Uphill struggle for drug producers to meet EU norms

Pharmaceutical companies will have to spend at least zl. 2 billion in order to meet standards and to secure certificates demanded by the EU, says the pharmaceutical industry chamber of commerce, Polfarmed. About 400 companies, mainly smaller producers, will have to modernize production facilities. "For a medicine with a list position, which is a single medicine and sometimes just a different dosage of a medicine, the cost of carrying out the procedures to obtain a certificate is between zl. 175,000 to zl. 200,000. With 3,500 medicines on the list, this totals zl. 500 million," said Malgorzata Wychowaniec from Polfarmed. Another zl. 1.5 billion is needed to raise production norms to EU standards. As Poland is not a member of the Pharmaceutical Inspection Convent (PIC), even the most important production quality GMP certificates, already obtained by 14 Polfa companies, are not accepted by EU members. (Puls Biznesu, p. 5) M.T.