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PACKS & CODES
The GTin code (14), constructed according to 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 email@example.com.
No. The 2D matrix code in Belgium needs to contain the following elements: GTin (GS1 standard), random Unique Identifier (maximum 20 numeric or alphanumeric code), batch number, expiry date.
The manufacturer can keep the CNK in human-readable format on the pack on a voluntary basis. 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 advice is to remove the UBC as soon as possible.
The release date is the date that the QA responsible is releasing the batch for distribution in the Supply Chain.
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). The best is to contact your local representative in the concerned country to retrieve information on the specific country requirements.
This rule is valid for all participating countries as specified in the Delegated Regulation, Article 7.
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.
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.
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.
An 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 an 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 requirement 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.
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.
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.
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.
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.
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.
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.
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 (e.g. 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).
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.
A GLN (Global Location Number) identifies each location with a unique number. For more information, consult GS1 website: https://www.gs1belu.org/nl/standaarden/gln
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 firstname.lastname@example.org.
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”.
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.
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.
No; packs released before 09/02/2019 do not need to be serialized 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.
No, these products are not allowed to carry the safety features.
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).
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.
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.
There is no mandatory sequence. However, several software systems have difficulties if the Product Code is not in 1st position. It is therefore strongly recommended to start always with the Product Code.
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.
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.
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.
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.
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.
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.
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 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 receiving confirmation by email on email@example.com.
In case you have registered one MAH but decide at a later stage to move the products under this MAH to another MAH, then the agreement can be transferred to that other MAH.