Einzelhandel mit frei verkäuflichen Arzneimitteln anzeigen

• § 44 Arzneimittelgesetz (AMG) (Ausnahme von der Apothekenpflicht)
• § 50 Arzneimittelgesetz (AMG) (Einzelhandel mit frei verkäuflichen Arzneimitteln/Sachkundenachweis)
• § 67 Arzneimittelgesetz (AMG) (Allgemeine Anzeigepflicht)
• Verordnung über apothekenpflichtige und frei verkäufliche Arzneimittel (AMVerkRV)
• Verordnung über den Nachweis der Sachkenntnis im Einzelhandel mit freiverkäuflichen Arzneimitteln (AMSachKV)

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.

Proof of expertise, for example through

• completed pharmacy degree
• Licence 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 chemist or 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:
  • a practical activity of at least three years in a commercial enterprise with over-the-counter medicinal products or
  • five years of commercial activity, including two years in a managerial position, with over-the-counter medicines

Note: If you are unable to provide this evidence, you must take an examination of expertise before an examination board of a chamber of industry and commerce. You must register with the Chamber of Industry and Commerce in whose district your place of employment or your training or further education centre or your place of residence is located.

• Knowledge and skills in the following areas:
  • Filling,
  • Packing,
  • Labelling and storage,
  • Placing medicinal products on the market,
  • 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 authorised by you to handle the sale

Note: If there are several branches, there must be a person with the required expertise in each branch.

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Further costs may arise, e.g. for the

• Business registration and
• possibly necessary examination of expertise at the IHK

You can report trade in over-the-counter medicines informally. Please state the address of the business premises and the authorised person. Please also notify any changes (e.g. change of address for the registered office, change of internet address) in good time.

You must also register your business with the municipal or city administration of your future business premises. Depending on what the Depending on what the municipality offers, you can obtain the application form there or download it from the Internet.

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

before commencing work

If you wish to operate a mail-order business for over-the-counter medicines, you must 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 authorised to sell medicinal products for human use by mail order over the Internet in accordance with its respective national law. At first glance, the consumer can recognise 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.

To obtain the mail order logo for your business, please contact the regional council where you have registered your activity.

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