Ensuring Compliance with MHRA's Legacy System Update

Dear Pharmaceutical Industry Professionals,

In the realm of pharmacovigilance and regulatory compliance, it is imperative for Marketing Authorization Holders (MAHs) to maintain rigorous standards in reporting individual case safety reports (ICSRs). As per the guidelines set forth by regulatory authorities such as the Medicines and Healthcare products Regulatory Agency (MHRA), adherence to protocols is not just a best practice, but a legal requirement.

Key Regulatory Updates:

1.PvEdge E2B R2 and R3 Compliance: We are pleased to announce that PvEdge database ensures full compliance with the E2B R2 and R3 standards, as mandated by MHRA and other regulatory authorities. This streamlines the process of ICSR submissions, enabling seamless communication with regulatory bodies.

2.Direct Submission to MHRA: In alignment with MHRA guidelines , MAHs are reminded of the necessity to submit all UK individual case safety reports (ICSRs) and serious non-UK ICSRs directly to MHRA. This can be facilitated through either ICSR Submissions or Gateway, ensuring prompt and efficient reporting of safety concerns.

3.Northern Ireland Reporting Protocol: It is crucial to note that for cases pertaining to Northern Ireland, the country code "XI" should be utilized when sending ICSRs to MHRA. This specific requirement ensures that reporting procedures remain consistent and compliant across all regions within the UK.

Our Commitment to Compliance:

As a provider of pharmacovigilance solutions, we understand the significance of adhering to regulatory guidelines. With PvEdge, we are dedicated to assisting MAHs in maintaining compliance with MHRA and other regulatory authorities. Our goal is to facilitate seamless reporting processes while upholding the highest standards of patient safety.

Training and Support:

To further support our clients in navigating regulatory requirements, we offer comprehensive training sessions and ongoing support from our team of experts. Whether you require assistance in understanding reporting protocols or technical guidance in utilizing our software, we are here to ensure a smooth and efficient experience.

Conclusion:

In current regulatory landscape, staying compliant is paramount. With PvEdge and our unwavering commitment to support, we are equipped to assist MAHs in meeting their regulatory obligations with confidence and ease. Together, let us prioritize patient safety and uphold the integrity of our industry. PvEdge is a cloud ready pharmacovigilance software for safety database management developed by Sarjen System Pvt Ltd A Trusted Digital Transportation and Automation Partner.