Relevant information for healthcare institutions can be found here.
Verification of the authenticity of the packaging and decommissioning of the Unique Identifier
Commission Delegated Regulation (EU) no. 2016/161 of 2 October 2015 provides that the healthcare institutions must verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public.
The obligations of the healthcare institutions are described in chapters III and VI of the Delegated Regulation.
Pursuant to article 105-A(9) of Decree-Law no. 26/2018 of 24 April, the establishments and services holding an authorization for the direct procurement of medicinal products issued by INFARMED, I.P., that are integrated in public or private healthcare institutions, that provide medical and pharmaceutical services and inpatient treatment, are obliged to be connected to the national medicines verification system. For more information, see the answer to question 21 of the document Dispositivos de Segurança – FAQ, prepared by INFARMED, I.P.
Access to the medicines verification system
For a user to access the national medicines verification system, the access validation process must be successfully completed. This process is called onboarding process and its purposes are the validation of the legitimacy to access the system, the technical validation and the signature of the agreement governing the relationship between each entity and MVO Portugal.
The onboarding process consists of the following steps:
- Filling in and sending the access request form. Once it is filled in, the form must be sent to the email address firstname.lastname@example.org.
- Registering in the portal https://sws-nmvs.eu/. The technical documents (i.e., code examples, description of the interfaces, etc.) necessary for the development of the integrations with the national medicines verification system are available in this portal;
- o Executing preliminary tests. The preliminary tests will be executed after successful registration in the portal referred to in the previous paragraph, using the baseline testing functionality. The tests are executed in the sandbox environment. The results of the tests must be documented in the form available for that purpose in the above mentioned portal and aqui;
- o Signing the draft of the contract. The draft of the contract will be sent by email after the reception of the access request form. Two hardcopies must be signed and sent to the following address: MVO Portugal – Associação Portuguesa de Verificação de Medicamentos, Torre de Monsanto, Rua Afonso Praça 30, 7º, 1495-061 Algés, Portugal.
After having been duly received and validated, one of the hardcopies, signed by MVO Portugal, will be returned.
Once the four steps described above have been successfully concluded, the access credentials to the national medicines verification system test environment will be granted and the process will be completed. Once the access credentials to the test environment, designated as IQE (see scheme below) have been granted, additional tests must be performed, prior to moving to the production environment. The tests to be executed are described in the document MVOPT-0065_Testing in IQE - Hospitals, and must be documented in the form MVOPT-0066_IQE Test Report - Hospitals.
Once the steps within the test environment, described above, have been successfully concluded and validated by MVO Portugal, the access credentials to the production environment will be granted and the process will be completed.
The pilot phase consists of a period of tests the main purpose of which is to use the system in conditions as close as possible to the real conditions in which the system will be used after the entry into force of the Delegated Regulation. For the execution of this set of tests, the participation of MA Holders or of Parallel Distributors, distributors, pharmacies and healthcare institutions is necessary, for each of them to perform their daily verification and unique identifier decommissioning tasks and to ensure that it is possible to verify the flux of packs from the manufacturer to the point of dispense.
The participation is voluntary and we invite all interested distributors to participate. For this purpose, distributors are required to complete the above mentioned onboarding process is necessary, in order to be able to use the test environment (IQE). The interested distributors should contact MVO Portugal through the email address email@example.com.
More information about the pilot phase can be found here.