Changes in products = changes in compliance documentation

Dear Ladies and Gentlemen!

Most of the products imported to Russia are subject to strict regulations under Russian and EAEU1 laws. They are regulated by:

• The general legislation of Federal Law No. 184-FZ dated 27 December 2002 “On Technical Regulation”, which is applied in the absence of special regulation;

• Special technical regulations for certain types of goods, e.g., on the safety of machinery and equipment, wheeled vehicles, light industry goods, goods intended for children and teenagers, food products, etc.;

• Special legislation for medicines, medical devices, dietary supplements, etc.

The compliance of goods is confirmed in the following ways, depending on the type of products:

• Certification/declaration; or

• State registration.

The circulation (including import and sale) in the Russian Federation of goods that do not meet regulatory requirements is prohibited. All imported goods must comply with the regulatory requirements and documentation that was provided to obtain documents confirming compliance.

If the manufacturer makes any ****modifications to the characteristics/documentation of the goods****, they must be reflected in Russian documents confirming compliance (if not available, such documents must be prepared again) ****before**** importing the modified goods into the Russian Federation. Otherwise, the circulation (including import and sale) of such modified goods in the Russian Federation runs counter to the law and entails ****administrative or criminal liability****, such as:

• A fine of up to 300,000 RUB (approximately 3,300 US$) for a violation of the requirements of technical regulations;

• A fine of up to 30,000 RUB (approximately 330 US$) for failure to take measures to prevent harm during the circulation of goods that do not comply with the requirements of technical regulations;

• A fine of up to 5 million RUB (approximately 55,000 USD), administrative suspension of activities for up to 90 days or criminal liability for the circulation of misbranded, counterfeit, or substandard unregistered medicines or medical devices, or the circulation of counterfeit dietary supplements.

In our practice, we see ****an increasing number of cases**** where products are imported into Russia with modifications that were not reflected in documents confirming compliance, as well as cases where the documentation that is the basis for obtaining documents confirming compliance has become invalid. In such cases, manufacturers and distributors often have to make ****product recalls and incur significant costs and reputational risks****.

****If you intend to make any changes in your products, we recommend considering the implications and making arrangements to confirm the compliance of products in advance. If you already have imported goods into Russia without making the appropriate modifications to the documents confirming compliance, please obtain expert advice on the actions required to mitigate any associated risks.****

ALRUD experts, ****with their extensive experience in advising on regulatory requirements and interaction with regulatory authorities****, can provide the necessary legal support on all issues related to your goods imported to Russia.

The Eurasian Economic Union includes the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic and the Russian Federation.