Home / Dz.U. 2001 nr 126 poz. 1381
Law of September 6, 2001, Pharmaceutical Law.
Ustawa z dnia 6 września 2001 r. Prawo farmaceutyczne.
Type
Law (Ustawa)
Status
act has a consolidated text (akt posiada tekst jednolity)
Announced
2001-09-06
Entry into force
2002-10-01
Texts
The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.
Keywords
research and development unitspackagingresearch and certificationprawo celneveterinary servicePublic Financeeconomic activityPharmacistsMedicines and Sanitary Articleshealth protectiontrademarksPharmaceutical Lawsupervisionregistersenvironmental protectionadvertisingpharmacieshealth insurancedrug addictionpenal provisionsControlDoctorsQualificationspermitsdocumentscompetitioninspectionwholesalersPharmaceutical Means
Related acts
Implementing Regulations (316)
- Regulation of the Minister of Health of December 3, 2015, on the requirements of Good Distribution Practice for active substances
- Regulation of the Minister of Health of May 25, 2026, amending the regulation on Good Distribution Practice requirements.
- Regulation of the Minister of Health of March 24, 2026, amending the regulation on the list of medicinal products that can be supplied on an ad hoc basis in connection with the provision of healthcare services, and the list of medicinal products included in anti-shock, life-saving kits
- Regulation of the Minister of Health of March 6, 2026, on the confirmation of qualifications of a Qualified Person and a Competent Person
- Regulation of the Minister of Health of February 20, 2026, amending the regulation on the form of an application for a permit to operate a pharmaceutical wholesaler
- Regulation of the Minister of Health of June 30, 2025, amending the regulation on the mail-order sale of medicinal products
- Regulation of the Minister of Health of April 23, 2025, amending the regulation on the list of active substances that are part of medicinal products which may be admitted for trade in non-pharmacy trade facilities and pharmacy points, and the criteria for classifying these products into individual lists
- Regulation of the Minister of Health of November 17, 2025, amending the regulation on the basic conditions for operating a pharmacy
- Regulation of the Minister of Agriculture and Rural Development of January 30, 2025, amending the regulation on the conditions that entities conducting retail trade of veterinary medicinal products dispensed without a prescription should meet, the criteria for classifying these products and their list
- Regulation of the Minister of Health of 1 October 2025 amending the regulation on organizational units that conduct qualitative tests of medicinal products and veterinary medicinal products, and on fees charged for these tests
- Regulation of the Minister of Health of August 12, 2025, amending the regulation on the detailed requirements that a pharmacy premises should meet
- Regulation of the Minister of Health of July 2, 2024, amending the regulation on prescriptions
- Regulation of the Minister of Health of April 9, 2024, amending the regulation on the detailed requirements that a pharmacy premises should meet
- Regulation of the Minister of Health of April 15, 2024, amending the regulation on the list of premises constituting the primary and auxiliary area of a pharmacy
- Regulation of the Minister of Agriculture and Rural Development of February 19, 2024, amending the regulation on the conditions that entities conducting retail trade in veterinary medicinal products issued without a prescription should meet, the criteria for classifying these products, and their list
- Regulation of the Minister of Health of December 4, 2024, amending the regulation on the requirements of Good Manufacturing Practice.
- Regulation of the Minister of Health of August 12, 2024, amending the regulation on Good Manufacturing Practice requirements
- Regulation of the Minister of Health of April 11, 2023, amending the regulation on the basic conditions for running a pharmacy
- Regulation of the Minister of Health of March 31, 2023 on the amount and method of determining and paying fees related to the authorization for placing veterinary medicinal products on the market
- Regulation of the Minister of Health of November 14, 2023, amending the regulation on entities authorized to purchase medicinal products from pharmaceutical wholesalers
- Regulation of the Minister of Health of October 31, 2023, amending the regulation on prescriptions
- Regulation of the Minister of Health of August 29, 2023, amending the regulation on prescriptions
- Regulation of the Minister of Health of 17 July 2023 amending the regulation on granting the statute to the Chief Pharmaceutical Inspectorate
- Regulation of the Minister of Health of 30 December 2022 amending the regulation on prescriptions
- Regulation of the Minister of Health of April 7, 2022, on entities authorized to purchase medicinal products from pharmaceutical wholesalers
- Regulation of the Minister of Health of February 16, 2022, amending the regulation on detailed requirements for pharmacy premises
- Regulation of the Minister of Health of December 31, 2021 amending the regulation on the detailed requirements that a pharmacy premises must meet
- Regulation of the Minister of Health of 27 October 2022 on the basic conditions for running a pharmacy
- Regulation of the Minister of Health of December 31, 2021 amending the regulation on the list of premises constituting the primary and auxiliary area of a pharmacy
- Regulation of the Minister of Health of October 24, 2022, amending the regulation on the list of active substances in medicinal products that may be authorized for sale in non-pharmacy retail outlets and pharmacy points, and the criteria for classifying these products into individual lists
- … +286
Amending Acts (102)
- Law of 30 August 2002 on the amendment of the Law - Pharmaceutical Law. · 2002-10-01
- Law of 27 July 2002 on amendment of the Law on pharmacy chambers and the Law – Pharmaceutical Law. · 2002-10-02
- Law of June 20, 2002, on the direct election of the village head, mayor, and city president. · 2002-10-27
- Law of 23 January 2003 on universal insurance in the National Health Fund · 2003-04-01
- Law of 17 October 2003 amending the Law on Chemical Substances and Preparations and amending certain other laws · 2003-12-07
- Law of March 11, 2004, on veterinary requirements for the non-commercial movement of companion animals and circus animals accompanying travellers and on the use of substances with hormonal, thyreostatic and beta-agonist effects · 2004-05-01
- Law of April 2, 2004, amending the law on animal feed and amending certain other laws · 2004-05-01
- Law of 20 April 2004 on medical devices · 2004-05-01
- Law of April 20, 2004, amending the Pharmaceutical Law, the Law on the Medical Profession and the law introducing the Pharmaceutical Law, the law on medical devices and the law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products · 2004-05-01
- Law of July 2, 2004 Provisions introducing the Law on freedom of economic activity · 2004-08-21
- Law of 27 August 2004 on healthcare benefits financed from public funds · 2004-10-01
- Law of November 25, 2004, amending the Law on Public Finance and amending certain laws · 2005-01-01
- Law of 21 April 2005 amending the Law – Pharmaceutical Law · 2005-06-14
- Law of July 27, 2005 on conducting competitions for the positions of heads of central government administration offices, presidents of state agencies and presidents of management boards of state targeted funds · 2005-09-01
- Law of 29 July 2005 on Counteracting Drug Addiction · 2005-10-04
- Law of 29 July 2005 on Public Offering and the Conditions for Introducing Financial Instruments into an Organized Trading System and on Public Companies · 2005-10-24
- Law of 24 August 2006 on the State Cadre Reserve and High State Offices · 2006-10-27
- Law of August 25, 2006, on food and nutrition safety. · 2006-10-28
- Law of November 16, 2006, on amending the Personal Income Tax Act and on amending certain other acts · 2007-01-01
- Law of February 16, 2007, on competition and consumer protection · 2007-04-21
- Law of March 30, 2007 amending the Law - Pharmaceutical Law and amending certain other laws · 2007-05-01
- Law of August 24, 2007 amending the Law on healthcare benefits financed from public funds and certain other laws · 2007-09-29
- Law of December 5, 2008, on the prevention and combating of infections and infectious diseases in humans · 2009-01-01
- Law of December 19, 2008, on amending the Law on Freedom of Economic Activity and on amending certain other laws · 2009-03-07
- Law of 21 November 2008 on Civil Service · 2009-03-24
- Law of January 23, 2009, on the voivode and government administration in the voivodeship · 2009-04-01
- Law of 7 May 2009 on the repeal of certain authorisations to issue executive acts · 2009-07-10
- Law of 24 April 2009 amending the Pharmaceutical Law · 2009-07-20
- Law of 23 January 2009 on amending certain laws in connection with changes in the organization and division of tasks of public administration in the voivodeship · 2009-08-01
- Law of 9 April 2010 on the repeal of the Law on veterinary medicinal products and on amending other laws · 2010-06-11
- … +72
Information on Consolidated Text (12)
- Announcement of the Marshal of the Sejm of the Republic of Poland of September 16, 2021, on the promulgation of the consolidated text of the Act - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of April 17, 2026, concerning the announcement of the consolidated text of the Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of May 21, 2025, on the announcement of the consolidated text of the law - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of April 12, 2024, on the promulgation of the consolidated text of the Law - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of October 7, 2022, on the promulgation of the consolidated text of the law - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of May 18, 2021, on the announcement of the consolidated text of the Act - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of May 15, 2020, on the promulgation of the consolidated text of the Law - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of 22 February 2019 on the promulgation of the consolidated text of the Act - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of October 30, 2017, on the promulgation of the consolidated text of the law - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of December 7, 2016, on the promulgation of the consolidated text of the Act - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of February 27, 2008, on the promulgation of the consolidated text of the Act - Pharmaceutical Law
- Announcement of the Marshal of the Sejm of the Republic of Poland of March 13, 2004, on the promulgation of the consolidated text of the law on pharmaceutical law
References (10)
- Law of March 30, 2001 on cosmetics.
- Law of November 19, 1999, on Business Activity.
- Law of November 26, 1998, on public finance.
- Law of April 24, 1997 on combating drug addiction.
- Law of February 6, 1997, on universal health insurance.
- Law of 5 December 1996 on the professions of physician and dentist.
- Law of 16 April 1993 on combating unfair competition.
- Law of August 30, 1991, on healthcare facilities.
- Law of April 19, 1991, on Pharmaceutical Chambers.
- Law of June 14, 1960, Code of Administrative Procedure.
Acts referring to this act
- Amended Acts: Law of 15 May 2026 on amending certain laws in connection with the development of e-health services
- Amended Acts: Law of November 21, 2025, on animal health
- Amended Acts: Law of September 26, 2025, amending the Law on healthcare benefits financed from public funds and certain other laws
- Amended Acts: Law of September 12, 2025, on amending the Pharmaceutical Law Act
- Amended Acts: Law of June 24, 2025, on amending the Pharmaceutical Law
- Amended Acts: Law of June 4, 2025, on amending the Pharmaceutical Law
- Amended Acts: Act of December 5, 2024, on amending the Act on healthcare benefits financed from public funds and certain other acts
- Amended Acts: Law of 17 August 2023 on amending the Law on the reimbursement of medicines, foodstuffs for special medical purposes and medical devices, and certain other laws
- Amended Acts: Law of July 13, 2023 on the amendment of the law on export insurance guaranteed by the State Treasury and certain other laws
- Amended Acts: Law of March 9, 2023 on the National Oncology Network
- Amended Acts: Law of March 9, 2023, on clinical trials of medicinal products for human use
- Amended Acts: Law of August 5, 2022, amending the Law on the nursing and midwifery professions and certain other laws
- Amended Acts: Law of 12 May 2022 on amending the Law - Pharmaceutical Law and the Law on the Pharmaceutical Profession
- Amended Acts: Law of May 12, 2022, on the Humanitarian and Medical Aid Team
- Amended Acts: Law of April 7, 2022, on medical devices
- Amended Acts: Law of April 8, 2022, on amending the law on assistance to Ukrainian citizens in connection with the armed conflict in the territory of that state and certain other laws
- Amended Acts: Law of November 17, 2021, amending the Law on healthcare benefits financed from public funds and certain other laws
- Amended Acts: Law of April 15, 2021, on amending the law on specific solutions related to the prevention, counteraction, and combating of COVID-19, other infectious diseases, and crises caused by them, and certain other laws
- Amended Acts: Law of December 10, 2020, on the profession of a pharmacist
- Amended Acts: Law of October 28, 2020, on amending certain laws in connection with counteracting crisis situations related to the occurrence of COVID-19
- Amended Acts: Law of 14 August 2020 amending certain laws to ensure the functioning of healthcare in connection with the COVID-19 epidemic and after its cessation
- Amended Acts: Law of 23 January 2020 on amending the Law on the State Sanitary Inspectorate and certain other laws.
- Amended Acts: Law of March 31, 2020, on amending certain laws concerning the healthcare system related to the prevention, counteracting and combating of COVID-19
- Amended Acts: Law of 2 March 2020 on special solutions related to the prevention, counteraction and combating of COVID-19, other infectious diseases and crises caused by them.
- Amended Acts: Law of 31 July 2019 amending certain laws to reduce regulatory burdens
- Amended Acts: Law of 19 July 2019 on the provision of social services by social service centers
- Amended Acts: Law of 11 September 2019 on amending the Law - Pharmaceutical Law and certain other laws
- Amended Acts: Law of 19 July 2019 amending certain laws in connection with the implementation of e-health solutions
- Amended Acts: Law of July 19, 2019, on amending the law on the system of monitoring road and rail transport of goods and certain other laws
- Amended Acts: Law of July 19, 2019, on amending the Pharmaceutical Law
- Amended Acts: Law of 26 April 2019 amending the Pharmaceutical Law and certain other laws
- Amended Acts: Law of 21 February 2019 on amending the law on healthcare benefits financed from public funds and certain other laws
- Amended Acts: Law of December 6, 2018, amending the Law on identity cards and certain other laws
- Amended Acts: Law of 6 December 2018 on the amendment of certain laws in connection with e-referrals and waiting lists for healthcare services
- Amended Acts: Law of October 4, 2018, on cosmetic products
- Amended Acts: Law of July 5, 2018, on the succession management of an individual's enterprise
- Amended Acts: Law of July 3, 2018 - Provisions introducing the Law on Higher Education and Science
- Amended Acts: Law of 5 July 2018 amending the Act on trust services and electronic identification and certain other laws
- Amended Acts: Law of July 5, 2018, on amending the law on combating unfair competition and certain other laws
- Amended Acts: Law of 20 July 2018 amending the Act on the Health Care Information System and certain other laws
- Amended Acts: Law of 7 June 2018 on amending the Law - Pharmaceutical Law and certain other laws
- Amended Acts: Law of 10 May 2018 amending the Law on the system of road transport monitoring of goods and certain other laws
- Amended Acts: Law of 6 March 2018 - Provisions introducing the Law - Entrepreneurs' Law and other laws concerning economic activity
- Amended Acts: Law of 1 March 2018 amending certain laws in connection with the introduction of e-prescriptions
- Amended Acts: Law of 25 May 2017 amending the Law on Healthcare Benefits Financed from Public Funds and certain other laws
- Amended Acts: Act of April 7, 2017 on amending the Act - Pharmaceutical Law
- Amended Acts: Law of November 16, 2016, - Provisions introducing the Law on the National Revenue Administration
- Amended Acts: Law of November 16, 2016, amending certain laws in connection with the establishment of the Ministry of Interior and Administration
- Amended Acts: Law of 5 September 2016 on trust services and electronic identification
- Amended Acts: Law of May 20, 2016, on amending the Law on the Public Blood Service and certain other laws