How can a foreign manufacturer enter the Russian pharmaceutical Market?

Numerous foreign manufacturers of medicinal products wish to enter the Russian pharmaceutical market due to higher growth rates compared to other western markets but don’t know where to start. This blog post is written to address this issue.

A prerequisite to enter the Russian pharmaceutical market is a thorough market analysis. This step can be performed individually or outsourced to a suitable company working in Russia for better results. If you decide to work with us, we can take care of this step for you. At Colinbrus+ we perform an elaborate market analysis taking into account various intricacies of the Russian market and data from previous years obtained from relevant organizations which helps to build a more accurate picture and an optimum strategy.

In the process of registration of a medical product, a few government bodies are involved i.e.

  • Ministry of Health (MOH, Minzdrav)

  • State institute of drug and good practices (GILS and NP)

  • Clinical trial department

  • Ethics board

To work with them an applicant needs to be selected. Therefore, either a representative office in Russia has to be opened (which currently is quite expensive and has many drawbacks and legal issues) or a representative in Russia has to be selected (which is highly difficult given the lack of experienced companies with a proven track record in registering foreign products that too at a reasonable price) . Fortunately, Colinbrus+ has the rights to act as an Applicant and represent your company before the government bodies.

Scheme of the process:

  • 1. The Applicant sends an application along with necessary documents to MOH for the registration of medical products in parallel he sends an application along with necessary documents to GILS for audit and obtaining the Russian GMP certificate of the production site.

  • 2. MOH sends the received documents to clinical trial department and ethics board for their conclusion.

  • 3. After receiving the conclusion, MOH informs the applicant on the possibility of conducting clinical trials, the applicant sends an application for permission to conduct clinical trials along with necessary information to MOH.

  • 4. After receiving permission the clinical trials are conducted. The results of the clinical trials, along with audit results as well as an application for quality expertise are sent to MOH.

  • 5. The request to assess the benefit risk ratio is sent to the clinical trial department.

  • 6. The clinical trial department sends it conclusion and pharmexpertise (quality control conclusion) to MOH.

  • 7. MOH provides its conclusion for registration.

As is clearly visible, the registration process involves several stages. At each stage the government bodies may send additional queries and requests for documents. Sometimes, minor delays in response and other seemingly trivial problems can lead to rejection from MOH. Therefore, active tracking and confident knowledge of every step is vital to avoid loss of time and resources.

Successful registration is highly uncertain. Nevertheless, at Colinbrus + we have a proven track record in registration of medical products. This can be explained by the fact that our specialists have extensive experience in pharmacy and have gone through the steps innumerable number of times and are fully aware of loopholes that may arise during the registration process. Due to in-depth understanding of the process, we are able to lower the costs of our services by optimizing each step and greatly increase the probability of your product to be registered. Our regular clients agree that working with Colinbrus + is the most efficient way to register a medicinal product in Russia.

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