This report covers the market developments in Q3/2014, January-September 2014 and the data available as of November 2014. Most pharmaceutical market indicators recorded y/y decline in January-September 2014, as shown by official statistics. Imports dropped by 1.1% y/y to €1.5bn in January-July, after having increased by 7.8% y/y to € 2.7bn in full year 2013. Exports also declined by 10.5% y/y over the period. Production of pharmaceuticals shrank by 4.4% y/y in January-August. The retail sales of the broader category of pharmaceutical and cosmetic products also dropped by 15.8% y/y in January-September. The major deterrents are related to regulatory measures and public spending, as demand for treatment continues to increase and is expected to follow the same upward tendency in the coming years. The future performance of the market is linked to the update of the reimbursed drug list, which had remained unchanged in the period 2008-2014. In November 2014, the health ministry announced the introduction of 40 new molecules and active substances and a further update of the list by the yearend. In addition to this, the authorities decided to calculate the clawback tax differently for the medicines newly added to the list. Another important regulatory measure expected on the market is the amendment to the Pharmacy Law regarding demographic criterion. The proposed law, supported by the industry, maintained the demographic criterion that establishes a maximum number of pharmacies per thousand inhabitants in towns. Nonetheless, in October the President sent the law back to Parliament for revision, arguing that the criterion should be eliminated as of end-2015. Key points: • Pharmaceutical imports, exports decline in Jan-Jul 2014 • Pharma market performance in 2015, linked to reimbursed drug list update • Pharma companies to pay different clawback tax for drugs newly added to reimbursed list • Pharmacy Law amendments referred to Parliament for revision • Polisano’s pharmaceutical plant to start oncological drug production next year • Sandoz to invest €13mn in expanding production capacity at Targu Mures plant • ADM Farm files to court arrangement procedure with creditors