Guatemala Cosmetic Product Registration

COSMETIC REGISTRATION IN GUATEMALA Regulatory Authority

Ministry of Health of Guatemala

Link for Regulatory Authority

https://medicamentos.mspas.gob.gt/

RTCA 71.03.35:21 COSMETIC PRODUCTS

1.   The application form must be signed and sealed by the Pharmaceutical Chemist responsible to the health authorities.
2. A pharmaceutical Power of Attorney must be granted to the legal representative and the responsible professional handling the product’s recognition in the country, and it should be duly legalized.
3. Upon submission of these documents, the health authority will provide the interested party with an opinion number, which must be referenced for further proceedings.
4. The applicant must provide a Certificate of Free Sale or health registration certificate issued by the Health Authority of the first legalized country, both in original and photocopy.
5. Accompanying the certificate, there should be a stamped sheet from the authority containing the qualitative formula issued by the manufacturer, specifying the quantities of restricted or controlled specifications of the finished product.
6. The original payment receipt and two additional copies must be included with all documentation.
7.  It is essential that all paperwork be submitted in Castilian/Spanish
8. Distribution or Manufacturing Agreement: A formally signed contract outlining the terms of the distribution or manufacturing arrangement between the involved parties, or a relevant excerpt from such an agreement.
9. Notarized Power of Attorney: An officially notarized document provided by the manufacturer granting authority to a third party to act as the holder of the sanitary registrations.
10. Clarification Letter: A letter duly signed by the manufacturer elucidating the commercial association between the manufacturer and the holder of the sanitary registration.

The responsible Pharmaceutical Chemist submits the application for recognition along with the required documents, in original and two photocopies, enclosed in a DARK COFFEE coloured folder at the reception window of the Department of Regulation and Control of Pharmaceutical and Related Products. 

The health authorities then verify and evaluate the submitted requirements. They may grant a single opportunity to complete or correct any deficiencies identified during the verification process. If non-compliance persists after this opportunity, the authority will proceed to archive the file, and the interested party must initiate the process anew.

In the event of rejection of the recognition, the authority will not refund the amount paid for the application. Upon approval, the health authorities affix the Acknowledgment Approval seal, internal control number, issue date, expiration date, and name and signature of the approving official on the original and a copy of the Acknowledgment Recognition Format. 

This process typically takes no more than 8 business days, after which the sealed copy is delivered 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.

The acknowledgment of registration, registration, or notification of cosmetic products will remain valid for a period of five (5) years from the date of issuance. Any alterations to the formulation will necessitate a new registration, registration renewal, or notification.

The certificate of Good Manufacturing Practices (GMP) is issued by the Department of Regulation and Control through the Surveillance, Monitoring, and Control Unit. This document certifies that the establishment adheres to Good Manufacturing Practices. The certificate applies to cosmetic products laboratories.