On behalf of our clients, we conduct the entire registration process for the pharmaceutical raw material, which in Poland is medical cannabis. We represent the Client before the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), prepare the complete documentation, and coordinate all formal and regulatory activities required to obtain a marketing authorization.
Our work includes an assessment of compliance with the requirements of pharmaceutical law, preparation of the registration dossier, GMP-related support, and ongoing communication with the regulatory authority at every stage of the procedure.
In Poland, medical cannabis has the status of a pharmaceutical raw material. This means that, by definition, it is a product intended exclusively for pharmacists, who use it to prepare compounded (magistral) medicinal products in a pharmacy. Only after the medicine has been prepared by a pharmacist — on the basis of a physician’s prescription — does the raw material become a medicinal product. This solution is unique on an international scale — only a limited number of countries apply a model in which medical cannabis functions as a pharmaceutical raw material rather than a finished medicinal product.
The manufacturing requirements applicable to such raw material encompass both regulations relating to active substances (Chapter 3a of the Pharmaceutical Law) and provisions concerning finished medicinal products (Chapter 3 of the Pharmaceutical Law). In practice, this entails compliance with the full scope of GMP (Good Manufacturing Practice) requirements applicable to medicinal products — from the quality of the plant raw material, through manufacturing and standardization processes, to quality control and manufacturing documentation.
The registration process for a pharmaceutical raw material consists of obtaining a marketing authorization issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). In accordance with the applicable regulations, the procedure takes a maximum of 210 days, provided that the applicant submits complete documentation compliant with the Regulation of the Minister of Health of 5 December 2017 on the template application for marketing authorization of a pharmaceutical raw material intended for the preparation of compounded medicinal products in the form of cannabis herb other than fiber-type cannabis, as well as extracts, pharmaceutical tinctures, and all other extracts from cannabis other than fiber-type cannabis and cannabis resin, together with the detailed scope of data and list of documents required for the application (Journal of Laws, item 2337).