Registration of medical cannabis - Regulations in Poland
Registration of medical cannabis is a popular topic nowadays. The use of cannabis for medicinal purposes was legalized in Poland in 2017. Until recently, the legislation prevented the cultivation of medical cannabis in Poland, therefore, it was mainly imported to Poland from other countries. The situation changed in May 2022, when amendments to the Act on counteracting drug addiction came into force.
Medical cannabis law evolves very dynamically. Undoubtedly, everyone who wants to register such a product in Poland must have knowledge of the relevant legal acts, such as the aforementioned Act on counteracting drug addiction or the Pharmaceutical Law.
The terminology used for the cannabis is very important, as cannabis products can be used for medical, industrial and intoxicating purposes. To avoid common mistakes, it is a good idea to read the document issued by the EMA on the nomenclature of medical products containing cannabis “Compilation of terms and definitions for Cannabis-derived medicinal products”. Therefore, for registration issues, the crucial classification divides hemp into two categories:
- fibrous hemp
- non-fibrous hemp.
This division is made on the basis of the sum of the content of active substances:
- THC (delta-9-tetrahydrocannabinol)
- and THCA (delta-9-tetrahydrocannabinolic acid)
in the flowering or fruiting tops of hemp plants from which the resin has not been removed.
In fiber hemp, this content does not exceed 0.3% on a dry weight basis. In non-fibrous hemp, this content is exceeding 0.3%, which determines the classification of hemp herb as a narcotic substance with high addictive potential. The following classification is provided by the Act on counteracting drug addiction. What needs to be highlighted is that, the medical cannabis, used for therapeutic purposes originates from non-fibrous hemp (of THC and THCA > 0.3%).
Cannabis can be registered both as:
- a pharmaceutical raw material for the preparation of prescription drugs;
- as well as a medicinal product.
In the case of cannabis registration as a pharmaceutical raw material for the preparation of prescription drugs, it has to be registered nationally, based on the documentation from Module 1 and Module 3.
The registration time is 210 days (this time does not include the Applicant's time for replies but only the assessment of the dossier by the Agency).
A marketing authorisation, as in the case of medicinal products, is issued for a period of 5 years.
The list of documents required for registration of cannabis as a pharmaceutical raw material, as well as the application form for registration, is defined by the Regulation of the Minister of Health. It is worth noting that Module 3 must include both active substance documentation and raw material documentation. The documents covered by the application and the documents detailing the data covered by the application may be presented in English, with the exception of the immediate packaging in descriptive form, which shall be presented in Polish.
When it comes to registering cannabis as a pharmaceutical raw material, there are also strict requirements for its nomenclature, for example, fantasy names are not accepted.
Regarding cannabis registration as a medicinal product containing cannabinoids, registration may be performed in any procedure - both in centralized and decentralized procedures (DCP, MRP). It is required to submit a full dossier (Modules 1-5). The time and cost of registration will then depend on the type of registration procedure.
It is worth noting that, depending on the country, registration requirements can be completely different. Some EU countries legally treat cannabis like others medicinal products, while in other, the use of cannabis (even for medical purposes) is strictly prohibited. It is therefore crucial to get familiarized with the legal requirements in a particular country and understand them properly. Due to the dynamically changing regulations in this area, it is worth keeping up to date.
If you need support with registration of your product or if you have questions regarding medical cannabis law, please contact us. Our experts will be happy to answer all your questions!
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