Service content
Description of the
Outside of pharmacies, retailers may only sell so-called over-the-counter medicines. Businesses and establishments must notify the local authority of this activity before commencing it. This also applies to individuals who carry out these activities on a self-employed and professional basis. The sale of medicines in the itinerant trade must also be notified to the local authority before commencing. This notification under the Medicines Act must be submitted to the local authority in addition to the business registration under the Trade Regulation Act.
Notes: The
retail sale of over-the-counter medicines may only be carried out if the business owner, or a person legally appointed to represent the business owner, or a person commissioned by the business owner to manage the business or handle sales, possesses the necessary expertise.In the case of companies with several operating centres, there must be one person with the relevant expertise for each operating centre.
Proof of expertise must always be provided by passing an examination at the relevant Chamber of Industry and Commerce. Certain examinations and certificates (e.g. pharmaceutical commercial clerk, pharmaceutical technical assistant) are also recognised as proof of expertise.
Legal basis
- § Section 67 (1) of the Act on the Trade in Medicinal Products (Medicinal Products Act - AMG)
General duty of disclosure
- § Section 50 (1) of the Act on the Trade in Medicinal Products (Medicinal Products Act - AMG)
Retail sale of over-the-counter medicines
- § 51, § 50 para. 3 in conjunction with para. Para. 1 Act on the Trade in Medicinal Products (Medicinal Products Act - AMG)
Levy in the travelling trade
- Ordinance on the Responsibilities of the Drug Monitoring Authorities and on the Enforcement of the Semen Donor Register Act and the Genetic Diagnostics Act (Drug Monitoring Responsibility Ordinance - ZustVAMÜB)
- Ordinance on the Proof of Expertise in the Retail Sale of Over-the-Counter Medicinal Products (AMSachKV)
- Ordinance on pharmacy-only and over-the-counter medicines (AMVerkRV)
- § Section 67 (1) of the Act on the Trade in Medicinal Products (Medicinal Products Act - AMG)