About
The rules governing veterinary medicinal products in the European Union (EU) establish standards and procedures to ensure proper regulation of these important products, both pre- and post-market entry. Prior to introducing any new veterinary medicinal product to the market, regulatory authorities conduct a thorough review to determine compliance with necessary standards. This process, known as the "Marketing Authorisation process," mandates that any new medicine is supported by a detailed data dossier that establishes the safety, quality and efficacy of a product.
The course will introduce you to the clinical and safety documentation (DACS - Detailed and Critical Summaries) required to support a veterinary marketing authorisation application in the EU.