An (institutional) pharmacy without a license according to § 63 AMG with regard to investigational medicinal products is only authorized to decant, including filling, packaging and labeling. Cf. the exemption from the authorization requirement listed in the AMG:
§ 62 para 2 (2) Not considered as establishments within the meaning of para 1 are.
[...] Z 3 3 Institutional pharmacies with regard to the manufacture of investigational medicinal products, insofar as this involves decanting including filling, packaging and labeling, and the investigational medicinal products are intended for use in a hospital,[...].
Here, use is made of the possibility granted to the Member States in Art. 9 Para. 2 of Directive 2005/28/EC to exempt the decanting, packaging and labeling of investigational medicinal products in pharmacies from the requirement of an operating license (see Government Bill 155 XXIV GP).
An (institutional) pharmacy without a license according to § 63 AMG can therefore in no case "confirm" compliance with EU GMP, i.e. release investigational medicinal products not authorized in the EU or manufactured in the EU for marketing.
In any case, a GMP certification/release by a qualified person of a company licensed for this purpose is required.
Only decanting including filling, packaging and labeling (of investigational medicinal products already certified/released by a qualified person) can be carried out by an (institutional) pharmacy without authorization according to Section 63 AMG.
§ Section 1(2)(6) of the Pharmacy Operations Ordinance 2005 stipulates that public pharmacies are entitled to produce and market proprietary medicinal products in accordance with the legal provisions as part of the provision of medicinal products to the general public. This authorization to place medicinal products on the market refers exclusively to the possibility of manufacturing pharmacy-own medicinal specialties and subsequently dispensing them through the pharmacy in which they were wholly or predominantly manufactured (cf. Section 1 (6) AMG in conjunction with Section 24 ABO). An interpretation of this provision that goes beyond this would contradict the relevant provisions of pharmaceutical law and pharmacy law and would require a corresponding authorization under pharmaceutical law pursuant to Section 63 AMG.
§ Section 1(2)(8) of the Pharmacy Operations Ordinance 2005 allows public pharmacies to occasionally supply medicinal products to other pharmacies. In the corresponding explanations of the Austrian Chamber of Pharmacists on this provision, it is stated with regard to the scope of the occasional supply that the limit to wholesale trade in medicinal products may not be exceeded.
"Z 8 lists the supply of medicinal products to other pharmacies. This is intended to enable occasional trade among pharmacies without exceeding the limits to trade (wholesale trade in medicinal products)."
From the point of view of the BASG, the borderline to a trade is crossed if deliveries are made regularly or with the intention of generating income or profit.
Pursuant to Section 3 (8) of the Arzneimittelbetriebsordnung 2009 (AMBO 2009), any procurement of medicinal products by pharmaceutical wholesalers via/from public pharmacies is unlawful, as any pharmaceutical wholesaler may only procure its stock of medicinal products from a pharmaceutical wholesaler, manufacturer or importer.
If a legal entity has a license as a pharmaceutical wholesaler in addition to the pharmacy license, it is therefore necessary not only to separate the activities in terms of space and organization, but also to differentiate legally according to the activities performed.
The public pharmacy and the pharmaceutical wholesaler, even if they are operated by the same legal entity, are two different functional entities, which act in different roles and on the basis of different laws, depending on their activities. Therefore, the company acts either as a public pharmacy or as a pharmaceutical wholesaler and is also to be treated officially either as a public pharmacy or as a pharmaceutical wholesaler.
A "shift" (i.e. purchase as a pharmacy and sale as a drug wholesaler) of drugs from the public pharmacy to the drug wholesaler, which often has the same name and is located within the same legal entity, is therefore to be regarded as an unlawful supply of drugs.