Relevant information for holders of a wholesale distribution of medicinal products for human use authorization 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 Wholesalers (e.g. pre-wholesalers, wholesalers, stockists) must perform the operations of verification and/or decommissioning of the packs in their possession.
The European medicines verification system was not conceived in a track & trace logic. This means that the performance of the operations of verification of the authenticity and of decommissioning of the unique identifier by the distributors are mandatory in the following situations (pursuant to article 22 of the Delegated Regulation):
- Medicinal products which he intends to distribute outside of the Union;
- Medicinal products which have been returned to him by persons authorized or entitled to supply medicinal products to the public or another wholesaler and cannot be returned to saleable stock;
- Medicinal products which are intended for destruction;
- Medicinal products which, while in his physical possession, are requested as a sample by competent authorities;
- Medicinal products which he intends to distribute to the persons or institutions referred to in article 23 of the Regulation, where required by national legislation in accordance with the same article. Decree-Law no. 26/2018, of 24 April provides in article 105-A(9) that the distributors must perform the operations of verification of the authenticity and decommissioning of the packs to be distributed to “Points of sale of medicinal products not subject to prescription” and to “institutions and services holding an authorization for the direct procurement of medicinal products issued by INFARMED, I.P., that are not integrated into public or private healthcare institutions, and that provide medical and pharmaceutical services and inpatient treatment. More information can be found in number 21 of the document Dispositivos de Segurança – FAQ, prepared by INFARMED, I.P.
According to the Delegated Regulation (pursuant to article 20), the distributors are also obliged to perform the operations of verification of the authenticity of the unique identifier of the medicinal products returned to them by persons authorized or entitled to supply medicinal products to the public or by another wholesaler and of the medicinal products they receive from a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorization nor a wholesaler who is designated by the marketing authorization holder, by means of a written contract, to store and distribute the products covered by his marketing authorization on his behalf.
According to the Delegated Regulation (pursuant to article 21), the distributors do not have to verify the authenticity of the unique identifier, when:
- that medicinal product changes ownership but remains in the physical possession of the same wholesaler;
- that medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, and no sale takes place.
The obligations of the distributors are described in chapters III and V of the Delegated Regulation.
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 for Authorization Holders with MVO Portugal consists of the following steps:
- Filling in and sending the access requestform. Once it is filled in, the form must be sent to the email address email@example.com.
- Registering in the portall 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;
- 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 here;
- 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,
Edificio ATLAS I,
Av. José Gomes Ferreira, nº 9, 4ºAfter having been duly received and validated, one of the hardcopies, signed by MVO Portugal, will be returned.
1495-139 Miraflores, Algés
Once the four steps described above have been successfully concluded, the access credentials to the national medicines verification system test environment will be granted. Once the credentials for the access 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-0069_Testing in IQE - Wholesalers, and must be documented in the form MVOPT-0070_IQE Test Report – Wholesalers.
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 decommissioning of unique identifier 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, the 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 must contact MVO Portugal through the email address firstname.lastname@example.org.
More information about the pilot phase can be found here.