Declaration on pack sizes

Notice to the MAH or person / company authorized for communication on behalf of MAH regarding declaration on pack sizes in MR or DC Type B.II.e.5 variations of medicinal products (Change in pack size of the finished product)

You are kindly requested to make a declaration on the newly authorized pack sizes, whether the MAH is going to register and purposing to launch them in Hungary as in CMS.

Please send the hard copy to National Institute of Pharmacy at the same time with submission of the variation.

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.