Regulation
The Federal Agency for Medicines and Health Products (FAMHP/FAGG/AFMPS) has published the guidelines and Q&A documents related to the Falsified Medicines Directive.
They are available in Dutch; French and English.
According to Art. 19 of the Delegated Regulation (DR 2016/161), manufacturers have to fulfil as well the requirements on wholesalers as set forth in Art. 20 (a), 22, 23, and 24 of the DR. However, the DR does not define that manufacturers need to do this via direct access to the national system.
SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE
The European Commission has prepared some specific answers to facilitate the implementation of the Delegated Regulation in a QUESTION AND ANSWER DOCUMENT.
There are two types of connections possible to the national system. A connection for wholesalers and a connection for pharmacies (public and hospital). If the manufacturer, marketing authorization holder or the 3rd party logistics partner of the MAH has a wholesaling licence in Belgium, a wholesaler type connection to the national system can be requested by registering in the Distribution Registration section, taking into account Question 5.11 in the Q&A version 17 of the EU commission.
There are two types of connections possible to the national system. A connection for wholesalers and a connection for pharmacies (public and hospital). If the manufacturer, marketing authorization holder or the 3rd party logistics partner of the MAH has a wholesaling licence in Belgium, a wholesaler type connection to the national system can be requested by registering in the Distribution Registration section, taking into account Question 5.11 in the Q&A version 17 of the EU commission.
The ‘Release’ is defined as the moment when the Qualified Person is giving the approval for release of the batch to the supply chain.
The national competent authorities have decided that Belgium will not extend the implementation period and expect the stakeholders to be ready by 9th February 2019.
2D matrix barcodes can be put on the packaging as from mid 2017. During the transition period, for reimbursable products that are bearing the Unique Barcode (UBC) with the serial number today, this linear barcode needs to remain on the packaging until August 2018. From that date on, packs with only the 2D matrix code will be allowed on the market.
The Directive 2011/22/EU is adding point 54(o) to the Directive 2001/83/EC stating that the safety features need to be applied “for medicinal products other than radio pharmaceuticals referred to in article 54a (1)…” The scope of FMD in Belgium has been defined by the competent authorities: – All products subject to prescription
– Plus the Black list (DR annex 2)
– Minus the White list (DR annex 1)
– Plus all reimbursable products that are bearing a serial code (UBC) today, except if they are on the White list
Depending on the setup of the scanner of the concerned distribution stakeholder, the scanner will be able to read the ‘alternative’ coding scheme of the 2D barcode. In case the scanner cannot read the 2D, the stakeholder must enter the code manually so the verification or decommissioning can be done in the repository of the concerned country through the EU Hub connection.
Depending on the setup of the scanner of the concerned distribution stakeholder, the scanner will be able to read the ‘alternative’ coding scheme of the 2D barcode. In case the scanner cannot read the 2D, the stakeholder must enter the code manually so the verification or decommissioning can be done in the repository of the concerned country through the EU Hub connection.
There is no deadline to bring the new packs on the market other than 9th February 2019. We suggest however to progress as soon as possible given the different aspects that need to be considered and implemented: connection to the verification system, adapting production lines, reviewing internal processes, …
The EMVS system (Hub and national system) has been designed that MAH and their 3rd party logistics partners can have access through the connection of the OnBoarding Partner. This connection, besides loading the product pack data, can also be used for verification and decommissioning. However, if the MAH or his 3rd party logistics partner is owner of a wholesaling license in Belgium, the concerned company can request for a “wholesaler type” connection by registrating in the Distributor Registration section.
The way the result of the scanning of the 2D matrix code is displayed and processed in the system of the pharmacists depends on the way his software vendor is developing the functionality. The pharmacists’ system will contain a Gtin-to-CNK conversion table allowing the system to display all needed product information for the pharmacist.
Yes, the end users in GD Luxembourg will also be connected to the Belgian Verification repository. Therefore, the data for all products that officially registered in Belgium and/or in GD Luxembourg will need to be loaded in the Belgian repository. The MAHs that have signed an agreement with the BeMVO and/or the LMVO will receive the technical details and guidelines on how the data for the two countries needs to be uploaded in the Country Specific Master data.
The OBPs, acting on behalf of the Marketing Authorisation Holders, can already upload the product master data today to the Hub. The Batch and Pack data (pack codes) for Belgium and Luxembourg can only be uploaded when the Belgian Verification system is connected to the Production environment of the Hub. This connection is scheduled for end of January 2018 (but can be subject to change). MAHs that have signed an agreement with the BeMVO will be informed about the exact date of the Go Live of the connection and will also receive the loading guidelines for the Belgian and Luxembourg data. MAHs that did not sign the agreement with the BeMVO or LMVO will not be able to upload the pack data.
The procedure to register and connect to the EU Hub is described on the EMVO-Medicines.eu website in the section On-Boarding.
The procedure to register and connect to the EU Hub is described on the EMVO-Medicines.eu website in the section Onboarding.
The product master data and the unique codes for the individual packs need to be uploaded in the Hub. The onboarding and loading procedures are documented on the EMVO-medicines.eu website. The codes will then automatically be downloaded to the national systems, including the BMVS (Belgian Verification system), referred to in the product master data. Important to be aware that the codes can only be loaded when the connection between the Hub and the National system is active. The files with unique pack codes are only kept active for 24 hours on the Hub. If the connection to the national system is not ready, the file with the codes will be deleted after 24 hours and the codes will have to be reloaded at a later stage.
The uploading of the product and pack data is done through a ‘OnBoarding Partner’ (OBP). Such OBP can group the data coming from different Manufacturers & MAH’s from the same corporation, including data coming from contracted manufacturing organizations and 3rd party logistic partners. For more details, please consult the OnBoarding information on the EMVO-medicines.eu website.
The local MAH is only managing the distribution where the manufacturing is done in a central location and also done by a contract manufacturing organisation. The corporate organisation can opt to regroup all loading activity through one OnBoarding Partner (OBP). The OBP needs to register to the EU Hub and organise the internal processes to load the data from the different locations. More information on the different options is available on the EMVO-Medicines.eu website in the section Onboarding.
KNOWLEDGE DATABASE EMVO
EMVO has prepared a specific FAQ LIST for the Marketing Authorisation Holders, explaining key facts related to their connection to the European Hub.
