AG confirms that the sale of medicines drawn off in different containers should be authorised

In her Opinion of 31 January 2013, Advocate General (AG) Sharpston found, considering the provisions and objectives of both Regulation 726/2004 and Directive 2001/83, that a marketing authorisation is required not only for the initial placing of a medicinal product on the market, but also for any subsequent modification of the product, which includes any changes to the container format in which it is sold.

The question was brought before the European Court of Justice in a preliminary reference from a German court (Case C-535/11, Novartis Pharma -v- Apozyt) on whether EU rules allow Apozyt to sell in Germany, without a marketing authorisation, the prescription medicines Lucentis® and Avastin® in a container different from that in which they are originally placed on the market by the respective EU-wide marketing authorisation holders Novartis and Roche Pharma AG.

According to the AG, Apozyt does not benefit from any of the Directive's exceptions to the marketing authorisation requirement. In particular, Apozyt cannot rely on the exception for medicines prepared in pharmacies, i.e. by or under the supervision of a pharmacist, in accordance with a medical prescription (Art. 3(1) and (2) of the Directive). The AG interpreted this exception restrictively stating that it is not sufficient for the preparation to be performed on a non-industrial basis, but that the involvement of a pharmacist is required. Responding to concerns expressed by Ireland, the AG noted that the commonly performed "drawing off" procedures at hospital pharmacies should thus in principle benefit from this exemption.

The court's final ruling in this case is still pending.

Please click on the links below for the other articles in the March 2013 Life sciences and regulatory newsletter

• Italian antitrust court ruling on access to data
• European Court of Justice rules on application of waste and chemicals law to duckboards in Lapland
• Actions against ECHA decisions identifying substances of very high concern under REACH found admissible but dismissed on substance
• European General Court upholds Commission decision for product recall and sales ban as a result of serious GMP shortcomings
• New actions before the European courts

_{Note: The Italian competition authority has opened a cartel investigation involving Novartis and Roche for alleged market-sharing in respect of Lucentis® and Avastin®.}