The definitions are not easy, but the differences between the products are very significant.
Dietary supplement
It is a product that is composed of nutrients and is regarded as a supplement to a proper diet. It is a concentrated source of vitamins, minerals or other substances. It can be in the form of tablets, capsules, powders or liquids.
Supplements are most often sold in pharmacies or drugstores combined with pharmacies, which may mislead the patient that it is a form of the drug. In the light of European Union legislation, dietary supplements were not and are not treated like drugs! In Poland, the approval of dietary supplements is handled by the Chief Sanitary Inspector and its subordinate offices (not the Chief Pharmaceutical Inspector and the Office for Registration of Medicines and Biocidal Products).
The purpose of using dietary supplements is not to treat disease. They are primarily intended for healthy people. Dietary supplements can reduce the effects of these risk factors, which affect them every day and can make you sick.
We may not find any indications for use on the supplement’s leaflet
Źródło: Krajowa Rada Suplementów i Odżywek (www.krsio.pl)
Lek
A drug, and more precisely a medicinal product, in accordance with the Act of September 6, 2001 Pharmaceutical Law, “is a substance or mixture of substances presented as having properties of preventing or treating diseases occurring in humans or animals, or administered to make a diagnosis or to restore, improve or modify the physiological functions of the body through pharmacological, immunological action. or metabolic ».
Drugs can be:
- issued only on prescription (RX), i.e. on prescription,
- without a prescription (OTC, Over The Counter), i.e. issued without a prescription.
The distinguishing feature of drugs is the tedious and complicated process of introducing them to the market. It requires years of work, a huge amount of documentation and approval by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB).
Leki są monitorowane przez Państwową Inspekcję Farmaceutyczną (jej pracami kieruje Główny Inspektor Farmaceutyczny), która odpowiada za wycofanie preparatu z rynku, gdy stwierdzono nieprawidłowości. Lek bardzo trudno rozpoznać po opakowaniu, ale musimy wiedzieć, że na opakowaniu leku znajduje się napis «produkt leczniczy» oraz numer pozwolenia na dopuszczenie leku do obrotu. Opakowanie zawiera również ulotkę, która musi zawierać informacje o wskazaniach, przeciwwskazaniach, ostrzeżeniach i skutkach ubocznych.
The drug cannot be recommended by a well-known person, scientist or a person with medical education. Prescription drugs cannot be advertised in Poland at all. All advertised drugs are over the counter. In an advertisement on TV and radio, you will recognize the medicine by the formula known to everyone “Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage as well as information on the use of the medicinal product, or consult a doctor or pharmacist, as each drug used improperly is a threat to your life or health”.
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Medical component
The definition is very broad and it does not only apply to what we are going to eat. Tools, appliances, devices, software, materials and other articles which are used to diagnose, prevent, monitor, treat or alleviate a disease can be considered a medical device; diagnosing, monitoring, treating, alleviating or compensating for an injury or handicap; investigating, replacing or modifying an anatomical structure or a physiological process; birth control », assuming that this effect is not achieved by pharmacological, immunological or metabolic agents, although they may be used as an auxiliary (Act of May 20, 2010 on medical devices).
Traditionally, this category includes plasters, dressings, diagnostic tests and medical equipment. Increasingly, the term medical device refers to capsules, tablets and syrups. Medical devices are something between a drug and a dietary supplement – their effects can be therapeutic, but only to a limited extent, and their introduction to the market is relatively easy. The Chief Pharmaceutical Inspector and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products are responsible for the safety, effectiveness and quality of medical devices.
How to assess whether we are dealing with a medical device? The sign is the confirmation CE (European Conformity) at the label. In an advertisement for a medical device, you can see the doctor’s opinion, as there is no legal regulation in this matter.
Source: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (www.urpl.gov.pl)
Dietary food for special medical purposes
These are products that are characterized by a special composition or method of preparation and are used to meet specific nutritional needs (Act of August 25, 2006 on food and nutrition safety).
Until recently, they were simply substitute milk and infant formula, recently it only includes nutritional supplements that can supplement or replace the diet. A characteristic feature of these products is a specific target group – e.g. infants, people with specific diseases, pregnant women. Dietary foods for special medical purposes must be substantiated by scientific research (quite contrary to dietary supplements). In addition to national guidelines, these preparations must take into account EU directives that define what information must be included on the product label (including energy and nutritional value, the amount of individual ingredients). On the packaging, we should look for the word “for dietary management” and information that it should be consumed under medical supervision!
On both, the bar code starts with the numbers 590 (for preparations made in Poland). In the case of an over-the-counter drug, the code shows the numbers 9990. However, in dietary supplements, this sequence is missing.
The text comes from: doktorekradzi.pl
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