• RoundupsRoundups

    EU Regulatory Roundup: Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers   Ireland’s Health Products Regulatory Authority (HPRA) has reported an almost four-fold increase in its annual number of marketing authorization holder (MAH) transfers. The jump covers the run up to the date on which the United Kingdom was originally due to leave the European Union.   In...
  • RoundupsRoundups

    EU Regulatory Roundup: Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply   Ireland’s Health Products Regulatory Authority (HPRA) has shared details of its work to mitigate the risk that a no-deal Brexit will disrupt the supply of medical devices. HPRA wants companies to consider their stocking levels and make arrangements to ensure they can replenish their supp...
  • Feature ArticlesFeature Articles

    Spain Reimbursement Profile

    This profile summarizes the reimbursement process in Spain, presents key stakeholders and highlights what should be considered early in the development process. Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are authorized by regulatory agencies (e.g., AEMPS) is a separate and crucial process without which ...
  • Regulatory NewsRegulatory News

    Spanish Regulator Cites Madrid Drugmaker for Manufacturing Violations

    The Spanish Agency of Medicines and Medical Devices (AEMPS) has issued a statement of non-compliance to Madrid, Spain-based drugmaker Angulema, S.L., and ordered the recall of more than 400 lots of the company's vaccines. According to AEMPS, "the quality of the products manufactured by this site cannot be assured," after a two-day inspection uncovered "critical and major deficiencies" impacting Angulema's quality system and manufacturing processes for the company's produ...
  • Spain Launches new Registry of API Manufacturers, Distributors, Importers

    The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, import and distribution of pharmaceutical active ingredients in Spain. The Unified Public Business Registry of Active Substance Businesses (RUESA) is part of the transposition of Directive 2011/62/EU , which addresses counterfeit drugs in the European Union and includes additional controls for active ingredients. The aim of the RUESA is to s...
  • Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines

    • 26 October 2012
    Two influenza vaccines manufactured by Novartis, a Swiss pharmaceutical company, have seen their marketing privileges temporarily revoked in at least three European countries this week as regulators expressed concerns regarding contamination and possible adverse side effects. The vaccines-Agrippal and Flaud-were first banned by the Italian Health Ministry after the Italian Pharmaceutical Agency (AIFA) said it was aware of the, "Presence of a protein aggregation phenome...