Provision of licensing of BMCP production

Following the last session on biomedical cell products (BMCP) within IPhEB 2019 (read more in the article), there was published the Order on the administrative regulations for the provision of licensing services for the production of BMCP on the website of Roszdravnadzor.

Licensing of production has long been a pressing problem in the organization of introduction of BMCP into circulation. General provisions on licensing of BMCP can be found in the article. Prior to the administrative regulations, other legal acts regulating licensing of BMCP were also published. Among them:

1. Regulation on licensing activities for the production of biomedical cell products.

2. Administrative regulations for the control of activities for the production of biomedical cell products.

It should be noted that the above-mentioned legislative acts imply the production of BMCP of autologous, allogenic, combined products, including BMCP unregistered in Russia — for preclinical and clinical trials. (read more about BMCP types here https://atomic-temporary-113638954.wpcomstaging.com/ru/biomedical-cell-products/)

What documents are required to obtain a license?

1) Statement

2) Copies of documents for the right to use premises in which BMCP production will be carried out

3) Copies of documents confirming the right to use technical means, equipment and technical documentation necessary for performance of works

4) Copies of regulations of production of BMCP

5) Copies of documents on education of employees, as well as information on certification of the authorized representative of the manufacturer * of BMCP

6) Inventory of attached documents

Cost and terms

1) Decision on granting (refusal to grant) a license — 45 working days from the date of receipt of the package of documents by Roszdravnadzor

2) Issuance (direction) of the license is carried out within 3 working days from the date of signing and registration of the license in a single register (http://www.roszdravnadzor.ru/services/licenses)

3) In case of detection of any violations, the applicant is given 30 calendar days from the date of receipt of the notification.

4) The state fee for obtaining a license is 7 500 rubles.

Reference *

When the BMCP is put into circulation, the authorized representative (AR) verifies the compliance of the BMCP with the requirements established during their state registration and guarantees that the BMCP is produced in accordance with the rules of good practice for working with BMCP. Certification of the AR includes testing of theoretical knowledge and practical skills and is carried out once in 5 years.

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1. Постановление № 1184 «ОБ УТВЕРЖДЕНИИ ПОЛОЖЕНИЯ О ЛИЦЕНЗИРОВАНИИ ДЕЯТЕЛЬНОСТИ ПО ПРОИЗВОДСТВУ БИОМЕДИЦИНСКИХ КЛЕТОЧНЫХ ПРОДУКТОВ»
2. Приказ № 8621 ОБ УТВЕРЖДЕНИИ АДМИНИСТРАТИВНОГО РЕГЛАМЕНТА ФЕДЕРАЛЬНОЙ СЛУЖБЫ ПО НАДЗОРУ В СФЕРЕ ЗДРАВООХРАНЕНИЯ ПО ПРЕДОСТАВЛЕНИЮ ГОСУДАРСТВЕННОЙ УСЛУГИ П ЛИЦЕНЗИРОВАНИЮ ДЕЯТЕЛЬНОСТИ ПО ПРОИЗВОДСТВУ БИОМЕДИЦИНСКИХ КЛЕТОЧНЫХ ПРОДУКТОВ
3. НК РФ Статья 333.33. Размеры государственной пошлины за государственную регистрацию, а также за совершение прочих юридически значимых действий
4. Приказ №694н "Об утверждении Порядка аттестации уполномоченного лица производителя биомедицинского клеточного продукта, требований к уровню образования и квалификации указанного уполномоченного лица и его полномочий по обеспечению качества биомедицинского клеточного продукта, вводимого в обращение”