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.

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 request form. Once it is filled in, the form must be sent to the email address mvo.portugal@mvoportugal.pt.
• 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 provided by MVO Portugal;
• 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, 4º
  1495-139 Miraflores, Algés

  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. 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 and must be documented according with the documentation provided by MVO Portugal..
  
  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.
  
  Schematically:
  

More information can be found here e here.