Packaging Requirements: Original Artwork Only, No Photocopies or Overlaid Labels

1. Key takeaways

Packaging is a formal requisite of Guatemalan registration: Article 5.1.10 of NT 37 Versión 5-2016 requires the submission of the original or a readable mock-up of the primary and/or secondary packaging, and states expressly that photocopies are not accepted, nor are overlaid labels. Sealed samples are submitted under Article 5.1.11, with quantities determined according to the list of quantities issued by the National Health Laboratory (LNS), and only when applicable. The same requirement carries through the change procedures — Articles 6.1.4, 6.2.4, 6.10.3, 6.11.3 and 6.12.4 all reiterate that photocopies are not accepted. Taken together, these provisions make packaging a continuous obligation that follows the product from the first filing through every subsequent variation, and a manufacturer who treats it as a one-off submission task will encounter the same refusal at each change window.

• Packaging must be submitted as the original or a readable mock-up; photocopies and overlaid labels are expressly excluded.
• Sealed samples follow the LNS quantity list and are required only when applicable.
• Sample quantities are fixed by the LNS list, not chosen by the applicant.
• Multiple change clauses restate the no-photocopy rule for packaging.
• Whether samples are needed at all depends on the risk class determined under Annex 1.
• Spanish-language instructions for use and warnings must appear on the packaging itself or on formal mock-ups.

2. Legal basis

The table below collects the clauses that govern packaging across registration and change procedures. Read as a group, they show that the standard treats packaging as a formal requisite whose form of presentation — original or readable mock-up, never a photocopy — is as decisive as its content.

3. Expert insights

Insight one: the rejection of overlaid labels closes the door on improvised packaging changes. The phrase “etiquetas sobrepuestas” in the clause refers to labels affixed on top of the original packaging. Read together with Article 7.1.2 — which requires that instructions for use and warnings of imported products appear in Spanish on the packaging — the operational conclusion is that the authority will not accept a Spanish-language sticker added after the fact to satisfy the language duty. The Spanish information must be embodied in the packaging itself or in the formal mock-up submitted for review. This is why the two provisions function as a pair: one defines the language obligation, and the other forecloses the shortcut of meeting it with an overlaid label.

Insight two: the packaging requirement runs through registration and every change procedure. Under Article 6, multiple change items — change of holder, change of manufacturer name, change of product name, change of packaging or specifications, and addition of an alternate manufacturing site — list packaging as a distinct document item, each restating that photocopies are not accepted. Packaging management is therefore a continuous obligation across the product lifecycle, not a single submission act performed once at registration. Companies that keep an always-current packaging master file, aligned with the version approved for the registration, move through change windows without scrambling for artwork at the last minute.

Insight three: sample quantities are decided by the LNS list, not by the applicant. Article 5.1.11 states that sealed samples are presented “según listado de cantidades de LNS” — according to the LNS quantity list. The applicant must prepare samples in the quantities the LNS list prescribes; deciding the quantity unilaterally risks either a shortfall that stalls the laboratory schedule or an excess that wastes product. Because the sample count feeds directly into testing logistics, confirming the applicable quantities before the samples are pulled is a simple step that prevents downstream scheduling friction.

Insight four: the sample obligation is bound to the risk class. Annex 1 makes Class I exempt from testing, while Classes II to IV require physicochemical and microbiological testing. Whether samples are needed therefore depends on whether the classification decision has been settled. Preparing samples before the class is fixed wastes resources if the product turns out to be exempt, and if the class is determined wrongly the sample specifications themselves will be wrong. The practical order is always: classify first, then sample.

4. Practical recommendations

• Prepare packaging as originals or formal readable mock-ups, and exclude photocopies and overlaid-label samples in every case.
• Build the Spanish instructions for use and warnings into the packaging itself or the formal mock-up, never as stickers added afterwards.
• Wait until the classification decision is settled before preparing samples, and then draw them strictly to the LNS quantity list.
• For change procedures, prepare packaging in step with the filing and check the corresponding clause to confirm whether packaging stands as a distinct document item.
• Self-audit packaging content item by item against Article 7, including batch number, expiry date, registration number and, where applicable, the word “Estéril”.

5. Verification checklist

• □ Packaging is submitted as the original or a readable mock-up
• □ No photocopies and no overlaid labels are present in the dossier
• □ Spanish instructions for use and warnings are embodied in the packaging itself
• □ The classification decision has been settled
• □ Sample quantities have been checked against the LNS list
• □ Packaging content has been self-audited item by item against Article 7

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Guatemalan market. Our team manages Ministry of Public Health and Social Assistance (MSPAS) registrations, coordinates import and distributor requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com