With the new veterinary regulations Regulation (EU) 2019/6 coming into effect in January 2022,isn’t it time to look at the benefits of streamlining veterinary product management? Wouldn’t it be beneficial to get support for submission planning, drill deep down into data using Analytics, minimise manual more error prone tasks and at the same time increase efficiency and data quality? Many pharmaceutical companies have implemented Regulatory Information Management (RIM) solutions, benefitting from improved business processes, data sharing (specifically across different business units) and shortening their timelines to submit marketing applications. Why should companies manufacturing and managing veterinary products not be able to achieve the same?
For some time, VNeeS has been the preferred submission format in Europe with the latest guidance version 2.7 to be implemented in October 2020. Already, with the implementation of Step 7, the VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, GL53) provided details of recommended electronic file formats. In contrast to the eCTD (electronic Common Technical Document) for human drugs, PDF/A has been favoured. PDF/A is an ISO standardised version of PDF (Portable Document Format), especially used for archiving electronic documents; however, PDF/A prohibits features such as external content references and encryption.
Regulatory Information Management can of course assist during the process of document creation, management and archiving, whether these documents are PDF/A or any other format. This already provides benefits of a single place of access across business functions, the ability to use and harmonise document structures, as well as data security. The real advantages though come from the ability to plan and manage the entire submission lifecycle via project templates, increase data consistency via the ‘single place of truth’ and synchronise business processes via the use of technology. Moreover, with management of multiple species per product and the addition of medical devices for animals, Regulatory Information Management suddenly becomes a viable option for companies that would like to increase their productivity. RIM can assist with secure data access, management of global product portfolios and task automation to bring life saving products to the market faster.
Samarind RMS is one of these options.
Please feel free to contact us with any questions or if you require further information.