Law of September 6, 2001, Provisions 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.

Texts

The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.

Keywords

Related acts

Acts referring to this act

• Repealing Acts: Law of December 29, 1992 on the amendment of the law on pharmaceutical agents, medical materials, pharmacies, wholesale warehouses, and pharmaceutical supervision.
• Repealing Acts: Judgment of the Constitutional Tribunal of June 13, 2000 case file K. 15/99.
• Repealing Acts: Law of October 10, 1991, on pharmaceutical products, medical materials, pharmacies, wholesale warehouses, and pharmaceutical supervision.
• Amending Acts: Law of 21 December 1990 on the veterinary profession and veterinary chambers.
• Amending Acts: Law of March 14, 1985, on the State Sanitary Inspectorate.
• Amending Acts: Law of February 6, 1997, on universal health insurance.
• Amending Acts: Law of 5 December 1996 on the professions of physician and dentist.
• Amending Acts: Law of 22 August 1997 on the Public Blood Service.
• Amending Acts: Law of April 3, 1993, on Assay.
• Amending Acts: Law of September 4, 1997, on government administration departments.
• Amending Acts: Law of August 30, 1991, on healthcare facilities.
• Amending Acts: Law of April 19, 1991, on Pharmaceutical Chambers.
• Amended Acts: Law of March 30, 2007 amending the Law - Pharmaceutical Law and amending certain other laws
• Amended Acts: 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
• Amended Acts: Law of 20 April 2004 on medical devices
• Amended Acts: Law of December 18, 2003 on amendment of the Law - Implementing Provisions of the Law - Pharmaceutical Law, the Law on Medical Devices and the Law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Amended Acts: Law of 23 January 2003 on universal insurance in the National Health Fund
• Amended Acts: Law of 30 August 2002 on the amendment of the Law - Provisions introducing the Law - Pharmaceutical Law, the Law on Medical Devices and the Law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Law on the Medical Profession.
• Amended Acts: Law of March 20, 2002, on amending the law - Provisions introducing the law - Pharmaceutical Law, the law on medical devices, and the law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
• Amended Acts: Law of 21 December 2001 on the amendment of the Law on the Universal Obligation of Defence of the Republic of Poland, the Law on the Military Service of Professional Soldiers, the Law on Universal Health Insurance, the Law on the amendment of the Law on Universal Health Insurance and certain other laws, the Law on State Medical Rescue, the Law - Provisions Introducing the Law - Pharmaceutical Law, the Law on Medical Devices, and the Law on the amendment of the Law on the amendment of the Law on the amendment of the Law on the Medical Profession and on the amendment of other laws.
• References: Regulation of the Minister of Health of July 20, 2006 on the method of determining and paying fees related to the marketing authorization of a veterinary medicinal product
• References: Regulation of the Minister of Health of 12 December 2002 on entities authorised to purchase medicinal products from a pharmaceutical wholesaler.
• Legal Basis: Regulation of the Minister of Health of June 27, 2008, amending the regulation on the amount of fees for extending a permit covering the completion and bringing of medicinal product documentation into compliance with pharmaceutical law requirements.
• Legal Basis: Regulation of the Minister of Health of 9 July 2007 on the amount of fees for the extension of a permit covering the supplementation and bringing of medicinal product documentation into compliance with the requirements of the Pharmaceutical Law
• Legal Basis from Art.: Regulation of the Minister of Health of 9 July 2007 on the amount of fees for the extension of a permit covering the supplementation and bringing of medicinal product documentation into compliance with the requirements of the Pharmaceutical Law
• Legal Basis from Art.: Regulation of the Minister of Health of June 27, 2008, amending the regulation on the amount of fees for extending a permit covering the completion and bringing of medicinal product documentation into compliance with pharmaceutical law requirements.
• Introductory Provisions: Law of July 27, 2001, on medical devices.
• Introductory Provisions: Law of September 6, 2001, Pharmaceutical Law.
• Introductory Provisions: Law of July 27, 2001, on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
• Repeals Resulting From: Regulation of the Minister of Health and Social Welfare of January 28, 1993, on the procedure for conducting inspections, principles and procedure for collecting samples for testing, conducting tests, and principles of payment.
• Repeals Resulting From: Order of the Minister of Health and Social Welfare of November 25, 1992 on the pattern and method of keeping a control book, the principles of making entries and the procedure for notifying about the removal of identified deficiencies.
• Repeals Resulting From: Regulation of the Minister of Health and Social Welfare of July 8, 1993, on requirements for the production of pharmaceutical products and medical materials.
• Repeals Resulting From: Regulation of the Minister of Health and Social Welfare of October 16, 1997, on additional professional qualifications of the head of a pharmacy and a pharmaceutical wholesaler.
• Repeals Resulting From: Regulation of the Minister of Agriculture and Food Economy of January 31, 1995, on the obligations of the manufacturer and importer of medicines regarding the placing on the market of pharmaceutical products and medical materials used exclusively in animals and batch control.
• Repeals Resulting From: Regulation of the Minister of Agriculture and Food Economy of December 30, 1994, on the register of pharmaceutical products and medical materials used exclusively in animals.
• Repeals Resulting From: Regulation of the Minister of Health of September 19, 2002, amending the regulation on the retail trade of pharmaceutical products and medical supplies outside pharmacies.
• Repeals Resulting From: Regulation of the Minister of Health and Social Welfare of July 27, 1994, on professional activities that may be performed in individual types of pharmacies by persons not having the right to independently practice the profession of a pharmacist.
• Repeals Resulting From: Regulation of the Minister of National Defence of November 15, 1993 on the determination of pharmaceutical products and medical materials that can be dispensed without a doctor's prescription by pharmacies operating within the national defence ministry, and the detailed principles for dispensing medicines and medical materials by these pharmacies.
• Repeals Resulting From: Regulation of the Minister of National Defence of 22 November 1993 on the retail trade of pharmaceutical products and medical materials outside pharmacies in the national defence ministry.
• Repeals Resulting From: Regulation of the Minister of Health of 21 September 2001 on the retail trade of pharmaceutical products and medical supplies outside pharmacies.
• Repeals Resulting From: Regulation of the Minister of Health and Social Care of October 26, 1998 on fees for registration in the register of pharmaceutical products or medical materials.
• Repeals Resulting From: Regulation of the Minister of Health and Social Welfare of July 19, 1993, on the principles of completing one-year practical training in pharmacies.
• Repeals Resulting From: Regulation of the Minister of Justice of April 23, 1993 on types of pharmacies in penal institutions, defining the premises and equipment requirements for these pharmacies, the rules for dispensing medicines and medical materials, and retail trade in pharmaceutical preparations and medical materials outside pharmacies.
• Repeals Resulting From: Regulation of the Minister of Agriculture and Food Economy of April 2, 1998, on the supervision of the trade in medicinal products and medical materials intended exclusively for animals and the qualifications of persons performing control functions.
• Repeals Resulting From: Order of the Minister of Health and Social Care of 6 April 1993 on the list of units authorized to conduct laboratory and clinical tests and the conditions for conducting these tests.
• Repeals Resulting From: Regulation of the Minister of Agriculture and Food Economy of October 4, 1994, on requirements concerning the production of pharmaceutical products and medical materials used exclusively in animals
• Repeals Resulting From: Regulation of the Minister of Transport and Maritime Economy of October 8, 1993, on the types of railway pharmacies, the scope and type of activities belonging to pharmacies of individual types, and the requirements concerning the premises and equipment of these pharmacies.
• Repeals Resulting From: Regulation of the Minister of Interior of September 1, 1993, on the type of pharmacies in healthcare facilities subordinate to the Minister of Interior, the determination of spatial and equipment requirements for these pharmacies, the rules for dispensing medicines and medical supplies, and the retail trade of pharmaceutical products and medical supplies outside pharmacies.
• Repeals Resulting From: Order of the Minister of Agriculture and Food Economy of October 28, 1994, amending the order on the fee for issuing a concession for the production of pharmaceutical agents and medical materials used exclusively in animals.
• Repeals Resulting From: Order of the Minister of Agriculture and Food Economy of March 24, 1994, on the fee for issuing a concession for the production of pharmaceutical products and medical materials used exclusively in animals.