⚡ DIRECT ACCESS TO OFFICIAL PORTAL
Drugstore / Distributor Sanitary License — MSPAS DRCPFA
→ Start at MSPAS 📞 MSPAS Contact
Before clicking, have ready:
  • 📄 Form F-AS-f-01 (Sanitary License Application)
  • 💰 Payment Slip V-CC-G-001 (current version)
  • 📚 Technical Standards 48-2020 and 7-2011 (download and read both)
  • 👨‍⚕️ Pharmaceutical Chemist Technical Director licensed and active
  • 🏢 Warehouse set up with quarantine, storage and dispatch areas
  • 🏛 Commercial license and NIT for the establishment
💰 Cost: Free (Q0) · ⏱ Time: 60 business days · 🆔 Verified: May 2026 (Catalogo Unico de Tramites del Estado, Service 3416)

The Drugstore / Distributor Sanitary License (Licencia Sanitaria de Distribuidora / Droguería) is the authorization that MSPAS issues through the Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA) for an establishment to import, store and wholesale medications, pharmaceutical products, pesticides and related products in Guatemala.

Quick summary: Free (Q0) procedure, 60 business days. Filed at the MSPAS DRCPFA using form F-AS-f-01. Governed by Technical Standards 48-2020 “Distribuidoras” and 7-2011 “Droguerías”. Result: Sanitary License + Technical Director (Pharmaceutical Chemist) Appointment Certificate.

Data verified against the official Catalogo Unico de Tramites del Estado (Service 3416 — MSPAS).

What This Procedure Is

The Drugstore / Distributor Sanitary License authorizes the wholesale handling of pharmaceutical products: imports, storage, quality control, distribution to pharmacies, hospitals, clinics and other distributors. It is mandatory to operate as a wholesaler in the Guatemalan pharmaceutical sector.

These licenses are the operational foundation for companies that:

  • Import medications to Guatemala
  • Distribute to pharmacy chains and hospitals
  • Manage large inventories with traceability
  • Operate as local representatives of international laboratories
  • Distribute pesticides, pharmaceutical inputs or related products

Who Needs It

  • Entrepreneurs opening a new distributor or drugstore in Guatemala
  • Wholesale medication importers distributing to pharmacies and hospitals
  • Local representatives of international pharmaceutical laboratories
  • Pesticide distributors (with MAGA coordination if regulated agricultural)
  • Pharmaceutical companies requiring a license to operate central warehouses
  • Branches or expansions of existing distributors (each location requires its own license)

If you will operate retail (to the public), you need a Pharmacy License — not this. If you only sell non-controlled medications retail, you need a Medicine Sales License.

Difference Between Distributor and Drugstore

Although they share many requirements, there are important differences:

FeatureDistributorDrugstore
Applicable standardTechnical Standard 48-2020Technical Standard 7-2011
Products handledMedications, pharmaceuticals, pesticides, relatedSpecifically pharmaceutical medications
ScopeBroader (includes pesticides)More focused on pharmaceuticals
Technical DirectorPharmaceutical ChemistPharmaceutical Chemist
Time60 days60 days
CostFreeFree

In practice, many establishments apply for both licenses to operate flexibly.

Difference From Other DRCPFA Licenses

LicenseEstablishment TypeTimeOperation
Distributor / DrugstoreWholesale distribution60 daysWholesale (not public)
PharmacyPublic sale with controlled drugs30 daysRetail (to public)
Medicine SalesRetail non-controlled sales30 daysRetail (to public)
Dental SupplyDental products60 daysWholesale (to clinics)
Natural ProductsSupplements and naturals30 daysRetail (to public)

Complete Requirements

Important: All requirements are defined in Technical Standards 48-2020 “Distribuidoras” and 7-2011 “Droguerías”. Download them 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)
  • Constitutional deed (if legal entity)
  • RTU SAT registration certificate

Technical Director (Pharmaceutical Chemist) Documents

  • Current DPI of the Technical Director
  • Pharmaceutical Chemist professional title
  • Active professional college membership certificate
  • Acceptance letter for the Technical Director role
  • Curriculum vitae and employment certificate
  • Schedule commitment (minimum required presence per standard)

Premises Documents

  • Location sketch (croquis) of the distributor / drugstore
  • Architectural plan of the premises with quarantine, storage, dispatch, administrative area and bathrooms
  • Habitability certificate or equivalent document
  • Lease contract or property title for the premises
  • Recent utility bill as proof of address

Owner Documents

Operational Documents (if applicable)

  • Inventory control and traceability systems
  • Standard operating procedures (POE) signed by the Technical Director
  • Pharmaceutical waste management plan
  • Cold chain protocols (if you will handle biologicals or vaccines)

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 48-2020 “Distribuidoras”
    • Technical Standard 7-2011 “Droguerías”
  2. Read both Technical Standards carefully — they define all installation, storage, minimum area, temperature condition and operation requirements.
  3. Properly fill out Form F-AS-f-01 with establishment, owner and Pharmaceutical Chemist Technical Director data.
  4. Assemble the complete file with all required documents in the indicated order.
  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 (generally a DRCPFA Pharmaceutical Chemist).
  11. The Professional Evaluator conducts the evaluation. For distributors / drugstores, it always includes a site inspection to verify quarantine areas, storage, temperature conditions and POEs.
  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. Inspection usually identifies several improvement points — address them and re-submit.
  14. Pick up your Sanitary License and Technical Director Appointment Certificate.

Cost and Time

ItemDetail
Official MSPAS costFree (Q0)
Official time60 business days from complete file submission
Validity1 year (annual renewal mandatory)
ModeIn-person at MSPAS (DRCPFA, Zone 11)

Associated costs (non-MSPAS): Pharmaceutical Chemist Technical Director fees (higher than other DTs), warehouse setup with specific conditions (temperature, ventilation, separated areas), initial inventory investment, cold chain equipment if applicable, notary costs.

Common Mistakes & What to Do If Rejected

  • Not reading Technical Standards 48-2020 and 7-2011 before applying — most rejections come because the premises do not meet minimum area, temperature condition or zone separation requirements that the standard specifies.
  • Technical Director without active college membership or insufficient presence — the Pharmaceutical Chemist must comply with minimum presence schedules. Verify the standard.
  • Warehouse without quarantine areas — every distributor must have separate areas for products under review, returns and expiration. Inspection verifies this.
  • No traceability systems — managing wholesale pharmaceutical inventory requires control systems. Without them, inspection rejects.
  • No cold chain protocol (if you will handle biologicals) — vaccines and biologicals require monitored refrigeration and specific POEs.
  • Mixing chemical products with pharmaceuticals without separation — pesticides and medications CANNOT be stored in the same space without physical separation.
  • If rejected, you will receive a note with specific observations. Address each point and re-submit the file with a copy of the original note — generally without needing to pay associated fees again.

The Drugstore / Distributor Sanitary License is governed by:

  • Technical Standard 48-2020 “Distribuidoras”: Defines requirements for distributors (broader scope).
  • Technical Standard 7-2011 “Droguerías”: Defines specific requirements for medication drugstores.
  • Decreto 90-97 — Health Code, Art. 161-175: Establishes the obligation of sanitary license for wholesale distribution.
  • Acuerdo Gubernativo 712-99: Current MSPAS Fee Schedule.