Einzelhandel mit Arzneimitteln anzeigen, die nicht der Apothekenpflicht unterliegen

If you want to sell over-the-counter medicines in retail outlets outside of pharmacies, you must report this. You can find out more here.

You may sell certain non-prescription and non-pharmacy-only medicines outside of pharmacies. These are known as over-the-counter medicines. The ordinance on pharmacy-only and over-the-counter medicines specifies which medicines these are.

The retail sale of over-the-counter medicines is subject to notification in accordance with the Medicines Act. Companies and establishments must notify the competent authority before commencing this activity. This also applies to persons who carry out these activities independently and on a professional basis. The activity must also be notified to the competent authority prior to commencement for the dispensing of medicinal products in the itinerant trade.

This notification in accordance with the Medicinal Products Act must be submitted in addition to the business registration in accordance with the Trade, Commerce and Industry Regulation Act.

Retail sales of over-the-counter medicinal products may only be carried out if the entrepreneur, a person legally appointed to represent the entrepreneur or a person entrusted with the management of the company or with the sale, has the necessary expertise.

Specialist knowledge is not required in the case of medicinal products that may be dispensed in the traveling trade, are intended for the prevention of pregnancy or sexually transmitted diseases, or disinfectants or oxygen intended exclusively for external use.

In the case of companies with several branches, there must be a person with the necessary expertise for each branch. If over-the-counter medicines are offered for self-service, a person with specialist knowledge must be available during opening hours.

Proof of expertise must be provided by passing an examination at the competent Chamber of Industry and Commerce. Certain professional qualifications (e.g. pharmaceutical commercial clerk, pharmaceutical technical assistant) are also recognized as proof of expertise.

• Identity document
• Proof of expertise, e.g. through:
  • IHK examination of expertise
  • Completed degree in pharmacy
  • 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 German 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 carried out one of the following activities before 1978 after passing the commercial assistant examination: if applicable, an additional practical activity of at least three years in a commercial enterprise with over-the-counter medicines or a five-year commercial activity, two years of which in a managerial position, with over-the-counter medicines

• Knowledge and skills in the following areas:
  • Filling,
  • packing,
  • labeling and storage
  • placing on the market

of medicinal products.

Regulations that apply to over-the-counter medicines:

• If you do not have the required expertise yourself, one of the following persons must have it:
  • a person legally appointed to represent the company
  • a person appointed by you to manage the company or
  • a person entrusted by you with the sale of the company

If there are several branches, there must be a person with the required expertise in each branch. If over-the-counter medicines are offered on a self-service basis, a person with specialist knowledge must be available during opening hours.

• You report the retail sale of over-the-counter medicines
• The competent authority checks your notification
• Once your notification has been approved, you can start retailing

Once you have notified us that you have started work, you may begin retailing.

The notification must be made before commencing work.

If you wish to operate a mail-order business for over-the-counter medicines, you must also register in the mail-order register, as every mail-order supplier of 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 company is authorized to sell medicinal products for human use by mail order via the Internet in accordance with its respective national law. At first glance, the consumer can recognize the Member State in which the mail order company is established.

The logo must be clearly visible on the website. The click leads to the mail order register.

• Notification Retail sale of over-the-counter medicines Receipt
• Retail sale of over-the-counter medicines is subject to notification
• Retail trade may only be carried out if the entrepreneur has the necessary expertise, either by a person legally appointed to represent the company or by a person entrusted with the management of the company or the sale.
• Exceptions apply to medicinal products
  • which may be dispensed in the itinerant trade,
  • are intended for the prevention of pregnancy or sexually transmitted diseases, and
  • for disinfectants or oxygen intended exclusively for external use
• Responsible: lower health authority

Lower health authority