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Medicine Sales Sanitary License — MSPAS DRCPFA
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Before clicking, have ready:
  • 📄 Form F-AS-f-01 (Sanitary License Application)
  • 💰 Payment Slip V-CC-G-001 (current version)
  • 📚 Technical Standard 31-2016 "Venta de medicinas" (download and read)
  • 👨‍⚕️ Technical Director licensed and active
  • 🏪 Premises set up with proper storage and dispensing areas
  • 🏛 Commercial license and NIT for the establishment
💰 Cost: Free (Q0) · ⏱ Time: 30 business days · 🆔 Verified: May 2026 (Catalogo Unico de Tramites del Estado, Service 3421)

The Medicine Sales Sanitary License (Licencia Sanitaria para Venta de Medicina) is the authorization that MSPAS issues through the Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA) for an establishment to sell medications retail (over-the-counter, non-controlled) to the public in Guatemala.

Quick summary: Free (Q0) procedure, 30 business days. Filed at the MSPAS DRCPFA using form F-AS-f-01. Governed by Technical Standard 31-2016 “Venta de medicinas”. Result: Sanitary License + Technical Director Appointment Certificate.

Data verified against the official Catalogo Unico de Tramites del Estado (Service 3421 — MSPAS).

What This Procedure Is

The Medicine Sales Sanitary License authorizes the retail sale of non-controlled medications to the public — OTC products, basic medicines without prescription, basic vitamin supplements, first-aid products. It is the type of license required by medicine warehouses in rural towns, small market sales or stores offering basic medicines without operating as a full pharmacy.

Unlike a Pharmacy License (which requires complete pharmaceutical infrastructure, controlled medication management and pharmaceutical Technical Director), this license has fewer technical requirements and operates under inventory restrictions.

Who Needs It

  • Stores in markets or towns that sell basic medications and first-aid products
  • Medicine warehouses in rural areas without access to full pharmacies
  • Medicine sales points annexed to convenience stores or grocery shops (with separate premises)
  • Sales points operating as complement to other commercial activities
  • Community sales or cooperatives that facilitate access to basic medications
  • Establishments that do not yet qualify as pharmacy but offer medicines to the public

If you are going to sell controlled medications (psychotropics, antibiotics, prescription drugs), you need a Pharmacy License — not this one. If you are going to wholesale, you need a Drugstore / Distributor License.

Difference From Other DRCPFA Licenses

LicenseEstablishment TypeTimeTechnical Director Required
Medicine SalesRetail of non-controlled medications30 daysYes
PharmacyRetail with controlled medications30 daysYes (pharmacist)
Drugstore / DistributorWholesale medication distribution60 daysYes (pharmacist)
Dental SupplyDental products60 daysYes (dentist or pharmacist)
Natural ProductsSupplements and natural products30 daysYes

Complete Requirements

Important: All requirements are defined in Technical Standard 31-2016 “Venta de medicinas”. Download it from medicamentos.mspas.gob.gt before assembling the file.

Establishment Documents

  • Form F-AS-f-01 (Sanitary License Application for Pharmaceutical Establishments) — current version
  • Payment Slip V-CC-G-001 (current version)
  • Current commercial license (patente de comercio)
  • NIT of the establishment (look up your CUI-NIT here)
  • RTU SAT registration certificate

Technical Director Documents

  • Current DPI of the Technical Director
  • Active professional college membership certificate (per Standard 31-2016)
  • Acceptance letter for the role
  • Curriculum vitae

Premises Documents

  • Location sketch (croquis) of the establishment
  • Architectural plan of the premises
  • Habitability certificate or equivalent document
  • Lease contract or property title
  • Recent utility bill as proof of address

Owner Documents

Step-by-Step Process

  1. Download official documentation from medicamentos.mspas.gob.gt:
    • Form F-AS-f-01
    • Payment Slip V-CC-G-001 (current version)
    • Technical Standard 31-2016 “Venta de medicinas”
  2. Read Technical Standard 31-2016 to ensure your premises meet all requirements.
  3. Properly fill out Form F-AS-f-01 with establishment, owner and Technical Director data.
  4. Assemble the complete file with all required documents.
  5. Make corresponding payments for the procedure.
  6. Submit the Payment Slip to Window 63-A2 of MSPAS to generate receipt 63-A2.
  7. Submit the complete file to the MSPAS Document Reception and Delivery Section.
  8. The Reception Section forwards the file to the Pharmaceutical Establishments Section (DRCPFA).
  9. The Pharmaceutical Establishments Section assistant receives, classifies and enters the file.
  10. The assistant assigns the file to a Professional Evaluator.
  11. The Professional Evaluator conducts the evaluation. May request a site inspection.
  12. If the file complies, it is forwarded to the Digitizers to generate the Sanitary License and Technical Director Appointment Certificate.
  13. If the file does not comply, a rejection note with specific observations is issued.
  14. Pick up your Sanitary License and Technical Director Appointment Certificate.

Cost and Time

ItemDetail
Official MSPAS costFree (Q0)
Official time30 business days from complete file submission
Validity1 year (annual renewal mandatory)
ModeIn-person at MSPAS (DRCPFA, Zone 11)

Associated costs (non-MSPAS): Technical Director fees, premises setup, initial inventory investment, notary costs.

Common Mistakes & What to Do If Rejected

  • Not reading Technical Standard 31-2016 before applying — most rejections come from installation requirements that the standard specifies.
  • Mixing inventory of controlled medications — this license does not authorize sale of psychotropics, antibiotics or prescription drugs. Selling these without a Pharmacy License generates penalties.
  • Technical Director without active college membership — verify membership is current.
  • Premises without separated areas — storage and dispensing must have clearly differentiated zones.
  • Incomplete form — the F-AS-f-01 must be filled out without empty fields.
  • Outdated Payment Slip version — always download the current version.
  • If rejected, you will receive a note with specific observations. Address each point and re-submit the file.

The Medicine Sales Sanitary License is governed by:

  • Technical Standard 31-2016 “Venta de medicinas”: Defines installation, storage and operation requirements.
  • Decreto 90-97 — Health Code, Art. 161-175: Establishes the obligation of sanitary license for medicine sales.
  • Acuerdo Gubernativo 712-99: Current MSPAS Fee Schedule.