Relevant information for pharmacies 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 pharmacies 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 pharmacies are described in chapters III and VI 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.
In the specific case of pharmacies, the Pharmacies Associations (AFP and ANF) will ensure the onboarding process of their members and the access to the national medicines verification system will be performed through the respective pharmacies portals.
The pharmacies that are not members of the AFP or of the ANF, may choose to connect to the national system through one of the Associations or through direct connection to the national system. For more information, please contact AFP through the email address firstname.lastname@example.org, ANF through the email address email@example.com, or MVO Portugal through the email address firstname.lastname@example.org.
For the pharmacies that are members of the AFP or of the ANF, the onboarding process consists of the signature of the agreement with the respective Association that, in turn, will ensure the performance of the remaining tasks. The process is identical for the pharmacies that are not members of the AFP or of the ANF but choose to use the pharmacies portal of one of them to access the national medicines verification system. The use of the pharmacies portals has no costs associated.
For the pharmacies that are not members of an association and that do not choose to use one of the pharmacies portals, 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 email@example.com.
- Registration 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;
- Execution of the 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;
- Signature of 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 test environment will be granted.
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-0067_Testing in IQE - Pharmacy, and musts be documented in MVOPT-0068_IQE Test Report – Pharmacy.
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 in order to participate, it is necessary to complete the respective onboarding process, as described above, in order to be able to use the test environment (IQE). The interested pharmacies must contact the respective Pharmacies Association (firstname.lastname@example.org or email@example.com). The pharmacies that are not members of an association must contact MVO Portugal through the email address firstname.lastname@example.org.