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The Current Regulatory Status of Licensing for Dispensaries, Cultivation, Processing & Manufacturing for poland marijuana
On July 20, 2017, Polish President, Andrzej Duda, signed into law the use of medical marijuana in Poland, which has been available through pharmacies since November 2017.
It is illegal to grow cannabis that contains more than 0.2% tetrahydrocannabinol (THC) in Poland itself, which restricts Polish pharmacies from production and self-cultivating cannabis, allowing them only to process cannabis tinctures, resins, oils and concentrates for medicinal purposes.
Medical cannabis can only be imported into Poland as pharmaceutical raw material for preparing prescription drugs, based on permits to sell Poland marijuana for medical use. The pharmacy must register with the Office for the Registration of Medicinal Products Points of Sale.
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Product Permit to Import Medicinal Cannabis
To obtain a permit to produce Poland marijuana medications from imported cannabis, the Polish pharmacy applies to the Main Pharmaceutical Inspector of Poland.
According to Article 39 of the Pharmaceutical Law Act, the application must contain:
- Applicant Name, address, and place of residence
- National Court Register entry number and tax identification number
- List of the name, dose, and pharmaceutical form of the medicinal product: The physical characteristics of the combination of active and non-active ingredients forming the medicinal product (tablet, liquid, capsule, etc.)
- Determination of the place of business: Where the pharmacy officers direct, control, and coordinate pharmacy activities
- Description of the scope of the medicinal product import: Properties of the medicinal product for treating or preventing disease in human beings administered to restore, correct, or modify physiological functions
In order to place medical cannabis on the Polish market, the pharmacy is required to obtain marketing authorization from the president of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
To obtain permission, the pharmacy submits an application containing:
- Name and active substance of the pharmaceutical raw material
- Packaging size
- Name and address of the responsible entity applying, and data on the manufacturer if the responsible entity is not the producer of the raw material
- List of documents submitted with the application
After examination of the submission, The President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
- Issues a marketing authorization for five years
- Refuses to grant such approval (if denied, an applicant may appeal)
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Licenses in Poland
If you are looking to attain a license for hemp or cannabis in Poland Higher Yields Cannabis Consulting can help. Our team of cannabis licensing consultants and technical writers has had great success helping newcomers and experienced operators attain licenses all over the world.
CONDITIONS FOR OBTAINING MEDICAL PRODUCT PERMIT
To obtain a product permit, the pharmacy/pharmacist must first meet certain conditions in order for the Main Pharmaceutical Inspector to issue a license that continues for an indefinite period. These conditions include:
- The qualified person, the applicant, must prove that the pharmacy possesses appropriate rooms and technical devices necessary for the import, control, and storage of cannabis
- Proof of employment of the qualified person by the applicant Article 48 of the Pharmaceutical Law Act states that the eligible person:
- Can verify successful completion of a four-year theoretical and practical university study in pharmacy
- Has acquisition of hands-on experience during a minimum of two years at one or more companies authorized to manufacture medicinal products in the European Union
- The cannabis importer is in the Register of Manufacturers and Importers Medicinal Products as a registered importer of medical cannabis
- As described in article 42 of the Pharmaceutical Law Act, the duties of the importer include:
- Importation and distribution of medicinal products within the proper scope
- Demonstrates the ability to securely store archival samples of the medicinal products for 1-3 years from the expiration date.
- Provide access to the Chief Pharmaceutical Inspector for inspections of the premises with permission to take samples for qualitative research
- Apply requirements for Good Manufacturing Practice for distribution of medicinal products including audits on manufactures and distributors of active substances with verification of authenticity
Medical Cannabis Marketing Denial of Permit
Denial of a permit may occur if:
- The application documentation does not meet the requirements set out in the Pharmaceutical Law Act
- The medicinal product has a risk of non-therapeutic effect in terms of the indications, contraindications, and recommended dosage given in the application
- The qualitative or quantitative composition of the medicinal product is not as reported
Last updated: July 2022