Source: https://www.basg.gv.at/en/inspections/gmp/-gdp/faq-medizinmarktueberwachung
Timestamp: 2020-02-23 17:57:38
Document Index: 30845858

Matched Legal Cases: ['§ 57', '§ 57', '§ 116', '§ 63', '§ 63', '§ 57']

FAQ - enforcement - BASG
Example for non-authorized recipients according to § 57 AMG
§ Section 57 (1) of the Austrian Medicines Act (AMG) lists those persons to whom drugs may be supplied by the manufacturer, depositee or pharmaceutical wholesaler.
In the following, examples are given which represent an unauthorised purchase of medicinal products.
Drug depots in hospitals:Pharmaceutical depots in hospitals represent a special form of pharmaceutical storage in hospitals without their own pharmacy. These deposits are subject either to the supervision of a public consulting pharmacy or a consulting pharmacy of the associated hospital group. Only blood and tissue products may be delivered directly to hospitals without a pharmacy (§ 57 Para. 2 AMG). The supply of drugs to supplement the drug requirements of these hospitals by manufacturers, retailers or pharmaceutical wholesalers may only take place via a pharmacy, ideally the responsible consulting pharmacy. Delivery by a pharmacy is deemed to have taken place when the order and invoicing is carried out via this pharmacy.
Commercial pharmaceutical wholesalers: Pharmaceutical wholesalers who hold a trade licence in accordance with § 116 of the Gewerbeordnung are only entitled to commence their activities as pharmaceutical wholesalers if they are authorised in accordance with § 63 AMG. This can be found in Section 2 (2) AMG.
Thus, for example, pharmacies which, apart from their public pharmacy, also operate a pharmaceutical wholesale business also require a licence in accordance with § 63 AMG. This is also necessary if the wholesale authorisation is used exclusively to purchase the medicinal products purchased for sale to the pharmacy itself.
Physician-operated pharmacies: According to § 57 Para. 1 No. 1 AMG, pharmacies of human physicians may only purchase the medicines they distribute from a pharmacy, but not directly from the manufacturer, depositary or pharmaceutical wholesaler. Delivery by a pharmacy is given when the delivery is under the direct control of the responsible pharmacist of the supplying pharmacy and invoicing takes place via this pharmacy.
Page last modified: 10. January 2012