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    Regulations for psyc...

    Regulations for psychotropic medications in Poland

    According to Article 41 of Polish Act of 29 July 2005 on Counteracting Drug Addiction, retail trade in psychotropic substances and precursors that are medicinal products shall be conducted by pharmacies, ensuring appropriate storage conditions preventing unauthorised access to these drugs and substances.

    Additionally, it should be noted that medications containing psychotropic substances shall be dispensed from the pharmacy only on the basis of a specially labelled prescription or requisition (these issues will be described in more detail later in the article).

    A conceptual image depicting a fragmented human head with scattered puzzle pieces, symbolizing mental health struggles. Next to the head, various psychotropic tablets are displayed, representing the complexity of mental health treatment. This image highlights the importance of understanding the regulations surrounding psychotropic medications in Poland, where nearly 5% of the population has used such medications within the last year. Key themes include mental health awareness, the role of psychotropic drugs, addiction risks, and the significance of proper prescription practices.

    Psychotropic substances are divided into groups: I-P, II-P, III-P and IV-P, depending on the degree of risk of addiction when used for non-medical purposes and the extent of their medical use.

    According to one of the studies of 2023: “Prevalence and determinants of psychotropic medication use in Poland”, nearly 5% of respondents in the general population used psychotropic medicines in the past 12 months. This suggests that the regulation of psychotropic drugs in Poland is an important issue affecting the mental health, because it affects a large part of the population.

    What is a psychotropic medication?

    A psychiatric or psychotropic medication is a psychoactive drug taken to exert an effect on the chemical makeup of the brain and nervous system. Thus, these medications are used to treat mental illnesses. These medications are typically made of synthetic chemical compounds and are usually prescribed in psychiatric settings. The most important documents regulating marketing of these drugs in Poland, are Polish Act of 6 September 2001. Pharmaceutical Law (hereinafter: PLaw) and mentioned above Act of 29 July 2005 on counteracting drug addiction (hereinafter: CDA). Additionally, it should be noted that the Act of 20 July 2018 amending the Act on CDA and the Act on the State Sanitary Inspectorate sets out a list of new psychoactive substances, the possession of which is linked to lesser sanctions. The list was introduced to combat so-called ‘legal highs’. The issue of medical cannabis as a pharmaceutical raw material in Poland has been discussed in more detail in the article -> click here.

    How does the regulation of psychotropic drugs affect the patient?

    From a practical point of view, relevant to Polish patients, it is worth noting that, from 1 November 2023, prescriptions for narcotic drugs or psychotropic substances can be issued only in electronic form.

    An evocative image showing two human heads side by side. The first head features tangled and disordered yarn, symbolizing poor mental health, while the second head has neatly arranged yarn, representing stability and well-being. In the center, a hand holds a pack of psychotropic medications, highlighting the role of these drugs in mental health treatment. This visual emphasizes the importance of understanding psychotropic medications, which are used to treat mental illnesses by affecting brain chemistry. The image reflects the regulatory landscape in Poland, where electronic prescriptions for such medications will be mandated from November 2023.

    In addition, in line with the latest requirements introduced by the regulation amending the Regulation on Narcotic Drugs, Psychotropic Substances, Category 1 Precursors, and Preparations Containing These Drugs or Substances, signed by the Minister of Health on 12 July 2023, doctors must verify the history of prescriptions for narcotic and psychotropic drugs before issuing a new prescription. This applies to prescriptions for preparations containing a narcotic drug of group I-N or II-N, a psychotropic substance of group II-P, III-P, or IV-P, or a precursor of category 1. It should also be noted that a patient who receives such a prescription will have 30 days to redeem it.

    Where should you start if you want to place a medicine containing a psychotropic substance on the Polish market? What should be noted when planning to place such a medicine on the market?

    We would like to point out that according to the Article 35 of CDA, authorisation from the Polish Chief Pharmaceutical Inspector is required to undertake activities related to the manufacturing, processing, altering, importing, or distributing of narcotic drugs or psychotropic substances. However, the processing of narcotic drugs, psychotropic substances, and precursors does not require such authorisation if it is carried out in a pharmacy according to the principles set out in the PLaw. Authorised medicinal products are given a special legal status, indicated as ‘Rpw – Medicinal product subject to medical prescription.’

    An image depicting a medication package displayed in a pharmacy, prominently featuring the no-entry symbol (Ө) associated with psychotropic drugs in Poland. This symbol signifies that the medication has strong effects on psychophysical coordination and indicates the prohibition of driving or operating machinery for 24 hours after use. The packaging reflects the regulatory requirements for psychotropic substances, which must be authorized by the Polish Chief Pharmaceutical Inspector and marked with the designation ‘Rpw – Medicinal product subject to medical prescription.’ This visual highlights the importance of proper labeling and awareness in mental health treatment.

    A curiosity regarding psychotropic drugs that should be brought to the attention of marketing authorisation holders interested in marketing a drug with a psychotropic substance is the issue of labelling. Namely, in accordance with the information under Article 62 of Directive 2001/83/EC, on labelling of such is recommended to place a road sign symbol/ a no-entry symbol (Ө) – which indicates a pharmaceutical product with strong effects on psychophysical coordination. Additionally, the label should include information about the prohibition of driving or operating machinery for 24 hours after use.

    References:

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