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23/11/2009 - HMA: All NCA's ready to accept electronic only The HMA (Heads of Medicines Agencies) published a special press release regarding e-submissions: The HMA notes that not all NCAs are ready to accept an electronic-only submission from 1 January 2010. An electronic-only submission is defined as an application for a marketing authorisation in electronic format without paper copies, except for cover letter, application form or other specific documents mainly for the sake of having a signed document. The status on e-readiness will be updated when new information becomes available. HMA will intensify the work on e-submissions and readiness by involving CMDs and TIGes and open up for discussions with industry associations during 2010. The above information concerns applications for medicinal products for human use. The intention is to also publish the status for veterinary medicinal products when this information is available. |
Submission Preparation and Management
Regulatory Affairs

