Reminder: CAP Conversion Conditions
Marketing Authorisation holders who converted centralised products into GB MAs from 1 January 2021 are reminded to complete the actions necessary to retain continued authorisation.
By 30th June 2021
Submit the following minimal information for each product:
- A completed memorandum document using the template provided within the application and authorisation explainer on our information hub.
- For pharmaceutical products only; finished product specification and active substance specification
- Flowchart of the final manufacturing process
By 1st January 2023
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Submit full baseline dossier. A copy of the full data dossier for each product which is current at the time you send it. This must include the open part of the Active Substance Master File (ASMF). There is no need to remove any EU references.
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MAHs must ensure the ASMF holders send the latest version of the restricted part of the ASMF to VMD via our Veterinary Medicines Digital Service (VMDS). ASMF holders must clearly identify which GB MA number and product name the ASMF relates to.
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Submit a variation application to update your packaging, to include your new Vm number and any other related changes. See application and authorisation explainer.