Introduction of medicinal products into civil circulation
The DOCLINX team provides services for introducing medicinal products into civil circulation (CC) in the Russian Federation.
Why is CC introduction necessary for medicinal products?
According to legislation, CC introduction is a mandatory condition for beginning the sale of a medicinal product in the Russian Federation. Before introducing each batch of a medicinal product for medical use (manufactured or imported into the Russian Federation) into CC, the company must submit a special package of documents to the federal executive authority confirming the quality of the product.
How does DOCLINX help companies introduce medicinal products into CC?
Our range of services includes:
1. Creating a system for introducing medicinal products into CC "from scratch":
- Developing all necessary powers of attorney/agreements between the Marketing Authorization Holder, Importer, and/or Manufacturer in Russian and/or English;
- Developing and coordinating with the Manufacturer a template for the certificate of analysis/conformity in English, as well as preparing a template for translation into Russian or preparing a bilingual certificate;
- Developing a template for CC introduction confirmation, signed by the person responsible for CC introduction;
- Concluding a contract with a laboratory;
- Processing the calculation of necessary materials at the laboratory's request;
- Assistance in ordering and importing necessary materials at the request of the Roszdravnadzor laboratory;
- Submitting all necessary materials to the laboratory;
- Full technical support during the introduction of the first imported batch of the medicinal product into civil circulation.
2. Introduction of medicinal product batches into CC:
- Collaboration option #1: DOCLINX performs all technical work on introducing the medicinal product into CC; an employee of your company is responsible for CC introduction
- Collaboration option #2: DOCLINX performs all technical work on introducing the medicinal product into CC and is responsible for CC introduction
Regardless of the chosen collaboration option, DOCLINX will perform all necessary actions to obtain the annual test protocol for the medicinal product that has entered civil circulation during the year (in accordance with Federal Law No. 61-FZ dated 12.04.2010, Article 52.1, Part 5).
Personalized commercial offer
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Regulatory acts
- Federal Law No. 61-FZ dated 12.04.2010 "On Circulation of Medicines", Article 52.1. "Introduction of Medicinal Products for Medical Use into Civil Circulation"
- Decree of the Government of the Russian Federation No. 1510 dated 26.11.2019 "On the Procedure for Introducing Medicinal Products for Medical Use into Civil Circulation"
- Decree of the Government of the Russian Federation No. 815 dated 31.05.2025 "On the Procedure for Introducing Medicinal Products for Medical Use into Civil Circulation"
- Order of Roszdravnadzor No. 9193 dated 28.09.2022 "On Approval of the Procedure for Providing Information on Medicinal Products for Medical Use Entering Civil Circulation"
- Administrative Offenses Code of the Russian Federation, Article 6.33. "Circulation of Counterfeit, Falsified, Substandard, and Unregistered Medicines, Medical Devices, and Circulation of Counterfeit Biologically Active Additives"
- Criminal Code of the Russian Federation, Article 238.1. "Circulation of Counterfeit, Substandard, and Unregistered Medicines, Medical Devices, and Circulation of Counterfeit Biologically Active Additives"