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Pharmaceuticals; notification of retail trade outside pharmacies
Anyone intending to dispense medicinal products in retail outlets outside pharmacies or in the traveling trade must notify the municipality before commencing the activity.
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Procedure details
Description
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 trade with over-the-counter medicinal products may only be carried out if the entrepreneur has a person legally appointed to represent the entrepreneur or a person appointed by the entrepreneur to manage the company or to sell the products has the necessary expertise.
In the case of companies with several operating sites, there must be a person with the necessary 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.
Legal bases
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§ 67 Abs. 1 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)Allgemeine Anzeigepflicht
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§ 50 Abs. 1 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)Einzelhandel mit freiverkäuflichen Arzneimitteln
Status: 17.04.2025
Editorial responsibility Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
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