Arzneimittel; Überwachung des Einzelhandels
Inhalt
Begriffe im Kontext
nicht vorhanden
Fachlich freigegeben am
17.04.2025
Fachlich freigegeben durch
Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention (Bavarian State Ministry of Health, Care and Prevention)
- Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
- Verordnung über apothekenpflichtige und freiverkäufliche Arzneimittel (AMVerkRV)
- Verordnung über den Nachweis der Sachkenntnis im Einzelhandel mit freiverkäuflichen Arzneimitteln (AMSachKV)
- Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)
The district administrative authorities are responsible for monitoring the retail trade in medicinal products outside pharmacies or in the itinerant trade.
Drugstores, drugstores, health food stores, specialist medical retailers, department stores, grocery stores, organic food stores, sex stores and fitness and bodybuilding centers are particularly suitable for monitoring.
During the on-site inspection of the business premises, the hygienic condition of the operating and business premises, facilities and their surroundings, means of transportation and storage facilities are checked in particular.
Care is taken to ensure that the range of medicinal products only contains preparations that are over-the-counter in accordance with the Medicinal Products Act or the Ordinance on Pharmacy-only and Over-the-counter Medicinal Products.
The sale of over-the-counter medicines requires the expertise of the entrepreneur or a person appointed by him to manage the company or to sell them. Proof of expertise must be provided by passing an examination at the competent Chamber of Industry and Commerce. Other specific examinations and certificates (e.g. pharmaceutical commercial clerk, pharmaceutical technical assistant) are also recognized as proof of expertise. It is determined whether a competent person is available.
Furthermore, the medicines are checked for proper storage and quality defects (detectable sensory defects, labeling defects, expiry date).
When dispensing medicinal products in the itinerant trade, checks are carried out to ensure that only finished medicinal products approved for the itinerant trade are dispensed. In addition, it is checked whether the medicinal products are stored properly and protected from light, temperature, weather conditions and contamination during transportation and placing on the market.
During the on-site inspection of the business premises, the hygienic condition of the operating and business premises, facilities and their surroundings, means of transportation and storage facilities are checked in particular.
Care is taken to ensure that the range of medicinal products only contains preparations that are over-the-counter in accordance with the Medicinal Products Act or the Ordinance on Pharmacy-only and Over-the-counter Medicinal Products.
The sale of over-the-counter medicines requires the expertise of the entrepreneur or a person appointed by him to manage the company or to sell them. Proof of expertise must be provided by passing an examination at the competent Chamber of Industry and Commerce. Other specific examinations and certificates (e.g. pharmaceutical commercial clerk, pharmaceutical technical assistant) are also recognized as proof of expertise. It is determined whether a competent person is available.
Furthermore, the medicines are checked for proper storage and quality defects (detectable sensory defects, labeling defects, expiry date).
When dispensing medicinal products in the itinerant trade, checks are carried out to ensure that only finished medicinal products approved for the itinerant trade are dispensed. In addition, it is checked whether the medicinal products are stored properly and protected from light, temperature, weather conditions and contamination during transportation and placing on the market.