Medicines and medicinal products – What does the term mean?
The world of pharmaceuticals is extremely complex, and their eligibility within legal frameworks is based on various regulations. The difference between prescription and over-the-counter medications not only affects the method of acquisition but fundamentally determines the safety and effectiveness of their use. The qualification and approval of medications are tied to strict procedures aimed at protecting public health and ensuring patient safety.
In addition to different types of medications, there are other products with less stringent regulations, such as dietary supplements, which also play a significant role in a health-conscious lifestyle. Laws are constantly changing, making it essential for patients and healthcare professionals to stay updated with the latest information in the field of pharmaceutical distribution.
These regulations govern not only medications but also various therapeutic products, dietary supplements, and other health-promoting items, thereby ensuring consumer protection.
Categories of Medications and Their Regulation
According to Hungarian legislation, medications can be divided into two fundamental categories: prescription (RX) and over-the-counter (OTC) medications. These categories not only define the method of purchase but also strictly regulate the safe application of medications. The use of prescription medications necessitates medical supervision, as they often come with more serious side effects or are subject to special application requirements.
Advertising prescription medications is prohibited, and the validity of prescriptions is generally 90 days, which can be extended in certain cases. Health insurance support also plays a significant role in this category, as most prescription medications may be associated with some form of support, while over-the-counter products generally do not enjoy such benefits.
In classifying medications, the National Public Health and Medical Officer Service (NNGYK) has also created various subcategories that contain additional regulations regarding the prescription of medications. These include products that pose an immediate danger, medications classified as narcotics, and medications that require a specialist’s prescription, which are subject to stricter controls.
Dietary Supplements and Other Health-Promoting Products
The approval of dietary supplements is also conducted by the NNGYK; however, these products fall under different regulations than medications. The notification of the distribution of dietary supplements is mandatory, but the process does not require as strict evidence as in the case of medications. During distribution, authorities primarily examine whether the products do not cause health damage.
The boundary between dietary supplements and functional foods is also blurred, as functional foods are natural foods that provide additional health benefits. These may contain vitamins, minerals, and aim to support health maintenance and disease prevention. For example, probiotic yogurts or iodized salts can be useful supplements in everyday nutrition.
The oversight of dietary supplements falls under the responsibility of public health authorities, which ensure that these products comply with relevant regulations. The sale and advertising within the legal framework are under strict supervision to ensure that consumer protection is always guaranteed.
Homeopathic and Traditional Herbal Medicines
The approval process for homeopathic and traditional herbal medicines is relatively simplified, yet they also fall into the category of medications. For traditional herbal medicines, authorities expect a minimum of 30 years of application history, of which 15 years must have occurred within the European Economic Area (EEA). Proof of the medicinal effect of these medicines is not required as long as they are included on the relevant list of the European Medicines Agency.
During the distribution of traditional herbal medicines, the label must clearly indicate that the product is intended for traditional use, meaning that no direct efficacy studies are available. Homeopathic preparations are also included among traditional medicines and can be used under strict regulations.
In the world of medications and other health-promoting products, compliance with regulations is fundamentally important for consumers to feel safe when using these products. Continuously monitoring the changing legal environment is essential to make informed decisions regarding our health based on the latest information.
