SUBMISSION OF SAMPLES / STANDARD APPLICABLE TO THE ANALYSIS FOR OBTAINING SANITARY REGISTRATION

Dear all, good morning.

Through this communication we inform you regarding NOTICE DM-DLNS-002-2025 issued by Licda. Maria Alejandra Morataya Morales Head of the Department of Medicines, Directorate of the National Health Laboratory (DLNS) related to ENTRY OF SAMPLES / STANDARD APPLICABLE TO THE ANALYSIS FOR OBTAINING THE HEALTH REGISTRATION.

DOCUMENT NAME NOTICE DM-D-LNS-002-2025
SUBJECT ENTRY OF SAMPLES / STANDARD APPLICABLE TO THE ANALYSIS FOR OBTAINING THE HEALTH REGISTRATION.
COUNTRY OF APPLICATION Guatemala
EFFECTIVE DATE November 3, 2025
SUMMARY
  • Once the DLNS dossier has been approved by the Test Method Review Section, an approval ruling will be issued and samples/standards may be submitted to the DLNS for the corresponding analysis (with a maximum term of 6 months for submission – from the moment it is reflected in SIAD that the dossier is at the service window –). Therefore, the submission of samples/standards together with the DLNS dossier does not apply.

 

  • As currently applied, there will be 3 review notes before DLNS with a response period of 6 months each (from the moment SIAD reflects that the dossier is at the service window), which will be delivered to VSAM.

 

  • APPLIES to the following processes:

*Pharmaceutical Specialty

*Homeopathic

*Officinal

*Post-registration changes (updates) Pharmaceutical Specialty, Homeopathic, Officinal that include submitting sample/standard

*Post-registration changes of Harmonized, Biological/Biotechnological products that already have first‐import analysis

 

  • DOES NOT APPLY to the following processes:

*Harmonized

*Natural Products

*Pharmaceutical Supplements (PFD)

*Biological / Biotechnological

*Renewal

 

  • Dossiers submitted prior to November 3 will continue according to the previous procedure (submission of samples/standards at the time of submitting the DLNS dossier).

 

 

  • Registration processes under GOVERNMENT AGREEMENT No. 178-2020 (Recognition of certificates of analysis from authorized third‐party laboratories): once the Approval Ruling from the Test Method Review Section of DLNS is obtained, the following must be submitted to the Authorized Third‐Party Laboratory:

*Samples and standards (same batch/expiry as those submitted to DLNS)

*True copy of the dossier approved by the Test Method Review Section of DLNS including remarks and responses.

 

 

In light of the above, we kindly request your support to proceed according to one of the following options regarding the submission of samples / standard for the Health Registration process:

  1. If the Approval Ruling from DLNS is NOT yet available, please ensure that the samples and the standard provided have a minimum validity of 18 months at the time of reception in Guatemala.
  2. In the event that the Approval Ruling from DLNS IS available, the samples and standard provided must have a minimum validity of 12 months at the time of submission to DLNS.