NEW HEMOFARM PREPARATIONS TO APPEAR SOON

someone from Croatia who comes here to sell medicaments. Of course, I am not asking for restrictions to be introduced
here, I believe that an agreement should be made on the level of the ministers of health, which would establish a full and
equal competition. I particularly have Slovenia in mind here, as the Krka medicaments are sold well here, and as far as I
know, nobody is selling anything from here in Slovenia. We also have a procedure here for the registration of
medicaments, a supervision over production, whereas there is no insight into the conditions under which medicaments are
produced by those who import them here from quite exotic countries. I would like to appeal to the Agency for
Medicaments to cover all these issues, so that we would all be in the same position. Hemofarm has invested a lot and has
used two loans from the European Bank for Reconstruction and Development and we are very aware how expensive
GMP is. It is a question of millions of Euros. I believe that in this GMP context those who worked on it have not been
awarded. It will not be possible to introduce it in a year and the worst would be to postpone the time schedule, as has
been seen in China, Russia and did not prove to be good. The European GMP has been introduced in practically all
Hemofarm plants, we were the first to get it already back in 2001 from European Regulation authorirites and it is verified
every two years and if others do not share this burden and this burden is not acknowledged as a cost, then this is certainly
not acknowledged. We must have the same conditions in the same match. I believe that we can do more ourselves so as
to make a more rational system and be more productive – pointed out the president of Hemofarm.
What is next?
The conclusions following the discussion of the first panel were that the competent ministries would undertake all required
measures so as to improve the status of the Serbian pharmaceutical industry in the economic and regulatory sense,
following the EU standards, as well as actions for the establishment of the national policy on medicaments, particularly in its
development segment. It has been agreed to continue activities related to harmonizing the prices of the local and foreign
medicaments, as well as to harmonizing the regulations and strengthening the supervision sector in the field of medicaments
and medical preparations. In the course of the discussion it was also concluded that actions would be undertaken to satisfy
the requirements of GMP, that the existing law on medicaments and medical preparations would be amended and
completed, but also harmonized with the latest EU directives and that activities would be speeded up in relation to the
expert preparations for the signature of the PIC convention. All this must be done so as to satisfy the conditions for the GMP
regulations before the given deadline.
Minister Predrag Bubalo spoke and answered questions about consulting and management in the pharmaceutical industry,
experiences from the region, market regulations and about how the pharmaceutical industry as one of the most organized
trade activities in our country is a ''target'' for foreign investors, which led to conclusions that foreign investors recognize the
pharmaceutical industry as a highly profitable industrial branch, that the consulting companies are very significant in
evaluating the quality of companies which foreign companies intend to purchase. Accent was given to the significance of
the work performed by consulting companies in the process of evaluation of company quality, but also to the advancement
of the legal ambience for foreign investors, fulfillment of European standards and distribution (GDP), as well as to
consistency in the implementation of the law on medicaments in the part related to the timeframes for the fulfillment of the
GMP and GDP, as elements of legal security of invested capital. It has been suggested that CEFTA be completed with
annexes, so that this specific field, trade with medicaments, could be harmonized and thereby it could be possible to avoid
repetition of the medicament registration procedure for each country in the region.
During the panel various issues were opened, among others also the free formation of prices of OTC products and
supervision over foreign producers who do business on our market, whereas their headquarters are out of EU and USA.
Current situation
The price of medicaments in Serbia is currently around 42 percent of the price in the referential countries, Croatia, Slovenia
and Italy. The law on medicaments stipulates that the prices of medicaments in Serbia should reach 80 percent of the