Abstract

The article presents the rules for keeping confidentiality of medicinal product registration data submitted to competent authorities in the marketing authorization granting procedure. Procedures for granting marketing authorizations are briefly described at the beginning. Then the article outlined legal grounds for keeping pharmaceutical registration data confidential and discusses what is covered by so understood pharmaceutical confidentiality with respect to individual stages of the proceedings. The discussion concerns both the clinical trial data and information contained in the evaluation report, as well as the data entered in the Register of Medicinal Products and included in the medicinal product dossier. In conclusion the author tried to systematize pharmaceutical data by dividing them into confidential, restricted and public data.