You are kindly requested to make a declaration on pack sizes the MAH is going to register and purposing to launch in Hungary as in CMS.
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send an electronic format to mrp-dcp-new-cms@ogyi.hu
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send the hard copy to National Institute of Pharmacy at the same time the national texts of product information submitted.
Take notice, that in case of several types of packaging approved in the documentation, the declaration has to be applied each of them, as the registration number depends on different types of packaging as well.