RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of August 31, 2023 No. 569

About state registration of dietary supplements to food

Based on Item 2-2 of the Presidential decree of the Republic of Belarus of May 12, 2017 No. 166 "About enhancement of special legal regime of the Chinese-Belarusian industrial Council of Ministers of the Republic of Belarus DECIDES: park "Great Stone"

1. Approve Regulations on procedure for state registration of dietary supplements to food of production of People's Republic of China it (is applied).

2. Make changes to the following resolutions of Council of Ministers of the Republic of Belarus:

2.1. add the Regulations on procedure for production and turnover of dietary supplements to food approved by the resolution of Council of Ministers of the Republic of Belarus of December 2, 2004 No. 1537, Item 5-1 of the following content:

"5-1. The appeal of the dietary supplements to food of production of People's Republic of China registered in People's Republic of China in the territory of the Republic of Belarus is allowed in the presence of their state registration.";

2.2. to add Item 9.5 of the single list of the ministerial procedures performed concerning subjects of the managing approved by the resolution of Council of Ministers of the Republic of Belarus of September 24, 2021 No. 548, with subitem 9.5.3 of the following content:

3. To the Ministry of Health to take measures for implementation of this resolution.

4. This resolution becomes effective since September 4, 2023.

Approved by the Resolution of Council of Ministers of the Republic of Belarus of August 31, 2023 No. 569

Regulations on procedure for state registration of dietary supplements to food of production of People's Republic of China

1. This Provision determines procedure of state registration of the dietary supplements to food (further, if is not determined other, – dietary supplement) productions of People's Republic of China (further – the People's Republic of China) registered in the People's Republic of China for the address in the territory of the Republic of Belarus.

2. State registration of dietary supplement is performed by the Ministry of Health before their release into the stream of commerce.

3. When carrying out state registration of dietary supplement by interested persons the legal entities of the Republic of Belarus with the location in the territory of the Chinese-Belarusian industrial park "Great Stone" acting as the representative as the manufacturer (producer) of person or the importer are (further – the interested person).

4. For carrying out state registration of dietary supplement the interested person represents:

the statement in form according to appendix;

notarially attested copy of the document of the authorized body confirming safety and official registration of dietary supplement in the People's Republic of China (further – the document on safety), containing data on the name dietary supplement, the manufacturer (producer) of dietary supplement, registration number, date of issue and effective period of the document on safety and also about the name of the authorized body which issued such document;

notarially attested translation on Belarusian or Russian of the document on safety.

5. State registration of dietary supplement is performed by entering of information about them into the Register of dietary supplement of production of the People's Republic of China registered in the People's Republic of China, who underwent state registration (further – the Register).

6. Effective period of state registration of dietary supplement is established for the entire period of action of the document on safety. After this term of the data on dietary supplement are excluded from the Register.

7. The document confirming entering of data into the Register is the statement from the Register issued by the Ministry of Health with indication of the name dietary supplement, the manufacturer (producer) of dietary supplement, the interested person, registration number, date of issue and effective period of the document on safety.

8. The organizational and technical works connected with documents acceptance, maintaining the Register, preparation of the statement from the Register are performed by public institution "Republican center of hygiene, epidemiology and public health".

9. The interested person bears responsibility for reliability of the data containing in the documents submitted for state registration of dietary supplement, and also for compliance of dietary supplement, which underwent state registration, to requirements of the legislation of the Republic of Belarus about sanitary and epidemiologic wellbeing of the population.

Appendix

to Regulations on procedure for state registration of dietary supplements to food of production of People's Republic of China

Form

Statement for state registration

The name of dietary supplement to _________________________ food

_____________________________________________________________________________

Name of the interested person ______________________________________

____________________________________________________________________________,

legal address ___________________________________________________________,

UNP ______________________________, _________________________________ phone,

________________________________________________________________________ fax

Name of the manufacturer (producer) _________________________________

____________________________________________________________________________,

legal address ___________________________________________________________,

place of implementation of production ______________________________________________

Are enclosed to the application:

_____________________________________________________________________________

_____________________________________________________________________________

In total it is provided documents and (or) data on ____ sheets.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info