Supplementary Label Boundary: Cannot Correct

1. Key takeaways

No, it cannot. The second paragraph of Article 19.1 of the principal regulation states expressly that the supplementary label (etiqueta complementaria) must not be used to change or correct information already contained in the label of origin (no debe utilizarse para cambiar o corregir información incluida en el etiquetado de origen), but that it may be used to add mandatory information that the original label does not contain. This boundary of can-add-cannot-change is the most misunderstood point in Costa Rican labelling compliance, and the easiest red line to trip.

• The dividing line is whether the mandatory information in question already appears on the label of origin: absent information may be added, existing information may not be altered.
• Differences in product code wording and country-of-origin wording are handled by clarification on the supplementary label, never by rewriting the original label.
• The supplementary label plan is a dossier document submitted under Article 11.7, and later label design changes are a notification matter under Article 18.6.
• Transitorio III of the approving decree opened an 18-month window for existing registrations to submit product labels through a post-registration change, extended from 6 months by the 2024 amendment.
• Industry-circulated clarification wordings without official text support are not adopted in this volume; the current position of the Ministry of Health governs.

2. Legal basis

The supplementary label boundary is drawn by the technical regulation RTCR 505:2022 in Article 19.1, supported by the dossier rule of Article 11.7, the definition in 4.30, the change provisions of Article 18.6, and the transitional rule Transitorio III of the approving decree Decreto Ejecutivo N° 43902-S as amended in 2024. The provisions relied on are listed below.

3. Expert insights

Insight one: The dividing line between can-add and cannot-change is whether the label of origin already states the information. The logic of the second paragraph of Article 19.1 is straightforward: where a mandatory item of information is not on the label of origin, it may be added by supplementary label; where it is already there — even if worded differently or expressed unclearly — the supplementary label may only clarify, not change. This distinction dictates the concrete approach: adding a missing Spanish translation is permitted; changing one value on the original label into a different value is prohibited.

Insight two: This boundary directly determines how product codes and country-of-origin wording are handled. The REF designation commonly used on manufacturers’ original labels is not the código identificador del producto referred to in Article 19.1.5, and the wording PRODUCT OF plus a country name usually points to the origin of the raw materials rather than the country of the manufacturer (Article 19.1.4 requires the country of the manufacturer). Under the boundary set by Article 19.1, the correct approach is to clarify on the supplementary label (stating that REF is the product code and that the PRODUCT OF wording refers to raw material sourcing), rather than rewriting the wording on the original label. Certain clarification formulations circulating in industry are not supported by official text and are not adopted in this volume; in practice the current position of the Ministry of Health governs.

Insight three: Article 11.7 requires the supplementary label plan to be submitted as registration material, and Article 18.6 lists label design changes as a notification matter. Article 11.7 provides that where the label of origin is not in Spanish, or is in Spanish but incomplete, a supplementary label plan must be submitted; Article 18.6 lists label design changes as one of the four matters handled by notification (using the 5 working-day channel of Article 5 of the approving decree). Together the two provisions mean that the supplementary label is a document subject to review, and its subsequent design adjustments are also a declarable matter.

Insight four: Transitorio III opened an 18-month window for existing registrations to submit labels, a period extended from 6 months by the 2024 amendment. The transitional provision grants 18 months from the entry into force of the regulation to submit product labels through a post-registration change (where the dossier contains none). This window targets existing registrations — products registered before the new regulation entered into force whose dossiers contain no label. Companies holding such registrations should verify and complete the submission within the window.

4. Practical recommendations

• Use the supplementary label only to add mandatory information missing from the original label, and never to change or correct anything the original label already states (Article 19.1).
• Route differences in product code wording and country-of-origin wording through the clarification path, without rewriting the original wording (Articles 19.1.4 and 19.1.5).
• Submit the supplementary label plan with the registration under Article 11.7; handle subsequent design adjustments as a notification change under Article 18.6.
• For existing registrations, verify within the 18-month window of Transitorio III whether the dossier contains a label, and submit any missing one promptly.
• Where a specific clarification wording is involved, follow the position currently published by the Ministry of Health and do not adopt industry-circulated texts.

5. Verification checklist

• □ The supplementary label is used only to add mandatory information not already stated (Article 19.1)
• □ It has not been used to change or correct information already on the original label (Article 19.1)
• □ Code and country-of-origin differences have been routed through clarification (Articles 19.1.4 and 19.1.5)
• □ The supplementary label plan has been submitted under Article 11.7
• □ Label design adjustments have gone through the notification route of Article 18.6
• □ Existing registrations have been checked against Transitorio III and missing labels submitted

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