Authority for Justice and Consumer Protection

View non-prescription drug retail stores

Prerequisites

You have knowledge and skills in the following areas:

• Filling
• Packing
• Marking and storage
• placing on the market of medicinal products
• Regulations applicable to over-the-counter medicines

If you do not have the necessary expertise yourself, one of the following people must have it:

• a person legally appointed to represent the company
• a person appointed by you to manage the company
• a person appointed by you to sell

If you operate multiple branches, each branch must have a person with the necessary expertise.

Expertise can be demonstrated by taking an exam at the relevant Chamber of Commerce and Industry. Certain exams and certificates are also recognized as proof of expertise, such as those required by pharmaceutical commercial employees or pharmaceutical technical assistants.

Documents required

• Identification document
• Evidence of expertise, for example through:
  • IHK expertise test
  • completed pharmacy studies
  • License to practice as a pharmacist
  • University degree in chemistry, biology, human medicine, veterinary medicine in conjunction with further evidence such as theoretical and practical instruction in certain basic subjects (Section 15 of the Medicines Act)
  • Completed training as a druggist
  • Final examination as a pharmacy assistant or pharmaceutical-commercial employee
  • Completed training as a pharmaceutical technical assistant
  • Proof that you have performed one of the following activities before 1978 after passing the commercial assistant examination:
    • at least three years of practical experience in a commercial business selling over-the-counter medicinal products or
    • Five years of commercial experience, including two years in a managerial position, with over-the-counter medicines

Please note

You are allowed to sell certain non-prescription and non-pharmacy-only medicines outside of pharmacies. These are known as over-the-counter medicines. What these medicines are is specified in more detail in the regulation on pharmacy-only and over-the-counter medicines.

If you want to operate a mail order business for over-the-counter medicines, you must register in the mail order register. Every mail order business selling medicines in the European Union is obliged to use the common European mail order logo on its website. It shows consumers that a mail order business is entitled to sell human medicines by mail order over the Internet under its respective national law. At first glance, consumers can see the member state in which the mail order business is established. The logo must be clearly visible on the website. Clicking on it takes you to the mail order register.

You must submit a notification of trading in these medicinal products in accordance with the Medicines Act in addition to registering your business.

Deadlines

Report retail sales of over-the-counter medicines before you start selling them.

Procedure

• You submit the written notification with a description of the intended trade in over-the-counter medicines and the necessary documents to the competent authority.
• The responsible authority will examine your report and your documents. If necessary, it will request further documents or information from you.
• The competent authority checks the requirements, in particular whether the necessary expertise is present.
• You will receive a confirmation of your ad.
• Your business will be included in the monitoring of the pharmaceutical trade.

Processing time

After you have announced that you have started your business, you are allowed to start retailing.

Fees

Fees apply. The amount of the fees is calculated based on the processing effort.

Legal remedies

No

Legal basis

• § 44 Medicines Act


• § 50 Medicines Act


• § 67 Medicines Act