Polish pharma views EU accession

Poland's pharmaceutical industry regards the country's forthcomingaccession to the European Union as a positive, in principle, but the biggest problem which ithis development will present for the drug sector will be the requirement to update the dossiers on about 10,000 medicinal products currently on the market, according to Magdalena Krekora of Pliva Krakow.

Moreover, some smaller manufacturers may not survive the updating exercise, Ms Krekora told the European Generic medicines Association's annual regulatory issues meeting in London, UK recently (Marketletter February 26).

Polish drug marketing authorizations are not recognized by the EU, and after accession they will no longer be valid. Failing to complete the dossier-updating program on time would present a risk to public health for Polish consumers, while for the national health system it would mean financial catastrophe, she said.