References
- 1. https://www.gov.pl/web/gif [access date: 18.04.2021]
- 2. https://sip.lex.pl/akty-prawne/akty-korporacyjne/zasadyprowadzenia-postepowan-przygotowawczych-o-przestepstwazwiazane-287346774 [access date: 18.04.2021]
- 3. The irregularities have been noticed by European agencies such as: The Heads of Medicine Agencies, the European Medicines Agency, and the Council and the European Commission. The problem of drug shortages in EU countries – pan-European research conducted by the European Association of Hospital Pharmacists (EAHP) – aimed at gathering information on emerging cross-border temporary drug shortages. https://www.eahp.eu/practice-and-policy/medicines-shortages/2018-medicines-shortage-survey
- 4. OJ L 311; 28.11.2001. p. 67.
- 5. The Register of Permits for Operating a Pharmaceutical Wholesaler is kept by the Chief Pharmaceutical Inspectorate pursuant to Article 83 of the Pharmaceutical Law Act and the Regulation of the Minister of Health of 3 October 2012 on the description of the IT system for keeping the Register of Permits for Operating a Pharmaceutical Wholesaler. Journal of Laws of 2012, item 1118.
- 6. https://rejestrymedyczne.csioz.gov.pl/rhf/search/public [access date: 18.04.2021]
- 7. Decision of the Voivodeship Administrative Court in Warsaw of 6 June 2019 r., Case no. VI SA/Wa 116/19.
- 8. Medical prescription contains recommendations, orders, instructions and suggestions for the patient. It should be consistent with: 1. Requirements set by the law (and the Medical Code of Ethics), 2. Current medical knowledge.
- 9. The Act of 9 April 2015 amending the Pharmaceutical Law Act and certain other acts. Journal of Laws of 2015, item 788.
- 10. Article 65 – Paragraph 1 of the Pharmaceutical Law Act.
- 11. Czerw A, Bilińska M. Dystrybucja produktów leczniczych w Polsce w świetle regulacji legislacyjnych. Farm Współcz. 2012;5:116-25.
- 12. https://www.nik.gov.pl/kontrole/P/17/110/ [access date:18.04.2021]
- 13. Journal of Laws of 2002, No. 216, item 1831.
- 14. On 1 April 2019, the obligation to submit data to the Integrated System for Monitoring Trade in Medicinal Products entered into force. The Integrated System for Monitoring Trade in Medicinal Products makes it possible to monitor the trade at retail and wholesale level and report the gathered data to the competent authorities.
- 15. Journal of Laws of 2019, item 959.
- 16. Journal of Laws of 2021, item 523, 1292, consolidated text.
- 17. Journal of Laws of 2020, item 1444, as amended.
- 18. Najmoła D, Liszewski K. Eksport – import równoległy a odwrócony łańcuch dystrybucji leków. Kwartalnik Prawno-Kryminalistyczny. 2016;3(28):20.
- 19. Activities of state authorities to ensure the availability of medicinal products, Supreme Audit Office. Warsaw; October 2018. https://www.nik.gov.pl/plik/id,18813,vp,21416.pdf
- 20. The Chief Pharmaceutical Inspectorate has imposed financial penalties on entities participating in ‘reverse distribution’ to the amount of PLN 280 million (as of 31 July 2019) – unfortunately, no amount has been enforced.
- 21. Pursuant to the provisions of Article 299 § 3 – Subparagraph 15 of the Tax Ordinance Act of 29 August 1997, Journal of Laws of 2019, item 900, as amended – the Chief Pharmaceutical Inspectorate is allowed to obtain information from the National Tax Administration, which is the basis for calculating the amount of fines.