Home / Dz.U. 2011 nr 82 poz. 451
Law of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ustawa z dnia 18 marca 2011 r. o Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Type
Law (Ustawa)
Status
act has a consolidated text (akt posiada tekst jednolity)
Announced
2011-03-18
Entry into force
2011-05-01
Texts
The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.
Keywords
Pharmaceutical MeansMedical Productsstate officeshealth protectionbiocidal products
Related acts
Repealed Acts (2)
Acts Declared Repealed (9)
- Regulation of the Minister of Health of 29 November 2002 on advisory bodies to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. · 2011-05-01
- Regulation of the Minister of Health of 4 November 2008 on the forms of documents submitted in connection with a clinical trial of a medicinal product and on the amount and method of paying fees for commencing a clinical trial · 2012-05-02
- Regulation of the Minister of Health of April 7, 2005, on the procedure and scope of conducting clinical trial controls · 2012-05-02
- Regulation of the Minister of Health of 11 March 2005 on the detailed requirements of Good Clinical Practice · 2012-05-02
- Regulation of the Minister of Health of February 7, 2005, on the Central Register of Clinical Trials of Veterinary Medicinal Products · 2012-05-02
- Regulation of the Minister of Health of August 6, 2004 on the requirements of Good Veterinary Clinical Practice regarding veterinary medicinal products · 2012-05-02
- Regulation of the Minister of Health of 6 August 2004 on the method and scope of conducting veterinary clinical trials in terms of their compliance with Good Veterinary Clinical Practice requirements · 2012-05-02
- Regulation of the Minister of Health of December 18, 2002 on making changes to the permit and documentation concerning the placing of a medicinal product on the market · 2012-05-02
- Regulation of the Minister of Health of 24 February 2010 amending the regulation on detailed requirements of Good Clinical Practice · 2012-05-02
Implementing Regulations (7)
- Order No. 63 of the Prime Minister of June 11, 2024, amending the order on granting the statute of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Order No. 172 of the Prime Minister of November 16, 2017 amending the order on granting the statute to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Order No. 62 of the Prime Minister of September 15, 2014, amending the order on granting the statute of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Order No. 37 of the Prime Minister of June 14, 2011, on granting the statute to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- Regulation of the Minister of Health of 18 July 2023 on the provision of scientific advice by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Regulation of the Minister of Health of June 29, 2011 on Commissions operating at the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Regulation of the Minister of Health of June 1, 2011, on the form of the declaration of absence of conflict of interest
Amending Acts (9)
- Law of January 13, 2012, on amending the law on reimbursement of medicines, foodstuffs for special nutritional purposes, and medical devices, and certain other laws · 2012-02-09
- Law of September 27, 2013, on the amendment of the law - Pharmaceutical Law and certain other laws · 2013-11-25
- Law of 9 October 2015 on biocidal products · 2015-12-05
- Law of 11 September 2015 on amending the law on medical devices and certain other laws · 2016-02-20
- Law of 7 June 2018 on amending the Law - Pharmaceutical Law and certain other laws · 2018-08-01
- Law of 11 September 2019 on amending the Law - Pharmaceutical Law and certain other laws · 2019-10-23
- Law of April 7, 2022, on medical devices · 2022-05-26
- Law of August 5, 2022, amending the Law on the nursing and midwifery professions and certain other laws · 2022-09-02
- Law of March 9, 2023, on clinical trials of medicinal products for human use · 2023-04-14
Amended Acts (4)
- Law of September 16, 1982 on State Office Employees. · 2011-05-01
- Law of 21 November 2008 on Civil Service · 2011-05-01
- Act of September 13, 2002 on biocidal products. · 2011-05-01
- Law of September 6, 2001, Pharmaceutical Law. · 2011-05-01
Information on Consolidated Text (5)
- Announcement of the Marshal of the Sejm of the Republic of Poland of May 4, 2020, on the promulgation of the consolidated text of the law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Announcement of the Marshal of the Sejm of the Republic of Poland of May 25, 2023, on the promulgation of the consolidated text of the law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- 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 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Announcement by the Marshal of the Sejm of the Republic of Poland of March 15, 2019, on the promulgation of the consolidated text of the law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Announcement of the Marshal of the Sejm of the Republic of Poland of September 16, 2016, on the promulgation of the consolidated text of the Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
References (8)
- Law of November 6, 2008, on Patient Rights and the Patient Ombudsman
- Law of December 5, 2008, on the prevention and combating of infections and infectious diseases in humans
- Law of August 25, 2006, on food and nutrition safety.
- Law of 27 August 2004 on healthcare benefits financed from public funds
- Law of 18 July 2002 on the provision of services by electronic means.
- Law of 21 August 1997 on the Restriction of Economic Activity by Persons Holding Public Office.
- Law of 6 June 1997 - Penal Code
- Law of June 14, 1960, Code of Administrative Procedure.
Acts referring to this act
- Repealing Acts: Act of 30 August 2002 on amending the Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- Repealing Acts: Law of July 27, 2001, on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- Amending Acts: Law of 21 November 2008 on Civil Service
- Amending Acts: Law of September 6, 2001, Pharmaceutical Law.
- Amending Acts: Law of September 16, 1982 on State Office Employees.
- Amending Acts: Act of September 13, 2002 on biocidal products.
- 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 April 7, 2022, on medical devices
- Amended Acts: Law of 11 September 2019 on amending the Law - Pharmaceutical Law 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 11 September 2015 on amending the law on medical devices and certain other laws
- Amended Acts: Law of 9 October 2015 on biocidal products
- Amended Acts: Law of September 27, 2013, on the amendment of the law - Pharmaceutical Law and certain other laws
- Amended Acts: Law of January 13, 2012, on amending the law on reimbursement of medicines, foodstuffs for special nutritional purposes, and medical devices, and certain other laws
- References: Law of September 27, 2013, on the amendment of the law - Pharmaceutical Law and certain other laws
- Legal Basis: Regulation of the Minister of Health of June 29, 2011 on Commissions operating at the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis: Order No. 172 of the Prime Minister of November 16, 2017 amending the order on granting the statute to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis: Regulation of the Minister of Health of June 1, 2011, on the form of the declaration of absence of conflict of interest
- Legal Basis: Order No. 63 of the Prime Minister of June 11, 2024, amending the order on granting the statute of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis: Regulation of the Minister of Health of 18 July 2023 on the provision of scientific advice by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis: Order No. 62 of the Prime Minister of September 15, 2014, amending the order on granting the statute of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis: Order No. 37 of the Prime Minister of June 14, 2011, on granting the statute to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- Legal Basis from Art.: Regulation of the Minister of Health of 18 July 2023 on the provision of scientific advice by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis from Art.: Regulation of the Minister of Health of June 1, 2011, on the form of the declaration of absence of conflict of interest
- Legal Basis from Art.: Order No. 172 of the Prime Minister of November 16, 2017 amending the order on granting the statute to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis from Art.: Regulation of the Minister of Health of June 29, 2011 on Commissions operating at the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis from Art.: Order No. 62 of the Prime Minister of September 15, 2014, amending the order on granting the statute of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis from Art.: Order No. 63 of the Prime Minister of June 11, 2024, amending the order on granting the statute of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Legal Basis from Art.: Order No. 37 of the Prime Minister of June 14, 2011, on granting the statute to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- Consolidated Text for an Act: Announcement of the Marshal of the Sejm of the Republic of Poland of September 16, 2016, on the promulgation of the consolidated text of the Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Consolidated Text for an Act: Announcement by the Marshal of the Sejm of the Republic of Poland of March 15, 2019, on the promulgation of the consolidated text of the law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Consolidated Text for an Act: Announcement of the Marshal of the Sejm of the Republic of Poland of May 4, 2020, on the promulgation of the consolidated text of the law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Consolidated Text for an Act: 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 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Consolidated Text for an Act: Announcement of the Marshal of the Sejm of the Republic of Poland of May 25, 2023, on the promulgation of the consolidated text of the law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- Repeals Resulting From: Regulation of the Minister of Health of 4 November 2008 on the forms of documents submitted in connection with a clinical trial of a medicinal product and on the amount and method of paying fees for commencing a clinical trial
- Repeals Resulting From: Regulation of the Minister of Health of December 18, 2002 on making changes to the permit and documentation concerning the placing of a medicinal product on the market
- Repeals Resulting From: Regulation of the Minister of Health of 6 August 2004 on the method and scope of conducting veterinary clinical trials in terms of their compliance with Good Veterinary Clinical Practice requirements
- Repeals Resulting From: Regulation of the Minister of Health of August 6, 2004 on the requirements of Good Veterinary Clinical Practice regarding veterinary medicinal products
- Repeals Resulting From: Regulation of the Minister of Health of February 7, 2005, on the Central Register of Clinical Trials of Veterinary Medicinal Products
- Repeals Resulting From: Regulation of the Minister of Health of 11 March 2005 on the detailed requirements of Good Clinical Practice
- Repeals Resulting From: Regulation of the Minister of Health of April 7, 2005, on the procedure and scope of conducting clinical trial controls
- Repeals Resulting From: Regulation of the Minister of Health of 24 February 2010 amending the regulation on detailed requirements of Good Clinical Practice
- Repeals Resulting From: Regulation of the Minister of Health of 29 November 2002 on advisory bodies to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.