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Eurasian product certification

Eurasian product certification


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EAC(TRCU)
Introduction of Eurasian Product Certification

Summary


TRCU abbreviated for Technical Regulation of Customs Union and stands for the technical regulations of the Customs Union centered on Russia.

TRCU is an integrated certification system that began with the Eurasian Customs Union “EACU, Eurasian Customs Union” formed by Russia, Kazakhstan and Belarus in 2010, and entered into force in the Eurasian Economic Union “EEU, Eurasian Economic Union” in 2015.

Currently, the Eurasian Customs Union/Economic Union consists of five countries: Russia, Kazakhstan, Belarus, Kyrgyzstan, and Armenia, and TRCU certification follows the stipulated certification procedure according to the decision of the Eurasian Economic Commission.

The EAC mark is affixed on the certificate, which means Eurasian Conformity.

EAC 인증 로고

EAC 인증 로고


TRCU EAC Regulation


Technical Regulation

Technical regulations specific content

Products

ТR CU 001/2011

“On safety of railway rolling stock”

railway rolling stock

ТR CU 002/2011

“On safety of high-speed railway transport”

high-speed railway transport

ТR CU 003/2011

 “On safety of railway transport infrastructure”

railway transport infrastructure

ТR CU 004/2011

“On safety of Low-voltage equipment”

Low-voltage equipment

ТR CU 005/2011

“On safety of packages”

packages

ТR CU 006/2011

“On safety of pyrotechnic articles”

pyrotechnic articles

ТR CU 007/2011

 “On safety of products intended for children and adolescents”

products intended for children and adolescents

ТR CU 008/2011

“On safety of toys”

toys

ТR CU 009/2011

“On safety of perfumes and cosmetics”

perfumes and cosmetics

ТR CU 010/2011

“On safety of machinery and equipment”

machinery and equipment

ТR CU 011/2011

“On safety of elevators”

elevators

ТR CU 012/2011

 “On safety of equipment in explosion hazardous environments”

equipment in explosion hazardous environments

ТR CU 013/2011

“0n requirements to motor and aviation petrol, diesel and marine, fuel, reactive engines fuel and black oil”

motor and aviation petrol, diesel and marine, fuel, reactive engines fuel and black oil

ТR CU 014/2011

“On safety of roads”

roads

ТR CU 015/2011

 “On safety of grain”

grain

ТR CU 016/2011

 “On safety of apparatuses working on gaseous fuel”

apparatuses working on gaseous fuel

ТR CU 017/2011

“On safety of light industry products”

light industry products

ТR CU 018/2011

“On safety of wheeled vehicles”

wheeled vehicles

ТR CU 019/2011

“On safety of personal protection equipment”

personal protection equipment

ТR CU 020/2011

“On safety of Electromagnetic compatibility of technical devices”

Electromagnetic compatibility of technical devices

ТR CU 021/2011

“On safety of food products”

food products

ТR CU 022/2011

 “On safety of food products in terms of their marking”

food products in terms of their marking

ТR CU 023/2011

“On safety of juice products made of fruit and vegetables”

juice products made of fruit and vegetables

ТR CU 024/2011

“On safety of oil & fat products”

oil & fat products

ТR CU 025/2012

 “On safety of furniture”

furniture

ТR CU 026/2012

“On safety of small-size crafts”

small-size crafts”

ТR CU 027/2012

“On safety of certain types of specialized food products, including food for dietary treatment and protective diet”

certain types of specialized food products

ТR CU 028/2012

“On safety of explosives and products on their basis”

explosives and products on their basis

ТR CU 029/2012

“On requirements for food additives, flavoring agents and processing supplements”

food additives, flavoring agents and processing supplements

ТR CU 030/2012

“On requirements for lubricants, oils and special liquids”

lubricants, oils and special liquids

ТR CU 031/2012

“On safety of agricultural and forestry tractors and trailers thereto”

agricultural and forestry tractors and trailers thereto

ТR CU 032/2013

“On safety of pressure equipment”

pressure equipment

ТR CU 033/2013

“On the safety of milk and dairy products”

milk and dairy products

ТR CU 034/2013

“On safety of meat and meat products“

meat and meat products

ТR CU 035/2014

“On safety of tobacco products”

tobacco products

TR EAEU 036/2016

“On requirements for liquified petroleum gases foe use as fuel”

liquified petroleum gases foe use as fuel

TR EAEU 037/2016

“Restricting usage of hazardous substances in the electrical goods and radio electronics”

electrical goods and radio electronics

TR EAEU 038/2016

“On safety of amusement rides”

amusement rides

TR EAEU 039/2016

“On requirements for mineral fertilizers”

mineral fertilizers

ТР EAEC 040/2016

“On safety of fish and fish products”

fish and fish products

TR EAEU 041/2017

“On safety of chemical products”

chemical products

(Scheduled to take effect on June 2, 2021)

TR EAEU 042/2017

“On safety of chemical products”

chemical products

TR EAEU 043/2017

“On safety of equipment for children’s playgrounds”

equipment for children’s playgrounds

TR EAEU 044/2017

“On safety of packaged drinking water, including natural mineral water”

drinking water, including natural mineral water

TR EAEU 045/2017

“On safety of oil prepared for transportation and(or) use”

oil prepared for transportation and(or) use

TR EAEU 046/2018

"On safety of natural flammable gas, prepared for transportation or usage"

natural flammable gas, prepared for transportation or usage

(Scheduled to take effect on January 1, 2022)

TR EAEU 047/2018

"On safety of alcohol products”

alcohol products



TRCU EAC certification type


    TRCU certificates are classified into two categories: Certification of Conformity (CoC) and Declaration of Conformity (DoC) according to the details.

    ⁘TRCU CoC
    This includes pressure vessels, hand tools, cranes, elevators, some machinery, test equipment, electrical and electronic products, etc., and a sample test or factory inspection is required.

    ⁘TRCU DoC
    This is a general product with relatively low risk, and some products can be issued certificate by only document review. In the case of CoC, product tests are conducted through designated testing laboratories in principle, but a number of certification agencies are issuing certificates after acknowledging CB safety reports without additional tests.

    EAC 인증 로고
    EAC CoC
    EAC 인증 로고
    EAC DoC


TRCU EAC certification validity period


    ⁘ One-Shipment (Single Delivery Certification): This is mainly in cases where products are exported on a one-off basis, such as plants, and in cases where resale to third parties or other general consumers is not possible, and is valid until the contract fulfillment period indicated in the contract with the importer.

    ⁘ Serial Production Certification: This is advantageous in cases where continued export is expected, and one certification can result in a certificate valid for up to 5 years.





TRCU EAC certification process


    1. Submit application form and product-related documents to the certification body

    2. Document review

    3. Check the type of certificate applied

    4. Check the Sample test and factory inspection

    5. Issuance of quotation and contract

    6. If sample test is needed, test and test report is issued after sending sample

    7. If factory inspection is necessary, proceed with the inspection

    8. Draft certificate issuance and customer verification

    9. Certificate issuance


TRCU EAC submission documents


    The documents to be submitted by the manufacturer are as follows: (Not limited to this, but can be added as needed.)

    ⁘ application

    ⁘ HS Code

    ⁘ Product manual (Russian or exporting country language)

    ⁘ Existing test report

    ⁘ Existing Certificate

    ⁘ Drawing (if applicable)

    ⁘ Technical document (if applicable)


Eurasian certification applicant (Eurasia Representative)


Rosakkreditasiya Register

TRCU certification and GOST R certification are registered on the Rosakkreditasiya website.
Go to Rosakkreditasiya website (https://www.fsa.gov.ru/) ☜ Click!

    -When applying for TRCU certification, GOST R certification, etc., only companies located in Russia or other customs union countries can become the applicant. The company must be a legal entity or a private business, and the general public can’t be an applicant for certification.

    -IGC provides the Eurasia Representative service for customers who don’t have a business operator who can act as an applicant in the Eurasia region.


Why is it important?


    Companies wishing to export products to the Eurasian region must obtain certification proving conformity to the applicable technical regulations and mark the conformity mark on the product, packaging or attached documents to be exported to that country.

IGC’s Competency


    IGC cooperates with the RUS-TEST PACIFIC certification body to provide the best competitive value to customers and stakeholders, and is reborn as a global certification body through continuous shared growth.

    IGC complies with:

    ⁘ Compliance with legal requirements

    ⁘ Teamwork and solidarity among members

    ⁘ Sincerity and fairness

    ⁘ Social and environmental accountability

    ⁘ Continuous development and improvement activities through knowledge and learning as a certification and registration service provider

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Related Services from IGC

  • 01System certification

  • 02Product certification (Europe, Eurasia, Americas, China, Southeast Asia)

  • 03Product test

  • 04Certification of audit qualifications

  • 05Professional manpower training

Medical Device
Introduction of Eurasian Product Certification

In order to register medical devices in Russia, it takes a lot of time and fee to perform separate tests according to compulsory requirements, even if tests are conducted for approval by CE or FDA. Since Russia has not entered into a certification agreement with the EU or the United States, it does not accept internationally recognized certificates such as CE certification from the EU or FDA approval from the United States.

Since 2002, the Russian government has started to change the part of the test to other forms such as product safety assurance, such as production site inspection, quality system check, and post-marketing continuous management. However, such attempts were unsuccessful and, therefore, from January 1, 2013, these procedures were operated in a more robust and realistic form.

유라시아 의료기기 제품 인증

The Medical Device Registration Certificate, an official document issued by Roszdravnadzor, the Russian Federation Health Supervisory Service, which provides health and social development services, has passed the preliminary evaluation of the relevant medical device and is therefore suitable for production, import, sale and use in Russia. All medical devices, whether produced in Russia or imported into Russia from abroad, must be registered.

The registration certificate contains the name of the manufacturer, distributor or legal representative. If the medical device for which cancer drug registration is to be registered is composed of modules/blocks manufactured by other manufacturers, but is not a branded product, each module/block must be registered individually. Government Decree Jan. For medical devices listed in 17, 2002 N 19, if there is a registration certificate, VAT is not collected from the manufacturing company.


Classification of medical devices


    Nomenclature and classification of medical devices operating in Russia are listed in Order N4H “About Conformation of Nomenclature Classification of Medical Devices” and in vitro diagnostic equipment is not included. In vitro diagnostic equipment is subject to separate class regulations.

    ✧ Class 1 – Low risk

    ✧ Class 2a – Medium risk

    ✧ Class 2b – High risk

    ✧ Class 3 – Top risk


Test type of Medical device registration progress


    Testing according to medical device registration can only be conducted in laboratories registered under the 2011 N 352 Act of 06 May 2011, and for clinical trials, a list of institutions that can perform this function is posted on the Roszdravnadzor website.

    ✧ Toxicity test

    ✧ Functional test

    ✧ Electromagnetic inspection

    ✧ Clinical trial


Medical device registration validity period



    Permanent (valid until the product registered in the certificate is discontinued.)


Medical device registration process


    1. The representative of the company must apply for permission to consent to sending samples to Russia by Rosdravnadzor, which is valid for 6 months. In addition, the representative must provide a description of the applied product, a contract with the laboratory, and a contract with an attorney or manufacturer.

    2. The representative must check in to get the sample through customs. In addition, the representative must also provide samples, contracts, documents to be submitted to customs officials, and invoices.

    3. Toxicity tests, technical tests, and electromagnetic tests are conducted in the case of electrical products at accredited laboratory.

    4. (Simultaneous with step 3) The company must prepare all technical documents required for registration.

    5. If the class of medical devices is determined, and there is no similar medical device registered in Russia, quality evaluation, efficiency and safety tests are conducted as the first step, and then clinical evaluation is carried out at two different medical institutions. Quality assessment, efficiency and safety assessments are carried out.

    6. The company submits the entire technical file to Rospotrebnadzor. After completing the registration of medical devices, GOST-R certificate, hygiene certificate for each item, and measuring instrument certificate according to the characteristics of the product must be secured based on the registration certificate.


Medical device registration submission documents


    ∷ Manufacturer's power of attorney following the registration and certification process (requires notarization)

    ∷ Proof of company registration in the home country (for example, chamber of commerce, internal FDA registration or company registration certificate, business license) must be notarized and submitted.

    ∷ 9001 or ISO 13485 certificate issued by national or international organizations applicable to medical devices

    ∷ Certificate of conformity according to the requirements of 93/42/EEC, declaration of conformity, free-selling certificate, FDA certification document, medical device certification document for national or other countries. (Must be notarized and submitted)

    ∷ Test reports proving safety (IEC 60601-1, IEC 60601-1-2, ISO 10993, etc.)-Accurate reports can help to simplify work during technical inspections in laboratory.

    ∷ Toxic Safety / Biocompatibility Safety Test Report

    ∷ Providing samples for technical and toxicity tests

    ∷ Medical device new registration application or renewal registration application. The application must use the letterhead of the applicant (a legal entity authorized to carry out registration in Russia). The application must include a description of all components and parts included in the medical device or device. Applications must be submitted in Russian.

    ∷ Submit a power of attorney for the appointment of a legal representative to perform the application. The manufacturing company must issue a power of attorney to a legal entity with registration authority (address to the head of the legal entity), and must be notarized in the country of origin of the manufacturer. It must also be translated into Russian and notarized by the Russian consulate in your country. The power of attorney must stipulate that the manufacturer must entrust the applicant to sign a contract to perform registration of medical devices/equipment, perform consultation and professional work, and obtain a registration certificate.

    ∎ The registration process does not require Good Manufacturing Practices (GMP) audits. However, legislation to introduce these screenings will be implemented in the near future.

    ∎. In general, the fee of registration depends on the scope of testing required.


Medical device registration confirmation


    You can check the registration status of medical devices on the website of Rospotrebnadzor in the Russian version.

    ☞ Go to Rospotrebnadzor website ☜
    Website address ==> http://roszdravnadzor.ru/registration/mi/login


    For medical devices of Class 1 and 2a, if the products are similar (same grade, applied in the same way, same efficiency), both products are registered on the basis of equivalent or technical testing, safety.

    All other products including Class 2b, 3, 1 and 2a (if no similar product has already been registered) are registered on the basis of technical tests, safety assessments, clinical and medical tests to confirm effectiveness and safety.


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Related Services from IGC

  • 01System certification

  • 02Product certification (Europe, Eurasia, Americas, China, Southeast Asia)

  • 03Product test

  • 04Certification of audit qualifications

  • 05Professional manpower training

Food
Introduction of Eurasian Product Certification

If you wish to export food to the Eurasian region, you must obtain a certification proving compliance with the applicable technical regulations. And the conformity mark (EAC) is affixed on the product, packaging or attached documents to export to that country.

Exporting to countries that have joined the Economic Union/Customs Union (Russia, Kazakhstan, Belarus, Kyrgyzstan, Armenia) requires EAC certification or GOST certification in accordance with the Technical Regulation of Customs Union (TRCU). Or exporting to other Eurasian countries such as Uzbekistan requires national certification.

Certification for food is divided into EAC, GOST and State Registration Certificate.

1. Eurasian Product Certification (EAC) (EAC)

    TRCU abbreviated for Technical Regulation of Customs Union and stands for the technical regulations of the Customs Union centered on Russia.

    TRCU is an integrated certification system that began with the Eurasian Customs Union “EACU, Eurasian Customs Union” formed by Russia, Kazakhstan and Belarus in 2010, and entered into force in the Eurasian Economic Union “EEU, Eurasian Economic Union” in 2015.

    Currently, the Eurasian Customs Union/Economic Union consists of five countries: Russia, Kazakhstan, Belarus, Kyrgyzstan, and Armenia, and TRCU certification follows the stipulated certification procedure according to the decision of the Eurasian Economic Commission.

    The EAC mark is affixed on the certificate, which means Eurasian Conformity.


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1) TRCU EAC applied items (food)

      TRCU EAC applied items (food)


      TR СU 015/2011 On safety of grain

      TR CU 021/2011 On safety of food product

      TR СU 022/2011 On food products in terms of its marking

      TR CU 023/2011 On juice production of vegetables and fruits

      TR CU 024/2011 On oil and fat products

      TR CU 027/2012 On safety of certain types of specialized food products, including foods for dietary treatment and dietary preventive nutrition

      TR CU 029/2012 Requirements for the safety of food additives, flavorings and technological aids

      TR CU 033/2013 On safety of milk and dairy products

      TR CU 034/2013 On safety of meat and meat products

      TR CU 040/2016 On safety of fish and fish products

      TR CU 044/2017 On the safety of packaged drinking water, including natural mineral water

      TR CU 047/2018 On safety of alcohol products


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2) EAC certificate type

    This is a general product with relatively low risk, and some products can be issued certificate by only document review. Food is subject to the EAC DoC.


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3) EAC certification information

    Documents to be submitted: application form, product manual, HS Code, drawing, technical document, test report, certificate (Documents to be submitted must be written in Russian) ∷ Sample test: Depending on the product, it is decided whether to submit and test the sample. ∷ Factory inspection: None ∷ Duration: 2 weeks (Excluding sample delivery and sample testing period) ∷ Certificate validity period: up to 5 years (Serial Production Certification)

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2.Eurasian Product Certification (GOST)

    GOST is a national technical standard specified by the Euro-Asian Council for Standardization, Metrology and Certification (EASC), an abbreviation of GOsudarstvennyy STandart, which means federal standard in Russian.

    Currently, GOST certificates issued by country and the subject of issuing certification bodies are different, so each country's GOST certificate is a different certificate, and it is classified as GOST-R in Russia and GOST-K in Kazakhstan.

    After the introduction of the EAC, an integrated certification system that took effect between customs alliance countries, the proportion of GOST certification in the country has decreased significantly compared to the past. However, GOST certification is still required for import customs clearance for compulsory certification items that have not yet been negotiated between customs alliances.


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1) GOST applied items (food)

    After the introduction of the integrated certification system that took effect between the countries of the Eurasian Customs Union such as meat, fish, shellfish, vegetables/fruits, grains, citrons, alcohol/drinks, etc., the share of GOST certifications in Russia has decreased significantly compared to the past.

    However, compulsory certification items that have not yet been negotiated between allies must be certified by GOST.

    In addition, EAC-certified companies may additionally apply for a voluntary GOST certificate for customer promotion and trust.

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2) GOST certificate type

    ✤ GOST DoC (Declaration of Conformity)

    ✤ GOST Voluntary

    GOST Voluntary is a certificate that proves that the product has been made in accordance with applicable regulations and guidelines, although it is not mandatory to obtain GOST certification.

    The additional acquisition of the GOST Voluntary Certificate will have the expected effect of more clearly demonstrating your management capabilities, thus securing the effect of increasing exports.


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3) GOST certification information

    ✤ Documents to be submitted: application form, product manual, HS Code, drawing, technical document, Existing test report, Existing certificate (Documents to be submitted must be written in Russian)

    ✤ Sample test: Depending on the product, it is decided whether to submit and test the sample.

    ✤ Factory inspection: None

    ✤ Duration: 2 weeks (Excluding sample delivery and sample testing period)

    ✤ Certificate validity period: up to 3 years (Serial Production Certification)




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4) Certification process

    TRCU EAC, GOST and State Registration Certificate certification process

    1. Submit application form and product-related documents to the certification body

    2. Document review

    3. Check the type of certificate applied

    4. Check the Sample test and factory inspection

    5. Issuance of quotation and contract

    6. If sample test is needed, test and test report is issued after sending sample

    7. If factory inspection is necessary, proceed with the inspection

    8. Draft certificate issuance and customer verification

    9. Certificate issuance

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3. State Registration Certificate

    The hygiene registration certificate issued by each country has been integrated into one certificate according to the Decision of CU commission No.299 adopted in 2010 by the Customs Union.

    One certificate can be used in all 5 countries of the Eurasian Customs Union (Russia, Kazakhstan, Belarus, Kyrgyzstan, Armenia).

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1) Food products to which national hygiene registration is applied

    ✦ Mineral water, bottled water, soft drinks, alcohol-including low alcohol and tonic drinks

    ✦ aby food, food for pregnant and breastfeeding women, dietary products, food for athletes, biologically active food additives, organic products, specialty foods including supplements

    ✦ Food additives (plant extracts, aromas, etc.)

    ✦ Food produced using genetically modified (transgenic) organisms

    ✦ Materials, devices, equipment and other technical products for use in drinking water supply

    ✦ Food contact products (excluding cutlery, tableware, and manufacturing equipment)

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2) National hygiene registration certification information

    ✦ Sample test: Depending on the product, sample submission and testing are decided.

    ✦ Factory inspection: Depending on the product, factory inspection may be required, and inspection M/D and fee are determined through quotation.

    ✦ Duration: 4~6 weeks (excluding sample sending and sample testing period)

    ✦ Validity period of certificate: 5 years

    ✦ Certification fee: It is different for each product, so consultation is required for accurate quotation.

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4. IGC인증원의 역량

    IGC provides a competitive and satisfactory service to its customers through several strengths.

    ⁙ Providing competitive services based on knowledge and technology secured through certification projects in various fields

    ⁙ Competitive certification fee

    ⁙ Minimum time required through rapid certification service

    ⁙ Provides One Stop Service for various system and product certifications

❉ ❉ ❉

Related Services from IGC

  • 01System certification

  • 02Product certification (Europe, Eurasia, Americas, China, Southeast Asia)

  • 03Product test

  • 04Certification of audit qualifications

  • 05Professional manpower training

Cosmetics
Introduction of Eurasian Product Certification

Companies wishing to export products to the Eurasian region must obtain certification proving conformity to the applicable technical regulations and mark the conformity mark on the product, packaging or attached documents to be exported to that country.

Exporting to countries that have joined the Economic Union/Customs Union (Russia, Kazakhstan, Belarus, Kyrgyzstan, Armenia) requires EAC certification or State Registration Certificate in accordance with the TRCU regulation. Exporting to other Eurasian countries such as Uzbekistan requires national GOST certification.

The certification for cosmetics is divided into EAC, GOST and State Registration Certificate according to product characteristics.

1. EAC

    TRCU is an integrated certification system that began with the Eurasian Customs Union “EACU, Eurasian Customs Union” formed by Russia, Kazakhstan, and Belarus in 2010 and entered into force in the Eurasian Economic Union “EAEU, Eurasian Economic Union” in 2015.

    ❁ TRCU EAC applied items (cosmetics)
        ⁖ TR СU 009/2011 On safety of cosmetics and perfumes

    ❁ EAC certificate type (cosmetics)
        ⁖DoC (Declaration of Conformity): This is a general product with relatively low risk, and some products can be issued certificate by only document review. Cosmetics require EAC DoC.

    ⁙ Certification Information

    ▥ Documents to be submitted: application form, product manual, HS Code, test report, certificate, etc. (Documents to be submitted must be written in Russian)

    ▥ Sample test: Depending on the product, it is decided whether to submit a sample or test. For cosmetics, sample tests are conducted

    ▥ Factory inspection: None

    ▥ Duration: 2 weeks (Excluding sample sending and sample testing period)

    ▥ Certificate validity period: 5 years (Serial Production Certification)

    ▥ Certification fee: It is different for each product, so consultation is required for accurate quotation.


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2. GOST

    GOST is a national technical standard specified by the Euro-Asian Council for Standardization, Metrology and Certification (EASC), an abbreviation of GOsudarstvennyy STandart, which means federal standard in Russian.

    Currently, GOST certificates issued by country and the subject of issuing certification bodies are different, so each country's GOST certificate is a different certificate, and it is classified as GOST-R in Russia and GOST-K in Kazakhstan.

    ⁙ GOST applied items (cosmetics)

    After the introduction of the EAC, an integrated certification system that took effect between customs alliance countries, the proportion of GOST certification in the country has decreased significantly compared to the past. However, GOST certification is still required for import customs clearance for compulsory certification items that have not yet been negotiated between customs alliances.

    EAC DoC or State Registration Certificate (National Hygiene Registration) is mandatory when exporting cosmetics to countries belonging to the Eurasian Economic Union (Russia, Kazakhstan, Belarus, Kyrgyzstan, Armenia), and GOST certification is not included. However, when exporting to Eurasian countries (such as Uzbekistan) other than the countries of the Economic Union, GOST certification for each country or State registration within the country is required.

    ⁙ GOST certificate type

    ▧ GOST DoC (Declaration of Conformity)

    ▧ GOST Voluntary

    ▧ GOST Voluntary is a certificate that proves that the product has been made in accordance with applicable regulations and guidelines, although it is not mandatory to obtain GOST certification. The additional acquisition of the GOST Voluntary Certificate will have the expected effect of more clearly demonstrating your management capabilities, thus securing the effect of increasing exports.

    ⁙ Certification Information

    ▧ Documents to be submitted: application form, product manual, HS Code, test report, and certificate (Documents to be submitted must be written in Russian)

    ▧ Sample test: Depending on the product, it is decided whether to submit or test the sample. (In the case of GOST Voluntary certification, a sample test of cosmetics is performed, but since it was conducted in the EAC certification process, no additional test is required)

    ▧ Factory inspection: None

    ▧ Duration: 2 weeks (Excluding sample sending and sample testing period)

    ▧ Certificate validity period: 3 years (Serial Production Certification)

    ▧ Certification fee: It is different for each product, so consultation is required for accurate quotation.


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3. State Registration Certificate

    The hygiene registration certificate issued by each country was integrated into one in accordance with the Decision of CU commission No.299 adopted in 2010 by the Customs Union.

    One certificate can be used in all countries of the Eurasian Economic Union (Russia, Kazakhstan, Belarus, Kyrgyzstan, Armenia).

    ⁙ Products subject to State Registration Certificate (cosmetics)

    Cosmetics that are classified as special cosmetics according to their ingredients, functions and purposes must obtain a national hygiene registration certificate.

    ✡ Tanning products

    ✡ Whitening products

    ✡ Products for tattoos

    ✡ Intimate care

    ✡ Perfume or cosmetics intended to protect the skin from the effects of harmful factors by individuals

    ✡ Infant cosmetics (Products for children under 14)

    ✡ Dyeing and Bleaching Products

    ✡ Products for perm, hair straights

    ✡ Perfume and cosmetics using nanomaterials (nanomaterials: insoluble or in-body stability substance, internal or Exterior particle size specially manufactured within a range of 1 to 100 nm)

    ✡ Brushing products

    ✡ Pilling agent (chemical filling). Products for removing surface cells from the epidermis using exfoliating agents)

    ✡ Fluoride oral hygiene products with fluorine content of 0.15% or higher (liquid products for oral hygiene of oral hygiene are 0.05% or higher)

    ✡ Contains zinc peroxide and peroxide elements concentrated in hydrogen peroxide or whitening products with hydrogen oxide. Other components that produce hydrogen peroxide (0.1-6.0%)

    ⁙ State Registration Certificate Certification Information

    ✡ Documents to be submitted: Application form, product manual, MSDS, copy of product and label (photo), test report, certificate (documents must be written in Russian)

    ✡ Sample test: Required

    ✡ Factory inspection: Depending on the product, factory inspection may be required, and inspection M/D and fee are determined through quotation.

    ✡ Duration: 4~6 weeks (Excluding sample sending and sample testing period)

    ✡ Certificate validity period: 5 years

    ✡ Certification fee: It is different for each product, so consultation is required for accurate quotation.

    ⁙ TRCU EAC, GOST and State Registration Certificate certification process

    1. Submit application form and product-related documents to the certification body

    2. Document review

    3. Check the type of certificate applied

    4. Issuance of quotation and contract

    5. If sample test is needed, test and test report is issued after sending sample

    6. Certificate issuance


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4. Cosmetic test

    Product samples submitted for certification or national state registration are tested by accredited laboratories in Eurasian countries for:.

    ✡ physical and chemical analysis test

    ✡ microorganism detection test

    ✡ toxicity test

    ✡ hygiene inspection

    ✡ other necessary tests and tests


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5. Why is it important?

    Companies wishing to export products to the Eurasia region must obtain certification proving conformity to the applicable technical regulations and mark the conformity mark on the product, packaging or attached documents to be exported to that country.

❉ ❉ ❉

6. IGC’s Competency

    IGC cooperates with the RUS-TEST PACIFIC certification body to provide the best competitive value to customers and stakeholders, and is reborn as a global certification body through continuous shared growth.

    IGC complies with:
    ⁘ Compliance with legal requirements

    ⁘ Teamwork and solidarity among members

    ⁘ Sincerity and fairness

    ⁘ Social and environmental accountability

    ⁘ Continuous development and improvement activities through knowledge and learning as a certification and registration service provider


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7.Why IGC?

    IGC provides a competitive and satisfactory service to its customers through several strengths.
    ⁙ Providing competitive services based on knowledge and technology secured through certification projects in various fields

    ⁙ Competitive certification fee

    ⁙ Minimum time required through rapid certification service

    ⁙ Provides One Stop Service for various system and product certifications


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Related Services from IGC

  • 01System certification

  • 02Product certification (Europe, Eurasia, Americas, China, Southeast Asia)

  • 03Product test

  • 04Certification of audit qualifications

  • 05Professional manpower training

Medicine
Introduction of Eurasian Product Certification

In accordance with Russian Federal Law (Pharmaceutical Distribution Act: #61-FZ / 2010.04.12), all pharmaceuticals and medical substances imported into the Russian Federation must obtain an import license and are subject to federal state control over the distribution of pharmaceuticals. State control bodies are territorial authorities under the Health Supervisory Service of the Russian Federation (ROSZDRAVNADZOR) and constituent bodies of the Russian Federation. The purpose of state supervision is to prevent, detect and contain violations of the requirements of the legislation of the Russian Federation in the field of drug distribution.

The need to comply with the Drug Distribution Act (#61-FZ)

    According to the current law, violations of the law on the distribution of drugs are subject to penalties under the laws of the Russian Federation.

    The relevant laws are:

    1. Resolution of the Government of the Russian Federation Article 5.1.4
    Health monitoring service (No323, 2004/06/30).
    State oversight includes the organization and conduct of inspections for compliance with the circulation of pharmaceuticals with requirements for the distribution, transportation, dispensing, sale of pharmaceuticals, and use of pharmaceuticals.

    2. Federal Law Regulations (#294-F3, 2008/12/26)
    It is about the protection of the rights of corporations and private companies in the implementation of state control (supervision) and local governments. Monitoring the integrity and quality of state supervision includes conducting inspections, identifying and eliminating violations of the applicant's rights, violating essential requirements, applying measures to contain the violation, and eliminating the consequences of such violations, reviewing, making decisions and preparing responses to the applicant's appeal.

    Therefore, if your company wants to distribute medicines in Russia, you must comply with the Drug Distribution Act and other relevant laws.


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Product license registration

    In order to register an import license, product registration must be preceded to the Russian Federation Health Supervisory Service (ROSZDRAVNADZOR). Product registration requires registration review and clinical trials conducted by the Federal Health Supervisory Service. The registration review is determined within the 210-day period excluding the clinical trial period, and document review, production process review, and sampling type test are required.

    In the case of clinical trials, the requirements for preclinical and clinical trials established by federal law of drug distribution and other regulatory laws of Russia must be complied. In accordance with Article 4, Paragraph 40 of the Drug Distribution Act (#61-FZ/2010.04.12), preclinical testing is defined as biological, microbiological, immunological, toxicological, physical testing, and stability testing of pharmaceuticals by other scientific evaluation methods. For clinical trials, this includes research into the diagnosis, treatment, prevention and pharmacological properties of a drug.

    This includes interactions with other pharmaceuticals and foods, not limited to processes such as absorption, allocation and transformation by scientific methods.


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Application for import permit

    After the drug is registered with the Federal Health Supervisory Service, you can apply for an import license, and all drug certifications that are initially registered are valid for five years. After that, upon renewal, the certificate of the approved drug is indefinitely valid.

    In addition to issuing a drug registration certificate, it is also necessary to obtain a Certificate of Conformity or a Declaration of Conformity according to Russian certification GOST R.


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Products subject to certification

    According to the legislation of the Russian Federation government (#982, 2009.12.01), the items that require certification are immunoglobulins, gamma globulin, serum, toxins, medical and veterinary vaccines. Items subject to the declaration of conformity include drugs, pharmaceutical chemicals, coenzymes, enzymes, amino acids, vitamins, organic products, and veterinary serum.

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Benefits of pharmaceutical certification: prospects of expanding Eurasian pharmaceutical certification

    Eurasian countries that require drug certification are expected to increase further. Currently, the member countries of the Eurasian Economic Union are in the process of forming a pharmaceutical market community as in the case of medical devices.

    ✦ On December 23, 2014, Russia, Belarus and Kazakhstan signed an agreement on common rules and principles for drug distribution within the EEC.

    ✦ and applied about 26 regulations including No. 78 Drug Registration Inspection Regulation (November 3, 2016) (Applicable date: 2017.05~)

    Therefore, the effectiveness and application of drug certification will be expanded.


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EAEU drug distribution regulation

    On May 5, 2017, the Eurasian Economic Commission announced that the 26-document EAEU drug distribution regulation came into effect on May 6, 2017. Transnational regulations apply to drug development, preclinical and clinical research, quality control, registration, production and distribution, while national regulations include preclinical and clinical trials, pricing, retail, public procurement, cost reimbursement, and advertising.

    There is a grace period until December 31, 2020, so if you need a registration certificate, you can choose between EAEU and national regulatory systems to apply. If applying for registration before December 31, 2018, EAEU manufacturers were required to submit according to the country-specific regulatory system instead of the EAEU GMP certificate. All drugs registered in accordance with the regulations prior to December 31, 2020 must be re-registered in accordance with the regulations of each market by December 31, 2025.


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IGC’s Competency

    ✥ IGC is providing certification services for medicines in cooperation with RUS-TEST PACIFIC, an Eurasian regional certification service provider.

    ✥ IGC auditors are contributing to the continuous development of customers by accurately evaluating the suitability through the technology and expertise accumulated over the years.

    ✥ IGC is a reliable global leader in Eurasian certification, providing certification for medical devices, cosmetics, food and EAC certification as well as pharmaceuticals.

    ✥ IGC has up-to-date knowledge of a wide range of specific scope and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operation.


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Related Services from IGC

  • 01System certification

  • 02Product certification (Europe, Eurasia, Americas, China, Southeast Asia)

  • 03Product test

  • 04Certification of audit qualifications

  • 05Professional manpower training