The European Commission has prepared some specific answers to facilitate the implementation of the Delegated Regulation in a Question and Answers document.
EMVO has prepared a specific FAQ list for the Marketing Authorisation Holders, explaining important facts concerning their connection to the European Hub.
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.
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.
Is a connection to the national system needed?
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 license in Belgium, a wholesaler type connection to the national system can be requested by registering in the Distribution Registration section.
However, it is up to this entity to decide if they require such connection or if they prefer to perform the transactions on the EU Hub connection through the OBP.
Batches released as from 9 February 2019 should as soon as possible remove the linear barcode with the UBC. What is the definition of ‘Release’?
The ‘Release’ is defined as the moment when the Qualified Person is giving the approval for release of the batch to the supply chain.
Belgium has the possibility to extend the implementation to a later date than 9th February 2019. Will Belgium use this possibility?
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.
When will Belgium be ready to accept the 2D matrix barcode on the packaging?
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 need 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.
What products are to be considered for FMD in Belgium?
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 radiopharmaceuticals 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
Belgian Verification system
In case that, through a derogation, a pack from another market is being delivered, will the code from this other country be readable and transmitted to the EU Hub?
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.
If we register to the Belgian Verification System, is there a deadline for bringing the FMD-designed packs in the supply chain?
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 MAH is working with local distribution partners and local repackaging partners. Can they have a connection to the National Verification System and under which conditions?
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.
When scanning of the 2D barcode, will the pharmacist see the PC, SN, expiry date and batch number on his screen or will it generate just one long number that is checked in the database for these 4 numbers?
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.
Will GD. Luxembourg also use the Belgian Verification repository?
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.
When will the On Boarding Partner (OBP) of the MAHs be able to upload product and pack data for Belgium and Luxembourg?
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.
What is the procedure to establish a connection to the EU Hub?
The procedure to register and connect to the EU Hub is described on the EMVO-Medicines.eu website in the section On-Boarding.
How is the connection between the EU Hub and the Belgian national system? Do the codes need to be loaded in both systems?
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.
Will the manufacturer be able to upload the product data and pack codes to the EU Hub for different MAH’s?
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 organisations and 3rd party logistic partners. For more details, please consult the OnBoarding information on the EMVO-medicines.eu website.
Is the MAH responsible for uploading the data in the EU Hub or can he select who does the uploading? 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 On Boarding.
Packs & Codes
The product registrations for the European products are all done from one single location with a GTin code obtained from GS1 in the concerned country. Can this GTin code continue to be used in Belgium?
The GTin code (14), constructed according the GS1 standard, can be used in the 2D matrix in Belgium. There is no need to create a separate code. It is important that the MAH communicates the relation between the GTin and the CNK to the pharmacist association APB at firstname.lastname@example.org.
Will there be a fifth element included in the 2D matrix code for Belgium?
No. The 2D matrix code in Belgium needs to contain following elements: GTin (GS1 standard), random Unique Identifier (maximum 20 numeric or alphanumeric code), batch number, expiry date.
Is it mandatory to remove the CNK code post FMD implementation? Or can the CNK remain in human readable format?
The manufacturer can keep the CNK in human readable format on the pack on a voluntary base. The CNK in a linear barcode should be removed as soon as possible to avoid confusion. For all new batches released after 8/2/2019, the advise is to remove the UBC as soon as possible.
How is the date of the release of a new batch defined?
The release date is the date that the QA responsible is releasing the batch for distribution in the Supply Chain.
Are other countries like France and The Netherlands ready to use the GTin codes?
Some countries are deviating from the standard to use the GTin or are having a mixed situation of GTin, NTin (and even PPN, specific national number). Best is to contact your local representative in the concerned country to retrieve information on the specific country requirements.
Is the exception for packs smaller than 10cm only valid in Belgian or is it a European rule?
This rule is valid for all participating countries as specified in the Delegated Regulation, Article 7.
During the transition period, when will it be possible to discontinue to print the UBC (unique linear barcode) on the package and only have the 2D code for reimbursable products?
The new legislation will foresee that packs with only the 2D matrix code can be released to the Supply Chain as from August 2018. However, not all distribution stakeholders might be ready with the FMD implementation and carefulness is advised.
The product that is distributed, is not delivered as such to the patients but is being processed by the pharmacies and decomposed in smaller units. Do we need to apply the safety features?
All packs that are in scope of FMD need to bear the safety features. The decommissioning needs to be done at the moment the original pack is opened by the pharmacist or hospital according article 28 of the regulation.
Can products that are not in scope for FMD also have a 2D matrix code?
Products that are not in scope for FMD in Belgium can also carry a 2D matrix code, but this code can only have 3 data elements: GTin code, Batch number and Expiry date. It is not allowed that they would carry a Unique Identifier.
Will a variation type IA be accepted for a FMD compliant notification?
A IA-variation is by definition a variation where no content evaluation of the submitted change is required . The implementation of the safety features happens by means of implementation of the new QRD template. This is possible with a IA-variation with an impact on the product information (this is, a change that requires the submission of the QRD-template) and where no content evaluation of the submitted document is needed.
So, the implementation of the safety features can be submitted with a type IA variation under the condition that
• the submission of the QRD-template is a requirements for the concerned variation, and
• that there are NO other changes implemented that would require an evaluation.
In case the implementation has an impact on the mock-up, then the proposal of the new mock-up cannot be part of the IA-variation because this would require an evaluation, but would require a submission with a separate notification art.34§4 of RD of 14.12.2006.
In which cases will FAMHP accept grouping of the submission?
The existing principles for grouping remain of application. FAMHP would allow for an additional possibility: for products approved under the national procedure and where the implementation of the safety features has no impact on the mock-ups of the concerned products, the notification for the implementation of the safety features for these products can be submitted in one variation. The variation will contain the adapted QRD-template for each concerned product. The fee will correspond with the grouping of a type IA-variation.
If no change is planned before 2019 (no variation file) and the implementation has no impact on the readability of the pack, should a notification be submitted or can the notification be done by simple letter (cover letter) with the mention that the CNK is replaced by the 2D matrix code and has no impact on the readability?Can products that are not in scope for FMD also have a 2D matrix code?
The implementation plan from EMA/CMDh indicates clearly that the notification of the implementation of the safety features need to be done by means of submission of an adapted QRD-template. The new QRD-template needs to be submitted as indicated in the implementation plan. For the national procedure products this can be done using the grouping described before.
What need to be done for ongoing variations when an additional change is required due to FMD?
For products submitted through MRP, the FAMHP will apply the QRD templates approved by the Reference Member State. For products handled under the national procedure, the implementation of the safety features can be added to the dossier as long as the concerned documents have not yet been approved. Concerning the mock-ups, if the evaluation of the mock-up has not been started yet, a new proposal for the implementation of the safety features can be submitted, even if the QRD-template has not yet been adapted.
Will there be a “standard formulation” for the confirmation that the changes “have no impact on the readability of the packaging” in the cover letter?
FAMHP has published the standard formulation on their website, together with other guidelines regarding FMD. Standard text for the declaration The undersigned [name of the person responsible for the information, company name] declares that the implementation of the safety features (the unique 2-D matrix barcode and the anti-tampering device) have no impact on the legibility of the mock-up, most recently approved by the FAMHP, of [name of medicinal product]. The undersigned bears full responsibility for this.
When should Free Samples be decommissioned?
Article 41 of the Delegated Regulation states that medicinal products intended to be supplied as free samples, need to be indicated as free samples in the repository system and the decommissioning must be done before providing them to the persons qualified to prescribe them. Therefore, free samples can be decommissioned at any time between the moment they are qualified as free samples in the system and the moment when they are being distributed.
Is it mandatory that all packs on the market after 9 February 2019 contain the safety features?
Only the batches “released” by the QP as from 9 February 2019 need to contain the safety features. Packs from batches released before 9 February 2019 and not yet carrying the safety feature are still allowed on the market after 9 February 2019 until their expiry date.
Should free samples carry the same GTIN code as the commercial product?
If the free sample is the same pack as the standard supplied pack, you can use the same GTIN code (or create another one if you prefer). If the free sample is a special pack (eg reduced pack size, …), a different GTIN seems appropriate. Important is that the packs are decommissioned as free samples before they are distributed (art. 41 of the DR).
For Reimbursable products that are carrying a serial number in the linear barcode today, but that are on the “white list” (annex I of the DR), do they need to carry the safety features when distributed through public pharmacies?
Products that are on the “white list” (annex I of the DR) do not need to carry the safety features and should not have a Unique Identifier. This without impact on their reimbursement status.
What is a GLN?
A GLN (Global Location Number) identifies each location with an unique number. For more information, consult GS1 website: https://www.gs1belu.org/nl/standaarden/gln
When can the 2D matrix code be placed on the box and when can the linear barcode be removed (in terms of release date)?
How is the relation between GTin and the CNK maintained?
The relation between GTin and CNK is maintained in a conversion table by the pharmacist association ABP. MAH’s need to communicate the relation between their GTin and CNK prior to market access to email@example.com.
How should the Human Readable information be mentioned?
On instruction of the Belgian Medicines Agency, the product code (GTIN) must always be preceded by “PC”. The Serial number (UI) must always be preceded by “SN”.
Is it still allowed for a new batch to contain both the 2D matrix and the Linear barcode?
Batches released after 9/2/2019 should no longer contain the linear barcode, unless it is not immediately possible to remove them. In that case they should be removed as soon as possible.
Is it acceptable that a pack contains both the linear (UBC/CBU) and the 2D Data Matrix code?
No, mainly to avoid possible confusion for the end user when scanning the pack. When both codes are present, the end user might not know which code to scan because the end user has no means of knowing if the pack was released before or after 09/02/2019.
The MAH’s should replace the linear barcodes with the 2D Data Matrix code as soon as possible. Applicable legislation has been published by RIZIV/INAMI. In case both the linear barcode and the 2D Data Matrix code is present, then the user should scan the 2D Data Matrix code.
Can the application of a label “Medical Sample – Not for sale” on a pack released before 09/02/2019 be considered as a repackaging in the sense defined in Art.48 of the Delegated Regulation (EU) 2016/161?
No; packs released before 09/02/2019 do not need to be serialised prior to labelling them as “Medical Sample”. In case such packs are released after 09/02/2019 then these packs need to be decommissioned as “Free Sample” under the responsibility of the concerned MAH.
Are medicines that are available “op schriftelijke aanvraag / sur demande écrite” in scope for the Delegated Regulation (EU) 2016/161?
No, these products do not need to carry the safety features.
Is it mandatory that the status of a serial code in the national verification system always corresponds to the real status of the pack?
Yes. When a pack is dispensed, destroyed or the batch is recalled (non-limitative list of examples), then the status of that pack needs to be updated accordingly (decommissioned) in the national verification system(s).
Is it allowed to label a pack, which has been released before 09/02/2019 and that has no 2D Matrix code, with a unique linear barcode (UBC/CBU) after 09/02/2019.
Is it required to submit a request to change the manufacturing authorization (MIA) and the wholesale authorization (WDA) (Art. 12bis & 12ter, law of 25/03/1964) to the FAMHP when implementing the equipment for applying the safety features (manufacturers) and for verification and decommissioning (wholesalers)?
No. The implementation and equipment will be inspected at the next routine inspection. However, the application of the safety features (2D Data Matrix code and anti-tampering device) can only be performed by holders of a manufacturing license (MIA; Art. 12bis Law 23/03/1964) with activity 1.5.2 Secondary package. In case you do not have an authorization for such activity, a request to obtain/change the manufacturing authorization needs to be submitted.
As a manufacturer I plan to outsource the serialisation of my products to a third party. Do I need to submit a request to the FAMHP to change my manufacturing authorisation (MIA) (Art. 12bis Law 25/03/1964) to include this subcontractor as an additional “Place of Execution” on my manufacturing authorisation?
No. The application of the safety features is considered a full manufacturing activity. Therefore, the Marketing Authorisation Holder needs to submit a variation to the MA conform the variation regulation in order to add the subcontractor as a manufacturing site for the Marketing Authorisation. More information is available at https://ec.europa.eu/health/sites/health/files/files/betterreg/pharmacos/classification_guideline_adopted.pdf.
In case of a participation to the Pilot phase, by when do the packs need to be ready?
The current plan is to start the Pilot phase in November/December 2017 for packs that are prescription-bound and not reimbursed. The concerned packs can however already be brought in the supply chain as of Q3-2017.
Reimbursable packs in scope can only be brought in the supply chain with the 2D code when the data stream from pharmacies to RIZIV/INAMI has been adapted to the new data elements, expected by Q1 2018.
Is it a problem if we plan to participate to the Pilot phase, but eventually are not ready in time?
BeMVO hopes that many companies participate to the Pilot and can bring the products in the supply chain in time, otherwise it will not be possible for the participating distribution stakeholders to test the connection to the BMVS. However, we understand that pharmaceutical production planning and distribution imperatives can lead to a delay. We do not consider this as a problem for participation.
Is there a minimum number of products to participate to the Pilot phase?
No, each MAH can participate with even only one product.
We would need to have the pilot products with FMD requirements on the market by November 2017. Does this mean, product released and on the market?
The current plan is to start the Pilot in November/December 2017. The Pilot implies that FMD-designed packs are available in the supply chain allowing the distribution stakeholders to test their connection to the Verification System.
Do you have any other practical guidelines for this pilot?
The technical and procedure guidelines are shared with the participants to the Pilot. They will also be made available on this website.
Is it possible to register and contract different MAH’s with only one form?
No, this is not possible. The agreement, that includes the registration form, is a legal binding document that needs to be signed by the legal representative of the concerned MAH.
Can a MAH who has no products in scope today, but is planning to have products in scope by 9th February 2019 already register today to the Belgian Verification System?
Yes it is possible to already register today.
Our company is 100% controlled by the central corporation and both the corporation and the local subsidiary are registered as MAH for a number of products. Do we need to register both entities or is one registration, by the local subsidiary or the central entity enough?
A registration is needed for EACH MAH that is registered in Belgium having at least one product in his portfolio that is in scope for FMD in Belgium, even if the different MAH’s belong to the same corporation.
What is the procedure to register to the Belgian Medicines Verification System?
The procedure is described on the website bemvo.be in the section Registration/MAH. The registration requires the submission of the Registration Form and the signed Registration Agreement. The registration becomes fully active when the payment of the one-off registration fee is received by BeMVO.
When will it be possible to receive information on the level of the Flat Fee applicable as of 2019?
The level of the Flat Fee will be dependent on the required budget for the system and the operations and of the number of MAH’s that will active in Belgium in 2019 with products in scope. A preliminary estimate might be communicated in the second half of 2018.
Is the registration and Flat Fee the same for all companies?
BeMVO is aligned with the Blueprint guidelines from EMVO and the EU stakeholder associations and is applying the Flat Fee principle. The Fees are equal for each MAH.
Does the contract and registration form have to be signed by the MAH or can we have it signed by the legal representative of the MAH?
The registration and contract needs to be signed by the MAH. The MAH is the legal party responsible for bringing the products to the market and is also therefore the legal party that needs to enter into a contractual agreement with the BeMVO.
What about centralized registered products where the MAH is a central located company abroad (eg the HQ). Do we have to pay the fee for these products or must this be done by our HQ?
The agreement needs to be signed by the MAH responsible for the registration of the products in Belgium (Marketing Authorisation Holder) The payment, as well as the further follow up of the project, can be managed by the local affiliated company. This is up to the MAH and corporate organisation to decide on their internal procedures.
The products in our portfolio are not in scope of FMD. Can BeMVO confirm we do not need to register to the Belgian Verification system?
The BeMVO does not have a view on the product portfolio of the different MAH’s. It is the responsibility of the MAH’s to assess and decide if one of their products is in scope for FMD in Belgium. The definition of products that are in scope for Belgium is defined on the bemvo.be website. In case the MAH considers he is not in scope, we appreciate to receive confirmation by email on firstname.lastname@example.org.
Can the agreement between the MAH and the BeMVO be transferred to another MAH?
In case you have registered one MAH but decide at a later stage to move the products under this MAH to another MAH, then then agreement can be transferred to that other MAH.
Supply chain – Distribution stakeholders
In case the 2D matrix is damaged and cannot be scanned and also the human readable text is missing (eg because it is a small packaging), is the pharmacist still allowed to deliver the product?
It will be up to the pharmacist to decide what to do, but it is strongly advised that he verifies as much as possible the origin and authenticity of the product (contact wholesaler, …). In case of an issue afterwards, the pharmacist can be contacted by the inspection.
What to do when the 2D matrix information is not corresponding to the human readable text?
Such situation is very suspicious because this indicates that the pack is not conform the legislation and can potentially be a falsification… The authorities need to be contacted.
If the 2D matrix code is containing the GTin, how will this be linked to the product information in my system?
A conversion table providing the link from the GTin code to the CNK will be available as from November 2017. The table will contain all known GTins for the Belgian market and can be downloaded without cost from the FTP server. More technical details will follow at that moment.
Should the user scan and submit a verification to the repository for all packs containing a 2D matrix code?
No, the user should only submit a verification request to the repository system for the packs that are in scope of FMD in the country. A logic needs to be implemented in the user’s system to exclude verification of packs that are not in scope.
When should a wholesaler scan and verify a product?
The general principle for wholesalers is a risk based verification. This means that the wholesaler needs to verify the pack code where a falsification risk can be assumed. More specifically this is the case when he receives a pack – returned to him from the pharmacy or hospital (or other client) – from another wholesaler who is not the manufacturer/MAH or a wholesaler acting on behalf of the manufacturer/MAH The wholesaler also needs to decommission the pack when – the pack is exported outside the EU – the pack is returned to him (by pharmacy, …) and he cannot take the pack back into the saleable stock – the pack is intended for destruction – the pack is provided to the authorities as a sample – the pack is sold to persons or institutions which are outside the traditional supply chain (see list in chapter C.)
When should a public pharmacy scan and verify a product?
The pharmacy must verify the pack at the moment when the pack is supplied to the public. The pharmacy can also scan and verify the pack earlier, eg at reception, but anyhow a verification and especially the decommissioning of the pack must be done at the moment of delivery. The pharmacy also needs to verify and decommission the pack when – the pack cannot be returned to the wholesaler or manufacturer – the pack is provided to the authorities as a sample – the pack is subsequently used as authorized investigational medicinal product or as authorized auxiliary medicinal product [EU Regulation 536/2014, 2(2),(9) and (10)] The pharmacy is exempted from the verification and decommissioning if the product is provided to him as a free sample. But the pharmacy has to verify the anti-tampering device of the sample. In case the pharmacy is only supplying part of the pack, the verification and decommissioning must be done at the moment when the pack is opened for the first time.
When should a hospital pharmacy scan and verify a product?
The hospital pharmacy can verify and decommission the pack at any moment when the pack is in his possession, so also when receiving the pack, provided that after the decommissioning the pack is supplied within the hospital. The pharmacy also needs to verify and decommission the pack when – the pack cannot be returned to the wholesaler or manufacturer – the pack is provided to the authorities as a sample – the pack is subsequently used as authorized investigational medicinal product or as authorized auxiliary medicinal product [EU Regulation 536/2014, 2(2),(9) and (10)] The pharmacy is exempted from the verification and decommissioning if the product is provided to him as a free sample. But the pharmacy has to verify the anti-tampering device of the sample. A hospital pharmacy can also be exempted if the decommissioning was done by a wholesaler who belongs to the same legal entity as the hospital, there was no sale between the wholesaler and the hospital and the product is supplied within the hospital.
What do I need to do in case of an alert following a verification/decommissioning?
The procedure to apply in case of an alert for a potential falsification is available on the BeMVO website (section End Users):
If the wholesale license holder or the pharmacy is confronted with a serialised pack, how can he know if the pack was released before or after 09/02/2019, in order to know whether the safety features on the pack need to be verified/scanned?
The system user cannot know. As a general rule, the 2D Data Matrix code needs to be scanned when present on the pack. FAGG/AFMPS considers that, based on Art. 48 of the Delegated Regulation (EU) 2016/161, when a 2D Data Matrix code is present on a pack, even if the batch was released before 09/02/2019, this 2D Data Matrix code should be compliant with delegated regulation and that the data need to be uploaded in the Hub. The upload can be done by the MAH retrospectively.
In specific cases a veterinarian can order medicines for human use from a public pharmacy, according the cascade procedure (Art. 230 & 231 KB-AR 14/12/2006), for administration of the product to an animal. Does the delivered pack, if carrying a serial number, needs to be decommissioned?
Yes. The pharmacist delivering the pack to the veterinarian has to decommission the unique code in the same way as required for any dispense.