FAQ (hospital) pharmacies

An investigational medicinal product that is not authorised in the EU or manufactured in the EU requires an EU QP clearance (cf. Official Journal of the European Union: 2010/C 82/01, point 62). Can this EU QP release be done by an (hospital) pharmacy?

A (hospital) pharmacy without a license according to § 63 AMG regarding investigational medicinal products is only authorised to decant, including filling, packaging and labelling. Cf. the exemption from the authorisation 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 labelling, 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 labelling of investigational medicinal products in pharmacies from the requirement of an operating license (see Government Bill 155 XXIV GP).

An (hospital) pharmacy without a license according to § 63 AMG cannot "confirm" compliance with EU GMP, i.e. release investigational medicinal products not authorised 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 labelling (of investigational medicinal products already certified/released by a qualified person) can be carried out by an (hospital) pharmacy without authorisation according to Section 63 AMG.

What does the scope of manufacture and marketing of medicinal specialties by public pharmacies pursuant to Section 1(2)(6) of the Pharmacy Operating Regulations 2005 (ABO 2005) include?

§ Section 1(2)(6) of the Pharmacy Operating Regulations 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 authorisation 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 authorisation under pharmaceutical law pursuant to Section 63 AMG.

What does the scope of occasional supply of medicinal products by public pharmacies to other pharmacies under Section 1(2)(8) ABO 2005 include?

§ 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.

May a drug wholesaler purchase drugs from a public pharmacy?

Pursuant to Section 3 (8) of the Austrian Ordinance on Good Manufacturing Practices 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 person 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 organisation, 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 body, 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.


Further inquiry note