OMC Medical
OMC Medical

 Cosmetics Registration in Guatemala

Regulatory Authority:

Ministry of Health of Guatemala

Cosmetic Regulation:

RTCA 71.01.35:21 COSMETIC PRODUCTS

Regulatory Authorities Website :

Ministerio de Salud Pública y Asistencia Social – Inicio (mspas.gob.gt)

Data Required:

  • Application form signed and sealed by the Pharmaceutical Chemist responsible to the health authorities with a pharmaceutical
  • Power of attorney granted to the legal representative and the responsible professional who will process the recognition of the product in the country, duly legalized. With the presentation of this requirement, the health authority will grant the interested party an opinion number, to which he or she must refer when making other
  • Certificate of Free Sale or health registration certificate issued by the Health Authority of the first legalized country (in original and photocopy), attaching a sheet stamped by the authority with the qualitative formula issued by the manufacturer in which the quantities of the restricted or controlled
  • Specifications of the finished
  • Original receipt of payment and two
  • All documentation must be submitted in Castilian / Spanish

Process: 

  1. The responsible Pharmaceutical Chemist submits the application for recognition and the established requirements, in original and two photocopies, in a DARK COFFEE color folder at the reception window of the Department of Regulation and Control of Pharmaceutical and Related Products.
  1. The health authorities verify and evaluate the requirements
  2. The authority may grant a single opportunity to complete or correct the In the event that non-compliance or non-compliance with the requirements is verified a second time, the authority will proceed to archive the file and the interested party must restart the process.
  3. In case of rejection of the recognition, the authority will not return the amount paid for the
  4. In case of approval, the health authorities affix the Acknowledgment Approval seal, the internal control number, the issue date, the expiration date, and the name and signature of the official who approves the Acknowledgment, on the original and a copy of the Acknowledgment. Recognition Format, within a period of no more than 8 business days, delivering the sealed copy to the interested party. The validity of the recognition of the registration or sanitary registration of the products will be equal to the validity of the original

The information of the recognized product is entered into the system.

Validity :

The validity of the Acknowledgment of the registration, registration or notification of Cosmetic products will be five (5) years from the granting. Any change in the formulation will require a new registration, registration or notification.