| Short summary 

Order is about the Form of registration certificate (marketing authorisation certificate) for biomedical cell product.

| Full text

Registered in the Ministry of Justice of Russia on 13 September 2017, no. 48162

 

MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION

 ORDER

dated 28 August 2017 no. 567н

 

ON APPROVAL OF THE MARKETING AUTHORISATION CERTIFICATE FORM FOR A

BIOMEDICAL CELL PRODUCT

 

In accordance with part 1 of Article 20 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 5.2.207.22 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; no. 33, art. 5202), I hereby order the following:

1. Approval of the Form of the marketing authorisation certificate for a biomedical cell product as per the attachment.
2. Decide that the marketing authorisation certificate for a biomedical cell product shall be issued on a paper document which is a protected printed product of B level protection.

 

Acting Minister

I.N. KAGRAMANYAN

 

 

Appendix

To the order of the Ministry of Healthcare

Of the Russian Federation

dated 28 August 2017 no. 567n

 

Form

 

Monochrome image of The State Coat of Arms Of the Russian Federation

           MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION

 

Marketing authorisation certificate of a biomedical cell product

___________________________________________________________________________

(registration number of the marketing authorisation certificate for a biomedical cell product)

Name of the biomedical cell product
Trade name of the biomedical cell product (if applicable)
Name of the holder of the marketing authorisation certificate for the biomedical cell product
Name and address of the manufacturer of the biomedical cell product
Address of the manufacturing facility of the biomedical cell product
Date of the state marketing authorisation of the biomedical cell product	(DD/MM/YYYY)
Validity term for the marketing authorisation certificate for the biomedical cell product	Until DD/MM/YYYY
Date of amendments made to the documents contained in the registration dossier for the registered biomedical cell product (date of replacement of the marketing authorisation certificate for the biomedical cell product)	(DD/MM/YYYY)
Type of biomedical cell product	(Autologous, allogenic, combined)
Intended use of the biomedical cell product as per the related Instruction for use (or Indications for use)
Specification of cell line (lines) used in the manufacture of the biomedical cell product
Details of rules and regulations relating to the biomedical cell product

 

_____________________ ___________ ____________________

(title)       (signature) (name)

l.s.

19.04.2018 – BW team