Law

Pharmaceutical Law

List of Regulations of Minister of Health to Pharmaceutical Law – Act of 6 September 2001:

  • Regulation of the Minister of Health on Good Manufacturing Practice requirements dated 1 October 2008.
  • Regulation of the Minister of Health on the form of the application for amending the manufacturing authorisation for a medicinal product and an investigated medicinal product, and amending the import authorisation for a medicinal product and an investigated medicinal product dated 12 January 2011.
  • Regulation of the Minister of Health on the form of the manufacturing authorisation and import authorisation for a medicinal product and an investigated medicinal product dated 12 January 2011.
  • Regulation of the Minister of Health on the amount and manner of collecting charges for granting and amending the manufacturing authorisation for medicinal products and granting and amending the import authorisation for medicinal products dated 10 March 2006.
  • Regulation of the Minister of Health on the amount and manner of covering the costs related to carrying out an inspection by GMP inspectors of the Main Pharmaceutical Inspectorate dated 24 February 2010.
  • Regulation of the Minister of Health on the initial batch control of medicinal products and raw materials used to prepare magistral and officinal medicines dated 10 April 2013.
  • Regulation of the Minister of Health on specifying the forms of documents related to conducting controls and inspections by the State Pharmaceutical Inspection and a form of the decision on the results of quality tests of collected samples dated 31 July 2009.
  • Regulation of the Minister of Health on the amount and manner of covering the costs related to carrying out an inspection by GMP inspectors of the Main Pharmaceutical Inspectorate dated 24 February 2010.
  • Regulation of the Minister of Health on the permission to process advanced therapy medicinal products dated 29 June 2011.
  • Regulation of the Minister of Health on the amount and manner of collecting charges for granting and amending the manufacturing authorisation for medicinal products and granting and amending the import authorisation for medicinal products dated 10 March 2006.
  • Regulation of the Minister of Health amending the regulation on requirements that must be met by a qualified person responsible for the quality and control of a medicinal product batch before it is marketed dated 29 June 2007.
  • Regulation of the Minister of Health on the conditions of mail orders for medicinal products issued without doctor’s prescription dated 14 March 2008.
  • Regulation of the Minister of Health on charges for an authorisation to run a pharmacy outlet or amending such authorisation dated 9 August 2007.
  • Regulation of the Minister of Health on a list of medicinal products that may be marketed in points of out-of-pharmacy sale and pharmacy outlets dated 22 October 2010.
  • Regulation of the Minister of Health on initial batch control of medicinal products and raw materials used for making magistral or officinal medicines dated 10 April 2013.
  • Regulation of the Minister of Health on a description of the ICT system used to maintain the National Register of Authorisations to Run Generally Accessible Pharmacies, Pharmacy Outlets and the Register of Granted Permissions to Run Hospital and Company’s Pharmacies dated 6 November 2012.
  • Regulation of the Minister of Health on qualifications of people issuing medicinal products in out-of-pharmacy sale establishments and on requirements which the premises and equipment of such establishments and pharmacy outlets must meet dated 2 February 2009.
  • Regulation of the Minister of Health on specifying detailed principles and method of withholding the sale of and recalling medicinal products and medical devices dated 12 March 2008.
  • Regulation of the Minister of Health on entities authorised to purchase medicinal products in pharmaceutical wholesale stores dated 12 December 2002.
  • Regulation of the Minister of Health on selling medicinal products and medical devices in pharmacies dated 18 October 2002.
  • Regulation of the Minister of Health on basic conditions for running a pharmacy dated 18 October 2002.
  • Regulation of the Minister of Health on the form of register of pharmacists and pharmacy technicians employed in pharmacies dated 18 October 2002.
  • Regulation of the Minister of Health on detailed requirements for pharmacy premises dated 30 September 2002.
  • Regulation of the Minister of Health on data required in a technical description of premises intended to house a generally accessible pharmacy dated 26 September 2002.
  • Regulation of the Minister of Health on the list of premises included in the basic and auxiliary pharmacy area dated 26 September 2002
  • Regulation of the Minister of Health amending the regulation on pharmacy internship for pharmacy technicians dated 22 June 2005.
  • Regulation of the Minister of Health on the maximum charge to be collected by a pharmacy for expedition of medicinal products at night and specification of a group of medicinal products that are issued at night without an extra charge dated 14 June 2002.
  • Regulation of the Minister of Health on the charge for granting an authorisation to run a pharmaceutical wholesale store dated 15 September 2008.
  • Regulation of the Minister of Health on procedures of Good Distribution Practice dated 26 July 2002.
  • Regulation of the Minister of Health on the description of the ICT system in which the Register of Authorisations for Running Pharmaceutical Wholesale Stores is maintained dated 3 October 2012.
  • Regulation of the Minister of Health on specification of detailed principles and procedures of withholding and recalling medicinal products and medical devices dated 12 March 2008.
  • Regulation of the Minister of Health on entities authorised to purchase medicinal products from pharmaceutical wholesale stores dated 12 December 2002.
  • Regulation of the Minister of Health on granting the charter to the Main Pharmaceutical Inspectorate dated 14 July 2009.
  • Regulation of the Minister of Health on the advertisement of medicinal products dated 21 November 2008.
  • Regulation of the Minister of Health on the manner and mode of preparing and agreeing communications on the safety of use of a medicinal product dated 28 November 2013.
  • Regulation of the Minister of Health on the manner and mode of conducting the competitive process to select a candidate for the position of the voivodship pharmaceutical inspector dated 25 June 2002.
  • Regulation of the Minister of National Defence on the cooperation between the Main Pharmaceutical Inspection and military authorities supervising the manufacture of and trade in medicinal products and medical devices dated 25 March 2013.
  • Regulation of the Minister of Health on the advertisement of medicinal products dated 21 November 2008.
  • Regulation of the Minister of Health on the list of medicinal products that can be delivered ad-hoc due to the provided medical service and the list of medicinal products included in life-saving anti-shock kits dated 12 January 2011.