The adoption of the serialization in pharmaceutical manufacturing can be quite challenging and of course, many questions arise due to the complex requirements and regulations worldwide.

 

As a trusted partner, we support and consult many pharmaceutical companies. Here are the most common questions regarding serialization and Track & Trace we get and the respective answers.

 

1. What do I need to be EU FMD compliant?

All prescription medicines need to be serialized and the packaging must be protected with a tamper-evident label.

 

  • Serialization Requirement:

 

The mandatory serialization elements included in the 2D Data Matrix and Human Readable Part are:

GTIN (CIP, PC)

LOT (batch number)

Expiration date

Serial Number (SN)

 

Other elements could be added to the Human Readable Part if required by the respective target market (i.e. Manufacture Date, National Reimbursement Number, etc.)

 

  • Quality Requirement:

 

Grade C or above

Barcode Size Requirements- Square Data Matrix with mapping matrix size at 24×24 pixels

2D Data Matrix Code should be readable/scannable after anti-tamper label application

 

Product Master Data (PMD) & Product Pack Data (PPD) create, upload and update

All European Medicines Verification Organisation (EMVO) required Serial Number Status changes

Target Markets

Capability to receive alerts and notifications from European Medicines Verification System (EMVS)

 

As every pharmaceutical company has its own specifics, we recommend you book a meeting with our Trace & Trace experts in order to give us details and help to find your perfect fitting traceability solution. Book your consultation now.


2. Where do I get the serial numbers from? Is it from the EU HUB?

Serial numbers could be generated by Marketing Authorization Holder (MAH) or Manufacturer (MAN) by using a specific generator (see SoftGroup® SaTT SNX Management).

The serial number generation logic needs to be compliant to EU FMD Requirements. In order to be FMD compliant, serial numbers must be random and unique and need to consist of up to 20 alphanumeric symbols.

Serial Numbers (SNs) can’t be generated by the EU HUB. After SNs are printed on secondary packaging must be sent to EMVS in order to be activated.

 

As every pharmaceutical company has its own specifics, we recommend you book a meeting with our Trace & Trace experts in order to give us details and help to find your perfect fitting traceability solution. Book your consultation now.


3. Can a Contract Manufacturing Organization (CMO) connect directly to the EMVS?

No, the Contract Manufacturing Organizations (CMOs) cannot connect directly to the EMVS. The reason is they are not On-Boarding Partner (OBP) and don’t have contractual relationships with the European Medicines Verification System (EMVS) therefore are not allowed to upload data to the EMVS.

The data can be uploaded to European Medicines Verification System (EMVS) by the On-Boarding Partner (Market Authorization Holder or Parallel Distributor) who is required to report product master data (PMD) and product pack data (PPD).

The Contract Manufacturing Organization is required to send the reports with serialized data to the respective Marketing Authorization Holder (MAH) of the product. This data exchange can be accomplished through an sFTP connection or a similar solution.

 

As every pharmaceutical company has its own specifics, we recommend you book a meeting with our Trace & Trace experts in order to give us details and help to find your perfect fitting traceability solution. Book your consultation now.


4. Do Parallel Traders need to be connected to the National Medicines Verification System?

In general, Parallel Importers do not require connection to the National Medicines Verification System (NMVS). They need to have a contract with EMVS similar as per Marketing Authorization Holders (MAH).

Parallel Importer needs to establish a connection with the European Medicines Verification System (the EU Hub) and to report all repackaged production.

Parallel Distributors has the responsibility to verify that source products are with status “Active” before repacking them. After repacking and before activation of the target products, the Parallel Trader must decommission the initial serial numbers with status “Checked-out”. The uploaded in the EMVO product pack data (PPD) will be distributed to the relevant National Medicines Verification System (NMVS) according to specified target markets.

 

As every pharmaceutical company has its own specifics, we recommend you book a meeting with our Trace & Trace experts in order to give us details and help to find your perfect fitting traceability solution. Book your consultation now.


5. Is it possible for the OBP to be connected to multiple vendors for serialization data upload to the European Market?

The answer is “Yes, it is possible”. Some of the participants prefer to use more than one Gateway provider for connection to the European Medicines Verification System (EMVS).

 

The procedure of choosing an additional vendor can be done during the on-boarding process or on a later stage. The steps for adding additional vendors are:

  1. Enter in On-Boarding Portal of the European Medicines Verification System (EMVS)
  2. Go to Step 1.3 “Connection Provider Information” and choose “Select Connection 2”
  3. If Step 1.3 “Connection Provider Information” not active go directly to Step 4.3 “Connection 2” where you need to execute metrics tests.

 

As every pharmaceutical company has its own specifics, we recommend you book a meeting with our Trace & Trace experts in order to give us details and help to find your perfect fitting traceability solution. Book your consultation now.


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