Expert knowledge check on trade in over-the-counter medicinal products
The retail sale of over-the-counter medicinal products outside pharmacies may only be carried out in accordance with Section 50 of the Medicinal Products (AMG) if the entrepreneur or a commissioned person has the necessary expertise. In the case of undertakings with more than one establishment, a competent person must be present for each establishment. The Chambers of Commerce and Industry are the examining body in accordance with Section 9 of the Ordinance on Proof of Expertise in the Retail Trade in Over-Sale Medicinal Products in conjunction with Section 1 of the Medicinal Products Assignment Ordinance.
The expert examination at the Chamber of Commerce takes place in writing, partly on the PC. The duration of the exam is 75 minutes. The examination sheet consists of 50 single-choice test questions (each 1 point) and 5 open examination questions on plant drugs (tea drugs, medicinal drugs) from the drug list (recognition and naming of the drug, main application and corresponding main ingredient, maximum 3 points per question). A total of 65 points are achievable in the expert examination (50 points through the single-choice test questions, 15 points by the open questions about the tea drugs). At least 33 points must be achieved in order to pass the examination of expertise. The purpose of the examination is to determine whether the subject has sufficient knowledge and skills of the proper filling, packaging, marking, storage and placing on the market of over-the-counter medicinal products and of the rules applicable to those medicinal products. In detail, it must be determined whether the subject overlooked the range of over-the-counter medicinal products, knows the plants and chemicals commonly used in over-the-counter medicinal products, as well as the dosage forms, clearly confused, falsified or spoiled over-the-counter medicinal products, may store over-the-counter medicinal products properly, in particular taking into account the storage temperature and the expiry date, has the necessary knowledge for the proper filling, packaging and supply of over-the-counter medicinal products; aware of the dangers associated with the improper handling of over-the-counter medicinal products, knows the rules of pharmaceutical suffrage and the right to advertise in the field of medicinal products applicable to over-the-counter medicinal products.