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Draft Commission Implementing Decision of XXX concerning, in the framework of Article 13 of Commission Regulation (EC) No 1234/2008, the marketing authorisations for medicinal products for veterinary use "Resflor solution injectable and associated names", which contain the active substances "Florfenicol and Flunixin"
Draft Commission Implementing Decision of XXX concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for " Suanovil 20 and associated names, Captalin and associated names and generic products thereof ", veterinary medicinal products which contain the active substance " spiramycin "
Draft Commission Implementing Decision granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Bovela", a veterinary medicinal product
Commission Implementing Decision of XXX amending, pursuant to the annual review, Decision C(2011)2785(final) granting in exceptional circumstances marketing authorisation for "BLUEVAC BTV8 - Bluetongue virus inactivated, serotype 8", a veterinary medicinal product
Commission Implementing Decision of XXX concerning, in the framework of Article 107e of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substance "Orlistat"
Commission Implementing Decision of XXX concerning, in the framework of Article 107i of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substance “hydroxyethyl starch (HES), solutions for infusion”
Commission Implementing Decision concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substance "methocarbamol/paracetamol 380 mg/300 mg"
Commission Implementing Decision of XXX concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of fosfomycin-containing medicinal products for human use which contain one or more of the active substances "fosfomycin calcium, fosfomycin disodium, fosfomycin sodium and fosfomycin trometamol"
Commission Implementing Decision …/... concerning, in the framework of Article 107e of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substance " midazolam (oromucosal solution, treatment of prolonged, acute, convulsive seizures)"
Commission Implementing Decision .../... of XXX concerning, in the framework of Article 29 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for “Ibuprofen Kabi 400 mg Infusionslösung and associated names”, medicinal products for human use which contain the active substance “ibuprofen” "
Commission Implementing Decision .../... concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for veterinary medicinal products containing stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof
Commission Implementing Decision of XXX concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for veterinary medicinal products containing tiamulin hydrogen fumarate presented as premix for medicated feeding stuff and oral powder for in-feed use to be administered to pigs
Commission Implementing Decision .../... concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for veterinary medicinal products “Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products “ containing the active substance “Albendazole”
Commission Implementing Decision .../... concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for veterinary medicinal products “Modified live porcine respiratory and reproductive syndrome (PRRS) virus vaccines“ containing “Porcine respiratory and reproductive syndrome virus vaccine (live)”
Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Commission Implementing Regulation (EU) …/... of XXX amending Regulation (EU) No 37/2010 as regards the classification of the substance sodium salicylate with respect to its maximum residue limit in foodstuffs of animal origin
Commission Implementing Regulation (EU) …/... of XXX amending Regulation (EU) No 37/2010 as regards the substance 17β-oestradiol
Commission Delegated Regulation (EU) …/... amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of the drug precursor Isopropylidene (2-(3,4-methylenedioxyphenyl)acetyl)malonate (IMDPAM) and other substances in the list of scheduled substances
Commission Delegated Regulation (EU) …/... amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use
Commission Delegated Directive (EU) .../… amending Directive 2010/63/EU of the European Parliament and of the Council as regards the requirements for establishments and for the care and accommodation of animals, and as regards the methods of killing animals

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