The Russian industry of pharmaceuticals is one of the fastest-growing on the globe, with an over 10% annual growth. Being one of the most profitable and also dynamic and promising specialized market, both in Russia and abroad, the pharmaceutical market is the second place in volume terms after the foodstuff market. Foreign investors must know that Russian pharmaceutical industry is a stable industry, being domestically oriented; it ranks among the top ten pharmaceutical markets in the world.
If you are interested in setting up a business in the pharmaceutical industry, our Russian company formation representatives can offer legal assistance on the subject.
Registration requirements when opening a Russian pharmaceutical company
An important aspect to be kept in mind is the fact that pharmaceuticals may be produced, sold, imported, and used in Russia only if they are registered with the state authority that is in charge with exercising control over the pharmaceuticals’ quality. In the present, these functions are offered by Federal Health Service.
Given this aspect, some of the following documents and information shall be filed with the Federal Health Service in order to register pharmaceuticals:
• application for state registration of a pharmaceutical company;
• document proving payment of state registration fee;
• legal address of the pharmaceutical’s manufacturer;
• original name of the pharmaceutical when being registered as a trademark;
• name of the pharmaceutical;
• usage instructions of the pharmaceutical company made according to the Pharmaceutical Law requirements;
• quality certificate for the pharmaceutical business;
• results of pharmacological and toxicological testing of the pharmaceutical;
• results of clinical trials;
• documents confirming the registration of the pharmaceutical, if it has been registered outside Russia etc.
The above documents plus other important information that shall be drafted in the Russian (or be translated by certified Russian translator) are relevant when registering a pharmaceutical company in Russia. Our Russian specialists in company formation will offer complete details on the specific requirements for the registration process of a pharmaceutical in Russia.
Licensing authorities and requirements for opening a pharmaceutical in Russia
The Pharmaceutical Law makes a priority for state to control the production, efficacy, quality and safety of pharmaceuticals. It provides the population with safe and high quality pharmaceuticals, since the health care sector it’s very important to the public. This is why it’s vital for companies to obtain a pharmacy license that will guarantee the legal environment for the pharmaceutical’s activity.
Here are the documents needed to be submitted by the applicant to the relevant authority (Federal Service or executive authorities in the constituent parts of Russia) for obtaining pharmacy license:
• documents needed under the licesing law: application form, constituent documents, proof of payment of the state duty;
• documents related to the pharmaceutical activity: data on the medical license, copies of documents which confirm having relevant equipment and premises, copies of documents which confirm the relevant qualification of the staff, data on a hygiene certificate etc.
If you want a team of accountants in Russia, you can discuss all the aspects that interest you with our specialists. According to Russian Accounting Standards and International Financial Reporting Standards (IFRS), companies with activities in this country must implement all procedures related to bookkeeping, payroll, and audits. There is also the obligation to prepare and submit the annual financial statements. Foreign investors who open a business in Russia can also opt for debt monitoring and tax returns.
Our Russian company formation representatives will give you further details on the documents and licensing required when registering a pharmaceutical company in Russia. Feel free to contact us if you are in need of legal assistance on the matter.