Abstract
The request for marketing authorization in Poland has to be submitted to the Bureau for Registration of Pharmaceutical and Medical Materials on the “Application for Pharmaceutical Product Registration.” All documentation to be provided, in either Polish or English, is specified in the application form and includes experts' reports.
The procedure is tiered. The dossier is divided into three areas of expertise: chemistry and pharmacy, pharmacology-toxicology and clinical medicine, and drug information. The final report, consisting of summaries of the area reports, is scrutinized by the Registration Commission. Subsequently, following a positive decision the drug enters the process of quality testing and further documentation assessment. When the final assessment is ready, the Registration Commission makes a decision on registration. If the Registration Commission decision is negative an appeal may be submitted to the Minister of Health and Social Welfare by the applicant within 14 days. In general, the documentation is being processed on paper. Nevertheless, there are two existing databases: clinical trials and drug information. DAMOS, a registrational regulatory software package, is now being implemented in the registration system.
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