Issues with regulatory pharmacovigilance in East European countries: the industry perspective.
The new European Union pharmaceutical legislation emphasizes the importance of ensuring the continued safety of medicinal products in use with the main purpose to protect the public health. To fulfil this task the Member States are obliged to establish pharmacovigilance systems, which could be continually adapted to take account of scientific and technical progress. The non-EU East European countries are oriented towards the same goal on their way to the community. They are changing their legal frameworks for pharmacovigilance to harmonize it with the European requirements. As the EU accession country, Croatia is also in a phase of harmonization of the national legislation on medicines with the latest European requirements. It has established the pharmacovigilance system in which the Croatian Agency for Medicines and Medical Devices has very important role, and it involves all stakeholders-pharmaceutical industry, Healthcare Professionals and patient organizations. Belupo Inc. is faced with changes in the field of pharmacovigilance on all its markets: in Croatia, in EU as well as in the East European countries outside the EU, which are traditionally Belupo's target markets. The structure and functioning of the pharmacovigilance system in Croatia and other non-EU East European countries based on Belupo's experience gathered through the activities of its Pharmacovigilance Department and activities of its Qualified Persons for Pharmacovigilance (QP) are presented.
Hanzl-Dujmović
Ivana
I
Regulatory Affairs Sector, Belupo, Pharamaceuticals and Cosmetics, Incorporated, I Savica 36, 10 000 Zagreb, Croatia. ivana.hanzl-dujmovic@belupo.hr
Sulić-Milisić
Zrinka
Z
Staresinić-Sernhorst
Ivana
I
D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D005061:Europe, Eastern; D005062:European Union; D006801:Humans; D033183:Interdisciplinary Communication; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing