Клинические исследования в Беларуси: что изменилось?
Компания «ФармАссистенс» приглашает на онлайн-вебинар о том, how clinical trials are currently conducted in Belarus.

15-16 September, the annual business conference 103DAY was successfully held at the Renaissance Hotel in Minsk 2025, bringing together key players in the medical market, pharmaceuticals, pharmacy chains and beauty industry

Recently, PharmAssistance LLC held a closed meeting with experts from the Ministry of Health of the Republic of Belarus. This allowed us to gain direct access to the regulator's plans and be the first to hear, what steps the market expects in the near future. We share with you the most important things.

Dear partners and colleagues, We are pleased to invite you to a webinar on the topic: "Key changes 2023 and trends 2024 in the pharmaceutical industry", which is organized and conducted jointly with REVERA law group. The webinar will take place 21 February 2024 with 10:00 to 11:30. The topic of our report: Major changes in legislation in the field of drug registration. funds in 2023 – has it become easier? Expectations in […]

Pharmaceuticals company was founded in 2012 year as a full-cycle contract research organization (KIO). We provide clinical research services, registration of medicinal products, medical products and dietary supplements, as well as in the field of pharmacovigilance. 7 August 2021 the company turned one year old 9 years! Over the years of operation, the Pharmasistens company has established itself, as a reliable and stable partner. We are not […]

When registering dietary supplements, the commission pays an important role to packaging and packaging materials. What are the requirements for the design of packaging for dietary supplements?? What will specialists pay attention to when registering and consumers when purchasing??There are several mandatory requirements. Failure to do so means a failed registration attempt.. The packaging must indicate in Russian, that the dietary supplement is not a drug, All components are listed in descending order. If the dietary supplement contains nutrients, it is necessary to indicate their content in absolute terms and as a percentage of the recommended daily intake. Directions for use, dosage, indications for use and contraindications for use of the supplement. Basic requirements for component composition, Possibility of use by different population groups, the need for special inscriptions is specified in TR TS021/2011 and TR TS 022/2011. That's all?No. Besides, date of manufacture must be indicated, storage conditions and expiration dates. Please note, that there must be information about state registration indicating the details of the document and its date of issue. And manufacturer's contact information. Be sure to include company contact information, which is responsible for consumer complaints. What are the most common mistakes in preparing packaging??Очень частой ошибкой становится помещение на упаковку фразы «экологически чистый продукт». Это ошибка – для характеристики пищевых продуктов такой термин не применяется. Еще одно важное замечание, which is often ignored by manufacturers - it is not allowed to include information on the label of a dietary supplement about, that the product is of natural origin, because this fact does not guarantee high quality, nor safety for humans. If the additive has been tested and registered, Means, it is recommended for sale?Такие сведения запрещено публиковать на упаковке. Несмотря на положительное решение относительно регистрации, It is prohibited to indicate the recommendations of the Ministry of Health. But some excerpts from official documents should be?Yes, the text of the label on the package regarding “indications for use” must fully comply with the content of the same paragraph in the registration document. You will find basic recommendations for developing a layout in TR CU 022/2011. Thus, packaging must contain only those data, which you listed and, we see, some information about the beneficial properties of the supplement?In no case: placing on the label information about the special beneficial properties of the additive, равно как и о полном отсутствии у нее побочных эффектов не допускается. Были случаи, when the packaging indicated the possibility of replacing the additive with specific therapy in case of human illness or other information, which may mislead the consumer regarding the properties and effectiveness of the dietary supplement. Instructions for use should not contain explicit medical recommendations., Dietary supplements can only contribute, improve, be recommended, […]

Dear friends! With this material we begin a series of publications, where PharmAssistance specialists will share their experience with you. Registration of medicines, dietary supplements, medical equipment 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, avoid pitfalls, 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. To be in full control of the situation and understand these changes, undoubtedly, it is necessary to understand the basics of legislation, clearly understand the prescription of drugs. We asked a consultant from a specialist from the PharmAssistance group to answer the editor’s questions. First Name Last Name What are dietary supplements, what is their function?Biologically active food additives are natural or identical to natural biologically active substances. Available in various pharmaceutical forms – extracts, infusions, balms, powders, syrups, tablets - they are intended to be consumed simultaneously with food or to be included in food products, drinks. Dietary supplements are animal sources, plant and mineral components, which are essential nutrients. A number of components of dietary supplements can be of biotechnological or chemical origin. However, they must be allowed for consumption. Dietary supplements are used to replenish vital substances in the daily diet, increasing the adaptive and immune capabilities of the body, improving carbohydrate, fatty, protein, vitamin metabolism. Besides, they can provide restorative, tonic, calming effects, contribute to the normalization of the microflora of the gastrointestinal tract, remove harmful substances from the body. Stimulation of universal adaptive and adaptive functions of the body under the influence of external and internal factors, without disturbing the functioning parameters of human physiological systems is another important property of dietary supplements. When did the definition of “biologically active food additive” 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 food additives”published in 1999. By this time, there was a need to form a legislative framework for dietary supplements. Over the past 21 years, this base has been improved, and the requirements, requirements for additives, grew. Can dietary supplements replace drug therapy?? Are they an alternative to medications??Biologically active food supplements can also be used for various diseases, but necessarily along with the use of specific therapy and only as components of a therapeutic diet, but in no case as a medicine, which they are not by definition. Supplements help shorten the duration of illness, speed up recovery, avoid some complications, transition of the disease to the chronic stage, reduce the volume of specific chemotherapy. However, it is necessary to take into account the compatibility of the composition of dietary supplements with drugs during their complex use in order to avoid possible negative effects on the absorption and use of drugs by the body, 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 circulation 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 after 2000. There are also methodological instructions “The procedure for organizing control over the production and circulation of biologically active food additives.” It is expected that the guidelines “Determining the safety and effectiveness of biologically active food additives” will be revised. Mandatory availability of a Certificate of Hygienic Registration, which extends to the territory of the customs union (Belarus, Russia, Armenia, Kazakhstan, Kyrgyzstan).Does it make sense to seek help from expert groups?, such as "PharmAssistance", on registration of dietary supplements?Number of failed registration attempts, and also time, strength and financial investments, which is required for self-registration, speak in favor of turning to experts. We went through the registration process multiple times, experience has been accumulated over the years, which helps to avoid standard mistakes and find optimal ways to solve non-standard problems. AND, Certainly, cooperation with professionals will minimize the financial side, save valuable time.

24 February, a joint webinar will be held between REVERA lawyers and PharmAssistance experts on registration of medicines in the new conditions. Information partner – leading Belarusian medical platform 103.by. At the webinar we will analyze the legal and practical aspects of registration of medicines in Belarus and the EAEU. Participation in the event will be useful for representatives of pharmaceutical companies, who want to receive complete qualified information, […]

Board of the Eurasian Economic Commission, Pharmacopoeia of the Eurasian Economic Union approved, which will begin to operate from 1 March 2021 of the year. (https://rceth.by/ )