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Petras K.J.,Belupo d.d. | Cvek J.,Agencija za Lijekove i Medicinske Proizvode | Kalodera Z.,University of Zagreb
Farmaceutski Glasnik

Given that herbal products can have medical, food (nutritional) and cosmetic purposes, the aim of this paper is to show the complexity of their regulatory classification into groups, and the importance of setting harmonized legal framework. Many herbal products due to their characteristics belong to various regulatory groups so we consider them to be herbal borderline products. Both at European and national level, there are still no clear standards or equal access to herbal products and their classification is not unambiguous since there is still no harmonized legal framework that would allow the same criteria for herbal borderline products. In this paper the examples of classification for some herbal borderline products are shown: herbal medicine - food supplement, herbal medicine - medical device. Also, this paper points out the importance of implementing a harmonized approach to herbal borderline products, so that all of them are released to the market having proven quality and safety for a presented purpose. It can be concluded that since a particular herbal product can be found on the EU market registered in various regulatory groups there is a need for adoption of harmonized legal framework for borderline products on European Union level. Harmonized legal framework for borderline products would define common criteria for classification and therefore facilitate the registration of borderline products. Also, only products of acceptable quality, safety and purpose would be available to consumers and patients. Source

Cogelja Cajo G.,Agencija za Lijekove i Medicinske Proizvode | Cogelja Cajo G.,Agency for Medicinal Products and Medical Devices | Osrecki V.,Agencija za Lijekove i Medicinske Proizvode | Osrecki V.,Agency for Medicinal Products and Medical Devices | And 2 more authors.
Kemija u industriji/Journal of Chemists and Chemical Engineers

Pharmaceuticals are a class of emerging environmental contaminants that are extensively and increasingly being used in human and veterinary medicine and are released continuously into the environment. A variety of pharmaceuticals have been detected in many environmental samples worldwide. The establishment of chemical analysis methods able to determine more polar compounds allow the determination and identification of trace quantities of drugs and their metabolites. Most regulatory agencies require that environmental risk assessment is performed as an integral part of their approval procedures for the marketing for medicinal products. Marketing approval for medicinal products in the European Union is regulated by the Directive 2001/83/EC. Based on the Directive, the European Medicines Agency (EMA) has published guidelines describing the procedure for the environmental risk assessment for medicinal products marketed in the EU. The requirements for the Environmental risk assessment (ERA) in Croatia are regulated by the Medicinal Products Act (Official Gazette No. 71/07) and the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 113/08). Source

Cvek J.,Agencija za Lijekove i Medicinske Proizvode | Balazin A.,Agencija za Lijekove i Medicinske Proizvode | Tomic S.,Agencija za Lijekove i Medicinske Proizvode
Kemija u industriji/Journal of Chemists and Chemical Engineers

Herbal medicines are traditionally considered natural and therefore safe products, but their increased consumption also increases the potential risk of interactions with conventional medicines and adverse reactions. Adverse reactions of herbal medicinal products may also occur because of the innate herbal toxicity, biological or chemical impurity of the raw herb, misrecognition and substitution with toxic herbal species or counterfeiting using cheaper substances or undeclared synthetic pharmacologically active substances. Numerous interactions of herbal and conventional medicines have been recorded, but for many of them the exact underlying pharmacological mechanisms have not been studied well nor has their clinical significance been established. Some of the better-known interactions are the ones in which the herbal medicine, such as St. John's wort, induces the hepatic enzyme CYP system responsible for metabolic transformation of many drugs, and therefore causing potentially serious and clinically relevant adverse reactions. For example, this type of interaction between St. John's wort and an immunosuppressant can lead to a decrease in the mass fraction of the immunosuppressant with consequent transplant rejection. For many of the widely used herbal medicinal products, e.g. Ginkgo, possible interactions can be expected based on published case reports. An example of a recommendation derived from case reports is the one by which the concomitant administration of Ginkgo and anticoagulant drugs (acetylsalicylic acid, warfarin) should be avoided due to increased risk of bleeding. For a relatively small number of herbal medicinal products the active principles and mechanisms of action are known and can therefore be used to predict possible interactions with other medicines. For example, hydroxyanthracene derivatives of Senna, along with other effects, can cause electrolyte excretion that can lead to toxic effect of cardiac glycosides, antiarithmics and potassium depleting drugs (e.g. non-potassium sparing diuretics). In the conditions of the ever-increasing consumption of herbal medicines, it is necessary to increase the level of consciousness and knowledge of interactions between herbal and conventional medicines in order to minimize the risk of interactions and consequential development of adverse reactions. In addition, it is of great importance to report all suspected adverse reactions to herbal medicinal products, as well as interactions and ineffectiveness, to the competent authority in order to contribute to the better understanding of the effectiveness and safety profile of a particular herbal medicinal product. Source

Tomic S.,Agencija za Lijekove i Medicinske Proizvode | Milcic N.,Agencija za Lijekove i Medicinske Proizvode | Sokolic M.,Agencija za Lijekove i Medicinske Proizvode | Sucic A.F.,Agencija za Lijekove i Medicinske Proizvode | Martinac A.I.,Agencija za Lijekove i Medicinske Proizvode
Lijecnicki Vjesnik

Counterfeit medicines are a growing problem in the world, for their use may endanger patient's health and therefore they pose an enormous public health risk. The manufacture of counterfeit medicines usually involves organised crime groups which place the counterfeit medicines on the market for reasons of profit. Detection and prevention of trade in counterfeit medicines requires close cooperation between medicine regulatory authorities, police, customs, judiciary and pharmaceutical industry. To this day, there have been no recorded cases of counterfeit medicines in the legal supply chain in Croatia. However, medicines without marketing authorisation in Croatia, originating from different countries, could be found on the illegal market. Most frequently, this includes medicines for the treatment of erectile dysfunction such as: sildenafil, tadalafil, vardenafil. In this study, 26 medicines for the treatment of erectile dysfunction, seized in illegal supply chain, were tested. High performance liquid chromatography (HPLC) was used for identification and quantification of active substances in the tested samples. It was determined that 13 out of 26 samples did not comply with declared composition of medicine and quality specification. Furthermore, two samples did not contain declared active substance vardenafil and that may indicate that these medicines are counterfeit. Source

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