State registration of dietary supplements. 

Biologically active additives (BAA) are subject to mandatory state registrationon the territory of the Russian Federationand the Customs Union (CU). We will help you get the certificate of state registration (PDS) in Rospotrebnadzoror in the Ministry of Health of the Republic of Kazakhstan.

We have a lot of experience, which helps to solve the situation of any level of complexity in this area. In principle, the procedure for obtaining the PDS is very simple. The applicant brings a set of documents in 2 copiesand product samples. One set of documents with samplesis sent to the competent testing centers (depending on the composition of dietary supplements can vary).

The testing laboratory on the basis of testing and analysis and received documents, prepares expert opinion (it usually takes a month). After receiving the second set of documents they are sent to the Federal Service of the Russian Federation (or in specialized units of the Ministry of Health of the Republic of Belarus or Kazakhstan), which after 30 days, issue the PDS. After that, turn BUD in the CU becomes legal.

 

For the PDS, they will need the following documents:

1. If dietary supplements are manufactured in the territory of the CU.

  1. If the registration takes no manufacturer companyand the reseller / dealer (will continue to own the PDS), you will need authorization from the manufacturerwith the right authority to third parties to carry out the procedure of state registration.

  2. Copies of the documentsin accordance with dietary supplements made. - Usually a TU (preferred), GOST, TI, specification and another documents.

  3. Receipt / Composition.

  4. Declaration about the as part of the GMO / GMI,nanomaterials, hormones and pesticides.

  5. Labels layout.

  6. The act of sampling.

  7. Test reports.

  8. Copying from ‘’ЕГРЮЛor ЕГРИП ‘’.

  9. In certain cases data may be required from clinical trials, bibliography, research papers, etc.

 

2. If dietary supplements are manufactured outside the vehicle.

  1. If the registration takes no manufacturer companyand the reseller / dealer (will continue to own the PDS), you will need authorization from the manufacturerwith the right authority to third parties to carry out the procedure of state registration. Documents are accepted only in Russian, therefore need to be translated, notarized (apostille is not required!).

  2. A copy of the contract for the supply of the territory of the Customs Union.

  3. Receipt / Composition.

  4. Documents confirming the high level of production - ISO, GMP, HACCP and others.

  5. Documents confirming the legitimacy of the legal entity / the manufacturer. Extracts from the local court,information that an entity is a VAT payer, extract from the local Chamber of Commerce and others depending on what is customary in this country.

  6. Declaration about the as part of the GMO / GMI,nanomaterials, hormones and pesticides.

  7. If the activity for the production of dietary supplementsin the country of production is allowed with the relevant authorities (permission from the Ministry of Health).

  8. Technological instruction / production scheme

  9. Labels layout.

  10. In certain cases data may be required from clinical trials, bibliography, research papers, etc.

  11. The act of sampling (it is difficult to explain this document to foreigners, but our bodies get used to it and it is easier to provide).

  12. Documents confirming the quality of dietary supplements produced (laboratory data of the manufacturer).

  13. If the product is already registered in the territory of the production - the documents confirming its registration.

  14. Copies of the documents confirming import of samples in the CU *

    * Note – until the middle of 2015 the state authorities demanded the presenting of the air waybill with the customs service stamp “import allowed”, but now these marks are not put on the import of dietary supplements, since the Decision of the Council the Eurasian Economic Commission № 78 dated September 18, 2014 “About modification in Part II of the Single List of goods subject to sanitary-and-epidemiologic supervision (control) at the customs border and customs territory of the Customs Union, due the come into force the technical regulations of the Customs Union” came into force (view the document), actual the source Unified list which was changed (view the document). With these changes some part of the goods that were passing SQC (sanitary and quarantine control) previously now are excluded, therefore the marks are not put now. It should be noted that in addition to dietary supplements (group 2106) groups 02, 04, 07-09, 11-13, 15, 17-20, 22, 23, 30, 44, 45, 56, 61, 62, 70, 76, 1601, 1602, 1603, 2101, 2102, 2103, 2105 and others don’t require the SQC.

 

The authorities governing the BAA turnover on the territory of the customs Union Countries (TC) (as on November 2014):

The Euroasian economic commission   http://www.eurasiancommission.org/

The Federal service of the Russian Federation  http://www.rospotrebnadzor.ru/

The Ministry of Health of the Republic of Belarus   http://minzdrav.gov.by/

The Ministry of national economy of the Republic of Kazakhstan. The Committee on consumer protection   http://azpprk.kz/

 

The main documents regulating the market BAA in the Territory of the Customs Union

 

1. Main document - ТР ТС 021/2011 About food safety. link

See as:

  • Commission Decision of the Customs Union number 880 from December 9, 2011 "On the adoption of technical regulations of the Customs Union" On food safety "

  • Decision of the Customs Union on amendments from June 11, 2013 № 129

  • Decision of the Customs Union on amendments from June 25, 2013 № 147

  • The list of standards , as a result of which, on a voluntary basis, compliance with the technical regulations of the Customs Union "On food safety" (TR CU - 021 - 2011).

  • The list of standards containing rules and methods of researches (tests) and measurements, including the rules of sampling required for the application and enforcement of the requirements of technical regulations "On food safety" (TR CU - 021 - 2011) and implementation of assessment (confirmation) conformity of the product.

  • Plan activities necessary for the implementation of technical regulations.

 

2. The unified list of goods subject to sanitary and epidemiological supervision (control) at the customs border and customs territory of the Customs Union. link

 

3. The uniform sanitary-and-epidemiologic and hygienic requirements to the goods which are subject to sanitary-and-epidemiologic supervision (control). link

 

It would be desirable to pay your attention that now there is active completion of ТР ТС 021/2011. Therefore at registration BAA is better to be guided including on requests which will appear in this document the next two years.

At registration BAA in territory of the Russian Federation including are used MP 2.3.1.2432-08.  link

About the designation on the certificate of the state registration of the conditions of selling of dietary supplements link

 

On the territory of the Russian Federation officials can refer to the following documents because formally they have not been canceled:

  • The decree of the Main state health officer of the Russian Federation from 17.04.03 №50 by which sanitary-and-epidemiologic rules and specifications are installed; SanPiN 2.3.2.1290-03 "Hygienic requirements to the organization of production and turnover of biologically active food additives (BAA)". link

  • The decree of the Main state health officer of the Russian Federation from 15.08.03 №146 "On the sanitary-epidemiological examination of biologically active additives".

  • Guidelines MUK 2.3.2.721-98 2.3.2. "Food and food additives. Determining the safety and efficacy of biologically active additives to food" (appr. Chief state sanitary doctor of the Russian Federation 15.10.98 (it is confirmed by the main state health officer of the Russian Federation 15.10.98)

 

"Register of dietary supplements" - check whether the supplements registered in the territory of the Customs Union is possible here:

  • Registries Rospotrebnadzor and sanitary-epidemiological service of Russia doc ico

  • Unified Register of state registration certificate of the Customs Union on the website of the Economic Commission Evraziskoy doc ico

Register of certificates of State Product Registration of Republic of Kazakhstan doc ico