Wholesale of active ingredients
An active ingredient is any substance or a mixture of substances intended for use in the production of medicinal products which in the production procedure becomes an active ingredient of a medicinal product whose purpose is pharmacological, immunological or metabolic effect in order to re-establish, improve or change physiological functions or to determine a diagnosis.
A business entity engaged in the wholesale of active ingredients and is entered in the registry of wholesalers of active ingredients is a wholesaler of active ingredients. A wholesaler of active ingredients performs its activity in accordance with the guidelines and principles of good distribution practice for active ingredients.
A wholesaler of active ingredients must meet the following conditions:
- employ an adequate number of experts with adequate education, considering the scope and complexity of wholesaling active ingredients;
- have adequate premises, devices and equipment for the storage and transport of active ingredients in accordance with the guidelines and principles of good distribution practice for active ingredients;
- perform the activity in accordance with the guidelines and principles of good distribution practice for active ingredients.
Conditions and evidence
- Status and registration The entry in the register of substances wholesalers Informing about counterfeits or suspected counterfeiting of substances Verification of the suitability of providers of substances Compulsory management of information on merchandise Establishment of working hours Minimum technical conditions in specially arranged room in a wholesale outlet Regular certification of metering devices
- Medicinal Products Act
- Rules on detailed conditions of wholesale of medicinal products and determining of fulfilment of these conditions and procedure of gain the permission for traffic of wholesale of medicinal products
- Trade Act
- Metrology Act
- Rules on minimum tehnical requirements for performing the trade activity