• Croatia Joins Ranks of EU Member States, Raising New Requirements for Industry

    The European Union is as of today one nation larger, with Croatia bringing its citizens into the union-and with them new responsibilities for companies marketing pharmaceutical products in the EU. In July 2013, the European Medicines Agency (EMA) issued an advanced warning to pharmaceutical companies that Croatia would be joining the EU as of 1 June 2013, requiring all labeling for medications to be translated and submitted to Croatia's regulatory authorities. "This p...
  • EU Marketing Authorization Holders Have 40 Days to Make Labeling Changes

    The European Medicines Agency (EMA) is once again warning applicants and holders of marketing authorizations to be mindful of the pending addition of Croatia to the EU, which has a number of regulatory implications for pharmaceutical companies. Holders of marketing authorizations (MAHs) are legally required to have their product information, including labeling, available in the official languages of all EU member states. As of March 2013, there are 27 such states, stretc...
  • Pfizer Settles With SEC Over Charges it Bribed Foreign Regulatory Officials

    Pharmaceutical manufacturing giant Pfizer has settled corruption charges leveled against it by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), both of which said the company had violated the Foreign Corrupt Practices Act (FCPA) by bribing foreign officials to win business and allow its products to access markets. SEC said in a statement the company and its agents had bribed officials in Bulgaria, China, Croatia, the Czech Republic, I...
  • EMA to Applicants: Go Digital--and Don't Forget Croatia

    • 06 July 2012
    The European Medicines Agency (EMA) has two messages for applicants of marketing authorization applications: please submit all applications electronically, and don't forget to submit labeling translations to Croatian regulatory authorities. In a statement released 5 July, EMA said it is imploring sponsors of pharmaceutical products to start taking advantage of its electronic application forms, including its eSubmission Gateway, due to its relative ease of use. The ag...