The adoption of 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.

Pharmaceutical

 

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.


 

Medical Devices

 

1. When does the Medical Devices Regulation (MDR) apply?

The MDR (EU) 2017/745 will apply from 26 May 2021 – the “Date of Application” (Date of Application -DoA). Some provisions of the MDR will come into force earlier (e.g. regarding Notified Bodies and the Medical Device Coordination Group). Some will apply later (e.g. regarding UDI labelling).


2. When do the existing Directives stop to apply?

In general, Directives 90/385/EEC and 93/42/EEC will be repealed on 26 May 2021 (the Date of Application- DoA). Nevertheless, there are some exceptions, such as:

  • for the continued marketing of devices that comply with the Directives
  • to serve as a backup since Eudamed will not be fully functional by the DoA.

3. What is the applicable legislation up to 26 May 2021?

Until the Date of Application (DoA), the laws and regulations adopted by Member States in accordance with the Directives will continue to apply.


4. Which classes of products require conformity assessment by a notified body?

Approval is required for Class IIa, IIb and III medical devices and Class B, C and D in vitro diagnostic devices.


5. What is the UDI?

The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard such as GS1. UDI permits the unambiguous identification of a specific medical device placed on the market. The UDI is comprised of the UDI-DI and UDI-PI. The unique identifier may include information on the lot or serial number and be able to be applied anywhere in the world

 

The production of a UDI comprises the following:

  • A UDI device identifier (‘UDI-DI’) specific to a device, providing access to the information laid down in Part B of Annex VI.
  • A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI.

6. Can manufacturers still place on the market/put into service Directive-compliant devices after the end of the transition period?

Yes, under certain conditions there will be an option to continue placing on the market/putting into service devices that comply with the Directives until their existing certificates expire. This may avoid the immediate need for a new certificate under the MDR. To use this option, all the existing certificates will have to be valid (including, for example, the QMS), the purpose and nature of the device must not change, and you must follow the new MDR rules for registration, surveillance and vigilance


7. What is the Basic UDI-DI?

The Basic UDI-DI is the main access key for device-related information in the Eudamed database and it is referenced in relevant documentation [e.g. certificates (including certificate of free sale), EU declaration of conformity, technical documentation and summary of safety and (clinical) performance)].

 

It is envisioned to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics.

 

It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item.

 

Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner.

 

MDCG 2018-1 v3 guidance provides additional information on Basic UDI-DI.


8. Who is responsible for placing the UDI carrier on the device itself, on the label and on the package of a device?

It is manufacturer’s responsibility for complying with all UDI related requirements. This includes the assignment of the UDI (and Basic UDI-DI), the UDI (and Basic UDI-DI) registration in the Eudamed database and the placement of the UDI carrier on the label of the device or on its packaging or, in case of reusable devices, on the device itself (direct marking).

  • What happens in the case of Article 16 of the MDR and IVDR? Which obligations do economic operators have regarding UDI when assuming obligation incumbent on manufacturers per Article 16 of the MDR and IVDR?
  • Any distributor, importer or other natural or legal person that assumes the obligations incumbent on manufacturers in accordance with Article 16(1), assumes all the relevant responsibilities related to UDI, including UDI labelling.
  • The distributor or importer carrying out the operations described in Article 16(2) (providing translation or repackaging of devices) shall ensure that:
    • the activities are performed by means and under conditions that in no way compromise the readability of the UDI carrier and its information identifying the actual device.
    • the specific procedures are part of the distributor’s or importer’s quality management system.
  • A dedicated guideline with additional information on this aspect is available at the MDCG 2018-6 guidance document.

9. Whеn does a new UDI-DI is required?

A new UDI-DI will be required every time there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, a new UDI-DI shall be required in the case of any change of the following elements:

name or trade name
device version or model
labelled as single use
packaged sterile
need for sterilization before use
quantity of devices provided in a package
critical warnings or contra-indications and CMR/Endocrine disruptors


10. What are the responsibilities of economic operators and health institutions in regard to UDI?

According to the two medical devices Regulations, manufacturers should be accountable for the UDI assignment and placement of the UDI carrier, as well as the initial submission and updates of the identifying information and other device data elements in the Eudamed database. Manufacturers should update the appropriate database record within 30 days of a change being made to an element, which does not require a new UDI-DI.

 

Distributors and importers should validate that, where applicable, a UDI has been assigned by the manufacturer.
All economic operators and health institutions should store and retain preferably by electronic means the UDI of the devices, which they have supplied or with which they have been supplied with if those devices belong to class III implantable devices. Please be advised that the European Commission may choose to approve additional acts to expand the devices scope for which economic operators should store and keep the UDI.


11. What is Eudamed and when it will be fully functional?

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics medical devices. According to the latest information Eudamed will be fully functional by May 2022


12. How is Eudamed structured?

EUDAMED is structured around 6 interconnected modules and a public website:
Actors registration- available December, 2020
UDI/Devices registration
Notified Bodies and Certificates
Clinical Investigations and performance studies
Vigilance and post-market surveillance
Market Surveillance


13. Who has to register in Eudamed?

Every economic operator – EU and non-EU manufacturers, authorized representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information.


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