The State Institute for Drug Control in Czech Republic (SUKL) has published the information with regard to reporting of registration holder pursuant to Section 33, paragraph 2 of Act on Pharmaceuticals. It draws the attention to the obligations set out in Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (hereinafter…
The Hungarian Association of Innovative Pharmaceutical Manufacturers (AIPM) has welcomed the fact that the size of the pharmaceutical budget (the price subsidy for medicinal products available in pharmacies) will increase according to the draft budget for 2018. According to the draft legislation, the size of the pharma budget will be 337.4 billion forints ($1.22 billion),…
In 2017 the pharmaceutical market in Poland posted a 5.4 percent growth. The industry continues to demonstrate value growth with a total market estimated at EUR9bn. The surge in demand for over the counter medicinal products largely contributed to the sector growth. It is access to innovative prescription pharmaceutical products and improvement of drug reimbursement…
The European Medicines Agency (EMA) on Wednesday said it expects fees paid by drugmakers for pharmacovigilance applications to rise by 1.4% in mid-January 2018. Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014, which includes provisions for the European Commission to adjust the fees to keep up with the rate of…