Pharmaceutics may fail to meet EU standards deadline

Late last month the Polish Chamber of Pharmaceutic Industry and Medical Equipment (PIPFiSM) sent an official request to the Government’s Plenipotentiary for Negotiation for Membership in European Union (EU) minister Jan Kulakowski to apply for a 10 year transition period for Poland’s pharmaceutics producers to fulfill all requirements concerning registration of medicines according to EU regulations and procedures. Representatives of the pharmaceutic industry believe that there is no possibility to complete registration procedures before the end of the year 2002, the date proposed by the Polish government for accession to EU structures. Producers emphasize that Polish regulations concerning medicine registration are still not adjusted to EU requirements. Nevertheless, Polish negotiators are planning to close negotiations with EU about the free flow of goods at the end of the March. Deputy Minister of Health Andrzej Rys doubts that there will be serious problems with registration of pharmaceutics. He thinks that employing a sufficient number of officials dealing with the procedures could solve the problem. The Ministry is to order an expert's report to examine the matter. (Gazeta Wyborcza, p. 4) A.D