Public procurement notice: Contract Notice
Published: 2022-12-27
Buyer: Statens Legemiddelverk
Country: NO
Contract type: Services
Procedure: Open procedure
CPV classification: 48100000 | 72220000: Systems and technical consultancy services | 72410000: Provider services
Estimated value: 6000000 NOK
Submission deadline: 2023-01-27
Award criteria: The most economic tender

Technical requirements: Procurement of a SaaS solution to handle dossiers connected to applications for marketing licences for medicines - eSubmissions.
The overall aim of the procurement is to solve the Norwegian Medicines Agency's (NOMA) need for eSubmission management. The procurement is connected to the ongoing process of modernising NOMA's case management systems. The modernisation has uncovered a need to reduce manual work connected to handling the reception, making available, and journaling of dossiers that are submitted for applications for marketing licences (MT) for case management. The existing systems are difficult to continue without a large part of the manual work be transferred from the archive function to executive employees. By introducing a system that both handles loading, validating, and making dossiers available, and which can be integrated with the next generation case management system in NOMA, this problem will be solved:
- To automise the process of receiving, validating, and making dossiers available that are received from CESP, Common Repository, and in the future DADI / PL
- Lay the basis for being able to automise corrections and updates to cases in NOMA's new case management system, DELE
- To facilitate NOMA's executive employees having a suitable and user friendly tool for insight in and processing of all relevant dossiers
Documented by a company registration certificate or equivalent documentation that shows that the tenderer is registered in a register of business enterprises, a trade register, a professional register or a register of commerce in their home country.
b. Solidity assessment from a company with a licence to run a credit information company. The evaluation must not be older than 3 months from the deadline for receipt of tenders. It must be based on the last approved accounting figures and should report on the credit worthiness and degree of bankruptcy risk (bankruptcy prediction).
K3 - Tenderers must have good competence and capacity for the delivery and further development of eSubmission management system.
Automatic downloading from CESP and Common Repository, technical validation, and making available in the offered system
K5 - Tenderers must have established a satisfactory management system for information security (ISMS).
A copy of an information security certificate (ISO27001/equivalent), issued by an accredited certification bodyies, if relevant.
A copy of a quality management certificate (ISO 9001/equivalent), issued by an accredited certification body, if relevant.
A description of the tenderer’s quality management system as well as how it is implemented and managed internally.

Eligibility requirements: Documented by a company registration certificate or equivalent documentation that shows that the tenderer is registered in a register of business enterprises, a trade register, a professional register or a register of commerce in their home country.

Award value: 6000000