Bolivia Labelling in Spanish: DS 25235 Article 149 and the Importer Identification Sticker

1. Key takeaways

Bolivian labelling rules have two sources. Section 2.5 of the Manual provides that multilingual labels are accepted, on the condition that Spanish is among the languages; the minimum content includes the product name, the lot number or serial number, the expiry date where applicable, the manufacturer and special warnings. Article 149 of Decreto Supremo N° 25235, published on November 30, 1998, separately requires every package to identify, by sticker, stamp or printing, the Bolivian company that sells the product, and the design of that identification must be included in the dossier. GRZAN’s practical observation is that the second requirement comes from an implementing regulation of 1998 and is often mistaken as applying to medicines only, whereas it is equally effective for devices. The two sources complement each other, and neither alone is a complete labelling specification for Bolivia. Companies that design packaging against the Manual alone will discover at review that an importer identification element is missing from every package, a defect that touches the entire product line at once. Both requirements must therefore be built into the label artwork from the outset, before printing plates or dielines are finalized. Because the label design forms part of the registration record, any later artwork change should be assessed for its regulatory impact before implementation. Packaging suppliers should receive the final approved draft as the controlled reference for production, and neither requirement is optional for any SKU offered in Bolivia.

2. Legal basis

3. Expert insights

Insight one: multilingual labels are permitted, and this lowers packaging cost. Section 2.5 accepts multilingual labels, provided Spanish is included. Companies do not need to open a separate set of molds or printing plates for Bolivia; it is sufficient to ensure Spanish is present on the existing multilingual label. This matters greatly for product lines with small volumes and many SKUs, where dedicated country-specific packaging would be uneconomical. The practical condition, however, is genuine content equivalence: the Spanish text must carry the same information as the other languages on the label, not a reduced summary, because a label whose Spanish panel is visibly thinner than its English panel invites questions during review. The equivalence should be verified field by field, including symbols and graphics, since these also form part of the approved design. Warnings deserve particular attention and should be checked by a bilingual reviewer before print. Where a product line already carries Spanish for another Latin American market, the wording should be reviewed for local usage rather than assumed to transfer unchanged, and warnings deserve particular attention because they carry safety content.

Insight two: three identification requirements stack on the same package. The minimum content of Section 2.5, the Bolivian company identification of Article 149, and the registration number printing of Section 5.7.1 all must land on the packaging. Their information sources differ, coming from the manufacturer, the importer and AGEMED respectively, and they must be merged into a single design draft, finalized before submission. Managing the three elements in separate workstreams is a common cause of late-stage rework, because a change forced by one requirement frequently disturbs the layout already approved for the others. A single artwork owner should consolidate all three sources of content into one controlled document. Changes to one element should be re-checked against the other two before the artwork is released to print, and the approval record of the final draft should be archived in the registration file, with the sign-off recorded so that the approved version remains traceable.

Insight three: because the identification design is part of the dossier, labels cannot be patched afterwards. Article 149 requires the identification design to be included in the file, while Section 5.7.1 provides that the registration number is printed after the certificate is granted. The practical solution is to submit, at filing time, a design draft that already contains the Bolivian company identification and reserves a position for the registration number, and to fill in the number before mass production once the certificate is issued. This sequence satisfies both provisions without reprinting the entire label set after approval. The reserved position should be sized for the format of Bolivian registration numbers and placed where overprinting cannot obscure other mandatory content.

4. Practical recommendations

1. Build a minimum content checklist for labels against the five items: product name, lot number or serial number, expiry date, manufacturer and special warnings, and verify every SKU against it before printing.
2. Integrate the Bolivian company identification and the reserved registration number position into the same design draft, and submit that draft with the dossier.
3. Confirm that the multilingual label genuinely contains Spanish, and that the Spanish content is consistent with the other languages in every field.
4. Freeze the artwork before dossier submission and control later changes through a formal review, since label content forms part of the approved registration record.

5. Verification checklist

• □ The multilingual label contains Spanish
• □ All five minimum content items are present
• □ The identification of the Bolivian selling company is included in the design draft and submitted with the dossier
• □ A reserved position for the registration number has been arranged in the design draft
• □ The special warnings content has a Spanish version

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Bolivia for manufacturers, importers and authorized representatives, covering label compliance review, artwork preparation, dossier assembly and regulatory correspondence. For assistance with labelling requirements and the full registration process, contact info@grzanglobal.com.