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Cevidra Guides Your Early Access Strategy in France

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As a pharmaceutical establishment, Cevidra is a committed and trusted partner. We provide tailor-made services to develop long term partnerships with our clients and all our activities are conducted in accordance with GDP & GMP standards. Our authorizations are periodically renewed by the French Health Authority (ANSM).

What is an early access program?

Early Access Programs (formerly Cohort ATU) allow patients facing a therapeutic impasse to access medicines without marketing authorisation for a specific indication. Granted by HAS for one year, access applies to pre-MA products (with MA submission planned) or post-MA products not yet reimbursed by Social Security (AP1 and AP2).

How to apply for an early access?

Early Access applications are submitted digitally to the HAS by the pharmaceutical company, with evaluation taking up to 3 months. A local representative (“exploitant”) is required. Cevidra offers expert support: eligibility assessment, EA strategy, PTU review, labelling, and full assistance throughout the application process via the Sesame platform.

everything you need to know about early access program in France

What is an early access program?

Early Access Programs allow temporary use of non-approved medicines for patients in need, granted by HAS under AP1 or AP2 schemes.

How to apply for an early access?

Early Access applications are submitted digitally to HAS by the company, with a 3-month review, requiring a local representative called “exploitant”.

How to manage an early access?

Once Early Access is granted, the exploitant manages product compliance, data collection, medical information, and pharmacovigilance throughout the program.

How to distribute products under early access?

Once Early Access is granted, hospital-only products must be delivered within 2 months. Cevidra manages storage, delivery, orders, invoicing, and payments.

How is the early access program funded?

Early Access grants full health insurance coverage. The company sets the price, fully reimbursed to hospitals, but must pay annual and retrospective rebates.

what are the different names for EAP?

EAP – Early Access Program

MAP – Managed Access Program

NPP – Named Patient Program

CUP – Compassionate Use Program

EUA – Emergency Use Authorization (often for pandemics or urgent public health needs)

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