However, did not (yet) end in litigation*. Or several patents concerning a specific INN* or R&D pole* has been raised, which, "Dispute" is understood as every exchange of views between two companies where, in particular, the actual or potential infringement, non-infringement or invalidity of one "DDD" is the assumed average maintenance dose per day for a drug used for its main "DCP" stands for Decentralised Procedure. However, in relation to marketing authorisation applications submitted before the above mentioned dates, the wording 'data exclusivity' refers to the six or ten-year protection period granted to the original MA holder before generic applicantsĬan file their applications for marketing authorisation. Accordingly, in relation to marketing authorisation applications submitted after 30 October 2005 for the applications filed in the framework of national procedures or 20 November 2005 for applications filed in the framework of the centralised procedure, 'data exclusivity' refers to the eight-year protection period during which generic applicant may not refer to the information of the original marketing authorisation holder and 'marketing exclusivity' refers to the ten-year period after which generic products can be placed on the market. "Data exclusivity" refers to the period during which the data of the original marketing authorisation holder relating to (pre-) clinical testing is protected. "CPME" stands for Standing Committee of European Doctors. "Country codes" refer to the abbreviations found on the following website: "Community Pharmacies" refers to publicly accessible pharmacies as opposed to "Blockbuster medicine" is defined as being one which achieves annual revenues of Medicinal product* authorised in the Community. "Biosimilar" is defined as a biological medicinal product* similar to a reference "Biopharmaceutical" is defined as a biological medicinal product*, in particular "BEUC" stands for the European Consumers' Association (Bureau Européen des International standard for classifying medicines. "ATC" stands for Anatomical Therapeutic Chemical classification, i.e. "API" stands for "active pharmaceutical ingredient". That INN*, or has sold the product* in any given period since January 2000. "Active" in an INN* means that an originator company* sells a product* belonging to MARKET CHARACTERISTICS AND STRUCTURE OF THE PHARMACEUTICAL SECTOR.19 For material quoted in this report that is derived from other sources, permission must be sought directly from the copyright holder." "Reproduction of parts of this report that are based on the Commission's own research is authorised, provided that the source is acknowledged. Subject: Pharmaceutical Sector Inquiry Final Reportĭelegations will find attached Commission document SEC(2009) 952. To: Mr Javier SOLANA, Secretary-General/High Representative Signed by Mr Jordi AYET PUIGARNAU, Director date of receipt: 9 July 2009 COUNCIL OF Brussels, 17 July 2009 THE EUROPEAN UNIONįrom: Secretary-General of the European Commission,
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