The unique identifier encoded in the 2D DataMatrix contains the elements required under the applicable EU and national requirements.
Where one pack is intended to circulate in more than one market and more than one national code is applicable, the relevant national codes are expected to be included in the DataMatrix.
The corresponding national codes must also be printed in human-readable form on the individual pack.
Therefore, for a multi-market pack:
DataMatrix national codes = human-readable national codes
The national codes should not be changed according only to the final destination of an individual pack where the pack itself is a common multi-market presentation.
Further country-specific details are available in Appendix 4 of the EMVS Master Data Guide.
Example: pack circulating in Portugal only
For a medicinal product pack circulating in Portugal, the unique identifier includes:
Product Code (GTIN)
Serial Number
Batch
Expiry Date
National registration number - Portugal
These elements are encoded in the GS1 DataMatrix and are also required to be printed on the individual pack in accordance with the applicable national requirements.
Example: multi-market pack for Portugal and Spain
For an individual pack intended to circulate in both Portugal and Spain, the unique identifier must contain:
Product Code (GTIN)
Serial Number
Batch
Expiry Date
National registration number - Portugal
National registration number - Spain
Accordingly, the DataMatrix contains six elements, including both national registration numbers.
The same six elements must also be printed on the individual pack in human-readable form.
This means that a Portugal/Spain multi-market pack should not contain only the Portuguese national code when shipped to Portugal and only the Spanish national code when shipped to Spain. Both national codes form part of the common multi-market pack configuration.
Example: multi-market pack for Spain, Portugal and Italy
Applying the same principle, where a single multi-market pack is intended for Spain, Portugal and Italy, all applicable national codes associated with those markets should be included in the pack configuration.
Conceptually, the DataMatrix would therefore contain:
Product Code / GTIN
Serial Number
Batch Number
Expiry Date
National registration number - Portugal
National registration number - Spain
National registration number - Italy
The same applicable national codes should also appear in human-readable format on the pack.
Therefore, an approach where an otherwise identical multi-market pack contains only the national code of the country to which a particular unit is subsequently distributed would not be consistent with the expected multi-market pack configuration.
Product Master Data
The applicable national code information must also be correctly reflected in the Product Master Data (PMD) for the respective markets.
There should therefore be consistency between:
Market configuration → Product Master Data → DataMatrix → Human-readable information
For example, where the product is configured for Portugal and Spain, the relevant national registration number for each market must be provided in the respective product data, while both codes are represented on the common multi-market pack where required.
Appendix 4 of the EMVS Master Data Guide should be used as the reference for determining the applicable national coding requirements for each market.
Human-readable information
The national codes encoded in the DataMatrix should correspond to the national codes printed on the pack.
There is generally no predefined order in which the unique identifier elements need to be printed, subject to applicable national requirements.
Country-specific presentation requirements may still apply. For example, the Spanish national code may be subject to specific positioning requirements on the packaging.
Important distinction: EMVS requirements vs national requirements
EMVO can provide guidance on the technical implementation of the EMVS and the corresponding product data requirements.
However, national requirements may determine:
which national code must be used;
how it must be formatted;
where it must appear on the packaging;
whether additional national information is required;
whether a particular multi-market presentation is acceptable; and
whether approval from a competent authority is required.
Where there is uncertainty regarding a national packaging or registration requirement, the Marketing Authorisation Holder should confirm the requirement with the relevant National Competent Authority and/or NMVO.
Key takeaway
For a multi-market pack, all applicable national codes for the markets covered by that pack should be included in the DataMatrix and should also appear in human-readable form on the packaging.
For example:
Portugal + Spain pack
DataMatrix:
GTIN + Serial Number + Batch + Expiry Date + National registration number - Portugal + National registration number - Spain
Human-readable:
the same applicable six elements
The national code should therefore not be selected solely according to the eventual destination market of an individual pack.