Verblisterung of medicaments

(openPR) - OVG Lueneburg, judgement of 16.05.2006 (Az. 11 LC 265/05)
Guiding principles of the court:

1. The manufacture term of the medicament right seizes also the Verblisterung of finished medicaments, i.e. the Auseinzelung the new packing in foil-welded containers, automated by medicaments from finished medicament packings, the following compilation of the tablets and caps after the individual needs of the individual medicament receiver and.
2. The commercial production of Arzneimittelblistern in the pharmacy holds itself in the context of the usual pharmacy enterprise.
3. For the commercial production of Arzneimittelblistern in a pharmacy no medicament-legal permission obligation exists.

From circumstances:
The plaintiff operates a pharmacy and he turns against a medicament-legal order of the Rechtsvorgängerin of the deplored ones, the district government Weser Ems, with which one forbids to him, finished medicaments in its pharmacy too verblistern.
In the context of its medicament-legal supervising activity the district government Weser Ems received knowledge in October 2002 from the fact that the plaintiff in its pharmacy in B. operates a Verblisterungsautomaten of the Austrian company Baxter. With the Ver¬blistern individual finished medicaments are arranged taken out of finished medicament packings (so-called Auseinzeln), after the individual needs of the medicament receiver and again packaged by means of an automat in foil-welded containers (so-called Verblistern). An on-site inspection of the district government in the pharmacy of the plaintiff on 7 April 2003 led to the following realizations: The plaintiff supplies 70 inhabitants of C. - home in D. with the again verblisterten medicaments. In addition the medication profile of the patients supplied at present is deposited in a computer. For new packing the tablets/caps determined for the weekly need are taken out of the finished medicament packings and filled into the way of the four-eye principle by two pharmaceutical-technically trained forces into the assembly fan of the Baxter automat. Afterwards the Baxter automat packs each individual tablet cap expenditure in tents of the medicament into a plastic small bag protected from light, on that the name of the pharmacy, the date of packing, the name of the patient with indication of station, the exact income time (days, date and income time), which is imprinted name of the medicament, income references, batch number and expiration date.

Source: OVG Lueneburg >>> for decision in the full text >>>
www.dbovg.niedersachsen.de/Entscheidung.aspInd=05000200500026511%20LC

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