Information for marketing authorisation holder
- Applications for Changes of the Labelling or PIL Not Associated with SmPC (Type P Variations)
- Applications for Transfers of Marketing Authorisations of Medicinal Products
- Applications for Revocation of Marketing Authorisations of Medicinal Products
- 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
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