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Final Report on pharmaceutical sector inquiry

Wednesday, July 8th, 2009 in News

On 08.07.09 the European Commission adopted the final report on the competition inquiry into the pharmaceutical sector. The inquiry was launched in January 2008. The Commission concludes that market entries of generic medicines are often delayed and that the number of new medicines coming to the market is declining. The ... read more...

EMEA transparency policy

Monday, July 6th, 2009 in News

The European Medicines Agency (EMEA) is launching a public consultation on the transparency policy, in order to enhance openness in all areas of EMEA's activity. The draft includes some new points, inter alia the issue of future protection of commercially confidential information in the operations of the Agency. The deadline ... read more...

First positive opinion of EMEA on advanced therapy product

Monday, July 6th, 2009 in News

Following a positive opinion from the Committee for Advanced Therapies (CAT), the Committee for Medicinal Products for Human Use (CHMP) gave the first recommendation for marketing authorisation for an advanced therapy medicinal product (ATMP) in the centralised procedure on a tissue engineered product. The CAT and the CHMP have required ... read more...

ECJ judgement on comparison lists

Tuesday, June 23rd, 2009 in News

On 18.06.09 the ECJ decided in the case of L´Oréal SA and others (C-487/07) that the proprietor of a trademark is entitled to prevent the use of comparison lists where goods from third parties are presented next to his goods. According to the ECJ, the use of such lists means ... read more...

ECJ judgement on generic marketing authorisations

Tuesday, June 23rd, 2009 in News

On 18.06.09 the European Court of Justice (ECJ) gave judgement in the case of Generics (UK) Ltd (C-527/07), regarding the question when a medicinal product can serve as reference medicinal product for the marketing authorisation of the generic product. The ECJ held that a medicinal product not centrally authorised which ... read more...