Information on the execution of tests in the IQE environment
Note: This information is addressed only to users who have not already performed IQE tests. “According to the EMVO release we inform you of the following (On August 20, 2019 EMVO communicated the following information): The EU HUB IQE environment will not be available on 08/23/2019 between 13: 00-17: 00 due to maintenance activities, which will affect the IQE test environment. During the above mentioned time period, please do not perform tests in the IQE SNVM environment, as their results will be erroneous and will not be validated by OSMR. We will return with information related to the normal return of the EU HUB IQE environment, respectively the IQE test environment, when they will be communicated by EMVO.

Instructiuni-Cod_Datamatrix_.docx

EMVO_LoA_0087_1.04.08-restoration

Obtaining and Maintaining the Access to the NMVS

The End-Users’ registration process to the National Medicines Verification System (NMVS) includes, as a mandatory preliminary step for the access to the production environment (PROD) of NMVS, the execution of tests by the End-Users in the test environment (IQE).

OSMR has communicated to the End-Users the deadlines for the execution of these tests, as well as the information necessary to complete this process, further available on this page and on:

Instructions Manual

Following the verifications carried out by OSMR regarding the accuracy of the tests executed by the End-Users as well as the LUF (End-Users’ Location) accounts created in the test environment, we would like to remind you that all End-Users have the obligation to create at least one LUF exclusively in the test environment (IQE) and initiate a number of 8 test scenarios. These have become mandatory after each major system change and should only be executed in the test environment (IQE).

In order to correct the data/accounts, during the next period, OSMR will notify all End-Users for whom the tests in the IQE environment and/or LUF accounts have not been executed according to the Instruction Manual.

We remind you that obtaining and maintaining access to NMVS’s production environment is conditioned by the accurate creation of the LUF and the documented existence of test transactions by uploading the Test Report to the SIMI account (Registering and Incident Management System).

Clarification of API tests in the NMVS IQE environment

OSMR aims to proactively offer End-Users the necessary clarifications to carry out the mandatory testing process in the National Medicines Verification System (NMVS) test environment (IQE).
The Local Application (Application Programming Interface – API) – represents any software application used by the End-Users (pharmacies, wholesalers, hospitals) to connect to the National Medicines Verification System (NMVS) in order to carry out activities related to the serialization process (e.g.: decommissioning, verification), prior to medicines being released to the patients.
API Tests are addressed exclusively to the Local Application.
We would like to mention here that there are End-Users with restricted access – according to the legal requirements, which do not use the local application (API), thus the only tests that can be done are those carried out via the WEB interface.
If you do not have the technical knowledge required in order to perform the API tests, please contact the software supplier you collaborate with or have collaborated with to connect your application to the NMVS.
Therefore, it is the responsibility of both the End-Users and their software providers to ensure the NMVS connection solution is properly qualified and that all due diligence is performed (carrying out the mandatory tests in IQE environment, together with the release of a major system version).

On 19.07.2019, on the NMVS integrated quality environment (IQE) a new major version of the NMVS application was rolled out.
Therefore, please be informed that starting with 30.07.2019 OSMR will create the corresponding ADMIN accounts for each End-User.
All End-Users (Clients) must create at least one End-User Location account (User) and perform a number of 8 testing scenarios, according to the documentation from the LINK’s found below.
The IQE testing became mandatory after each major update of the application and it must be performed exclusively in the testing environment (IQE).
Please, after completing the tests, upload the report in crm simi, under the document type “iqe report”
Please be reminded that the access to NMVS is conditioned by the documented evidence of this testing phase.
The lack of the testing can lead to loss of access rights to the NMVS.

Testing report

Completion model IQE TEST REPORT (EXAMPLE)

Test cards / Test Data