Medicines quality control

Medicines quality control

 

  1. The Constitution of Ukraine
  2. Code of Ukraine on Administrative Offenses
  3. Law of Ukraine as of 04.04.1996 № 123/96-ВР “On Medicinal Products”
  4. Law of Ukraine as of 02.03.2015 № 222-VIII “On Licensing of Certain Types of Economic Activity”  
  5. Law of Ukraine as of 05.04.2007 № 877-V “On the Main Principles of State Supervision (Oversight) in the Area of Commercial Activity”
  6. Law of Ukraine as of 05.07.2012 № 5065-VI “On Amendments to Certain Legislative Acts of Ukraine Regarding Increase of Liability for the Falsification or Circulation of Falsified Medicinal Products”
  7. Law of Ukraine as of 19.11.1992 № 2801-XII “Fundamentals of the Legislation of Ukraine on Health Care”
  8. Law of Ukraine as of 08.09.2011 № 3718-VI “On Amendments to Certain Legislative Acts of Ukraine Regarding Preventing Falsification of Medicines”  
  9.  Law of Ukraine as of 02.10.1996 № 393/96-ВР «On Citizens’ Appeals»
  10.  Law of Ukraine as of 13.01.2011 № 2939-VI «On Access to Public Information»
  11. Law of Ukraine as of 07.06.2012 № 4908-VI «On Ratification of the Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health»
  12.  Resolution of the Cabinet of Ministers of Ukraine as of 12.08.2015 № 647 «On Approval of the  Statute on the State Service of Ukraine on Medicines and Drugs Control»
  13.  Resolution of the Cabinet of Ministers of Ukraine as of 06.05.2000 № 770 «On Approval of the List of  Narcotic Drugs, Psychotropic Substances and Precursors»
  14.  Resolution of the Cabinet of Ministers of Ukraine as of 28.04.2000 № 728 «On Approval of the Procedure for Export from Ukraine or Disposal of Poor Quality or Unsuitable to Consumption Goods (Subjects) of Humanitarian Aid”
  15.  Resolution of the Cabinet of Ministers of Ukraine as of 14.09.2005 № 902 “On Approval of the Procedure for Carrying out Quality State Control of Medicines Imported into Ukraine”
  16. Resolution of the Cabinet of Ministers of Ukraine as of 31.10.2007 № 1279 “On Approval of the Procedure for Reimbursement made by a Business Entity for Expenses Related to Product Sampling”
  17. Resolution of the Cabinet of Ministers of Ukraine as of 31.10.2007 № 1280 “On Approval of the Procedure for Product Sampling and Defining Indicators and Forms for Products Sampling”
  18. Resolution of the Cabinet of Ministers of Ukraine as of 26.05.2005 № 376 “On Approval of the Procedure for State Registration (Re-Registration) of Medicines and Amount of Money for their State Registration (Re-Registration)”
  19.  Resolution of the Cabinet of Ministers of Ukraine as of 03.02.2010 № 260 «Certain Issues on State Quality Control of Medicines”
  20. Resolution of the Cabinet of Ministers of Ukraine as of 08.12.2010 № 1114 «On Approval of Agreement on Cooperation in Counterfeit with Falsified Medicines Trafficking”
  21. Resolution of the Cabinet of Ministers of Ukraine «On Approval of the Regulation for Control over Correspondence of Immunological Products Used in Medical Practice to the State and International Standards”
  22. Order of the Ministry of Health of Ukraine as of 15.01.1996 № 73 “On Approval of the Rules for Medicines  Manufacturing and Quality Control  in Pharmacies”
  23.  Order of the Ministry of Health of Ukraine as of 29.09.2014 № 677 “On Approval of the Procedure for Medicines Quality Control while Wholesale and Retail Trade»    
  24. Order of the Ministry of Health of Ukraine as of 22.11.2011 № 809 “On Approval of the Procedure for  Prohibition (Termination) and Renewal of Trade of Medicinal Products within Ukraine”
  25. Order of the Ministry of Health of Ukraine as of 17.06.2005 № 287 “On Approval  of the Procedure for Cooperation between the State Inspection on Quality Control of Medicinal Products of the Ministry of Health of Ukraine and the State Pharmaceutical Center of the Ministry of Health of Ukraine within the framework of medicinal products trade”
  26. Order of the Ministry of Health of Ukraine as of 16.12.2003 № 584 “On Approval of the Rules for Storage and Quality Control of Medicinal Products in Healthcare Facilities” 
  27. Order of the Ministry of Health of Ukraine as of 14.01.2004 № 10 “On Approval of the Procedure for Sectoral Attestation of Laboratories for Quality Control and Safety of Medicinal Products”
  28. Order of the Ministry of Health of Ukraine as of 15.01.2003 № 8 “On Approval of the List of Permitted Excipients and Colouring Agents for Manufacture of Medicines that are Registered in Ukraine and Manufactured in Pharmacy Conditions and in accordance with Doctors’ Prescriptions and Healthcare Facilities’ Requests”
  29. Order of the Ministry of Health of Ukraine as of 26.10.2001  № 428 “On Approval of the Guideline for Recording of Administrative Offences for Violation of Law on Ensuring of Medicines Quality”
  30. Order of the Ministry of Health of Ukraine as of 25.08.2010 № 722 “On Approval of the Procedure for Applying Braille Labeling to Medicines”
  31. Order of the Ministry of Health of Ukraine as of 24.04.2015  № 242 “On Approval of the Rules for Utilization and Disposal of Medicinal Products”
  32. Order of the Ministry of Health of Ukraine as of 26.04.2011  № 237 “On Approval of the Procedure for Import of Unregistered Medicinal Products, Standardized samples, Reagents into Ukraine”
  33. Order of the Ministry of Health of Ukraine as of  06.06.2012  № 422 “On Certain Issues of Prohibition on Advertising Medicines”
  34.  Order of the Ministry of Health of Ukraine as of 27.12.2006 № 898 “On Approval of the Procedure for Conducting Pharmacovigilance” 
  35. Order of the Ministry of Health of Ukraine as of 01.10.2014 № 698 “On Approval of the Procedure for Control over Correspondence of Immunological Products Used in Medical Practice to the State and International Standards ” 
  36. Order of the Ministry of Health of Ukraine as of 22.04.2013 № 321 «On Determining Terms of “Big” and “Extra Big” Amounts of Falsified Medicinal Products”