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Pharmacy Sanitary License — DRCPFA MSPAS
→ Start at MSPAS DRCPFA 📞 MSPAS 2304-0000
Before you click, have ready:
  • 📋 Form F-AS-f-01 and Payment Slip V-CC-G-001 downloaded from medicamentos.mspas.gob.gt
  • 👨‍⚕️ Technical Director — active licensed pharmacist (Pharmacy College certificate)
  • 🏪 Location meeting Technical Norm 4-2011 (pharmacy) or Norm 7-2011 (drugstore) — minimum area, counter, storage
  • 🏢 Active NIT, current RTU, business patente if a corporation
  • 📍 In-person submission at MSPAS, zone 11, Guatemala City
💰 Cost: Free (Q0) · ⏱ Time: 30 business days · 🆔 Verified: May 2026 (DRCPFA operational)

The Pharmacy Sanitary License (Licencia Sanitaria de Farmacia) is the document issued by the Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA) of MSPAS, through the Pharmaceutical Establishments Section, authorizing the opening of pharmacies and drugstores in Guatemala. The license certifies that the establishment complies with Technical Norm 4-2011 (pharmacies) or Technical Norm 7-2011 (drugstores) and has a licensed Technical Director.

Summary: Free (Q0) — no official fee. In-person process at MSPAS central office, zone 11. 30 business days from file submission. Annual renewal. Requires a licensed pharmacist Technical Director, SAT NIT/RTU, and a location compliant with the technical norm.

Applies to: neighborhood pharmacies, chain pharmacies (Cruz Verde, Galeno, Meykos, La Económica, etc.), private hospital pharmacies, and wholesale drugstores.

What is this license?

DRCPFA (Department of Regulation and Control of Pharmaceutical and Related Products) is the MSPAS unit regulating pharmaceutical establishments in Guatemala. The sanitary license is the legal document proving that your pharmacy or drugstore:

  • Meets the location’s physical requirements (minimum area, storage, counter, refrigeration)
  • Has a Technical Director — an active licensed pharmacist responsible for medication handling
  • Has the procedures required by Technical Norm 4-2011 (pharmacies) or 7-2011 (drugstores)
  • Is registered in the MSPAS database

Pharmacy vs drugstore difference: A pharmacy sells to the end consumer (retail counter open to public). A drugstore distributes medicines wholesale — selling to other pharmacies, hospitals, clinics. Each has its own technical norm and form.

The license is valid for 1 year and renews via a similar but shorter process if no structural changes occurred.

Who needs it?

You’re required to hold the DRCPFA sanitary license if you’ll operate:

  • 💊 Independent pharmacy — retail point of sale to end consumers
  • 🏬 Pharmacy chain branch — Cruz Verde, Galeno, Meykos, Batres, La Económica, etc. (each branch needs its own license)
  • 🏥 Private hospital pharmacy — inside a private hospital
  • 🚛 Drugstore — wholesale medicine distributor
  • 📦 Medicine importer — additional to other import procedures

Does NOT apply to:

  • IGSS or MSPAS pharmacies (public sector)
  • Natural-product stores selling only dietary supplements without medications (that’s a separate license — see Natural Products Sanitary License)
  • Stores selling only personal hygiene products and cosmetics

Watch out: Selling medications without a sanitary license is illegal in Guatemala. Penalties include fines, merchandise seizure, and possible closure. The PNC and MSPAS conduct routine operations.

Full requirements

DRCPFA requires a specific list of documents accompanying the pharmacy and drugstore sanitary license application. Verify the current list at medicamentos.mspas.gob.gt before assembling your file — requirements may have norm updates.

Forms and applications (downloadable at medicamentos.mspas.gob.gt):

  • Form F-AS-f-01 — Application for Sanitary License of Pharmaceutical and Related Establishments (current version)
  • Payment Slip V-CC-G-001 — current version
  • Cover letter to the DRCPFA Director

Owner documents:

  • DPI of the owner (foreign owners use passport + residence card; original and copy)
  • If a corporation: articles of incorporation, legal representative appointment, Mercantile Registry patente de comercio
  • NIT and SAT RTU certificate listing pharmaceutical product sales as economic activity

Technical Director documents (mandatory):

  • DPI of the Technical Director
  • Active membership certificate from the Pharmacists’ and Chemists’ College of Guatemala (Colegio de Farmacéuticos y Químicos)
  • Signed acceptance letter for the Technical Director role
  • University degree in Pharmaceutical Chemistry (legalized copy)
  • If the Technical Director covers multiple pharmacies: justification and compliance with the Technical Norm limit

Establishment documents:

  • Location sketch with clearly identified areas (counter, storage, refrigerated area, restroom)
  • Location map
  • Recent utility bill (water, electricity, max 3 months)
  • Lease contract if rented
  • List of pharmaceutical products to be sold
  • Standard Operating Procedures (SOPs) for medicine reception, storage, dispensing, and returns
  • Plan for managing expired and returned medications
  • Authorized supplier registry (drugstores from which you’ll purchase)

Technical norm compliance documents (Norm 4-2011 or 7-2011):

  • Pest control plan signed by an authorized company
  • Pharmaceutical waste management plan
  • Compliance with minimum area per the norm

Tip: Technical Norm 4-2011 requires specific minimum areas that many small locations cannot meet. Before signing a lease, read the full norm and verify the location is eligible.

Step-by-step process

  1. Download forms and norms. Visit the DRCPFA page — www.medicamentos.mspas.gob.gt. Download Form F-AS-f-01, Payment Slip V-CC-G-001 (current version), and the current Technical Norms (4-2011 for pharmacy, 7-2011 for drugstore).

  2. Properly complete Form F-AS-f-01. Fill in all requested information. Errors or omissions here bounce the file.

  3. Prepare the file complying with all requirements. Gather documentation per the current technical norm (4-2011 or 7-2011), including the Technical Director appointment.

  4. Make corresponding payments. Even though the official fee is Q0, the V-CC-G-001 Payment Slip is a control document entered into the system. Complete it as the form indicates.

  5. Submit the Payment Slip at Window 63-A2. At the MSPAS central office — this generates the 63-A2 receipt required for the file.

  6. Submit the complete file at the Document Reception and Delivery Section. Central window receiving all DRCPFA files at MSPAS headquarters.

  7. Reception Section forwards to DRCPFA. Internally, the file moves to the Pharmaceutical Establishments Section.

  8. Pharmaceutical Establishments Section assistant receives and reviews. Verifies the submission is complete and registers file entry.

  9. System classification and entry. The assistant classifies, enters into the database, and assigns the file to an evaluator.

  10. Professional evaluation. Professional Evaluators review the file for compliance with the relevant technical norm. If the norm requires site inspection, it’s scheduled.

  11. Sanitary License generation. If the file complies, it goes to the Digitizers who generate the Establishment Sanitary License and the Technical Director Appointment Certificate.

  12. Signature and delivery. Documents are signed by DRCPFA leadership and delivered to the applicant via the Document Reception and Delivery Section.

Cost and time

ItemDetail
Official feeQ0 — free
Validity1 year from issue date
RenewalAnnual — similar shorter process
Time from submission30 business days
ResultSanitary License + Technical Director Appointment Certificate

Real out-of-pocket costs:

  • Technical Director (if hired externally rather than the owner): Q3,000-Q8,000/month (~US$390-US$1,050) depending on experience and hours
  • Location upgrade to Technical Norm 4-2011: Q15,000-Q60,000 (one-time, depends on starting condition)
  • Standard Operating Procedures (SOPs) if outsourced: Q3,000-Q8,000 (one-time)
  • Pest control plan: Q800-Q2,500/year
  • Furniture, refrigerator, A/C, inventory control software: variable

Economic reality: Although the license is free, technical norm compliance and the Technical Director’s salary are the bulk of the cost. Realistic plan to open a small pharmacy: Q40,000-Q120,000 (~US$5,200-US$15,500) covering license, upgrade, initial inventory, furniture, and the first 3 months of the Technical Director.

Common mistakes & what to do if denied

Top five rejection causes:

  1. Technical Director without active college membership or with too many establishments. The system cross-checks with the College.
  2. Location failing minimum area per Technical Norm 4-2011. The most expensive mistake — means finding a different location.
  3. Missing Standard Operating Procedures (SOPs) or copied from generic template. As in other MSPAS procedures, evaluators recognize templates.
  4. Payment Slip V-CC-G-001 incorrectly filled or not submitted at Window 63-A2. Without a 63-A2 receipt generated, the file doesn’t advance.
  5. Incomplete Technical Director documentation — missing acceptance letter, legalized degree copy, or College certificate.

If denied:

  • You receive a formal note with specific findings
  • You have time to correct and resubmit
  • No new payment (it’s free), but you must reprocess the Window 63-A2 entry

Recommendation: Consult in advance with an experienced licensed Technical Director who has handled pharmacy openings. The investment in initial advice (Q2,000-Q5,000) saves months of delays.

  • Technical Norm 4-2011 — Pharmacies: defines all physical, technical, and personnel requirements for pharmacies.
  • Technical Norm 7-2011 — Drugstores: defines requirements for wholesale drugstores.
  • Health Code — Decreto 90-97: general framework empowering MSPAS to regulate pharmaceutical products.
  • Government Agreement 712-99 and related regulations — general DRCPFA regulation.

Operating a pharmacy or drugstore without a sanitary license is a Health Code violation carrying:

  • Administrative fines
  • Medication seizure
  • Temporary or permanent closure of the establishment
  • For the Technical Director (if acting in an illegal establishment): sanctions from the Pharmacists’ College