Heads of Medicines Agencies - Central European Submission Platform
Technologies: IIS, .NET, ASP.NET, SQL Server, sFTP
Customer Profile
The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of Medicinal Products for human and veterinary use in the European Economic Area. The Heads of Medicines Agencies is supported by working groups covering specific areas of responsibility and by the Heads of Medicines Agencies Management Group and Permanent Secretariat.
Business Situation
The HMA set out to establish a single portal for electronic submissions to multiple competent authorities for European registration and post-approval procedures in the European Economic Area.
Applicants had been sending each submission to each national authority separately on CD-ROM or DVD, with a paper submission letter or application form alongside. The Central European Submission Platform (CESP) was conceived by a group of EU member states and industry representatives, managed by HMA, to replace that with one secure electronic channel for both human and veterinary medicinal products.
Solution
Engine Solutions built CESP to provide a simple and secure mechanism for exchange of submission information between applicants and agencies, covering the following:
- National, Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) application types
- Initial, variation and renewal submissions
The system was designed to:
- Provide a secure method of communicating with the regulatory agencies via one platform
- Allow submission of an application once to reach all required agencies
- Remove the burden on industry and regulators of submitting and handling applications on disc
Results
Applicants submit once through CESP and the submission reaches every agency it is addressed to, with no parallel discs or paper. CESP is available to all EU and EEA member states and to authorisation applicants and holders, and is accessed at cesp.hma.eu.
Each company appoints its own company administrator, who sets up and maintains CESP access for the company's staff.