- Form F-AS-f-03 for notifications and replacements
- Payment slip V-CC-G-001 with the Q25 amount
- Original license number (if known)
- DPI of the owner or legal representative
The sanitary license replacement is the procedure issued by the Ministry of Public Health and Social Assistance (MSPAS) through the Department of Regulation and Control of Pharmaceutical Products and Related Items (DRCPFA) to replace a lost, damaged, stolen or deteriorated sanitary license of a pharmaceutical establishment that meets current technical norms. It applies to pharmacies, drugstores, distributors, medicine sales, natural product sales, medicinal gas dispensers and technical direction.
Quick summary: Cost Q25, 21 business days notification time, result replacement sanitary license, channel online to download forms + physical filing of the file at the DRCPFA. Legal basis: Technical Norms 4-2011, 7-2011, 23-2011, 31-2016, 38-2016, 48-2020 and 63-2014.
What Is the DRCPFA?
The Department of Regulation and Control of Pharmaceutical Products and Related Items is the MSPAS unit responsible for regulating the operation of pharmacies, drugstores, drug distributors, sales of natural products and similar establishments in Guatemala. It issues the sanitary licenses required to operate legally and verifies compliance with current technical norms.
Covered establishments:
- Pharmacies (Norma 4-2011)
- Drugstores (Norma 7-2011)
- Pharmaceutical product distributors (Norma 48-2020)
- Medicine sales (Norma 31-2016)
- Natural product sales (Norma 38-2016)
- Medicinal gases (Norma 63-2014)
- Technical direction of pharmaceutical establishments (Norma 23-2011)
Requirements
Forms and payment slip
- Form F-AS-f-03 — Application for notifications and replacements of sanitary licenses (downloaded from the DRCPFA site)
- Payment slip V-CC-G-001 current version, for Q25
- Receipt 63-A2 generated when the slip is filed at Window 63-A2
Establishment documents
- Original sanitary license number (if available)
- Establishment data (trade name, NIT, location, type)
- Owner’s DPI (individual) or legal representative’s (legal entity)
- Business patent for corporations
Justification of the replacement
- If lost or stolen: PNC police report or notarized statement
- If damaged: the deteriorated license (still legible parts) plus an explanation
- Signed letter requesting the replacement and stating the reason
Compliance with norms
The establishment must stay in compliance with the technical norm that applies to its type. The replacement does not exempt the establishment from meeting: physical conditions, professional records, proper dispensing and other requirements.
Steps
These steps follow the official procedure published by the MSPAS:
- Download from the DRCPFA site (medicamentos.mspas.gob.gt) the form F-AS-f-03, the V-CC-G-001 payment slip and the technical norm that applies to your establishment type.
- Complete the F-AS-f-03 form with establishment data, owner data and the reason for the replacement. Prepare the file meeting the requirements of the applicable norm. Make the corresponding payments.
- File the payment slip at Window 63-A2 so that receipt 63-A2 is generated.
- File the complete file at the Reception and Document Delivery Section of the MSPAS.
- The Reception Section sends the file to the Pharmaceutical Establishments Section.
- The assistant of the Pharmaceutical Establishments Section receives and reviews the submission.
- The assistant classifies, enters and assigns files to the evaluating professionals.
- Evaluating professionals review the file.
- If the file complies, a favorable resolution is issued and the applicant is notified to pick up the replacement license.
Cost and Time
| Item | Value |
|---|---|
| Procedure cost | Q25 (Slip V-CC-G-001) |
| Official time | 21 business days (notification) |
| Realistic time | 25 to 35 days if observations arise |
| Result | Replacement sanitary license |
| Validity | Same expiration date as the original license |
The Q25 cost only covers the procedure at the MSPAS. There may be additional expenses for:
- Notarized loss statement
- Police report (no cost, but takes time)
- Outside legal advisory or agent
How to Apply
All documentation is handled with the DRCPFA, part of the MSPAS, at its offices in Guatemala City. Forms and technical norms are downloadable from the official site and the file is filed in person.
Official DRCPFA site: medicamentos.mspas.gob.gt
MSPAS HQ: 6a Avenida 3-45 Zona 11, Guatemala City (central Ministry).
Recommendation: Before filing, make sure form F-AS-f-03 is fully completed and that payments are in order. Form errors are the #1 cause of delays. If your establishment is far from Guatemala City, consider hiring an agent to deliver the file and pick up the license.
Related MSPAS Procedures
- New sanitary license for care establishments
- Replacement of sanitary registry certificate
- Habitability certificate for care establishments
- Sanitary license for food
- Health card
- Lung card
- Register a company (for legal entities)
- CUI / NIT lookup at SAT
Tips
- Download current versions. Versions of form F-AS-f-03 and slip V-CC-G-001 change periodically. Always verify you have the version posted on the official site.
- Original license number. Having the number of the license you are replacing speeds up assigning the file to an evaluator.
- Formal report of loss. If stolen or lost, file a PNC police report or notarized statement. This strengthens the request.
- Compliance up to date. Use this procedure to verify the establishment still complies with the current technical norm. If there are observations for non-compliance, fix them first to avoid problems during evaluation.
- MSPAS phone: 2444-7474 / 1517 (information line).
- Technical direction. If the lost license was for technical direction (Norma 23-2011), this same procedure applies with the same form and slip.