Фото: Medicines based on cannabis: production and sale rules for pharmacies and medical facilities

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Yeromenko Darya Oleksandrivna

Specializes in providing advice on obtaining disability and appealing the decision of MSEC, collecting material compensation for physical and moral damage caused; assistance in collecting evidence on the fact of medical error, and negligence on the part of medical personnel.

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Medicines based on cannabis: production and sale rules for pharmacies and medical facilities

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The legalization of medicinal cannabis in Ukraine has opened up new opportunities for the medical industry, allowing the use of this powerful tool in the treatment of various diseases. The decision on legalization was an important step in the development of national medicine, but with legalization comes the need to develop and implement clear rules for the circulation of cannabis-based drugs, which we will talk about below.

What are the production and sales rules for pharmacies and medical facilities?

medicinal products with cannabis

  1. In order to obtain a license for the production of narcotic drugs, psychotropic substances and precursors, it is necessary to submit a package of documents to the State Medical Service, including permission from the National Police to use the relevant facilities and premises.
  2. The procedure for purchasing seeds is regulated by the Cabinet of Ministers. The seed must be conditioned, certified and registered in the seed quality register.
  3. Laboratory studies to determine the THC content in dried hemp straw are mandatory. Sampling is carried out with the participation of the National Police, but harvesting is prohibited until the results of the research are obtained.
  4. A substance is made from the crop. In order to enter a substance into the register of medicinal products, it is necessary to submit documents confirming its effectiveness, safety and quality.
  5. Pharmacies have the right to purchase the substance of cannabis and manufacture medicines after obtaining the appropriate license, and the dispensing of such medicines is registered in the electronic health care system.

Importantly! Recipients of a license for the production of cannabis must, in a mandatory manner, protect the sowing and storage places of the plants. In addition, they are obliged to conduct video surveillance and provide 24-hour access to it to the police.

What is needed in order for pharmacies to be able to manufacture and sell medicines based on medical cannabis?

  • Obtain licenses for the circulation of narcotic drugs, psychotropic substances and precursors, as well as for the economic activity of the production of medicinal products in the conditions of a pharmacy;
  • Purchase a cannabis substance that is registered;
  • Register the release of medicinal products in the unified accounting information system;
  • Manufacture and sell medicines only by electronic prescription, following the dosage forms approved by the Ministry of Health.

An authorized person, who is determined by order of the head of an enterprise that sells medical cannabis, keeps records of all controlled substances and cannabis for medical purposes. This record includes the weight, number of seats, destination, number and date of the consignment note, EDRPOU code and the name of the recipient in the journal established by the enterprise.

In addition, this person is responsible for checking the correctness and compliance of the quantity and information in the accompanying documents during the release and acceptance of medical cannabis and medicinal products made from it. She also ensures the correctness of labeling and packaging, and then signs the relevant accounting documents.

How can we help?

The lawyers of the company "Prykhodko and partners" will provide competent legal support in the field of cannabis-based medicines and their production:

  • We will help with obtaining the necessary licenses for the production and circulation of narcotic drugs and psychotropic substances, including support in interaction with regulatory bodies.
  • We will advise on the registration of medicinal products, maintaining legal documentation and compliance of activities with legislative requirements in this field.

Choose a reliable partner to provide legal support for your business in the field of medical cannabis - contact "Pryhodko and Partners". For a consultation, fill out the form below.

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Specializes in providing advice on obtaining disability and appealing the decision of MSEC, collecting material compensation for physical and moral damage caused; assistance in collecting evidence on the fact of medical error, and negligence on the part of medical personnel.

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