According to the decision of the Steering Committee of the European Medicines Verification System project implementation at national level, of July 16th 2018, the PILOT phase was held between August 1st – October 31st.
The PILOT Concept, undergone between May and July 2018 by the GL5-PILOT team, led by Mrs. Daniela Vasilescu, Senior Pharmacist, Head of Regulatory Affairs (HRA) Romania, Worldwide Safety & Regulatory-Innovative, Europe and International Regulatory Affairs, Pfizer Romania, contains the general description, technical and operational pre-requisites, End-Users types, test run, reporting results, test scenarios and successful test criteria.
Between August 1st and 15th 2018, the process of collecting End-User data from participants willing to take part in the PILOT phase of the PROD (operational) environment of the National Medicines Verification System (NMVS) has been taking place, announcement of the pilot phase. It should be noted that the enrollment of the End-Users in the PILOT phase could have taken place anytime during the testing period without any limitation to registration!
Taking part in the PILOT phase has involved fulfilling the following conditions by the entities responsible with verifying / decommissioning the unique identifier:
– making sure, beforehand, that the IT supplier provides assistance for each End-User location registered by the entity;
– the required technical and operational conditions available in the End-Users locations, namely:
• terminal/s with upgraded software application, allowing thus the connectivity with the NMVS,
• scanner that decodes two-dimensional Data Matrix ECC 200 code, linked to the terminal / application,
• operator and internet connectivity (direct or through local server);
– filling in and electronically signing the “Declaration of consent for voluntary participation in the PILOT phase” form which was later on sent to the following address: email@example.com ;
– successfully completing the registration and testing process in the NMVS IQE environment, for each End-User location, according to the OSMR Working Instruction related to the use of the NMVS. The organizations which do not have upgraded software applications, could have initially taken part in the PILOT phase using only the NMVS graphic web interface for testing those transactions which are accessible only from the web interface.
Here you can find the testing Scenarios for OSMR, for the Authorities, for Distributors, for Pharmacies, for Hospital Pharmacies, annexes to the original document:
1. PILOT Concept
2. OSMR_Authority (Test plan PILOT)
3. OSMR_Distributor (Test plan PILOT)
4. OSMR_Pharmacy (Test plan PILOT)
5. OSMR_Hospital Pharmacy (Test plan PILOT)
6. OSMR_OSMR (Test plan PILOT)