Abstract

The article presents the analysis of available procedures regarding registration of the herbal medicinal products, considering both the Polish law and the EU regulation context that results from harmonization of the pharmaceutical law. The article organizes regulations regarding admissibility of transactions connected with this specific category of medicinal products and discusses registration procedures applied in the European Union, including national, decentralized, mutual recognition and centralized procedures. The article also presents grounds for registration relevant to the herbal medicinal products, especially regarding the traditional herbal medicinal products and the ones with an established medical use. Special emphasis is placed on the differences between certain procedures and grounds for registration and their importance in practice regarding admissibility of transactions of the herbal medicinal products.