THE EU FMD
Processes may vary slightly, but in the first instance the manufacturer or marketing authorization holder (MAH) will be responsible for packaging and serializing the drug product. Their
process may involve working with internal sites, with CMOs, or
in conjunction with third party logistics (3PL) distribution sites.
The MAH will then be required to submit product master
data, and packaging data including serialization information
to the EU Hub. This requires establishing an account with the
European Medicines Verification Organization (EMVO) through
their on-boarding process and determining how the resultant
On-Boarding Partner (OBP) will connect to and communicate
information to the Hub.
Parallel importers/distributors (PI) must also submit similar data into the EU Hub for the medicines they repackage or
relabel. Think of the Hub as a ‘router’ that takes information
about a product and passes it to the national systems serving the
market(s) where that product is targeted for distribution.
Pharmacies are then able to perform verification enquiries
against the national system in their country.
EU SERIALIZATION, VERIFICATION AND COMPLIANCE
The EU FMD requires four key data elements to be encoded and
submitted to the EU Hub. The first is the manufacturer product
code. There is no single form of product code used across Europe.
Depending on the country that a particular product is being targeted in, this product code may be a global trade item number
(GTIN), a national trade item number (NTIN) or a unique national market code. Multi-market packs may require more than
one product code to be configured.
A serial number must be added that adheres to a 1: 10,000
randomization methodology. Finally, the expiration data and
batch number also need to be applied. Other additional data elements may include a national healthcare reimbursement number (NHRN), which can enable products to be distributed across
multiple countries. All information must be provided in both human readable form and encoded in a 2D data matrix code.
The MAH/PI must generate and manage many details about
products that are being prepared for sale. The data, which may
span across multiple transactions being reported to the EU Hub,
includes information such as the product master data reporting
requirements. This includes the product code, product strength,
pack type and pack size. It also includes information about the
markets and member states that a product will be distributed
into, as well details of the MAH and the wholesalers authorized
to store and distribute the product on behalf of the MAH.
Serialized product pack data, which includes the unique prod-
uct identification information about every individual sales pack
needs to be reported, as well as notifications of any batch recalls.
Should product master data be modified, or the status of a prod-
uct pack be changed, this information needs to be updated in the
The frequency of data transactions will vary. For some types
of information, such as the product master data, this may need to
be submitted initially and only updated if the information chang-
es. For other information, such as the product pack serialization
data, companies will have to determine how often and with what
granularity this is communicated, batch-by-batch, shipment-by-
shipment, or other.
Finally, any serialization information or related product data,
which is produced or modified by CMOs or 3PLs, is the responsibility of the MAH to capture and report to the EU Hub.
OTHER REGULATORY REQUIREMENTS
There are several product coding schemes in existence and depending where a product is targeted, MAHs may have to apply
different product codes and submit these to the EU Hub as part
of the product master data. Depending on the country, the serialization and compliance system may need to manage a variety
of different complex coding schemes. In particular, the GTIN- 14,
GS1 NTIN and the Pharmacy Product Number (PPN).
Further challenges include the issues related to multi-market
packs that may be distributed into multiple countries. While the
regulations do not allow packaging to have more than one 2D
data matrix code, there is an ability to add additional product
codes into the barcode following specific encoding rules.
Manufacturers must keep records of every operation they perform using a unique pack identifier and unique product identifier.
There is a requirement for records of both of these activities to be
kept for one year past the expiration date or five years after the
pack has been supplied into the supply chain.
Finally, there are also grandfathering and catch-up provisions.
Products that are packaged and released for sale before February 2019 may be distributed and sold until the expiration date.
Records of products, which are serialized and released into the
market prior to February 2019, should be kept to enable submission to the EU Hub when the deadline occurs, thus enabling the
Hub to have a correct record of all serialized packs which have
been put into the supply chain.
“The ability to connect to a
track-and-trace network for the
pharmaceutical supply chain via
a single connection has the
potential to significantly speed-up
and simplify the ability to serialize,
report and manage products