Labelling in Panama: 12 Items and the Ban on Re-Labelling

1. Key takeaways

Article 40 of Decreto Ejecutivo N° 490 requires the label on the primary and/or secondary packaging to carry twelve items of information, where applicable. Article 39, item 4 then states expressly that re-labelling (re etiquetado) and over-labelling (sobre etiquetado) are not accepted on any packaging used in Panama. The consequence is that a practice common elsewhere, applying a Spanish sticker over a label printed in another language, is not accepted in Panama: the label must be an original part of the packaging rather than something added to it. Where a product has no secondary packaging, all of the information must appear on the primary packaging, as the final sentence of Article 40 provides.

The prohibition is reinforced by Ley N° 90 of 26 December 2017, Article 34 of which prohibits repackaging, re-labelling and reconditioning of devices. Between the decree and the law, the ban is stated twice, and the decree adds the specific form of over-labelling while extending the scope to any packaging.

• Twelve label items under Article 40, each applicable where relevant.
• No re-labelling and no over-labelling on any packaging used in Panama.
• Sterile devices must carry the information on both the primary and the secondary packaging.
• Where there is no secondary packaging, the primary packaging must carry everything.
• Label information may be in two or more languages provided that one of them is Spanish.

2. Legal basis

Articles 39 and 40 of Decreto Ejecutivo N° 490 of 4 October 2019 govern labelling. Article 39 sets the framework and the prohibition, Article 40 sets the content, and Article 2 of the same decree defines the two prohibited practices. Ley N° 90 adds a statutory prohibition in Article 34.

The two definitions matter because they divide the prohibition into two distinct acts. Re-labelling removes the original and substitutes something else. Over-labelling leaves the original in place and adds a layer on top. Both are prohibited, and the second is the one most frequently proposed as a practical workaround.

3. Expert insights

Insight one: Article 39, item 4 and Article 34 of Ley 90 create a double prohibition, and the wording covers any packaging. Both the administrative decree and the statute prohibit re-labelling, and the decree adds the specific form of over-labelling while stating that the scope is any packaging (en ninguno de los empaques). Definitions 82 and 89 then separate the two acts: removing the original label, and affixing a label onto the original. The practical meaning is that even where the added content is entirely correct and fully compliant with Article 40, the form itself is prohibited.

Insight two: the wording of item 5, country of origin or of provenance, follows the same logic as item 11 of Article 36. Article 40, item 5 refers to the name of the country of origin or of provenance, so either one may be shown. This does not conflict with the rule that the certificate of free sale is obtained from the country of provenance: the label may carry either, while the certificate must come from the country of provenance. Understanding the difference avoids unnecessary work spent trying to make the label and the certificate match on a point where the law does not require it.

Insight three: item 11 imposes dual-packaging marking for sterile products. The text provides that if the product is sterile, the information described above must be indicated on the primary and secondary packaging. For sterile devices, the information must therefore appear on both layers. This echoes the definition in item 43 of primary packaging, which for sterile devices is the packaging that maintains the device in a sterile condition until use: the marking of the sterile barrier system cannot sit only on the outer layer.

Insight four: item 8 places expiry date, lapse date and shelf life side by side, which accommodates different time-related characteristics of devices. The wording covers expiry date, lapse date or shelf life. Definition 60 of Decreto Ejecutivo N° 490 explains that the expiry date is the maximum period set by the manufacturer to guarantee the quality specifications, and in some cases the sterile condition, and that it applies to sterile devices and to devices containing active substances, so not every device has an expiry date. That definition explains the use of the qualifier where applicable in item 8: where a device has no expiry date, marking one is not required.

4. Practical recommendations

• Fix the labelling scheme at the packaging design stage, and do not plan on adding labels to finished goods.
• Build a twelve-line label checklist against Article 40 and mark each line as applicable or not applicable.
• For sterile devices, confirm that both the primary and the secondary packaging carry the information required by item 11.
• Print multilingual labels with Spanish included, rather than opening a Panama-specific print run.
• Where symbols are used, provide the Spanish explanation in the instructions or insert under Article 39, item 1.
• Where there is no secondary packaging, verify that the primary packaging carries all twelve items rather than only the subset normally printed there.

5. Verification checklist

• □ Label content checked line by line against the twelve items of Article 40
• □ No re-labelling or over-labelling confirmed, per Article 39, item 4 and Article 34 of Ley 90
• □ Primary and secondary packaging both marked for sterile devices
• □ Label contains Spanish under Article 39, item 2
• □ Where no secondary packaging exists, primary packaging carries all of the information
• □ Symbols explained in Spanish in the instructions or package insert

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Panamanian market. Our team manages Ministry of Health (MINSA) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 29 October 2026.