Einzelhandel mit freiverkäuflichen Arzneimitteln anzeigen

If you wish to carry out a retail trade in over-the-counter medicines, you must notify us in advance.

The Hessian State Office for Health and Care (HLfGP) monitors the movement of medicinal products for human use at all pharmaceutical companies as well as wholesalers and retailers in Hesse. In addition to a risk graded inspection of companies, the monitoring includes the taking and testing of drug samples.

In order for the authorities to fulfill their monitoring obligations, there is a duty of notification (Section 67 of the German Medicines Act (AMG)) for companies and facilities that develop, manufacture, clinically test or residue test, test, store, package, place on the market or otherwise trade in medicinal products.

If you wish to engage in retail trade with over-the-counter medicinal products, you must notify us in advance.

Proof of expertise of the person responsible.

• You must appoint a responsible person with the necessary expertise
• You must carry out a retail business

Note: According to Section 50 (2) of the German Medicinal Products Act (AMG), the required expertise is possessed by anyone who demonstrates knowledge and skills in the proper filling, packaging, labeling, storage and placing on the market of over-the-counter medicinal products as well as knowledge of the regulations applicable to these medicinal products

• You submit your notification to the competent authority using the online form and upload the required document
• the confirmation will be issued if the competent authority determines that the legal requirements have been met

The notification must be made before the start of the activity.

Administrative court action

• Display retail sale of over-the-counter medicines
• The sale of over-the-counter medicines in retail stores requires notification.
• Darmstadt Regional Council
  

Please contact the Hessian State Office for Health and Care (HLfGP).

Hessian State Office for Health and Care.

Forms/online services available: Yes
Written form required: No
Informal application possible: No
Personal appearance necessary: No