcare professionals (HCPs), healthcare institutions (HCIs), and Health Authorities in some countries may request earlier access to treatments for their patients by requesting a Pre-Registration Import License (PRIL) from Sanofi.
What is a Pre-Registration Import License (PRIL)?
A PRIL is a temporary authorization to import a medicinal product that has already been registered by the Food Drug Administration (FDA) or European Medicines Agency (EMA), but that has not yet been registered in the country from which the request comes and where the product is expected to be launched.
The purpose of this product-supply pathway is to give patients with specific medical needs earlier access to new, approved products.
What are the requirements?
In all situations, the request for a PRIL must come from a HCP, HCI or Health Authority, and the following conditions must be met:
- The unsolicited request applies solely to a recently launched Sanofi product (i.e. new treatment option).
- The Sanofi product must be registered by the FDA or the EMA.
- There must be an existing commitment from Sanofi to apply for the Marketing Authorization Application of the product in the country within 2 years of the request date.
- The unsolicited request comes from Health Authorities, HCIs or HCPs to address the medical needs of patients or a group of patients.
- The Sanofi product will be sold to the requester at a price that is formally agreed by Sanofi and the competent department of the Health Authorities of the country where the request is being made.
- The requester does not intend to use the Sanofi product for clinical trial purposes, directly or indirectly.
- The requester does not intend to sell the Sanofi product to a third party, whether directly or indirectly.
- The PRIL is authorized by regulators in the country where the request is being made.
- The requester complies with all applicable pharmacovigilance requirements in the country where they are based.
- All HCPs and medical staff who will receive the Sanofi product for use will be duly trained on the usage of the Sanofi product, including its safety profile, prior to the use of the Sanofi product.
How to make a request for a PRIL
A request for a product that is not yet authorized, or that is not yet commercially available in a particular country, can be made by:
- the treating physician (i.e., an HCP),
- a representative from the HCI or
- a representative from a local Health Authority.
To make a request, please click on the link below. Sanofi will acknowledge receipt of the request by email within one business day.
Sanofi will evaluate the request in consideration of its internal rules and under the applicable local rules and regulations.
If you have any questions about Pre-Registration Import License (PRIL), please contact the local Sanofi medical team in your country.
Please note that Managed Access Programs are not an option for providing early access to approved treatments. For details, see our dedicated page on Managed Access Programs.