Medicinal marijuana is a controversial topic. People without awareness often perceive medicinal marijuana as a dangerous, addictive drug used illegally. Meanwhile, medicinal marijuana is a product containing properly selected and laboratory-tested quantities of active substances. It has legal conditions related to processing and marketing.
All Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practice (GMP) standards are maintained during production.
Before the product is released to the market, it is thoroughly tested. As a result, we do not have to fear that a medical product, such as medicinal marijuana will be the same drug being sold illegally.
Medicinal marijuana, due to its composition, has an increasingly important role in the treatment of various diseases, such as:
• alleviating side effects occurring during chemotherapy and radiation therapy – nausea and vomiting;
• drug-resistant epilepsy;
• phantom pain;
• chronic pain syndromes;
• multiple sclerosis;
• spasticity due to spinal cord injury;
• anxiety and depression syndromes;
• neuropathic pain;
• Parkinson’s disease,
• Alzheimer’s disease;
• Tourette’s syndrome;
From a legal point of view, in Polish law, the terms: “marijuana” and “medicinal marijuana,” are not used. According to the Act on Counteracting Drug Addiction, the terms used are: “cannabis,” “fibrous cannabis” , and “non-fiber cannabis herb and cannabis resin.”
Cannabis is a plant in the genus Cannabis (Cannabis L.), and fibrous cannabis is a plant in the genus Cannabis sativa (Cannabis sativa L.), in which the sum of delta – 9-tetrahydrocannabinol (THC) and tetrahydrocannabinolic acid (THC acid) in the floral or fruiting tops of plants from which the resin has not been removed, depending on the country does not exceed 0.2% or 0.3% on a dry weight basis.
In Poland, it is legal to grow fibrous cannabis containing THC (delta- 9 -tetrahydrocannabinol) content that does not exceed 0.3% on a dry weight basic. However, non-fiber cannabis herb is any above basis part of the hemp plant (single or in a mixture), excluding seeds, containing more than 0.3% of the sum of delta -9- tetrahydrocannabinol and tetrahydrocannabinolic acid.
There are several legal conditions governing the use of and requirements for cannabis:
a) legal acts in force in Poland:
– Law on Counteracting Drug Addiction of July 29, 2005. (O.G..2005, No. 179, arts.1485 as amended),
– Act of March 24, 2022, on amending the Act on Counteracting Drug Addiction (Journal of Laws of 2022, item 763),
– Act of March 24, 2022, on amending the Act on Counteracting Drug Addiction and some other acts (O.G. of 2022, arts.764),
– Act of September 6, 2001. Pharmaceutical Law (O.G. of 2001 No. 126 arts.1381 as amended),
– Announcement of the Speaker of Poland’s Parliament dated October 7, 2022, on the announcement of the consolidated text of the Pharmaceutical Law (O.G. of 2022. Arts.2301),
– Regulation of the Minister of Health of November 9, 2015, regarding the requirements of Good Manufacturing Practice (O.G. 2015 No. 19, arts. 1979),
– Notice of the Minister of Health of April 28, 2022, on the announcement of the uniform text of the Regulation of the Minister of Health on the requirements of Good Manufacturing Practice ( Journal of Laws of 2022, arts1273),
– Regulation of the Minister of Health of March 13, 2015, regarding the requirements of Good Distribution Practice (O.G.2015 entry381), as amended,
– Regulation of the Minister of Health of June 27, 2022, on the announcement of the uniform text of the Regulation of the Minister of Health on the list of substances, psychotropic substances, narcotics, and new psychoactive substances (O.G.2022 entry1665),
– Regulation of the Minister of Health of January 27, 2022, amending the Ordinance on the list of psychotropic substances, narcotics, and new psychoactive substances (O.G.2022, arts.274),
-Regulation of the Minister of Health of March 11, 2021, amending the Regulation on the list of psychotropic substances, narcotics, and new psychoactive substances (O.G.2021, arts.518),
b) according to European law, the most important regulations we can include are:
– EudraLex: Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use,
-Directive 2011/62/EU of June 8, 2011, amending Directive 2001/83/EC onCommunity Code relating to medicinal products for human use, – regarding the prevention of the entry of falsified medicinal products into the legal distribution chain.
The required regulations are aimed at classifying cannabis-derived medicines as psychoactive substances.
According to the Act on Counteracting Drug Addiction:
a) Narcotics are divided into groups:
I-N,
II-N,
III-N,
IV-N,
depending on the degree of risk of addiction when used for non-medical purposes and the extent of their medical use.
b) Psychotropic substances are divided into groups:
I-P,
II-P,
III-P,
IV-P,
depending on the degree of risk of addiction when used for non-medical purposes and the extent of their medical use.
c) In the case of narcotics I-N and II-N and psychotropic substances of groups II-P, III-P, and IV-P may only be used for medical, industrial, or research purposes.
Until recently, cannabis herb and cannabis resin were included in group IV-N (i.e., used exclusively for research and in animal treatment).
Most recently (based on an amendment to the Health Minister’s decree of January 27, 2022, issued a decree amending the list of psychotropic substances, narcotics, and new psychoactive substances on August 17, 2018), cannabis and resin were classified as group I-N substances (which allows for medical / industrial use /conducting research).
Due to the amendment of the above regulations, for an entrepreneur to use herb cannabis other than fibrous, as well as extracts, pharmaceutical tinctures, and in any other manner, use non-fiber cannabis, extract resin from non-fiber cannabis for pharmaceutical raw material, or manufacture any pharmaceutical raw material from cannabis or produce pharmaceutical raw materials from cannabis must obtain:
a) a market authorization issued by the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products and,
b) authorization from the Chief Pharmaceutical Inspector to manufacture, process, processing, convert, import or distribute narcotic drugs or psychotropic substances.
For this purpose, it is necessary to:
– implement a system of procedures and controls for conducting operations,
– have a security system for production and storage premises,- store (against theft or access of unauthorized persons) narcotic drugs and psychotropic substances in separate rooms with alarm installation, which are equipped with doors of suitable design (locked with at least two locks), windows secured against burglary, or in closed metal cabinets/refrigerator cases that are fixed permanently to the floor or wall of the room,
– has an RFID system (Radio-frequency identification system) identifying each plant
– keep records of receipt and disbursement of the aforementioned funds,
– employ a Qualified Person (with appropriate education and professional experience) for the supervision of narcotic drugs or psychotropic substances,
– keep technical records of consumption standards and permissible losses at the stages of production and control,
– has a laboratory with equipment for assessing plant and harvest quality.
The process of manufacturing the active substance for the production of pharmaceutical raw materials in the form of non-fibrous cannabis herb and extracts, pharmaceutical tinctures, and all other extracts of non-fibrous cannabis and non-fibrous cannabis resin includes crushing dried plant parts and performing physical and chemical operations leading to the formation of this substance, including extraction, and bulk packaging and is subject to the requirements of Good Manufacturing Practices for active substances.
On the other hand, the process of manufacturing the pharmaceutical raw material, in the form of cannabis other than fiber includes repackaging of the active substance from bulk packaging to the packaging in which the raw material will be delivered to pharmacies and is subject to the requirements of Good Manufacturing Practice for medicinal products.
In the case of fiber cannabis, it is extremely important to ensure the quality of cultivation and harvesting is done by following the GACP (Good Agricultural and Collection Practices). By adhering to the above practice We receive a final product of the highest quality:
– Using the right seeds,
– Using suitable soil (free of pesticides and contaminants such as nitrates or heavy metals),
– Using appropriate temperature and humidity conditions during cultivation,
– Using appropriate air conditions at the cultivation site (including air movement, monitoring of air composition),
– use of appropriate lighting and irrigation of crops,
– use of appropriate maintenance work,
– use of appropriate cleaning and hygiene procedures in production and storage facilities,
– use of appropriate crop drying and storage procedures. The use of appropriate microclimates makes it possible to obtain a final product of the highest possible quality.
According to the regulations, cultivated plants (fiber cannabis) must not contain more than 0.3% THC.
However, in the case of final products (resulting from the processing of cannabis), THC content must not exceed 0% (below the detection limit).
If the level of THC is detected in the final product – these products will be treated as narcotics – intoxicants.
Supervision over the manufacture and market of controlled substances (fiber cannabis) is exercised by the Chief Pharmaceutical Inspector.
THC, as a psychoactive substance, is subject to strict controls at all stages of production, storage, and disposal.
To this end, a system of documentation and supervision of records should be implemented, which will include.
scope:
– purchase of starting material / raw material,
– internal receipt of raw material,
– conducting laboratory tests and analysis of the starting material / raw material,
– processing,
– storage,
– transportation and shipment to the market,
– disposal.
The above activities should be performed and carried out only by trained persons, authorized for this purpose (presence of two employees, work constantly documented) with observance of appropriate/necessary hygiene rules.
In the event of non-compliance (the appearance of deviations), appropriate steps should be taken related to the development of corrective/remedial actions. It is the Qualified Person who supervises and controls the steps involved in the manufacture of products containing controlled substances to present these actions with a deadline for implementing
The Qualified Person supervising the manufacture, processing, transformation, or import of narcotic drugs, and psychotropic substances included in the medicinal product, must meet the conditions:
a) master’s degree in engineering, master’s degree, or an equivalent title obtained as a result of the completion of studies related to education in medical analytics, biology, biotechnology, chemistry, pharmacy, medicine, veterinary, and at least:
b) 2-year work experience in the company holding a license to manufacture or import medicinal products, as referred to in Article 38 (1) of the Law of September 6, 2001. – Pharmaceutical Law (O.G.2008 No. 45, arts. 271 as amended);
Considerations on the production and market of controlled substances (fiber cannabis), it is necessary to take into account considering the GMP requirements for buildings and equipment (utilities, installations, systems), equipment involved in the process (production-laboratory equipment), and systems computerized.
For the above requirements, you should also develop appropriate documentation describing the correctness of the operation/maintenance of the above-mentioned elements and how to clean them.
When developing documentation, You should also remember to keep records of raw materials, packaging materials, final products, and waste. Important in this regard include:
records at the stage of manufacture, storage, and disposal. For this purpose, it is necessary to keep a Book of Control (of substances of groups I-N, II-N, and IV-N, or psychotropic substances of groups I-P and II-P).
When it comes to documentation, it is also necessary to develop production instructions and introduce production batch records. Laboratory control documentation with strictly defined manufacturing control parameters should also be kept in mind.
In terms of storage and shipping, it is necessary to have properly secured storage facilities and to implement documentation for handling controlled substances.
Record keeping, as mentioned earlier, is a key control tool at every production stage.
For production involving fiber cannabis, it is necessary to comply with GMP standards, therefore several qualifications/validations are required, among others:
– premises qualification,
– utilities/systems qualification,
– production/laboratory equipment qualification,
– process validation,
– transport validation,
– analytical methods validation,
– computer systems validation.
eCValidation company offering enables the development of the procedures and instructions necessary to implement the laws required to launch and implement “medicinal marijuana”.
To carry out the necessary qualification/validation for this project – our company also has the appropriate equipment and qualified employees who will reliably perform the commissioned qualification/validation.
Kamil Melson
Validation Specialist
