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The European Court of Justice (ECJ) has made an important judgement on how exceptions within EU law that permit the production of medicinal products within a pharmacy should be applied.
The ECJ judgement of 16 July 2015 follows a request for interpretation from the Swedish Advocate General (see background below).
There are a number of key points in the judgement of relevance to hospital pharmacy. The legal requirements around pharmacy production of medicines, as set out in Article 3 of Directive 2001/83, were reiterated and given emphasis in the ECJ determination.
In particular, the judgement makes clear that:
in order to benefit from the exception provided for in Article 3, point 1, of Directive 2001/83 (magisterial formula) a medicinal product produced in a pharmacy must ‘of necessity be prepared after the prescription for a specified patient has been issued’;
the implementation of Article 3 point 2 exemptions (officinal formula) require the preparation of the medicine takes place:
in a pharmacy,
‘in accordance with the prescriptions of a pharmacopoeia’ and
be ‘intended to be supplied directly to the patients served by the pharmacy in question’.
Determination of whether Swedish production of Noradrenalin APL and Metadon APL was in breach of these rules of exception is now referred back to the Swedish Advocate General.
While, the ECJ judgement could pose questions for hospital pharmacy practice in some countries in relation to production of medicines in the hospital pharmacy and centralised centres, it should be borne in mind that the background to the case stemmed largely from the production and delivery of a medicinal product that was also commercially available, a practice not common in most member states. See final section below.
Background to the case
The case originated in Sweden where, until July 2009, the pharmacy market was characterised by a legal monopoly: only the State-owned …
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