How to market a blood derived product in France?
Plasma-derived medicine, commonly called blood derived products, are medicinal products prepared industrially out of blood or blood components. They are products of blood plasma fractionation.
The specificities of blood derivatives
The regulation applicable to blood derivatives differs from that applicable to blood or chemical products. The specific regulation applicable to this category of products is provided in the Public Health Code (Art. R5121-181 to R5121-201).
The release of the batches requires an analysis by a state certified organisation;
- The packaging must include three detachable bar-coded labels indicating the name, dosage and pharmaceutical form of the medicinal product, the manufacturer and the batch number;
- The product is subject to specific traceability processes during its administration to the patient;
- Pharmacovigilance involves monitoring from manufacturing to administration and immediate reporting of any suspected adverse reaction;
Documents must be kept for forty years.
Furthermore, blood-derived products prepared out of paid plasma donations are not eligible for a standard MA but only for a renewable 2-year provisional MA (for a registration (MRP or DCP) – Art. L.1221-3 to L.1221-7 and Art.L.5121-11.
Blood derived products in France
In France, and in Europe more generally, blood derivatives have been subject to production tensions and even shortages for years.
This is due, on the one hand, to an increase in patient needs, but also to difficulties in the supply of plasma, which reduces the availability of the base product. Manufacturers are therefore facing difficulties and cannot cover the market’s needs anymore.
To remedy this situation, the ANSM has implemented quotas that define a hierarchy of indications to prioritize the availability of products according to pathologies. Unfortunately, the crisis has exacerbated supply problems following a sharp drop in plasma collection.
The European market will need several months to recover its production capacities since it generally takes nine months between the blood collection operations and the actual availability of the medicinal product.
In the meantime, it is possible to use imported products on a transitory and exceptional basis to partially cover the market’s needs. Cevidra can assist you in this process and in the distribution of the product in the country.
Cevidra’s expertise and know-how
Support offered by Cevidra
Cevidra knows blood derivatives well as several have been included in our portfolio in the past years. We have a good knowledge of local regulation and will help you navigate this complex environment.
Based on this experience, we offer different types of support for projects seeking to bring products to the market or even to sell them:
- Support for the introduction of blood-derived medicinal products on the French market, whatever the status: standard MA, provisional MA, Special Importation
- Communication with public authorities around mandatory procedures, including of reimbursement rights (ANSM, DGOS…)
Labelling for product compliance (low volume)
- Strategic advice for medicinal product registration
- Support to the manufacturer’s operational teams regarding packaging requirements
- Product exploitation including local pharmacovigilance
Communication with hospital purchasing platforms regarding product distribution
Customized support for the marketing in France of a blood derivative used to treat a rare disease.
Support for the exceptional implementation of an import of blood-derived medicinal products following supply tensions in France and support for the registration of product registration.