Strategic Regulatory Partner for Success in Russia

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Russia

With a global Regulatory framework coupled with expectations to be the powerhouse destination for pharmaceutical manufacturers, Russia offers a good fortune for medicinal product manufacturers to invest in the region. Manufacturers must obtain market authorizations from Federal Service for Surveillance in Healthcare Roszdravnadzor to enter the region. With the recently set up Regulatory framework, foreign manufacturers might face challenges navigating through various Regulatory procedures for timely approvals.  

As a specialized global Regulatory partner, Freyr provides expert Regulatory affairs consulting services to assist foreign manufacturers get through the complex mandatory requirements for time-critical approvals. Freyr’s Regulatory services in Russia span across:

Industries We Serve in Russia

Russian medicinal product market is perceived with positive outlook. The demand projections are in support of this trend. Roszdravnadzor (or) Federal Service for Supervision in Health Care functioning under the Ministry of Health (MoH) supervises and approves, the distribution and marketing of medicinal products for human and veterinary purposes. However, to obtain market entry in a compliant way, manufacturers should follow a stringent Regulatory process.

The growing demand for cosmetic and personal care products makes Russia one of the most preferred markets in the world. The current cosmetics legislation in Russia is known as the Technical Regulation on the Safety of Cosmetic Products (CU TR 009/2011). The regulations governing cosmetic product registration in Russia came into force in 2012 and are overseen by the Russian Ministry of Health (MoH). However, the same cosmetic regulations, CU TR 009/2011, have been adopted not only by Russia but also by countries like Kazakhstan, Belarus, Armenia, and Kyrgyzstan. These countries have come together to form the Eurasian Economic Union (EAEU), formerly known as the Customs Union, aiming to establish a harmonized Regulatory framework.

In Russia, food supplements are regulated and implemented by the Russian Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing or Rospotrebnadzor. The issues related to the state registration of food supplements in Russia are regulated by the Technical Regulations of the Customs Union on food safety, sanitary regulations and standards, and other technical regulations. Certain products, like vitamins, mineral supplements, and herbal ingredients, require pre-market approval before they are placed on the market. Herbal ingredients can also be classified as supplements, and authorities maintain a list of forbidden plants that can be used as food supplements/herbal Ingredients/supplements.

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management
  • Regulatory Submissions

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with MOH Russia
  • Team with 25+ years of strong foothold in the region
  • Proven track record for device registrations and submissions
  • End-to-end cosmetic Regulatory consultation
  • Structured and cost-effective approach to ensure speed to market

Looking for Regulatory Support in Russia

Contact us now for Expert Guidance and Support