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Inhalt
Begriffe im Kontext
- Erlangung von Lizenzen, Genehmigungen oder Zulassungen im Hinblick auf die Gründung und Führung eines Unternehmens
Fachlich freigegeben am
Fachlich freigegeben durch
- § Section 50 of the German Medicinal Products Act (AMG)
- §§ 1-5 Ordinance on proof of expertise in the retail sale of over-the-counter medicinal products
- § Section 50 of the German Medicinal Products Act (AMG)
- §§ 1-5 Ordinance on proof of expertise in the retail sale of over-the-counter medicinal products
- § Section 50 of the Medicinal Products Act
- Ordinance on the Proof of Expertise in the Retail Sale of Over-the-Counter Medicinal Products (AMSachKV)
- Ordinance on the Transfer of Pharmaceutical Tasks (AAÜVO) of November 17, 1997
According to Section 50 of the German Medicinal Products Act (AMG), the retail sale of over-the-counter medicines outside of pharmacies may only be carried out if the company or an authorized person has the necessary expertise.
In accordance with Section 50 of the German Medicines Act (AMG), the retail sale of over-the-counter medicines outside pharmacies may only be carried out if the entrepreneur or an authorized person has the necessary expertise. In the case of companies with several branches, a competent person must be present for each branch. The Chambers of Industry and Commerce are responsible for this in accordance with Section 9 of the Ordinance on Proof of Expertise in the Retail Sale of Over-the-Counter Medicinal Products in conjunction with Section 1 of the Ordinance on the Assignment of Tasks for Medicinal Products the examining body.
IHK Neubrandenburg for the eastern part of Mecklenburg-Vorpommern: Examination fee 65,00 Euro
IHK Rostock: examination fee 110,00 Euro
IHK in Schwerin: examination fee 85.00 euros
The knowledge test at the IHK takes place in writing, partly on a PC. The examination lasts 75 minutes.
The examination sheet consists of 50 single-choice test questions (1 point each) and 5 open examination questions on the plant drugs (tea drugs, medicinal drugs) from the drug list (recognizing and naming the drug, main area of application and corresponding main ingredient, maximum 3 points per question).
A total of 65 points can be achieved in the knowledge test (50 points from the single-choice test questions, 15 points from the open questions on the tea drugs).
At least 33 points must be achieved in order to pass the knowledge test. The purpose of the examination is to determine whether the candidate has sufficient knowledge and skills in the proper filling, packaging, labeling, storage and marketing of over-the-counter medicinal products as well as knowledge of the regulations applicable to these medicinal products.
In particular, it must be determined whether the candidate
- is aware of the range of over-the-counter medicines,
- knows the plants and chemicals commonly used in over-the-counter medicinal products and the dosage forms,
- can recognize obviously mixed-up, adulterated or spoiled over-the-counter medicines,
- can store over-the-counter medicinal products properly, in particular taking into account the storage temperature and the expiry date,
- has the knowledge required for the proper filling, packaging and dispensing of over-the-counter medicines,
- is aware of the risks associated with the improper handling of over-the-counter medicines,
- is familiar with the provisions of the law on medicinal products and the law on advertising in the field of medicine applicable to over-the-counter medicinal products.
Registration deadline: at least 4 weeks before the desired examination date
Note: The knowledge test will only be held if there are sufficient participants.
- The retail sale of over-the-counter medicines outside of pharmacies may only be carried out if the company has appointed an appropriate person with the necessary expertise.
- In the case of companies with several branches, a competent person must be present for each branch.
- The examining body is the competent Chamber of Industry and Commerce.