Order of Ministry of Health of Russia dated 31.05.2017 № 281n

| Short summary 

Order is about maintenance of register of registered biomedical cell product (how to maintain registration certificate database for biomedical cell product (marketing authorisation certificates database).

| Full text

Registered in the Ministry of Justice of Russia on 22 June 2017, no. 47125

 

 MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION

ORDER

dated 31 May 2017 no. 281n

 

ON APPROVAL OF THE PROCEDURE FOR THE MAINTENANCE OF THE STATE REGISTER OF BIOMEDICAL CELL PRODUCTS

 

In accordance with Article 25 of Federal Act no. 180-ФЗ dated 23 June 2016, “On biomedical cells products” (Legislative Corpus of the Russian Federation, 2016, no. 26, art. 3849) and sub-paragraph 5.2.207(25) of the Regulation on the Ministry of Healthcare of the Russian Federation dated 19 June 2012, no. 608 (Legislative Corpus of the Russian Federation, 2012, no. 26, art. 3526; 2013, no. 16, art. 1970; no. 20, art. 2477; no. 22, art. 2812; no. 33, art. 4386; no. 45, art. 5822; 2014, no. 12, art. 1296; no. 26, art. 3577; no. 30, art. 4307; no. 37, art. 4969; 2015, no. 2, art. 491; no. 12, art. 1763; no. 23, art. 3333; 2016, no. 2, art. 325; no. 9, art. 1268; no. 27, art. 4497; no. 28, art. 4741; no. 34, art. 5255; no. 49, art. 6922; 2017, no. 7, art. 1066), I hereby order the following:

  1. Approval of the Procedure attached for the maintenance of the state register of biomedical cell products (hereinafter “Procedure”)
  2. Department of Information Technologies and Communications (responsible person E. L. Boyko) and Department of State Regulation of Medicinal Drug Circulation (responsible person A. G. Tsyndymeev) to ensure maintenance of the state register of biomedical cell products as per the Procedure approved by this order.

Acting Minister

I.N. KAGRAMANYAN

 

 

Approved

By order of the Ministry of Healthcare

Of the Russian Federation

dated 31 May 2017 no. 281н

 

PROCEDURE FOR THE MAINTENANCE OF THE STATE REGISTER OF BIOMEDICAL CELL PRODUCTS

  1. This Procedure defines the procedure for the maintenance of the state register of biomedical cell products.
  2. The state register of biomedical cell products (hereinafter “Register”) is the federal level information system containing information regarding biomedical cell products for which state marketing authorisation has been granted.
  3. This register has to be maintained in electronic form using an automated system, by means of specific entries made in the Register.
  4. The Register has to be maintained as per unitary organisational, methodological and technical (software) principles necessary to ensure compatibility of the Register and its interaction with other federal information systems and networks.
  5. The entry in the Register for a biomedical cell product shall contain the following information:

1) name of the biomedical cell product;

2) type of biomedical cell product (autologic, allogenic, combined);

3) name of the holder of the marketing authorisation certificate for the biomedical cell product;

4) name and address of the manufacturer of the biomedical cell product;

5) designation (code name) of the cell line (lines) used as a component of the biomedical cell product;

6) names (international generic, group or chemical) and amounts of the medicinal drugs contained in the biomedical cell product, and number of the related regulation;

7) names of medical devices included in the biomedical cell product, along with the name and reference number of the related regulation;

8) expiry date of the biomedical cell product;

9) storage conditions for the biomedical cell product;

10) indications for use and contraindications for the biomedical cell product concerned;

11) adverse reactions associated with the use of the biomedical cell product;

12) date of marketing authorisation for the biomedical cell product and its registration number;

13) date of replacement of the marketing authorisation certificate for the biomedical cell product, date of confirmation of the state marketing authorisation of the biomedical cell product, or date of cancellation of the state marketing authorisation of the biomedical cell product.

  1. Entries shall be added to the Register no later that during one working day after the following actions of the Ministry of Healthcare of the Russian Federation:

1) positive decision on the state marketing authorisation of the biomedical cell product;

2) positive decision on the confirmation of the state marketing authorisation of the biomedical cell product;

3) decision on the implementation of amendments to the documents contained in the registration dossier for the registered biomedical cell product.

  1. Information on the biomedical cell product shall be excluded from the Register within no more than one working day following the decision of the Ministry of Healthcare of the Russian Federation on the cancellation of the state marketing authorisation of the biomedical cell product with subsequent removal of the biomedical cell product in question from the Register (stating the date of such decision), on the following grounds:

1) if the federal supervision service for healthcare provides a conclusion stating that there is a risk or possible harm to human life and well-being associated with the use of the biomedical cell product, and the risk outweighs the efficiency, based on the safety monitoring of the biomedical cell product conducted by the said service;

2) if the holder of the state marketing authorisation certificate applies for the cancellation of the state marketing authorisation of the biomedical cell product;

3) if the Ministry of Healthcare of the Russian Federation decides not to confirm the state marketing authorisation of the biomedical cell product upon the expiration of the actual market authorisation certificate for the biomedical cell product;

4) if the applicant failed to provide information which may result in the need to make amendments to the registration dossier of the biomedical cell product concerned, stated in part 2 of Article 23 of Federal Act dated 23 June 2016, no. 180-ФЗ “On biomedical cell products” (Legislative Corpus of the Russian Federation, 2016, no. 26, art. 3849) within 30 working days after the occurrence of such amendments;

5) if there is a court ruling stating the infringement of owner rights to intellectual property regarding the biomedical cell products in question.

  1. The Register is published on the official web site of the Ministry of Healthcare of the Russian Federation located in the information and telecommunication network known as the Internet, and it is updated on a daily basis while maintaining a history of amendments to every entry.
  2. Information contained in the Register is protected in accordance with the applicable legislation of the Russian Federation. A backup copy of the Register is created at least once per month.
  3. Information in the Register is public and commonly available, it can be provided to any interested person in accordance with the applicable legislation of the Russian Federation.
  4. Work to ensure the integrity and relevance of information contained in the Register must be performed in accordance with Article 14 of Federal Act dated 27 July 2006, no. 149-ФЗ “On information, information technologies and protection of information” (Legislative Corpus of the Russian Federation, 2006, no. 31, art. 3448; 2010, no. 31, art. 4196; 2013, no. 23, art. 2870; no. 52, art. 6961; 2015, no. 1, art. 84) by the federal state budgetary enterprise reporting to the Ministry of Healthcare of the Russian Federation, exercising the authority of the Ministry of Healthcare of the Russian Federation on issuing permits for clinical studies of biomedical cell products and/or on state marketing authorisation of biomedical cell products in accordance with Article 11 of Federal Act dated 23 June 2016, no. 180-ФЗ “On biomedical cell products”.