Managing the importation of medicinal products into France
An importation is defined as a physical flow organized by a company of medicinal products into France, whereas an exportation is a flow out of the country. Both operations are regulated activities and may be subject to pre-approvals by the ANSM. Our aim is to ensure a smooth flow of medicinal imports and exports and to verify their compliance with the customs regulations in force.
Importation: a process regulated by the ANSM
An import license is not required when a product is already approved in France through a Marketing Authorization or an early access, provided that the import product corresponds to the approved packaging.
For all other medicinal products to be placed on the market/distributed in France, it is necessary to obtain an import license delivered by the ANSM as a pre-requisite to the physical importation. The import license application is a paper-based system placed under the responsibility of a pharmaceutical company. The request is sent to a special division within the ANSM. This step should be undertaken at least 2/3 weeks before the importation.
Cevidra is an authorised importer of products, covering the physical storage and the batch release of imported batches. Cevidra regularly manages requests for importation of products into France and ensures the delivery of the import license in a timely manner.
Importation: a process regulated by the ANSM
After the delivery of the import license by the ANSM, the importation of products is organized by the company designated as the importer within the license’s validity period.
Depending on the country of origin, some steps may be undertaken to facilitate customs clearance which may require:
- The provision of specific documents
The payment of fees
Cevidra takes care of all the operations related to the importation of products and enjoys a privileged partnership with qualified administrative staff to ensure customs clearance whatever the transport used (road, air).
Exportation of products to other markets
A company authorised as wholesaler may export medicinal products to other countries, subject to authorization by the French Health Authority. Cevidra has been registered as an exporting wholesaler since 2015.
What are the options to store & distribute medicinal products in France?
Only pharmaceutical companies that are duly authorized for wholesale activities can store and distribute medicinal products in France.
Secure premises for appropriate storage
Pharmaceutical companies must have secure premises to store medicinal products. These premises are periodically inspected to verify compliance with GDP regulation.
In addition, premises are also purpose-built and maintained to provide adequate environment conditions (hygrometry, temperature) with alert systems to prevent incidents such as temperature excursions.
Cevidra’s premises are protected against intrusions of anyone not allowed to access the pharmaceutical areas. Moreover, Cevidra offers two purpose-built temperature environments for product storage:
Refrigerated temperature (cold storage and backup solution)
Cevidra is equipped with a Building Management System to ensure the complex’s 24/7 monitoring and has all processes in place to manage properly any threat to product safety and quality.
Wholesalers and hospitals use different systems to place their orders. They may use a paper-based system with a fax or a dematerialized procedure (EDI) which requires a special interface to facilitate order entry and stock monitoring. Some orders can be urgent and may require reactivity and organization to ensure quick delivery.
Cevidra has its own logistic platform and a team fully dedicated to logistic and sales operations. Cevidra has a strong expertise in the daily management of the ordering process and is equipped with an ERP to closely monitor inventory and adjust it to any new coming orders.
We offer a customer service to answer questions and queries from our clients.
Medicinal products must be transported by appropriate carriers and can only be delivered to authorised health structures (hospitals, retail pharmacies, wholesalers…). The delivery process is under the responsibility of a pharmaceutical company, even if the transport is outsourced.
Cevidra operates storage and distribution activities in compliance with GDP requirements. Cevidra is open from Monday to Friday between 9:00 and 18:00 and ensures with its preferred partners deliveries around France in 24/48 hours under controlled temperature (no deliveries during the weekend).
Any logistics complaints notified to Cevidra are followed-up until the issue is resolved.
Stock inventory and rolling forecasts
Pursuant to Decree n°2016-993 (July 2016), a close monitoring of stock is required to prevent any shortages or disruptions in supply. The ANSM published guidelines about Shortage Management Plan and safety stock. The implementation of these measures is the responsibility of the exploitant, who is also responsible for the declaration of any risk of shortages to the Agency.
To ensure a full compliance with all of these requirements, Cevidra has implemented adequate processes including the generation of periodic rolling forecasts shared with the MAH, the deployment of key indicators and a weekly control of stocks.
Cevidra uses an ERP system to adequately manage stocks and product status. Acting as exploitant, Cevidra also ensures that shortage management plans are renewed annually with the support of the MAH and submitted to the ANSM, as required.
How can your secondary packaging comply with local requirements?
Compliance with local requirements
Some products may require additional information on the labels to be placed on the French market. It applies for example to:
Orphan medicinal products with multi-lingual pack
Specific categories e.g. blood derivatives for which 3 detachable labels are expected for traceability purposes
Imported products for which the pack is not in French
In this case, the ANSM requires upon MA/import license delivery that these obligations are fulfilled before distributing the products in France. The Agency is responsible for labelling approval.
Labelling operations is considered as a pharmaceutical operation and can only be performed by a pharmaceutical company authorized as a manufacturer and offering a GMP environment.
To support packaging compliance, Cevidra became secondary packaging operations manufacturer in April 2021.
How to ensure the batch release of medicinal products in France?
Medicinal products must be fully released before distribution. Requirements for France are identical to other European countries. This release is performed according to Annex 16 of the EU GMP by a Qualified Person linked to a manufacturing site and ensures compliance of the batch with the MA.
As a manufacturer, Cevidra provides EU Qualified Persons with experience in batch release activities. Release by Cevidra is possible for:
Batches manufactured by Cevidra (secondary packaging only)
Batches imported by Cevidra from EU, MRA countries or Third Countries
Cevidra has all processes in place to cover all the different scenarios and to guarantee compliance with GMP requirements.