I. List of regulatory legal acts of the Eurasian Economic Union
(EAEU legal portal, webpage: https://docs.eaeunion.org/en/)
· Agreement on Common Principles and Rules of Circulation of Medicinal Products within the Eurasian Economic Union dated 23 December 2014
· Protocol on the Accession of the Republic of Armenia to the Agreement on Common Principles and Rules of Circulation of Medicinal Products within the Eurasian Economic Union
Decisions of the Council of the Eurasian Economic Commission
· Decision No. 78 of the Council of the Eurasian Economic Commission "On the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use" dated 3 November 2016
· Decision No. 55 of the Council of the Eurasian Economic Commission "On Amendments to Decision No. 78 of the Council of the Eurasian Economic Commission dated 3 November 2016" dated 14 June 2018
· Decision No. 9 of the Council of the Eurasian Economic Commission "On Amendments to the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use" dated 30 January 2020
· Decision No. 128 of the Council of the Eurasian Economic Commission "On Amendments to Decision No. 78 of the Council of the Eurasian Economic Commission dated 3 November 2016" dated 23 December 2020
· Decision No. 14 of the Council of the Eurasian Economic Commission "On Amendments to Decision No. 78 of the Council of the Eurasian Economic Commission dated 3 November 2016" dated 5 March 2021
· Decision No. 34 of the Council of the Eurasian Economic Commission "On Amendments to the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use" dated 23 April 2021
· Decision No. 36 of the Council of the Eurasian Economic Commission "On Amendments to the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use" dated 17 March 2022
· Decision No. 79 of the Council of the Eurasian Economic Commission "On Adoption of the Good Clinical Practice of the Eurasian Economic Union" dated 3 November 2016
· Decision No. 80 of the Council of the Eurasian Economic Commission "On Adoption of the Good Distribution Practice of the Eurasian Economic Union" dated 3 November 2016
· Decision No. 81 of the Council of the Eurasian Economic Commission "On Adoption of the Good Laboratory Practice of the Eurasian Economic Union in the Area of Medicines Regulation" dated 3 November 2016
· Decision No. 84 of the Council of the Eurasian Economic Commission "On the Procedures for Creation and Management of the Common Register of Authorised Medicinal Products of the Eurasian Economic Union and Medicinal Product Information Databases" dated 3 November 2016 establishes the following:
- Procedure for Creation and Management of the Common Register of Authorised Medicinal Products of the Eurasian Economic Union
- Procedure for Creation and Management of the Common Information Database of Substandard, Falsified, and/or Counterfeit Medicinal Products Seized in the Eurasian Economic Union Member States
- Procedure for Creation and Management of the Common Information Database of Adverse Drug Reactions (Effects), Including Reports of Lack of Therapeutic Efficacy in the Eurasian Economic Union Member States
- Procedure for Creation and Management of the Common Information Database of Suspended, Recalled or Prohibited Medicinal Products for Human Use in the Eurasian Economic Union Member States
· Decision No. 85 of the Council of the Eurasian Economic Commission "On Adoption of the Rules for Conducting Bioequivalence Studies of Medicinal Products in the Eurasian Economic Union" dated 3 November 2016
· Decision No. 67 of the Council of the Eurasian Economic Commission "On Amendments to the Rules for Conducting Bioequivalence Studies of Medicinal Products in the Eurasian Economic Union" dated 4 September 2020
· Decision No. 86 of the Council of the Eurasian Economic Commission "On the Procedure for Cooperation between the Eurasian Economic Union Member States in Detecting Falsified, Substandard, and/or Counterfeit Medicinal Products" dated 3 November 2016
· Decision No. 87 of the Council of the Eurasian Economic Commission "On Adoption of the Good Pharmacovigilance Practice of the Eurasian Economic Union" dated 3 November 2016
· Decision No. 81 of the Council of the Eurasian Economic Commission "On Amendments to the Good Pharmacovigilance Practice of the Eurasian Economic Union" dated 19 May 2022
· Decision No. 76 of the Council of the Eurasian Economic Commission "On Adoption of Labelling Requirements for Medicinal Products for Human and Veterinary Use" dated 3 November 2016
· Decision No. 88 of the Council of the Eurasian Economic Commission "On Adoption of Requirements for the Package Leaflet and Summary of Product Characteristics of Medicinal Products for Human Use" dated 3 November 2016
· Decision No. 80 of the Council of the Eurasian Economic Commission "On Amendments to Decision No. 88 of the Council of the Eurasian Economic Commission dated 3 November 2016" dated 19 May 2022
· Decision No. 89 of the Council of the Eurasian Economic Commission "On Adoption of the Rules for Studies of Biological Medicinal Products in the Eurasian Economic Union" dated 3 November 2016
· Decision No. 110 of the Council of the Eurasian Economic Commission "On Amendments to the Rules for Studies of Biological Medicinal Products in the Eurasian Economic Union" dated 15 July 2022
· Decision No. 90 of the Council of the Eurasian Economic Commission "On Adoption of the Procedure for Creation and Management of the Register of Pharmaceutical Inspectors of the Eurasian Economic Union" dated 3 November 2016
· Decision No. 92 of the Council of the Eurasian Economic Commission "On Specific Aspects of Medicine Regulation" dated 3 November 2016
· Decision No. 77 of the Council of the Eurasian Economic Commission "On Adoption of the Good Manufacturing Practice of the Eurasian Economic Union" dated 3 November 2016
· Decision No. 65 of the Council of the Eurasian Economic Commission "On Amendments to the Good Manufacturing Practice of the Eurasian Economic Union" dated 14 July 2021
· Decision No. 83 of the Council of the Eurasian Economic Commission "On Adoption of the Rules for Conducting Pharmaceutical Inspections" dated 3 November 2016
· Decision No. 7 of the Council of the Eurasian Economic Commission "On Amendments to the Rules for Conducting Pharmaceutical Inspections" dated 8 February 2021
· Decision No. 93 of the Council of the Eurasian Economic Commission "On the Recognition of the Results of Inspections of Medicinal Product Manufacturers" dated 3 November 2016
· Decision No. 66 "On Amendments to the Decision No. 93 of the Council of the Eurasian Economic Commission dated 3 November 2016" dated 4 September 2020
· Decision No. 15 of the Council of the Eurasian Economic Commission "On Adoption of the Good Practice for Cultivation, Collection, Processing, and Storage of Starting Materials of Herbal Origin" dated 26 January 2018
· Decision No. 96 of the Council of the Eurasian Economic Commission "On Interim Measures for Establishing Regulations for Medicinal Products for Human Use" dated 10 June 2022
· Decision No. 75 of the Council of the Eurasian Economic Commission "On Adoption of the Terms of Reference of the Expert Committee on Medicines" dated 3 November 2016
Decisions of the Board of the Eurasian Economic Commission
· Decision No. 79 of the Board of the Eurasian Economic Commission "On the Requirements for the Electronic Format of Applications and Registration Dossier Documents Submitted for Marketing Authorisation and Evaluation of Medicinal Products for Human Use" dated 30 June 2017
· Decision No. 178 of the Board of the Eurasian Economic Commission "On the Rules for Determining Categories of Prescription and OTC Medicines" dated 29 December 2015
· Decision No. 172 of the Board of the Eurasian Economic Commission "On Adoption of the Nomenclature of Dosage Forms" dated 22 December 2015
· Decision No. 51 of the Board of the Eurasian Economic Commission "On Amendments to the Nomenclature of Dosage Forms" dated 29 March 2022
· Decision No. 69 of the Board of the Eurasian Economic Commission "On Adoption of Requirements for Stability Testing of Medicinal Products and Active Pharmaceutical Ingredients" dated 10 May 2018
· Decision No. 86 of the Board of the Eurasian Economic Commission "On Amendments to paragraph 5 of the Requirements for Stability Testing of Medicinal Products and Active Pharmaceutical Ingredients" dated 30 June 2020
· Decision No. 113 of the Board of the Eurasian Economic Commission "On Adoption of the Guideline for the Validation of Analytical Procedures for Medicinal Products Testing" dated 17 July 2018
· Decision No. 151 of the Board of the Eurasian Economic Commission "On Adoption of the Guideline for the Preparation of a Medicinal Product Specification File" dated 7 September 2018
· Decision No. 202 of the Board of the Eurasian Economic Commission "On Adoption of the Guideline on Preclinical Safety Studies for the Conduct of Clinical Trials and Marketing Authorisation for Medicinal Products" dated 26 November 2019
· Decision No. 111 of the Board of the Eurasian Economic Commission "On Adoption of the Guideline on Pharmacokinetic and Clinical Bioequivalence Studies of Intravenous Liposomal Medicinal Products" dated 15 September 2020
· Decision No. 169 of the Board of the Eurasian Economic Commission "On Adoption of Requirements for Stability Testing of Herbal Preparations (Derived from Herbal Substances) and Herbal Medicinal Products" dated 7 December 2021
· Decision No. 119 of the Board of the Eurasian Economic Commission "On the Concept of Harmonisation of the Pharmacopoeias of the Eurasian Economic Union Member States" dated 22 September 2015
· Decision No. 121 of the Board of the Eurasian Economic Commission "On the Terms of Reference of the Pharmacopoeial Committee of the Eurasian Economic Union" dated 22 September 2015
· Decision No. 100 of the Board of the Eurasian Economic Commission "On the Pharmacopoeia of the Eurasian Economic Union" dated 11 August 2020
Recommendations of the Board of the Eurasian Economic Commission
· Recommendation No. 19 of the Board of the Eurasian Economic Commission "On the Guideline for Validation of the Manufacturing Process of Medicinal Products for Human Use" dated 26 September 2017
· Recommendation No. 31 of the Board of the Eurasian Economic Commission "On the Requirements for Water for Pharmaceutical Use for the Manufacturing of Medicinal Products" dated 13 December 2017
· Recommendation No. 2 of the Board of the Eurasian Economic Commission "On the Guideline for the Quality of Oral Modified-Release Medicinal Products" dated 16 January 2018
· Recommendation No. 6 of the Board of the Eurasian Economic Commission "On the Guideline for the Quality of Herbal Medicinal Products" dated 10 May 2018
· Recommendation No. 11 of the Board of the Eurasian Economic Commission "On the Guideline for General Aspects of Clinical Trials" dated 17 July 2018
· Recommendation No. 17 of the Board of the Eurasian Economic Commission "On the Guideline for the Quality of Inhalation and Nasal Medicinal Products" dated 7 September 2018
· Recommendation No. 2 of the Board of the Eurasian Economic Commission "On the Guideline for the Selection of Trade Names of Medicinal Products" dated 29 January 2019
· Recommendation No. 3 of the Board of the Eurasian Economic Commission "On the Guideline for the Manufacturing of Finished Dosage Forms of Medicinal Products" dated 29 January 2019
· Recommendation No. 6 of the Board of the Eurasian Economic Commission "On the Guideline for the Selection of Tests and Acceptance Criteria for Specifications of Herbal Substances, Herbal Preparations (Derived from Herbal Substances) and Herbal Medicinal Products" dated 12 February 2019
· Recommendation No. 8 of the Board of the Eurasian Economic Commission "On the Guideline for Dose Selection for Medicinal Products" dated 12 March 2019
· Recommendation No. 13 of the Board of the Eurasian Economic Commission "On the Rules for Using Generic Names of Medicinal Products" dated 23 April 2019
· Recommendation No. 23 of the Board of the Eurasian Economic Commission "On the Guideline for the Assessment and Control of DNA-Reactive (Mutagenic) Impurities in Medicines and the Establishment of Potential Carcinogenic Risk Limits" dated 6 August 2019
· Recommendation No. 24 of the Board of the Eurasian Economic Commission "On the Guideline for Controlling Risks of Microbial Contamination in Herbal Substances, Herbal Preparations (Derived from Herbal Substances) and Herbal Medicinal Products" dated 6 August 2019
· Recommendation No. 25 of the Board of the Eurasian Economic Commission "On the Guideline for Preclinical and Clinical Development of Fixed Combination Medicinal Products" dated 2 September 2019
· Recommendation No. 28 of the Board of the Eurasian Economic Commission "On the Guideline for Determination of the Scope of Laboratory Testing for Medicinal Products" dated 10 September 2019
· Recommendation No. 42 of the Board of the Eurasian Economic Commission "On the Guideline for the Selection of Non-Investigational Medicinal Products to Be Used in Clinical Trials of Medicinal Products" dated 17 December 2019
· Recommendation No. 1 of the Board of the Eurasian Economic Commission "On the Guideline for the Preparation of Clinical Documentation (Clinical Trials, Therapeutic Equivalence) for Inhalation Medicinal Products for the Treatment of Bronchial Asthma in Adults, Adolescents, and Children and Chronic Obstructive Pulmonary Disease in Adults" dated 14 January 2020
· Recommendation No. 2 of the Board of the Eurasian Economic Commission "On the Guideline for Calculation of the Start of Shelf Life of Finished Dosage Forms of Medicinal Products for Human and Veterinary Use" dated 26 February 2020
· Recommendation No. 9 of the Board of the Eurasian Economic Commission "On the Guideline for the Production of Medicines Containing Hazardous Substances" dated 21 May 2020
· Recommendation No. 10 of the Board of the Eurasian Economic Commission "On the Guideline for Repeated (Multiple) Dose Preclinical Toxicity Studies of Medicinal Products for Human Use" dated 21 May 2020
· Recommendation No. 15 of the Board of the Eurasian Economic Commission "On the Guideline for Quality Assessment and Bioequivalence Studies of Certain Groups of Medicines" dated 15 September 2020
· Recommendation No. 18 of the Board of the Eurasian Economic Commission "On the Guideline for Safety Pharmacology Studies of Medicinal Products for Human Use" dated 27 October 2020
· Recommendation No. 19 of the Board of the Eurasian Economic Commission "On the Guideline for the Use of Biostatistics Principles in Clinical Trials of Medicinal Products" dated 3 November 2020
· Recommendation No. 20 of the Board of the Eurasian Economic Commission "On the Guideline for Design, Operation, Qualification, and Maintenance of Heating, Ventilation, and Air-Conditioning Systems for Non-Sterile Medicinal Products" dated 3 November 2020
· Recommendation No. 33 of the Board of the Eurasian Economic Commission "On the Guideline for Toxicokinetics Studies and Assessment of Systemic Exposure in Toxicity Studies of Medicinal Products" dated 22 December 2020
· Recommendation No. 26 of the Board of the Eurasian Economic Commission "On the Guideline for the Development and Production of Active Pharmaceutical Ingredients" dated 22 December 2020
· Recommendation No. 6 of the Board of the Eurasian Economic Commission "On the Guideline for Aseptic Processes in Pharmaceutical Production" dated 1 March 2021
· Recommendation No. 8 of the Board of the Eurasian Economic Commission "On the Guideline for Quality Assessment of Medicinal Products Containing Combinations of Herbal Substances and/or Herbal Preparations (Herbal Medicinal Products)" dated 25 May 2021
· Recommendation No. 11 of the Board of the Eurasian Economic Commission "On the Guideline for Transfer of Technologies and/or Analytical Procedures in Medicinal Products Manufacturing" dated 8 June 2021
· Recommendation No. 23 of the Board of the Eurasian Economic Commission "On the Guideline for Acceptability of Using Dosage Forms in Paediatric Practice or for Specific Groups of the Paediatric Population with the Aim of Including Relevant Information in the SmPC and Package Leaflet of Medicinal Products for Human Use" dated 13 September 2021
· Recommendation No. 30 of the Board of the Eurasian Economic Commission "On the Guideline for Pharmaceutical Development of Paediatric Medicinal Products" dated 21 December 2021
· Recommendation No. 20 of the Board of the Eurasian Economic Commission "On the Guideline for Specifying the Name and Content of Herbal Substances, Herbal Preparations (Herbal Medicinal Products) in the SmPC, Package Leaflet, and Labelling of Herbal Medicinal Products for Human Use" dated 17 May 2022
· Decision No. 107 of the Eurasian Economic Commission "On Amendments to the Rules for Classification of Medicinal Products as Prescription or OTC Medicines" dated 17 September 2024
· Recommendation No. 19 of the Board of the Eurasian Economic Commission "On the Updated Glossary of Terminology Used in the Eurasian Economic Union in the Area of Medicinal Products Regulation" dated 23 September 2024
II. List of federal laws and other regulatory legal acts of the Russian Federation (official Internet portal of legal information www.pravo.gov.ru)
1. Medicinal products
Federal laws
· Federal Law No. 61-FZ "On Circulation of Medicines" dated 12 April 2010
· Federal Law No. 323-FZ "On the Fundamentals of Public Health Protection in the Russian Federation" dated 21 November 2011
· Federal Law No. 3-FZ "On Narcotic Drugs and Psychotropic Substances" dated 8 January 1998
· Federal Law No. 38-FZ "On Advertisement" dated 13 March 2006
· Federal Law No. 3-FZ "On Public Radiation Safety" dated 9 January 1996
· Tax Code of the Russian Federation (Part II) No. 117-FZ dated 5 August 2000
· Civil Code of the Russian Federation (Part IV) No. 230-FZ dated 18 December 2006
· Federal Law No. 171-FZ "On State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products and on Restriction of Consumption (Drinking) of Alcoholic Products" dated 22 November 1995
· Federal Law No. 99-FZ "On Licensing of Certain Activities" dated 4 May 2011
Regulatory Legal Acts of the Government of the Russian Federation
· Order No. 286n of the Ministry of Health of the Russian Federation "On Invalidation of Certain Orders of the Ministry of Health of the Russian Federation Regulating Medicinal Products for Human Use" dated 4 June 2024
· Decree No. 2406-r of the Government of the Russian Federation "On Adoption of the List of Vital and Essential Medicines, as well as Lists of Medicines for Human Use and the Minimum Range of Medicines Required for Medical Care" dated 12 October 2019
· Decree No. 441 of the Government of the Russian Federation "On Specific Aspects of Regulation of Medicinal Products for Human Use Intended for Use under Threat of Emergencies, during Actual Emergencies, for the Provision of Medical Care to Persons Affected by Emergencies, for the Prevention of Emergencies, for the Prevention and Treatment of Diseases That Pose a Threat to the Public, and Diseases and Injuries Resulting from Exposure to Adverse Chemical, Biological, and Radiation Factors" dated 3 April 2020
· Decree No. 1832 of the Government of the Russian Federation "On Amendments to Decision No. 441 of the Ministry of Health of the Russian Federation" dated 16 November 2020
· Decree No. 593 of the Government of the Russian Federation "On Specific Aspects of Regulation of Medicinal Products for Human Use in the Case of Shortage or Risk of Shortage Due to Restrictive Economic Measures Imposed against the Russian Federation" dated 5 April 2022
· Decree No. 440 of the Government of the Russian Federation "On Adoption of Specific Requirements for Variations to Marketing Authorisations in the Case of Shortage or Risk of Shortage of Medicinal Products Due to Restrictive Economic Measures Imposed against the Russian Federation" dated 23 March 2022
· Decree No. 1360 of the Government of the Russian Federation "On the Procedure for Determining Interchangeability of Medicinal Products for Human Use" dated 5 September 2020 (to be read in conjunction with the "Rules for Determining Interchangeability of Medicinal Products for Human Use")"
· Decree No. 1357 of the Government of the Russian Federation "On Adoption of the Rules for Using Information on Interchangeable Medicinal Products for Human Use and Provision of Explanations on Interchangeability of Medicinal Products for Human Use, as well as on Amending Requirements for the Contents of Purchasing Documents for Medicinal Products for Human Use that Are Procured by Government and Municipal Agencies" dated 4 September 2020
· Decree No. 1510 of the Government of the Russian Federation "On the Procedure of Batch Release of Medicinal Products for Human Use" dated 26 November 2019 (to be read in conjunction with the "Rules for Submitting Documents and Information on Medicinal Products for Human Use for Batch Release", "Rules for Issuing a Test Protocol on Compliance with the Predefined Quality Specification of the First Three Batches or Lots of Medicinal Products for Human Use (with the Exception of Immunobiological Medicinal Products) Produced for the First Time in the Russian Federation or Imported into the Russian Federation for the First Time", "Rules for Batch or Lot Release of an Immunobiological Medicinal Product, and Issuance of a Certificate of Compliance of a Batch or Lot of an Immunobiological Medicinal Product with the Requirements Established during its Marketing Authorisation", "Rules for Batch or Lot Recall of a Medicinal Product for Human Use")
· Decree No. 1556 of the Government of the Russian Federation "On Adoption of the Framework for Tracking Medicinal Products for Human Use" dated 14 December 2018
· Decree No. 716 of the Government of the Russian Federation "On the Procedure for Compiling a List of Medicinal Products for Human Use That Have to Comply with the Established Requirements for Container Volume, Packaging, and Package contents, a List of Veterinary Medicines That Have to Comply with the Established Requirements for Container Volume, and for Establishment of Such Requirements" dated 23 July 2016 (to be read in conjunction with the "Rules for Compiling a List of Medicinal Products for Human Use That Have to Comply with the Established Requirements for Container Volume, Packaging, and Package Contents, a List of Veterinary Medicines That Have to Comply with the Established Requirements for Container Volume, and for Establishment of Such Requirements")
· Decree No. 686 of the Government of the Russian Federation "On Adoption of the Regulations on Medicine Manufacturing Licensing" dated 6 July 2012
· Decree No. 547 of the Government of the Russian Federation "On Adoption of the Regulations on Licensing of Pharmaceutical Activities " dated 31 March 2022
· Decree No. 1314 of the Government of the Russian Federation "On Confirming Medicine Manufacturers Compliance with the GMP Requirements" dated 3 December 2015 (to be read in conjunction with the "Rules for Organisation and Conduct of GMP Inspections of Medicine Manufacturers, as well as Issuing Compliance Certificates")
· Decree No. 1049 of the Government of the Russian Federation "On Federal State Control (Surveillance) in the Area of Medicine Regulation" dated 29 June 2021 (to be read in conjunction with the "Framework of the Federal State Control (Surveillance) in the Area of Medicine Regulation")
Other Regulatory Legal Acts
· Order No. 75n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Considering the Necessity of Modifying the Clinical Trial Protocol of a Medicinal Product for Human Use" dated 17 February 2025
· Order No. 468n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Elaboration of General and Individual Monographs for the Russian Pharmacopoeia, and Publication of Updates on the Russian Pharmacopoeia on the Official Website dated 13 September 2024 (registered by the Ministry of Justice of the Russian Federation on 18 October 2024, registration No. 79811)
· Order No. 274n of the Ministry of Health of the Russian Federation "On Invalidation of the Order No. 200n of the Ministry of Health of the Russian Federation "On Adoption of the Good Clinical Practice" dated 1 April 2016" dated 29 May 2024
· Order No. 586n of the Ministry of Health of the Russian Federation "On Adoption of the Terms of Reference of the Ethics Committee, the Procedure for Its Establishment and Activities, Qualification and Experience Requirements for the Ethics Committee Experts Regarding Expert Evaluation of Scientific, Medicinal, and Ethical Aspects of Clinical Trials of Medicinal Products for Human Use, Procedure for Organisation and Conduct of Ethical Review, Forms of the Ethics Committee Conclusions, Procedure for Sharing Information about the Members, Work Plans, and Current Activities of the Ethics Committee" dated 31 October 2024
· Order No. 3518 of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) "On Adoption of the Pharmacovigilance Procedure for Medicinal Products for Human Use" dated 17 June 2024 (registered by the Ministry of Justice of the Russian Federation on 5 September 2024, registration No. 79394)
· Order No. 95n of the Ministry of Health of the Russian Federation "On Amendments to the Classification of Variations to the Registration Dossier for an Authorised Medicinal Product for Human Use Adopted by Order No. 959n of the Ministry of Health of the Russian Federation "On Adoption of the Classification of Variations to the Registration Dossier for an Authorised Medicinal Product for Human Use" dated 13 December 2016" dated 6 March 2023 (registered on 14 April 2023, registration No. 73020)
· Order No. 459n "On Adoption of the List of Medicinal Products for Human Use Subject to Strict Record Keeping and Storage" dated 1 September 2023 (registered by the Ministry of Justice of the Russian Federation on 2 October 2023, registration No. 75422)
· Order No. 558n of the Ministry of Health of the Russian Federation "On Adoption of the Rules for Evaluation of Medicinal Products for Human Use and Specific Aspects of Evaluation of Certain Types of Medicinal Products for Human Use (Reference Products, Generic Products, Biologicals, Biosimilars, Homeopathic Medicines, Herbal Medicines, Combination Medicines), Forms of Expert Commission Conclusions" dated 24 August 2017 (registered by the Ministry of Justice of the Russian Federation on 18 December 2017, registration number 49287)
· Order No. 682n of the Ministry of Health of the Russian Federation "On Adoption of the Form for Monitoring the Efficacy and Safety of a Medicinal Product by the Marketing Authorisation Holder or its Legal Representative" dated 7 September 2016 (registered by the Ministry of Justice of the Russian Federation on 22 September 2016, registration No. 43768)
· Order No. 959n of the Ministry of Health of the Russian Federation "On Adoption of the Classification of Variations to the Registration Dossier for an Authorised Medicinal Product for Human Use" dated 13 December 2016 (registered by the Ministry of Justice of the Russian Federation on 9 January 2017, registration No. 45123)
· Order No. 202 of the Ministry of Health of the Russian Federation "On the Metrology Service of the Ministry of Health of the Russian Federation in the Area of Medicine Regulation" dated 20 March 2020 (to be read in conjunction with the "Terms of Reference of the Metrology Service of the Ministry of Health of the Russian Federation in the Area of Medicine Regulation")
· Order No. 80n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Maintaining the National Register of Medicinal Products for Human Use" dated 9 February 2016 (registered by the Ministry of Justice of the Russian Federation on 21 March 2016 No. 41471)
· Order No. 343n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Provision of Scientific Advice on Issues Related to Preclinical and Clinical Trials of Medicinal Products, Evaluation of Medicinal Products Quality, Efficacy and Safety, and Marketing Authorisation Procedures" dated 30 May 2019 (registered by the Ministry of Justice of the Russian Federation on 6 September 2019, registration number No. 55838)
· Order No. 777n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Suspending a Medicinal Product for Human Use" dated 14 November 2018 (registered by the Ministry of Justice of the Russian Federation on 27 February 2019, registration No. 53907)
· Order No. 778n of the Ministry of Health of the Russian Federation "On Adoption of the List of Medicinal Products for Human Use That Have to Comply with the Established Requirements for Container Volume, Packaging, and Package Contents" dated 31 July 2020 (registered by the Ministry of Justice of the Russian Federation on 4 September 2020, registration No. 59651)
· Order No. 779n of the Ministry of Health of the Russian Federation "On Adoption of Requirements for Container Volume, Packaging, and Package Contents for Medicinal Products for Human Use" dated 31 July 2020 (registered by the Ministry of Justice of the Russian Federation on 13 November 2020, registration No. 60886)
· Order No. 646n of the Ministry of Health of the Russian Federation "On Adoption of the Good Storage and Transportation Practices for Medicinal Products for Human Use" dated 31 August 2016 (registered by the Ministry of Justice of the Russian Federation on 9 September 2017, registration number 45112)
· Order No. 30n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Inclusion of Medicinal Products for Human Use in the List of Medicines Subject to Strict Record Keeping and Storage" dated 20 January 2014 (registered by the Ministry of Justice of the Russian Federation on 3 April 2014, registration No. 31809)
Regulatory Legal Acts on Human Cell-Based Medicinal Products
· Federal Law No. 180-FZ "On Human Cell-Based Medicinal Products" dated 23 June 2016
· Decree No. 49 of the Government of the Russian Federation "On Adoption of the Rules for Distribution of Human Cell-Based Medicinal Products" dated 23 January 2018
· Decree No. 706 of the Government of the Russian Federation "On Adoption of the Rules on Destruction of Falsified, Substandard, and Counterfeit Human Cell-Based Medicinal Products" dated 14 June 2017
· Order No. 512n of the Ministry of Health of the Russian Federation "On Adoption of the Good Practice for Handling Human Cell-Based Medicinal Products" dated 8 August 2018
· Order No. 14n of the Ministry of Health of the Russian Federation "On Adoption of the Specification Form for a Human Cell-Based Medicinal Product" dated 19 January 2017
· Order No. 32n of the Ministry of Health of the Russian Federation "On Adoption of the Submission Procedure for a Human Cell-Based Medicinal Product and the Application Form for Marketing Authorisation of a Human Cell-Based Medicinal Product" dated 31 January 2017
· Order No. 542n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Consultations on Issues Concerning Preclinical and Clinical Trials, Evaluation, and Authorisation of Human Cell-Based Medicinal Products" dated 23 August 2017
· Order No. 30n of the Ministry of Health of the Russian Federation "On Adoption of the Rules for Evaluation of Human Cell-Based Medicinal Products, and Conclusion Forms by an Expert Commission of the Federal State Budgetary Institution Responsible for Evaluation of Human Cell-Based Medicinal Products" dated 31 January 2017
· Order No. 191n of the Ministry of Health of the Russian Federation "On Adoption of the Terms of Reference for the Ethics Committee Established to Issue Conclusions on Ethical Feasibility of a Clinical Trial of a Human Cell-Based Medicinal Product, Rules of Procedure, and Qualification and Experience Requirements for the Ethics Committee Experts" dated 27 April 2017
· Order No. 840n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Organisation and Conduct of Evaluation of Ethical Feasibility of Clinical Trial of a Human Cell-Based Medicinal Product, and Form of the Ethics Committee Conclusion" dated 20 October 2017
· Order No. 193n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Online Publication of the Information about the Composition of the Ethics Committee Established to Issue Conclusions on Ethical Feasibility of Clinical Trial of a Human Cell-Based Medicinal Product, Its Work Plans, and Current Activities" dated 27 April 2017
· Order No. 195n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Quality Assessment of a Human Cell-Based Medicinal Product at the Production Site Using the Manufacturers Equipment" dated 28 April 2017
· Order No. 123n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Creation, Use, Storage, Keeping, and Destruction of the Permanently Deposited Collection of Standardised Cell Lines" dated 27 March 2018
· Order No. 282n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Clinical Trial Approval for Human Cell-Based Medicinal Products" dated 31 May 2017
· Order No. 836n of the Ministry of Health of the Russian Federation "On Adoption of a Form for Presenting Safety Monitoring Results for Human Cell-Based Medicinal Product by the Marketing Authorisation Holder" dated 20 October 2017
· Order No. 281n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Maintenance of the State Register of Human Cell-Based Medicinal Products" dated 31 May 2017
· Order No. 669n of the Ministry of Health of the Russian Federation "On Adoption of the Good Clinical Practice for Human Cell-Based Medicinal Products" dated 22 September 2017
· Order No. 145n of the Ministry of Health of the Russian Federation "On Adoption of the Label Content of the Primary Packaging, Secondary Packaging, and Transportation Packaging of Human Cell-Based Medicinal Products" dated 31 March 2017
· Order No. 800n of the Ministry of Health of the Russian Federation "On Adoption of the Labelling Procedure for Primary and Secondary Packaging of Autologous and Combination Human Cell-Based Medicinal Products Using Radio Frequency Identification to Tag the Product as Belonging to a Specific Patient" dated 13 October 2017
· Order No. 564n of the Ministry of Health of the Russian Federation "On Adoption of the Rules of Transportation of Biological Material, Cells for Cell Line Production, Cell Lines for Human Cell-Based Medicinal Products, and Human Cell-Based Medicinal Products" dated 28 August 2017
· Order No. 5072 of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) "On Adoption of the Procedure for Safety Monitoring for Human Cell-Based Medicinal Products" dated 2 August 2018
· Order No. 5071 of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) "On Adoption of the Procedure for Receiving, Keeping, Processing, Analysing, and Storing Notifications of Adverse Events, Adverse Reactions, Serious Adverse Reactions, Unexpected Adverse Reactions, Specific Aspects of Interaction with Medicinal Products, Medical Devices, Food, other Human Cell-Based Medicinal Products, Idiosyncratic Reactions, and other Facts and Circumstances Posing Threat to Human Life or Health or Affecting the Ratio of Expected Benefit to Potential Risk of Human Cell-Based Products, Obtained from Human Cell-Based Products Entities and Public Authorities by Marketing Authorisation Holders, Legal Persons Holding Authorisations for Clinical Trials of Human Cell-Based Medicinal Products or Qualified Persons or other Legal Persons" dated 2 August 2018
· Order No. 120n of the Ministry of Health of the Russian Federation "On Adoption of the Procedure for Suspending a Human Cell-Based Medicinal Product" dated 27 March 2018
