Information for marketing authorisation holder
- Notification of Request for Exemption to Continue Medicinal Product Batch Control Testing in the United Kingdom (UK) after Brexit
- Waiver of Reimbursement of Costs for Additional Strengths/Pharmaceutical Forms of a Particular Product upon Take-over of the Role of the RMS Due to Brexit
- Reminder of the method of provision of information upon suspension or termination of marketing of medicinal products
- Centralised Procedure Documentation – change in submission to Czech NCA
- Changes in Sending Decisions/Notifications/Notices to Physical Entities and Foreign Legal Entities without a Data Box
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