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Article 61(3) Notification

Pharmexon offers expert guidance and comprehensive support for Article 61(3) notifications, which are essential for managing changes to a product’s labelling or patient leaflet. We help clients navigate the regulatory requirements and ensure that all necessary documentation is accurately prepared and submitted in compliance with current regulations.

With a deep understanding of the latest regulatory updates, Pharmexon provides tailored advice to ensure your product meets the required standards and remains in full compliance throughout the process. Our team stays constantly informed about regulatory changes, allowing us to offer accurate and timely guidance for any Article 61(3) notification.

Why

Choose Pharmexon for Article 61(3) Notifications

Expert Guidance for Labelling Changes

We help you navigate the intricacies of labelling and patient leaflet changes, ensuring compliance with Article 61(3) while minimizing regulatory risks.

Comprehensive Documentation Preparation

Pharmexon prepares all the necessary documentation and ensures it meets the required standards, facilitating a smooth submission process.

Ongoing Regulatory Monitoring

Our team keeps track of the latest regulatory changes and updates, ensuring that the advice and support we provide is always based on the most current information.

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+420 602 378 935

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Pharmexon Consulting s.r.o
Štěpánská 65, Prague 1
11000 Prague, Czechia