The European Medicines Agency (EMA) has implemented the European Medicines Verification System (EMVS) to ensure the safety of medicines in the European Union (EU). As part of this system, the EMA has also implemented the EMA Electronic Veterinary Medicines Product Database (EVMPD). In this essay, we will discuss the EMA EVMPD regulations and how they affect the veterinary medicines industry.
What is EVMPD?
The EMA EVMPD is a database that contains information on veterinary medicines authorized for sale in the EU. It provides a standardized way for manufacturers to report information on their products to regulatory authorities. The EVMPD contains data on the product, its packaging, and its manufacturer.
Why is EVMPD important?
The EVMPD is an important tool for the EMA to ensure the safety and quality of veterinary medicines in the EU. It allows for the tracking and tracing of veterinary medicines, which helps to prevent counterfeit or substandard products from entering the market. The EVMPD also allows for the quick identification and recall of products if safety concerns arise.
Reporting Requirements in EVMPD Regulations
Manufacturers of veterinary medicines must report information on their products to the EVMPD. This includes information on the product’s composition, its intended use, its packaging, and its manufacturer. Manufacturers must also report any changes to this information within a specific timeframe.
Submission Process in EVMPD Regulations
Manufacturers must submit information on their products to the EVMPD through the EMA’s electronic submission system. The information must be provided in a specific format that complies with the EVMPD’s requirements. Manufacturers must ensure that the information they provide is accurate and up-to-date.
Compliance
Manufacturers must comply with the EVMPD regulations to ensure that their products can be marketed in the EU. Failure to comply with these regulations can result in regulatory action, including the suspension or revocation of a product’s authorization. Manufacturers must ensure that they keep their product information up-to-date in the EVMPD.
Data Access in EVMPD Regulations
The EVMPD is accessible to regulatory authorities and other authorized parties. This includes the EMA, national competent authorities, and marketing authorization holders. The information contained in the EVMPD is confidential and can only be accessed by authorized parties.
Future Developments
The EVMPD is constantly evolving to improve the safety and quality of veterinary medicines in the EU. The EMA is working on implementing a new database, the EU Veterinary Product Information Management System (EUV-PIMS), which will replace the EVMPD. The EUV-PIMS will provide a more comprehensive and streamlined way for manufacturers to report information on their products.
The EMA EVMPD regulations play a crucial role in ensuring the safety and quality of veterinary medicines in the EU. The EVMPD allows for the tracking and tracing of veterinary medicines, which helps to prevent counterfeit or substandard products from entering the market. Manufacturers of veterinary medicines must comply with the EVMPD regulations to ensure that their products can be marketed in the EU. The EVMPD is constantly evolving to improve the safety and quality of veterinary medicines, and the EUV-PIMS will provide a more comprehensive and streamlined way for manufacturers to report information on their products.
Templarpharma expertise in EVMPD Regulations
Templarpharma’s EVMPD Data Management Services include a comprehensive strategy from organization readiness assessment, development of implementation road-map to end-to-end process implementation.
Assess Organizational Readiness
- Number and Complexity of Products
- The flow of current EVMPD data within the organization and among partners, as well as the sources of data and the potential fragmentation of data across the organization, are important factors that need to be considered.
- Regulatory Information Management Technology Components
- Compliance Expectations
- Time & Cost Commitments
Develop Strategy & Implementation Road Map
- Business Process Changes
- Product Data Ownership & Responsibility Commitments
- Interim Submission needs based on EVPRM
- Migration to Final Submissions based on IDMP compliance needs
- Technical Approach to Current vs. Future State Data Flow Needs
Process Implementation
- provides EVMPD data management and maintenance services that encompass the processes of data collation and data mapping to ensure compliance with regulatory requirements.
- Submission Management and Workflow Implementation
- Regulatory Information Systems Implementation & Validation
- Key Highlights
- Onsite Consulting Services at your premises
- Ongoing real-time coordination with Templarpharma’s EVMPD Conversion Services team
- Saves Time
- Cost-Effective model
Key Benefits
- Ready-to-use, Web-Based, On-Demand Solution
- Minimal setup and Out-of-the-box solution
- Saves Time
- No Lead Time lost in ‘Building a System’
- No Preliminary Implementation required
- Minimal start-up Cost
- Simple and Cost Effective Licensing Module
- 100% EVPRM Compliant XML Generation
- Assures compliance with the guidelines and business rules set forth by the European Medicines Agency (EMA).
- Online Training and Support