Natural Products Sanitary License MSPAS Guatemala 2026: Opening Process

The Natural Products Sales Sanitary License (Licencia Sanitaria de Venta de Productos Naturistas) 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 natural-product stores, herbal shops, dietary supplement and vitamin sellers in Guatemala. It is governed by Technical Norm 38-2016.

Summary: Free (Q0) — no official fee. In-person process at MSPAS central office, zone 11. 30 business days from file submission. Annual renewal. Requires location compliant with Technical Norm 38-2016, SAT NIT/RTU, and only products with current sanitary registration.

Applies to: natural-product stores, herbal shops, dietary supplement and vitamin sellers, distributors specialized in plant-based products with therapeutic use.

What is this license?

DRCPFA classifies natural products as a category of related pharmaceutical products. Establishments dedicated exclusively to selling these products require their own sanitary license, distinct from the pharmacy license.

The license certifies that your natural-product store:

• Meets the location’s physical requirements per Technical Norm 38-2016
• Sells only products with current sanitary registration from MSPAS
• Has appropriate handling and storage (especially refrigeration when applicable)
• Is registered in the MSPAS database

The license is valid for 1 year and renews annually.

Natural-products store or pharmacy? If your store sells only natural products (supplements, vitamins, herbal medicine) → natural-products license (this one). If you also sell classic pharmaceuticals → you need the pharmacy license which covers both. A pharmacy with DRCPFA license can sell registered natural products without an additional procedure.

Who needs it?

You’re required to hold the DRCPFA natural-product sales sanitary license if you’ll operate:

• 🌿 Independent natural-product store — retail sales of supplements, vitamins, plant-based products
• 🌱 Traditional herbal shop — medicinal plants, infusions, traditional medicine derivatives
• 💊 Dietary supplement specialty store — proteins, vitamins, minerals, omegas
• 🍃 Natural-product chain branch — Tienda de Diosa, Naturasol, GNC, and similar (each branch with its own license)
• 📦 Wholesale natural-product distributor — with physical sales point

Does NOT apply to:

• Pharmacies with DRCPFA license (already covered)
• Supermarkets selling packaged products with their own registration (those have a different classification)
• Nutritional consulting services without product sales

Ambiguous case: “healthy food” stores (gluten-free foods, sugar-free, vegan products) without a pharmaceutical component generally don’t need this license — they may need the food sanitary license if they handle prepared foods. Confirm with DRCPFA if you have both product types.

Full requirements

DRCPFA requires a specific list of documents accompanying the natural-products sanitary license application. Verify the current list at medicamentos.mspas.gob.gt before assembling the file.

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 natural-product sales as economic activity

Establishment documents:

• Location sketch with clearly identified areas (counter, storage, refrigerated area if applicable)
• Location map
• Recent utility bill (water, electricity — max 3 months)
• Lease contract if rented
• Complete product list to be sold with their MSPAS sanitary registration numbers (the most critical document)
• Procedures for product handling, reception, storage, and dispensing
• Plan for managing expired and returned products
• Authorized supplier list

Technical Director documents (when applicable):

• DPI and active college membership certificate
• Acceptance letter for the role
• Relevant university degree (Pharmacist or other approved profile)

Technical Norm 38-2016 compliance documents:

• Pest control plan signed by an authorized company
• Waste management plan
• Written commitment not to sell unregistered products

Critical tip: the #1 rejection cause is submitting a product list with expired registration numbers or unregistered products. Before assembling the list, verify each product in the MSPAS database.

Step-by-step process

1. Download forms and Technical Norm 38-2016. Visit www.medicamentos.mspas.gob.gt. Download Form F-AS-f-01, Payment Slip V-CC-G-001, and Technical Norm 38-2016.

2. Properly complete Form F-AS-f-01. All information must be complete and legible.

3. Prepare the file complying with Norm 38-2016. The key step is the complete product list with current MSPAS sanitary registration numbers. Don’t include unregistered or expired-registration products.

4. Complete Payment Slip V-CC-G-001. Even though the fee is Q0, this control document must be entered into the system.

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

6. Submit the complete file at the Document Reception and Delivery Section. MSPAS central office, zone 11.

7. Reception forwards to DRCPFA. The file moves internally to the Pharmaceutical Establishments Section.

8. DRCPFA assistant receives and reviews. Verifies submission completeness.

9. System classification and entry. Assistant classifies, registers in the database, and assigns to an evaluator.

10. Professional evaluation. Professional Evaluators review the file and especially verify each sanitary registration on the product list one by one against the MSPAS database. If the norm requires a site inspection, it’s scheduled.

11. Sanitary License generation. If the file complies, the Establishment Sanitary License and, when applicable, the Technical Director Appointment Certificate are generated.

12. Signature and delivery. Documents are signed by DRCPFA leadership and delivered to the applicant.

Cost and time

Real out-of-pocket costs:

• Location upgrade per Norm 38-2016: Q5,000-Q25,000 (~US$650-US$3,250)
• Refrigeration (if you handle sensitive products): Q3,000-Q15,000 (one-time)
• Initial inventory of registered products: variable, Q20,000-Q200,000 depending on scale
• Pest control plan: Q500-Q1,800/year
• Technical Director (if external): Q2,500-Q6,000/month (~US$325-US$780)
• Inventory tracking software: variable

Economic reality: Opening a small natural-products store with a diversified inventory has a realistic total cost of Q50,000-Q150,000 (~US$6,500-US$19,500) covering license, upgrades, furniture, initial inventory, and the first 3 months of operation.

Common mistakes & what to do if denied

Top five rejection causes:

1. Products on the list without current sanitary registration. This is the #1 cause. Each product must have its MSPAS registration number verifiable in the database.
2. Imported products without equivalency procedure. Importing and selling foreign products without an equivalency or local registration is illegal and the entire list is rejected.
3. Location without separated areas. The counter cannot mix with storage; refrigerated products need their own zone.
4. Payment Slip V-CC-G-001 incorrectly filled or not submitted at Window 63-A2.
5. Missing or vague expired-products handling plan. It’s an explicit requirement.

If denied:

• You receive a formal note with specific findings
• You have time to correct the list, obtain missing registrations, or adjust the location
• No new payment (it’s free), but you must reprocess Window 63-A2 entry

Recommendation: Before assembling the product list, dedicate a full day to verifying each sanitary registration in the MSPAS database one by one. It’s tedious work but it’s what prevents the most rejections.

For imported products without local registration: consider hiring a sanitary-registration agent who can process the equivalency or local registration before including them in your inventory and application.

Legal basis

• Technical Norm 38-2016 — Sale of Natural Products: specific norm regulating natural-product sales establishments.
• Health Code — Decreto 90-97: general framework empowering MSPAS to regulate pharmaceutical and related products.
• Government Agreement 712-99 and related regulations — general DRCPFA regulation.
• Natural products and dietary supplements regulation — specific norm for each product’s registration.

Operating a natural-products store without a sanitary license, or selling unregistered products, is a Health Code violation carrying:

• Administrative fines
• Seizure of unregistered products
• Temporary or permanent closure of the establishment

Related processes

• 🏥 MSPAS Hub — Health Procedures — all Ministry of Health procedures
• 💊 Pharmacy Sanitary License — if you’ll also sell medicines
• 💄 Beauty Salon Sanitary License — another DRCPFA establishment
• 🏥 Health Establishment Sanitary License — clinics and hospitals
• 🍽 Food Sanitary License — if you handle prepared foods
• 🧾 SAT RTU Registration — prerequisite
• 🏢 Register a Company at the Mercantile Registry — for corporations

Official links

• DRCPFA — Department of Regulation and Control of Pharmaceutical and Related Products
• MSPAS — Main page
• MSPAS phone: +502 2304-0000
• Headquarters: MSPAS, zone 11, Guatemala City