Dear friends! With this material we begin a series of publications, where PharmAssistance specialists will be
share my experience with you. Registration of medicines, dietary supplements, medics
Russian technology is very painstaking work, getting started, advice from professionals will never hurt
, working in this field for many years. The “Our Experience” section will allow you to avoid many difficulties, get around
"underwater rocks", acquire new knowledge, gain a general understanding of all processes. Good luck!
Requirements for registration of dietary supplements change several times a year., are becoming tougher. So that
You are in full control of the situation and understand these changes, undoubtedly, need to understand
basics of legislation, clearly understand the prescription of drugs. Answer questions from the editors
We asked a consultant from a specialist from the PharmAssistance group. First name Last name
What are dietary supplements, what is their function?
Biologically active food additives are natural or identical to natural biological
Yes active substances. Available in various pharmaceutical forms – extracts, infusions, balsa
We, powders, syrups, tablets - they are intended to be consumed simultaneously with food or to include
inclusion in food products, drinks. Biologically
active supplements are animal sources, plant and mineral components, which regarding
supply of essential nutrients. A number of components of dietary supplements can be biotechnical
biological or chemical origin. However, they must be allowed for consumption
nuyu.
Dietary supplements are used to replenish vital substances in the daily diet
V, increasing the adaptive and immune capabilities of the body, improving carbohydrate, fatty, proteinog
about, vitamin metabolism. Besides, they can provide restorative, tonic, calm down
action, contribute to the normalization of gastrointestinal microflora-
intestinal tract, remove harmful substances from the body.
Stimulation of universal adaptive and adaptive functions of the body under exposure conditions
external and internal factors, without disturbing the functioning parameters of physiological systems
human system – another important property of dietary supplements.
When did the definition of “biologically active food supplement” appear in Belarus??
This concept was defined by the order of the Ministry of Health
“On approval of the Regulations on the procedure for state hygienic registration of biologically active drugs
food supplements”
published in 1999. By this time, there was a need to form a legislative framework for
iologically active additives. Over the past 21 years, this base has been improved, and the requirements, present
to supplements, grew.
Can dietary supplements replace drug therapy?? Are they an alternative
medicines?
Biologically active food supplements can also be used for various diseases, but definitely
along with the use of specific therapy and only as components of a therapeutic diet, but not in which
in this case not as a medicine, which they are not by definition. Supplements help reduce
reduce the duration of illness, speed up recovery, avoid some complications, crossing the fence
Levania into the chronic stage, reduce the volume of specific chemotherapy. However, it is necessary

o take into account the compatibility of the composition of dietary supplements with drugs during and
x complex use to avoid possible negative effects on absorption and used
by the body as medicines, and the components of the supplement itself. The same applies to food.
, the composition of which can both increase, and reduce the effectiveness of chemotherapy with different diets.
Besides, The timing of taking medications and food is also important.
What documents regulate the turnover of dietary supplements??
“Hygienic requirements and nutritional value of food products”, having two additions,
“Guide to methods of quality control and safety of biologically active food additives”,
“Hygienic requirements for the organization of production and circulation of biologically active food additives”,
"Recommended levels of consumption of nutritional and biologically active substances." These documents were published according to
after 2000.
There are also methodological instructions “The procedure for organizing control over the production and turnover of biol
ogically active food additives." It is expected that the guidelines “Definition of safe
"Authority and effectiveness of biologically active food additives".
Mandatory presence of a Certificate of Hygienic Registration, which extends to the territory
customs union (Belarus, Russia, Armenia, Kazakhstan, Kyrgyzstan).
Does it make sense to seek help from expert groups?, such as "PharmAssistance", regarding registry issues
Istrations of dietary supplements?
Number of failed registration attempts, and also time, strength and financial investments, which is necessary
we at self-registration, speak in favor of turning to experts. We have passed through many times
registration process, experience has been accumulated over the years, which helps to avoid standard errors and find optimal
small ways to solve non-standard problems. AND, Certainly, cooperation with professionals will allow minimal
organize the financial side, save valuable time.