The health license is the authorization issued by the Ministry of Public Health and Social Assistance so that a health establishment can manufacture, transport, distribute, handle, store, package, sell, dispense, import and export health products, as well as provide health services, once it meets all the technical and legal requirements in force in the country. It is issued by the Department of Regulation and Control of Pharmaceutical and Related Products when the establishment manufactures, distributes or markets pharmaceutical, cosmetic, hygienic and related products; while food sanitary licenses are issued by the Department of Food Regulation and Control.

The price of obtaining a license is made up of 2 parts, the fee set by the Ministry of Health for said license (ranging from Q.100.00 to Q.500.00 depending on the establishment) and the fees of the professional Chemist Pharmacist in charge of the procedure and responsible for it before the MSPAS, these fees also vary according to the type of establishment to which the license is opened or renewed.

In the Ministry of Health and Social Assistance, particularly the General Directorate of Regulation, Surveillance and Control of Health -DGRVCS- located at Avenida Bolívar 28-07 zone 8 of Guatemala City. Department of Regulation and Control of Pharmaceutical and Related Products -DRCPFA- (3rd and 4th level) Department of Food Regulation and Control –DRCA- (5th level) The procedure is carried out by a Pharmaceutical Chemist professional who is responsible for the establishment before the Ministry of Health.

The requirements or required documentation will vary depending on the type of establishment for which you wish to obtain the health license. Some of the documents frequently required for most license procedures are the following: Copy of the DPI of the owner or legal representative. Original and photocopy of the plan of the premises or sketch indicating the square meters of each area. Simple photocopy of the company's trade license. Simple copy of the company's RTU. When it is a legal person (corporations): Authenticated original photocopy of the incorporation of the company or photocopy of the certificate of current opinion of the incorporation of the company issued by the DRCPFA. When it is a legal person (corporations): Authenticated original photocopy of the current appointment of the legal representative or photocopy of the current legal representation opinion certificate issued by the DRCPFA. For a license renewal it is necessary to have the Sanitary License in original and in case of loss present a note from the owner taking responsibility for the loss of the document. Copy of health cards or current medical certificates of the establishment's staff.

The sanitary license will be valid for five (5) years, leaving the establishment subject to control inspections throughout that period. If your license is about to expire, the license renewal process must be carried out at least one month before its expiration.

The process depends on the paperwork presented to the Ministry of Health, if everything is correct in the file, the issuance of the license can take between 2-3 weeks, while if the paperwork needs some correction, the time needed to correct and resubmit the paperwork.

Pharmacies Pharmacy Pharmacy with recipe book Drugstores Drugstore Drugstore with primary fractionation (authorized to fractionate in primary packaging, which is the container in direct contact with the product, and if applicable, place pharmaceutical products in secondary packaging) Drugstore with secondary fractionation (authorized only to place all pharmaceutical specialties and related products in secondary packaging). Distributors Distributor of cosmetic, hygienic and related products Over-the-counter medicine distributor Distributor with primary fractionation (authorized to fractionate in primary packaging and, if applicable, place certain raw materials and related products in secondary packaging) Distributor with secondary fractionation (authorized only to place certain raw materials and related products in secondary packaging). Raw material distributor Pesticide distributor Manufacturers laboratories: Laboratory of pharmaceutical products for human use Laboratory of medicinal natural products Laboratory of cosmetic products and personal hygiene Medical gas factory Factory or laboratory of hygienic products Medical device factory Factory of diagnostic reagents Factory of raw materials and premixes for the pharmaceutical or related industry Pesticide formulator for domestic and professional use Quality Control Laboratories Private quality control laboratory Official quality control laboratory Dental deposit Beauty salons Kiosks for cosmetic, hygienic and related products

In the following documents you will find the current regulations of the Ministry of Public Health and Social Assistance of Guatemala with all the requirements for obtaining health licenses for pharmaceutical, cosmetic and related products. If you have any questions, you can contact one of our representatives to start the relevant procedures for your health license Regulation No 4-2011: Pharmacies Regulation No 5-2011: Laboratories manufacturing pharmaceutical and related products Regulation No 7-2011: Drugstores Regulation No 31-2016: Sales of medicine Regulation No 38-2011: Sales of natural products Regulation No 48-2020 V04: Distributors Rule No. 23-2011: Technical management of pharmaceutical and related establishments. Regulation No. 85-2021: Quality control laboratories

Depending on the type of establishment, the sanitary license is obtained with or without inspection. If your facility requires inspection for license approval and the paperwork submitted is correct, Ministry of Health inspectors will contact you to schedule the inspection, usually within 7 business days. When the establishment is located in the department of Guatemala, prior to delivering the Sanitary License, supervision is needed to determine if it meets the hygienic locative conditions, habitability and if the equipment, furniture and materials are adequate for the activity that it develops. , this supervision is carried out an average of five working days. If the establishment is located in the interior of the Republic, you must attach a certificate of habitability to your file, which is issued by the nearest Area Headquarters or Health Center, depending on the jurisdiction.