Chapter 16. Final Provisions

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)

Article 70. Declaring Inoperative Separate Legal Acts (Provisions of Legal Acts) of the Russian Federation

To declare inoperative:

1) Federal Law of June 22, 1998, No. 86-FZ On Medicines (Corpus of Legislative Acts of the Russian Federation 1998, No. 26, Art. 3006);

2) Federal Law of January 2, 2000, No. 5-FZ On Entering Amendments to Federal Law On Medicines (Corpus of Legislative Acts of the Russian Federation 2000, No. 2, Art. 126);

3) Article 40 of Federal Law of January 10, 2003. No. 15-FZ On Entering Amendments to Certain Legal Acts of the Russian Federation in Connection with Adoption of Federal Law On Licensing Separate Activities (Corpus of Legislative Acts of the Russian Federation 2003, No. 2, Art. 167);

4) Article 31 of Federal Law of June 30, 2003, No. 86-FZ On Entering Amendments to Certain Legal Acts of the Russian Federation, Declaring Inoperative Separate Legal Acts of the Russian Federation, Provision of Separate Guarantees to Employees of Bodies of Internal Affairs, Authorities Responsible for Control Over Narcotic Products and Psychotropic Substances Circulation and Tax Police Federal Authorities to Be Abolished in Connection with Taking Measures to Improve the State Administration (Corpus of Legislative Acts of the Russian Federation 2003, No. 27, Art. 2700);

5) Article 101 of Federal Law of August 22, 2004, No. 122-FZ On Entering Amendments to Legal Acts of the Russian Federation and Declaring Inoperative Certain Legal Acts of the Russian Federation in Connection with Adoption of Federal Laws On Making Amendments to Federal Law On General Principles of Organization of Legislative (Representative) and Executive Public Authorities of the Russian Federation Constituent Entities and On General Principles of Organization of Local Government in the Russian Federation (Corpus of Legislative Acts of the Russian Federation 2004, No. 35, Art. 3607);

6) Article 28 of Federal Law of December 18, 2006, No. 231-FZ On Promulgation of Part 4 of the Civil Code of the Russian Federation (Corpus of Legislative Acts of the Russian Federation 2006, No. 52, Art. 5497).

Article 71. Enactment of the This Federal Law

1. This Federal Law comes into force on September 01, 2010.

2. The medicines registered before the date of enactment of this Federal Law are subject to inclusion into the state registers of the medicines introducing the mentioned in Clause 1 of Article 33 hereof information of these medicines without repeated procedure of the state registration of the medicinal products.

3. The state registration of the medicinal products except medicinal products for medical use, submitted for the mentioned registration prior to the effective date of this Federal Law shall be exercised in accordance with this Federal Law on the basis of the documents and the data provided before coming into force date hereof.
(as amended by Federal Law of October 11, 2010, No. 271-FZ)

3¹. State registration of medicinal products for medical use submitted for the mentioned registration prior to the effective date of this Federal Law, and State registration of medicinal products for medical use submitted for expert examination of medicinal products prior to the effective date of this Federal Law in order to subsequent state registration, shall be exercised in accordance with this Federal Law on the basis of the documents and the data provided before coming into force date hereof and the statement of the state registration of the medicinal product in accordance with this Federal Law, documents and data, required for the state registration of the medicinal product in accordance with this Federal Law and provided by the manufacturer medicinal drugs or authorized by him person into authorized federal executive body before March 1, 2011 without request of payment of the state duty provided for by the legislation of the Russian Federation. (as amended by Federal Law of November 29, 2010, No. 313-FZ)

3². The conformation of the state registration of medicinal products for medical use submitted for the conformation of the mentioned registration prior to the effective date of this Federal Law, and the conformation of the state registration of medicinal products for medical use submitted for expert examination of medicinal products prior to the effective date of this Federal Law in order to subsequent conformation of the state registration, shall be exercised in accordance with this Federal Law on the basis of the documents and the data provided before coming into force date hereof and the statement of the conformation of the state registration of the medicinal product provided by the manufacturer medicinal drugs or authorized by him person according to this Federal Law into authorized federal executive body before March 1, 2011 without request of payment of the state duty provided for by the taxes-and-duties legislation of the Russian Federation. (as amended by Federal Law of November 29, 2010, No. 313-FZ)

3³. Approval of or refusal to approve amendments of the documents, contained in the registration dossier for a registered medicinal product for medical use, and submitted prior to the effective date of the Federal Law, and approval of or refusal to approve amendments of the documents, contained in the registration dossier for a registered medicinal product for medical use, and submitted to expert examination of medicinal products prior to the effective date of the Federal Law shall be exercised on the basis of the documents and the data provided before coming into force date hereof and the statement of the state registration of the medicinal product in accordance with this Federal Law, documents and data, required for the state registration of the medicinal product in accordance with this Federal Law and provided by the manufacturer medicinal drugs or authorized by him person into authorized federal executive body before March 1, 2011 without request of payment of the state duty provided for by the taxes-and-duties legislation of the Russian Federation.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

3⁴. Issue of permits for the conduct of clinical trials of medicinal products for medical use, and on the base of statements submitted prior to the effective date of this Federal Law, as well as statements submitted after the effective date of this Federal Law on the base of results of expert examinations performed prior to the effective date of this Federal Law, shall be exercised n accordance with this Federal Law on the basis of the documents and the data provided prior to effective date of this Federal Law, as well on the basis of the copy of the preliminary contract of compulsory insurance of the life and health of patients involved in the clinical trial of the medicinal product for medical use, or the copy of the contract of compulsory insurance of the life and health of patients involved in the clinical trial of the medicinal product for medical use, or copy of the contract of compulsory insurance made in accordance with the standard rules for compulsory insurance with specifying the maximal number of patients involved in clinical trial of medicinal products for medical use without request of payment of the state duty provided for by the taxes-and-duties legislation of the Russian Federation.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

3⁵. Registered in the foreign currency prior to the effective date of this Federal Law maximum foreign manufacturers' ex-works prices for the medicinal products included into the list of vital and the most important medicinal products, shall be translated in roubles at exchange rate specified by Central bank of Russian Federation on the date, prescribed by  the Government of the Russian Federation, without submitting of the statement of price recalculation with respective amendments to state register of manufacturers’ maximum ex-works prices for the medicinal products included into the list of vital and the most important medicinal products.

3⁶. Registered prior to the effective date of this Federal Law maximum Russian manufacturers' ex-works prices for the medicinal products included into the list of vital and the most important medicinal products, shall be indexed from November 1, 2010 on the base of estimated inflation specified by the Federal Law of December 2, 2009 No. 308-FZ “On Federal Budget for 2010 and scheduled period 2011 to 2012” on 2011.

3⁷. After March 1, 2011 the manufacturing and import of medicinal products in packaging with labeling made prior to the effective date of this Federal Law are not allowed. Upon expiration of the above mentioned period the retail, transfer and use of this medicinal products may be performed up to its expiration date. (as amended by Federal Law of November 29, 2010, No. 313-FZ) (clauses 3¹- 3⁷ introduced by Federal Laws of October 11, 2010, No. 271-FZ)

4. From the date of enactment of this Federal Law until April 30, 2011 inclusive, experts of the expert institution may carry out expert examination of the medicines before their certification in the manner established by the authorized federal executive body.

5. From the date of enactment of this Federal Law until December 31, 2013 inclusive the transfer to the manufacturing of medicines in accordance the good manufacturing practice and quality control of the medicines mentioned in Clause 1 of Article 45 hereof shall be exercised in full scope. The dates of the medicines manufacture to the manufacturing thereof in compliance with specific requirements of the good manufacturing practice, including the time for certification of authorized parties mentioned in Clauses 6 and 7 of Article 45 hereof, shall be determined by the Government of the Russian Federation.

6. Licenses for manufacturing of medicines granted before January 01, 2014 shall be effective after January 01, 2014 till their expiry provided that the licensee meet the good manufacturing practices and quality control of the medicines mentioned in Clause 1 of Article 45 hereof.

7. The creation of state task on expert examination of medicine for federal state-financed institution carrying out expert examination of medicines and finance support of this task shall be performed in the manner established by the Federal Law of January 12, 1996, No. 7-FZ “On non-commercial institutions.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

D. Medvedev
President
Russian Federation

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)