Freiverkäufliche Arzneimittel Sachkenntnisprüfung zum Verkauf ablegen
Inhalt
Begriffe im Kontext
- Arbeit und Ruhestand innerhalb der Union
- Erlangung von Lizenzen, Genehmigungen oder Zulassungen im Hinblick auf die Gründung und Führung eines Unternehmens
- Aus-, Weiterbildung und Sachkunde (2030300)
- Befähigungs- und Sachkundenachweise (2010200)
- Prüfung und Nachweise für Sachkunde und Sicherheit (2120300)
Fachlich freigegeben am
Fachlich freigegeben durch
- § 1 Law on the Legal Status of Pre-qualified Trainee Pharmacists (ApoAnwRstG)
- § 50 German Medicines Act (AMG)
- § 1 Ordinance on Proof of Expertise in the Retail Trade of Over-the-Counter Medicinal Products (AMSachKV)
- § 2 Ordinance on Proof of Expertise in the Retail Trade of Over-the-Counter Medicinal Products (AMSachKV)
- § 3 Ordinance on Proof of Expertise in the Retail Trade of Over-the-Counter Medicinal Products (AMSachKV)
- § Section 4 Ordinance on Proof of Expertise in the Retail Trade of Over-the-Counter Medicinal Products (AMSachKV)
- § Section 5 Ordinance on Proof of Expertise in the Retail Trade of Over-the-Counter Medicinal Products (AMSachKV)
- § Section 10 Ordinance on Proof of Expertise in the Retail Trade of Over-the-Counter Medicinal Products (AMSachKV)
- § Section 11 Ordinance on Proof of Expertise in the Retail Trade of Over-the-Counter Medicinal Products (AMSachKV)
In order to be able to offer so-called over-the-counter medicines in the trade, you must prove the corresponding expertise by passing an examination.
In principle, drugs may only be sold in pharmacies. However, there are exceptions for so-called over-the-counter drugs. These can be, for example, teas, ointments or tablets containing herbal substances such as valerian. If you want to sell these products in your store, an employee with proven expertise must always be on site. You can demonstrate this expertise by taking the exam.
The examination determines whether you have sufficient knowledge and skills about the proper filling, packaging, labeling, storage and marketing of over-the-counter medicinal products, possible dangers in the event of an overdose of the active ingredients, as well as knowledge about the legal regulations for handling and selling these medicinal products.
In detail, it must be determined whether you
- overlook the range of over-the-counter medicines,
- know the plants and chemicals commonly used in over-the-counter medicines, as well as the dosage forms,
- can recognize over-the-counter drugs that are obviously mixed up, adulterated or spoiled,
- be able to store over-the-counter medicines properly, in particular taking into account the storage temperature and expiry date,
- have the knowledge required for the proper filling, packaging and dispensing of over-the-counter medicines,
- know the hazards associated with the improper handling of over-the-counter medications,
- know the provisions of the law on medicinal products and the law on advertising in the field of medicine that apply to over-the-counter medicinal products.
The questionnaire includes 50 multiple-choice questions and 5 open-ended questions. You should prepare for the exam in terms of content, for example by attending a preparatory course. However, this is not a prerequisite for registering for the exam.
With a university degree or vocational training in the field of pharmacy, you may already have the expertise and do not need to prove it by taking a separate exam; you can find more on this in the additional information.
First, you register in writing or online with the responsible IHK.
- The IHK confirms your registration
- You take the exam on the selected date
- If you pass the exam, you will receive a certificate.
After receiving the certificate, you are allowed to sell medicines that are not subject to compulsory pharmacy sales.
You will usually receive the certificate within a few days after passing the exam.
If you can provide one of the following examination certificates, you do not have to take the examination:
- the certificate of a university degree in pharmacy the certificate of a university degree in chemistry, biology, human or veterinary medicine in connection with the evidence of sufficient knowledge in the required subjects
- the certificate of the veterinary examination passed after the completion of university studies in veterinary medicine, as far as medicinal products intended for use in animals are concerned,
- the certificate of having passed the preliminary pharmaceutical examination
- the certificate of the passed state examination for the profession of pharmaceutical-technical assistant or the proof of the equivalence of the educational level according to the Law on the Profession of Pharmaceutical-Technical Assistant,
- the certificate for the state-recognized training profession as a druggist,
- the certificate for the state-recognized training occupation as a pharmacy assistant or as a pharmaceutical-commercial employee.
Expertise is not required for anyone who places finished medicinal products on the market in the retail trade which
- may be distributed in the travel trade,
- are intended for the prevention of pregnancy or venereal diseases in humans,
- disinfectants intended exclusively for external use, or
- oxygen.
Detailed information on how to appeal an examination result can be found in the notice of failure.
- Expertise test for the trade with over-the-counter medicinal products Acceptance
- In principle, medicinal products may only be sold in pharmacies. However, there are exceptions for so-called over-the-counter medicines.
- The examination determines whether the examinee has sufficient knowledge and skills about the proper filling, packaging, labeling, storage and marketing of over-the-counter medicinal products, possible hazards in the event of overdosage of the active ingredients, as well as knowledge of the legal regulations governing the handling and sale of these medicinal products.
- Examination can be taken at the responsible IHK (Chamber of Industry and Commerce)
- Registration takes place at the IHK, in writing or online
- Different fees depending on the fee schedule of the respective IHK
- The IHK responsible is the one in whose district the (future) company headquarters is located.
Please contact the Chamber of Industry and Commerce (IHK) responsible for the district of your future place of business.
You can find the Chamber of Industry and Commerce responsible for you here:
- Form: Registration form
- Online procedure: Online registration partially possible
- Written form requirement: no
- Personal appearance: You must appear in person for the examination