Please find relevant information for holders of marketing authorizations and Parallel Import Authorization holders here.
Placement of safety features
Pursuant to the provisions of Directive 2001/83/EC, of the European Parliament and of the Council of 6 November 2001, amended by Directive 2011/62/EU, of the European Parliament and of the Council, of 8 June 2011 and of Commission Delegated Regulation (EU) 2016/161, of 2 October 2015, the manufacturers must place safety features on the packaging of the medicinal products.
The safety features are the following:
- Unique identifier: the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product;
- Anti-tampering device: the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with.
More information on safety features can be found here.
In addition to the obligation to place safety features on the packaging of medicinal products, the companies holding marketing authorizations (MAH) or parallel import authorizations (parallel distributors) must upload the data to the EU Hub. More information can be found here.
The obligations to be complied with by the companies holding marketing authorizations (MAH) or parallel import authorizations (parallel distributors) are described in chapters III, IV and VIII of the Delegated Regulation.
Access to the repository system
In order to access the medicines verification system, the companies holding MA or the Parallel Distributors must complete the onboarding processes with the European Medicines Verification Organization (EMVO) and the National Medicines Verification Organizations (NMVO) of the countries in which they operate. In the Portuguese case, the national onboarding is made with MVO Portugal.
Onboarding process – European medicines verification system
The companies holding MA’s or Parallel Import authorizations must connect to the European medicines verification system through the EU Hub. The MA or Parallel Import authorization holders will upload the data regarding the medicinal products to be marketed through the EU Hub. More information on the data to be uploaded can be found here.
The connection to the EU Hub will be established by the onboarding partner (OBP). The onboarding partner (OBP) is the legal entity that will conclude a contract with EMVO to upload data to the EU Hub. This legal entity will act in representation of the companies of the group it belongs to. For example: in the multinational group XPTO that operates in the 32 countries involved in the project, the legal entity XYZ will be the onboarding partner before EMVO and will upload the data regarding the packs that will circulate in the 32 countries. The countries do not need to individually connect to the EU Hub.
We highly recommend starting as soon as possible with the onboarding to the EU Hub. For more information please visit the following link: https://emvo-medicines.eu/.
To initiate the onboarding process with the EMVO, please visit the following link: https://emvo-medicines.eu/pharmaceutical-companies/obp-portal/.
Onboarding process – national medicines verification process
Onboarding with MVO Portugal consists of two steps:
- Filling in, signing and sending the draft of the contract to MVO Portugal. More information can be found in the document MVOPT-0044_Onboarding of Authorization Holders;
- Proceed to the payment of the respective participation fee. More information can be found in the document MVOPT-Custos participação Titulares de AIM_AIP para 2019.
The drafts can be requested by email to the following address firstname.lastname@example.org.
The MA holders or the Parallel Distributors will perform the operations in the system through the EU Hub. However, onboarding with MVO Portugal (and with each NMVO regarding the countries in which they operate) is necessary for the obligations set forth in the Directive and in the Delegated Regulation to be complied with.
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 MA Holders or Parallel Distributors to participate. For this purpose, completion of the above mentioned onboarding processes is necessary, both with the EMVO and with MVO Portugal. The interested Marketing Authorization or Parallel Import Authorization holders must contact MVO Portugal through the email address email@example.com.
More information about the pilot phase can be found here.