MAGA Veterinary Medicine Sanitary Registration Guatemala 2026: For Manufacturers (Free)

The Sanitary Registration of Operation of Manufacturer of Veterinary Medicines and Related Products is the document issued by VISAR (Vice-Ministry of Agricultural Health and Regulations) of MAGA, authorizing legal operation of plants manufacturing veterinary medicines (antibiotics, vaccines, antiparasitics, vitamins) and related products (medicated feed, supplements, animal-care products) in Guatemala.

Summary: Q0 (free fee). In-person procedure at VISAR’s OSU with physical plant inspection. 20 business days from file submission. Registration remains in force as long as the plant maintains the conditions under which it was granted. You need an active Veterinarian regent, NIT/RTU with manufacturing activity, commercial license and GMP manuals.

Applies to: veterinary pharmaceutical labs, animal vaccine and biological manufacturers, medicated feed manufacturers, veterinary product maquila plants, antiparasitic, supplement and animal hygiene product manufacturers.

What is this procedure?

The manufacturer sanitary registration is the MAGA’s official authorization to operate a manufacturing plant for veterinary medicines and related products. It is distinct from the sanitary registration of each product (also mandatory): the manufacturer registration authorizes the company and the plant, while the product registration authorizes each specific formula you will sell.

The procedure is regulated by the Central American Technical Regulation RTCA 65.05.51:08 for Veterinary Medicines and related products, meaning Guatemala’s registration is recognized with similar procedures in El Salvador, Honduras, Nicaragua and Costa Rica (with complementary verifications).

Who needs it?

You are required to have this registration if:

• 💉 You manufacture veterinary medicines — injectable or oral antibiotics, internal/external antiparasitics, vitamins, hormones, anesthetics
• 💊 You manufacture vaccines and biologicals — vaccines for cattle, poultry, pigs, pets
• 🧪 You manufacture related products — medicated feed, medicated premixes, electrolyte solutions, livestock disinfectant products
• 🏭 You maquila veterinary products for third-party brands (foreign labs producing in Guatemala)
• 🐄 You manufacture animal care products — medicinal shampoos, tick baths, mineral supplements

You do NOT need this registration if:

• You only import already-manufactured veterinary medicines (you need an importer registration and product registration, both different)
• You only distribute and market product manufactured by another company (you need a trader registration)
• You are a veterinarian prescribing and selling registered product (you need a veterinary pharmacy, different registration)

Complete requirements

VISAR maintains the official list at its procedure simplification portal. Confirm latest version before assembling the file. This is the typical list requested under Ministerial Agreement 390-2006 and RTCA 65.05.51:08:

Applicant legal documents:

• Official MAGA Manufacturer Sanitary Registration form
• Owner or legal representative DPI (original and copy)
• Active NIT and SAT RTU with veterinary product manufacturing economic activity
• Commercial license (legal entities — manufacturers must be in practice)
• Public deed of incorporation
• Current legal representative appointment

Technical regent (Veterinary Doctor) documents:

• Certificate of active regent Veterinary Doctor, with current College of Veterinarians member number
• Acceptance letter signed by regent, with copy of professional ID
• Regent’s curriculum vitae

Manufacturing plant documents:

• Architectural and area distribution blueprints (raw material reception, manufacturing, packaging, warehouse, quality control, administrative area)
• Descriptive memorandum of the manufacturing process for each product to be manufactured
• List of equipment and machinery (with photographs and specifications)
• Good Manufacturing Practices (GMP) Manual aligned with RTCA 65.05.51:08
• Standard Operating Procedures (SOPs) for cleaning, sanitization, pest control, waste management
• Process validation and quality control program
• List of raw materials and suppliers

Additional that VISAR may request:

• Plant water analysis (microbiological, chemical)
• Stability studies of each product
• Labels and inserts (artwork project) of each product to manufacture
• Accredited laboratory analysis of product samples

Veteran manufacturer tip: Before submitting, hire a private GMP compliance audit (Q5,000-Q15,000) with an independent consultant. It identifies weak points before the VISAR inspector and saves you observation cycles that can stretch the process to 2-3 months.

Step-by-step process

1. Download the form. Go to www.maga.gob.gt or the simplification portal and download the Manufacturer Sanitary Registration form. Fill it on computer.

2. Designate the regent Veterinary Doctor. Hire an active VD registered with the College of Veterinarians. The regent signs the file and must commit part-time or full-time to the plant depending on production volume.

3. Assemble the file. Gather all company legal documentation, plant blueprints and descriptive memorandum, GMP and SOP manuals, equipment and raw material lists. Order per requirements list.

4. Submit the file. Hand in the physical file at the VISAR Customer Service Office (OSU) at MAGA headquarters (Monja Blanca Building, zone 13, Guatemala City). The OSU verifies completeness and gives you a receipt slip.

5. Address documentary observations. VISAR’s technical team reviews the file. If observations arise (e.g. incomplete descriptive memorandum, regent without updated signature, GMP manuals with gaps), you’ll be notified to correct.

6. Physical plant inspection. The VISAR inspector schedules a technical visit to the plant to verify that facilities, equipment, raw material handling and processes correspond to what is declared in the file. The most sensitive stage — prepare as if it were a regulatory audit.

7. Compliance with inspection recommendations. If inspection finds findings, you receive specific observations and a deadline to correct. Document corrections with photographs and request reinspection.

8. Issuance of sanitary registration. Once inspection is approved, VISAR prepares the manufacturer sanitary registration certificate.

9. Pickup of registration. OSU notifies when to pick up the signed and stamped registration. Bring the receipt slip and legal representative’s DPI.

10. Operation under registration. Once the plant is authorized, you can begin manufacturing. Remember that each product you manufacture requires its own product sanitary registration (separate procedure).

Cost and time

Unofficial costs you’ll have:

• Veterinary Doctor regent fees: Q5,000-Q25,000/month depending on operation volume
• GMP compliance consultant (preparatory audit): Q5,000-Q15,000 (one-time)
• GMP and SOP manuals if hired with consultant: Q15,000-Q40,000 (one-time)
• Initial process validation and quality control: Q20,000-Q80,000 depending on number of products
• Plant improvements VISAR may require (epoxy floors, ventilation, area separation): Q50,000-Q500,000+ depending on previous condition

Budget tip: Although the fee is Q0, the real cost of complying with GMP and operating under veterinary sanitary registration in Guatemala is between Q150,000 and Q800,000 in the first year (plant + manuals + regent + validations). It’s a capital-intensive business — don’t enter veterinary medicine manufacturing without serious budget.

Common errors / what to do if you’re rejected

The five most frequent reasons for VISAR observations:

1. Veterinary Doctor regent without current signature or without active membership. Verify regent status with the College of VD before submitting.
2. Generic GMP and SOP manuals. Inspectors recognize templates — manuals must be specific to your plant and your processes.
3. Areas not physically separated in the plant. Raw material reception, manufacturing, packaging, warehouse and quality control must have clear physical separation — walls, not just floor tape.
4. Lack of water and environmental condition control. Microbiological water analyses, temperature/humidity records and pest control are common verification.
5. Inconsistency between descriptive memorandum and actual plant. If file says one thing and inspection finds another, rejection is immediate. Review file against reality before submitting.

If you’re rejected:

• You receive a technical note with specific observations
• You have a reasonable timeframe to correct (typically 30-60 days depending on severity)
• Document corrections (photographs, supplier improvement certificates, updated manuals)
• Request reinspection — no additional payment
• If corrections are major, consider a private audit before requesting reinspection

Recommendation: For new manufacturers, plan your operation under GMP from plant design, not after. Building or remodeling a plant to comply with GMP when already operating is 3-5× more expensive than designing it well from the start.

Legal framework

• Decree 36-98 — Plant and Animal Health Law: authorizes MAGA to regulate manufacture, importation and marketing of veterinary medicines.
• Government Agreement 745-99 — Plant and Animal Health Law Regulation: regulates operation of veterinary medicine manufacturers and sanitary registration procedures before VISAR.
• Ministerial Agreement 390-2006: requirements for registration of individuals and legal entities performing activities related to animal inputs and for registration, renewal, importation, exportation and return of animal inputs.
• RTCA 65.05.51:08: Central American Technical Regulation for Veterinary Medicines and related products — standardizes manufacturing, registration, labeling and quality control requirements in Central America.

Operating a veterinary medicine manufacturing plant without sanitary registration is a violation of the Plant and Animal Health Law:

• MAGA administrative fines
• Temporary or permanent plant closure
• Seizure of product manufactured without registration
• In serious cases (products causing harm to animals or public health), criminal liability

Related procedures

• 🌾 MAGA Hub — Agricultural Procedures — all procedures of the Ministry of Agriculture
• 🐄 MAGA Zoosanitary Constancy — for movement of livestock products
• 🌱 MAGA Phytosanitary Export Certificate — to export plant products
• 🌿 MAGA Phytosanitary Import Permit — to import plants and seeds
• 🌱 MAGA Fertilizer Registration — for distributor companies
• 🧾 SAT RTU Registration — prior requirement
• 🏢 Business Registration (Mercantile Registry) — for legal entities
• 🏭 MSPAS Food Sanitary License — if your product crosses with human food

Official links

• MAGA — Procedure Simplification Portal (Veterinary Products)
• VISAR — Vice-Ministry of Agricultural Health
• MAGA — Main page
• MAGA phone: 1557 (toll-free) / 2413-7000
• VISAR / OSU address: Monja Blanca Building, MAGA, zone 13, Guatemala City