CROATIA

To be marketed in Croatia, it is mandatory for medications to have the marketing authorisation, issued either by the Croatian agency for medications and medical devices (HALMED) or by The European Commission (EC).

Halmed can issue the marketing authorisation for medications approved by the national approval mechanisms, as well as joint European approval mechanisms: Mutual Recognition Procedure (MRP) and The Decentralized Procedure (DP), while The European Commission issues approvals for the medications processed by the centralized mechanism.

The list of medications for which Makpharm holds the marketing authorisation for the Republic of Croatia can be found on our Product List.

SLOVENIA

In Slovenia, Makpharm currently holds marketing authorisation for Benmak and Klofarabin Makpharm.

SERBIA

In Serbia, Makpharm currently holds marketing authorisation for Benmak.

NORTH MACEDONIA

In North Macedonia, Makpharm currently holds marketing authorisation for Benmak.

ROMANIA

In Romania, Makpharm currently holds marketing authorisation for Benmak.

BULGARIA

In Bulgaria, Makpharm currently holds marketing authorisation for Benmak.

ALBANIA

In Albania, Makpharm currently holds marketing authorisation for Benmak, Bonosta and Bosentan.