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19 January 2016 EMA/327516/2014 Rev. 3 Information Management EMA splitting of the full presentation name of the medicinal product best practice Procedure and principles to handle product name in
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EMA splitting of form refers to dividing a single EMA (European Marketing Authorization) into multiple smaller marketing authorizations.
Companies or individuals holding the EMA who wish to split it into smaller marketing authorizations are required to file the EMA splitting form.
The EMA splitting form can typically be filled out online through the respective regulatory authority's website or by submitting a physical form with the required information.
The purpose of EMA splitting of form is to allow for easier management of marketing authorizations, for example to target specific patient populations or indications.
Information such as the proposed split of the EMA, justification for the split, and any supporting data or documentation may need to be reported on the EMA splitting form.
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