Marketing authorisation & regulatory affairs
Advice on marketing-authorisation procedures (national, centralised European, mutual recognition), management of variations, renewals and additional registrations.
→ Health · Sub-expertise
The pharmaceutical industry is one of the most heavily regulated sectors: marketing authorisations, regulated advertising, transparency, pricing, distribution. Non-compliance exposes you to severe sanctions and reputational risk. We support laboratories, contract manufacturers and market players across all their obligations.
→ What we cover
Advice on marketing-authorisation procedures (national, centralised European, mutual recognition), management of variations, renewals and additional registrations.
Compliance of advertising aimed at professionals and the general public, ANSM audits, management of sanctions, training of sales forces.
Compliance with transparency obligations (declaration of conflicts of interest, agreements and benefits), management of the Transparence Santé database.
Negotiation with the CEPS (pricing committee), alignment with the HAS and UNCAM, defence in the event of a price cut or delisting.
Pharmaceutical distribution agreements, hospital vs. community-pharmacy exclusivity, management of supply disruptions, agreements with wholesaler-distributors.
Alignment with pharmacovigilance obligations, management of batch recalls, crisis communication, defence in the event of a claim.
→ Our approach
01
Analysis of the regulatory situation of the product or company, identification of the applicable obligations and the risk areas.
02
Compliance plan, updating of processes, training of teams, alignment with the authorities (ANSM, CEPS, HAS).
03
Support during ANSM or other authority audits, response to observations, negotiation of the outcomes.
04
Defence in the event of administrative or criminal sanctions, appeals before the competent courts (administrative court, Conseil d'État).
→ Who we help
Support for a laboratory in launching a new medicinal product: marketing authorisation, price negotiation with the CEPS, advertising compliance, training of the sales force.
Defence of a laboratory facing an ANSM audit of the compliance of its advertising materials: analysis of the grievances, negotiation, appeal in the event of a sanction.
Compliance audit of transparency obligations (DMOS), updating of internal processes, corrective declaration on the Transparence Santé database, training of teams.
Support for a laboratory experiencing a supply disruption: ANSM declaration, management plan, communication to professionals, alignment with the legal obligations.
→ Q&A
Administrative sanctions (suspension of the marketing authorisation, product withdrawals, financial penalties), criminal sanctions (fines, additional penalties) and reputational consequences. The amounts vary according to the practice and its seriousness, but can be very significant. A preventive compliance approach is essential.
The ANSM grants the marketing authorisation and monitors safety of use. The HAS assesses the medical benefit and the improvement provided. The CEPS negotiates the price on the basis of the HAS assessments. Coordinating these parties is essential for a successful launch.
Healthcare players must declare the agreements and benefits paid to healthcare professionals and students on the Transparence Santé database. The thresholds, deadlines and sanctions are set by law (the Bertrand DMOS law) and its implementing decree.
Immediately mobilise the legal and regulatory teams, secure the relevant documents, accompany the inspectors without exceeding the scope of the audit, formalise the exchanges. A structured and anticipated response limits the risk of sanctions.
→ Go further
Let's talk. We respond within one business day to qualify your transaction and direct you to the firm's most suitable lawyer.
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