Anja Holm
Anja Holm is CEO, Central VetPharma Consultancy.
JournalNew data protection for maximum residue limits
Maximum residue limits (MRL) have been a requirement for all substances included in veterinary medicines intended for food-producing animals since the 1990s. The new Veterinary Medicines Regulation ([EU] 2019/6) provides an opportunity for data protection in relation to the data package submitted to the European Medicines Agency (EMA) when applicants ...
Meeting ReportVM3: Regulation 2019/6 on antimicrobials; requirements and availability
During the session, the speakers presented an overview of the new and revised rules and guidance, explored the major hurdles for new AMs, and discussed how we can protect existing AMs on the market through measures such as harmonisation of summaries of product characteristics (SPC) and flexible dosing labels.