Prior to its authorization every medicinal product undergoes an appropriate regulatory process. The Member States of the European Union possess institutions responsible for conducting the registration and granting relevant decisions. In Poland this institute is called the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The Polish Office of Registration participates actively in all types of procedures.

The registration process is multistage and consists of formal validation of the application form submitted by the applicant (Department of Registration of Medicinal Products) and  dossier assessment (Department of Documentation Assessment). The final stage is granting a marketing authorization or rejection of an application. For medicinal products authorized via centralized procedure these decisions are granted by the European Commission. For the medicinal product authorized via national procedure, mutual recognition procedure and decentralized procedure the decisions are granted by national competent authorities. In Poland the decisions are granted by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Assessment of chemical, pharmaceutical and biological documentation submitted in the registration process is performed with regards to its compliance with requirements of  pharmaceutical law, actual editions of Pharmacopoeia and actual CHMP ,CVMP, ICH guidelines. Assessment of quality of a medicinal product results in assessment report issued by an expert. During the assessment the applicant is obliged to update the documentation according to comments arising from the assessment. According to the legislation analytical tests  of a medicinal product during  the registration process are allowed in case the doubts of the experts may be solved only on experimental basis. Before the product is tested the President of the Office informs the Marketing Authorization Holder and provides a rationale of the testing.

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1. The Pharmacopoeia in preparation and assessment of pharmaceutical, chemical and biological documentation of medicinal products
2. Registration dossier of chemical active substance
3. EUROPEAN CRITERIA FOR QUALITY ASSESSMENT OF CHEMICAL AND BIOLOGICAL MEDICINAL PRODUCTS DURING THE REGISTRATION PROCESS