Pharmaceuticals; notification of retail trade outside pharmacies

Outside of pharmacies, only so-called over-the-counter medicines may be sold by retailers. Businesses and establishments must notify the municipality of this activity before commencing it. This also applies to persons who carry out these activities independently and on a professional basis. The activity must also be reported to the municipality prior to commencement for the distribution of medicinal products in the traveling trade. This notification in accordance with the Medicinal Products Act must be submitted to the municipality in addition to the business registration in accordance with the Trade Regulation Act.

Notes:
Retail sales of over-the-counter medicinal products may only be carried out if the entrepreneur has the necessary expertise, either by a person legally appointed to represent the entrepreneur or by a person appointed by the entrepreneur to manage the company or to sell the products.

In the case of companies with several operating sites, there must be one person with the relevant expertise for each site.

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 recognized as proof of expertise.

• § Section 67 (1) of the Act on the Marketing of 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)

  Travel trade tax

• Ordinance on the Responsibilities of the Drug Monitoring Authorities and on the Enforcement of the Semen Donor Register Act and the Genetic Diagnostics Act (Ordinance on the Responsibilities of the Drug Monitoring Authorities - ZustVAMÜB)
• Ordinance on Proof of Expertise in the Retail Sale of Over-the-Counter Medicinal Products (AMSachKV)
• Ordinance on pharmacy-only and over-the-counter medicines (AMVerkRV)