Guide
Pharmaceutical packaging in Ethiopia: EFDA barcode rules for medicine boxes
Every medicine sold in Ethiopia must carry a barcode on its label (Food and Medicine Administration Proclamation No. 1112/2019, Article 53(5)). EFDA’s traceability directive No. 43/2019 requires a GS1 DataMatrix that encodes the GTIN, expiry date, batch number and serial number, with the human-readable text next to it. The medicine box must leave a clean, flat space for it.
Key facts
| The law | Food and Medicine Administration Proclamation No. 1112/2019, Article 53(5) |
|---|---|
| The directive | EFDA pharmaceutical products traceability directive No. 43/2019 |
| Barcode | GS1 DataMatrix (square form recommended) |
| Must encode | GTIN, batch or lot number, expiry date, serial number |
| Next to it | The same data in human-readable text, preferably underneath |
What does Ethiopian law require on medicine packaging?
Article 53(5) of the Food and Medicine Administration Proclamation No. 1112/2019 says: “No person may import or place into use any medicine or medical device unless its labeling contains a barcode.” The Ethiopian Food and Drug Authority (EFDA) turned that into detailed rules in its pharmaceutical products traceability directive No. 43/2019. The directive makes a GS1 DataMatrix barcode mandatory on the pack. The aim is to fight substandard and falsified medicines, make recalls work, and reduce medication errors.
What must the barcode contain?
The GS1 DataMatrix must encode four data elements, each introduced by its GS1 Application Identifier (AI). These do not replace the other labelling rules for medicines.
| AI | Data | Length |
|---|---|---|
| (01) | Global Trade Item Number (GTIN) | 14 digits |
| (10) | Batch or lot number | Up to 20 characters |
| (17) | Expiry date (YYMMDD) | 6 digits |
| (21) | Serial number | Up to 20 characters |
Where should the barcode go on the box?
EFDA’s factsheet asks for the barcode to be printed on one side of the pack, on the front or an end, preferably on a flat surface, and on the same side where possible. It should avoid folds, seams, flaps, perforations, die-cuts, curves and rough textures, which spoil scanning. The best contrast is black on a white background. The human-readable text of each element, with its Application Identifier in brackets, must sit close to the barcode, preferably underneath it. Barcodes carrying different GTINs must never appear on one item.
What to agree with your carton printer
The serial number and expiry date change from pack to pack or batch to batch, so they are usually added on the packing line, not when the box is printed. The printed medicine box therefore has to leave a clear, flat, light area of the right size where the code and its text will go. Agree that area before the artwork is final.
- Decide which face carries the barcode, and mark the area on the dieline.
- Keep that area free of print, varnish and folds, with a light background.
- Check the space against the size of the code your data needs.
- Test-scan printed samples before the full run.
Questions
Which barcode does EFDA require on medicines?
A GS1 DataMatrix, the two-dimensional barcode used for medicines around the world. EFDA recommends the square form.
What data must an EFDA medicine barcode encode?
Four elements: the GTIN (14 digits), the batch or lot number, the expiry date (YYMMDD) and a serial number, each with its GS1 Application Identifier.
Can a medicine box carry more than one barcode?
Not barcodes with different GTINs. EFDA warns that several barcodes on one item cause scanning problems and dangerous confusion.
Does the barcode replace the printed label information?
No. The barcode is added to the other labelling requirements for medicines in Ethiopia; it does not replace them.
Sources
- Overview of barcode use for pharmaceutical products in Ethiopia (factsheet) · Ethiopian Food and Drug Authority (EFDA), 2023
