Instructions on content and procedure for submitting medicinal product information in national procedure available now
We would like to inform hereby marketing authorisation holder/applicants in Croatia that HALMED has published Instructions on the content and procedure for submitting medicinal product information in the national procedure.
This instruction is aimed at facilitating the creation of the most quality text proposals of product information in procedures for granting marketing authorisations, variations and upgrading. Therefore, HALMED encourages marketing authorisation holders to submit their proposals and comments on use of this instruction by e-mail to HALMED at nacionalni_QRD@halmed.hr. In order to improve this instruction, these proposals and comments will be considered by HALMED and taken into account at the next revision of this instruction.
The instruction on the content and product information submission in the national procedure may be found here.