Dietary supplements in Belarus: briefly about the most important

Dietary supplements are widespread on the Belarusian market with high requirements imposed on them, as their use has an impact on human health. 

In this regard, it is particularly important to comply with the statutory requirements for the production, sale and advertising of dietary supplements.

Let us consider the main aspects in the regulation of dietary supplements in Belarus.

Production

The following requirements should be complied with the production of dietary supplements:

  1. production should be carried out after the state registration has taken place;
     
  2. production should be organised in accordance with sanitary norms and regulations in the field of quality assurance and product safety;
     
  3. all operations of the technological process of production of dietary supplements should be carried out in premises and on equipment specially designed for these purposes, controlled with the use of appropriate devices;
     
  4. personnel involved in production must get a medical checkup, receive hygiene training, and observe the rules of personal hygiene.

Labeling

Labeling of dietary supplements should be complied with the requirements of the legislation of both the EAEU (TR CU 022/2011, Decision of the Customs Union Commission No. 299 of 28.05.2010) and Belarus (Decision of the Council of Ministers No. 1537 of 02.12.2004).

Basic rules of labelling of dietary supplements are the following:

  1. it is forbidden to specify medical indications of dietary supplements, as well as to claim that dietary supplements have therapeutic properties and (or) are medicines;
     
  2. the package should contain the name, composition, date of manufacture, expiry date, storage conditions, recommendations and (or) restrictions on the use of dietary supplements;
     
  3. the labeling should be complied with the requirements for the colour and size of the font used for inscriptions.
    For example, the colour of the background should contrast with the colour of the information printed on it, the name and composition of the dietary supplement should be indicated in a font at least 2 mm high;
     
  4. if necessary, the package should be labeled with warning notices. For example, if a dietary supplement contains certain colouring agents, the package should contain the following warning notices: «Contains colouring agent(s) that may have a negative effect on the activity and attention of children».

Selling

The selling (circulation) of dietary supplements is permitted only if they are state-registered. 

When selling dietary supplements in bulk, each batch of dietary supplements should be accompanied by copies of documents confirming their quality and safety.

When selling dietary supplements, attention should be paid to the following aspects:

1. Place of sale of dietary supplements.

  • only pharmacies are permitted to sell dietary supplements used to maintain the functional activity of the organism within physiological limits (i.e. containing vitamins, trace elements, minerals, amino acids, etc.);
     
  • dietary supplements used to fortify human food (i.e. containing additional sources of proteins, fats, carbohydrates, dietary fibre) are permitted to be sold in specially designated places in shops.

2. Distance selling of dietary supplements.

The terms and conditions of distance selling of dietary supplements differ depending on the type of dietary supplement.

  • distance selling of dietary supplements used to maintain the functional activity of the organism within physiological limits is prohibited;
     
  • distance selling of dietary supplements used to fortify human food is allowed only under the following conditions:
     
    1. if the seller has a trading facility and (or) storage premises where such dietary supplements are sold and (or) stored, as well as 
       
    2. where the seller is a manufacturer of such dietary supplements regardless of whether it has a trading facility and (or) storage premises.

Important!
A draft ordinance has been developed by MART that would permit the distance selling of dietary supplements used to maintain the functional activity of the organism within physiological limits.

However, as of September 2023, these changes have not been adopted.

Advertising

Only state-registered dietary supplements may be advertised.

When advertising dietary supplements you should pay attention to the following rules:

1. Approval of advertising with the Ministry of Health.

It is prohibited to place advertisements of dietary supplements without the approval of the Ministry of Health.

No approval is required for outdoor and vehicle advertising.

To obtain approval it is necessary to submit the following documents to the Republican Unitary Enterprise  «Centre for Expertise and Tests in Health Service»: 

  • application;
  • a document confirming the payment of the fee;
  • samples of advertising materials;
  • copies of documents confirming the advertising authenticity;
  • consumer labeling samples.
     

Term for obtaining approval: 15 days, and in case of sending advertising materials for expertise - 1 month.

Approval validity period: 1 year.

The service is chargeable and you can view the price list here.

2.    Requirements for advertising of dietary supplements.

Advertisements for dietary supplements should contain:

  1. an indication that this information is of an advertising nature;
  2. the name of the dietary supplement, as well as the manufacturer of the dietary supplement;
  3. information that the object of advertising is a dietary supplement, is not a drug, is not intended for the treatment of diseases;
  4. information on medical contraindications to its use and adverse reactions (if any);
  5. information on the need to familiarise with the recommendations on the use of dietary supplements.
     

Advertisements for dietary supplements should not contain:

  • statements or assumptions that consumers of the advertisement have certain conditions that require the use of dietary supplements, or statements that give a healthy person the impression of the need to use dietary supplements;

A sign of violation of this prohibition is a direct address to the consumer of advertising using the phrases "You", "We", "your". For example, "Are you tired of pain?", "Do you have a cough?". 
 

  • indicating the possibility of receiving any form of financial incentive, except for discounts, in case of purchase of dietary supplements;


Financial incentives are defined as:

  1. receiving a gift for the purchase;
  2. provision of the service free of charge for the purchase of dietary supplements.
     
  • information that does not correspond to the information contained on the consumer label of the dietary supplement;
     
  • information on medical indications for the use of advertised dietary supplements, including therapeutic properties and (or) influence on the speed and degree of human recovery;

In practice, this prohibition is most often violated.

Please note that when advertising it is not allowed:

  1. to use the phrases "sore throat", "runny nose", "cold", as they are considered a health disorder and qualifies as a disease;
  2. to use the phrases "improves sleep, appetite, vision", "normalises microflora", "restores joint mobility", as they are qualified as medical indications for use.

Joint advertising of dietary supplements and medicines is also not allowed. For example, it is not allowed to mention vitamins to improve eyesight when advertising eye drops.

  • others.
     

The full list of prohibitions is specified in the Law of 10.05.2007 No. 225-Z «On Advertising», as well as the Resolution of the Ministry of Health of 23.07.2013 No. 63.

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