Belize drug registration: GMP, CPP and COA rules for peptide drugs

Every injectable peptide that reaches a Belizean patient legally has passed through one short legal instrument: the Food and Drugs (Registration, Licensing and Inspection) Regulations, 2017, Statutory Instrument No. 54 of 2017, made under section 55 of the Food and Drugs Act and gazetted on 29 July 2017¹. The rules apply to any drug "manufactured, sold or represented for use" in treating a disease in man or in "restoring, correcting or modifying organic functions in man"¹. That covers GLP-1 receptor agonists such as semaglutide and tirzepatide, insulin and every other peptide medicine. For physicians the practical question is simple: what has to be on file before such a product may be sold here, and who checks it?

What a peptide drug needs before it can be sold in Belize

Regulation 3 is blunt: "A person shall not commercialize any drug, unless that person has obtained registration of, and receives a product licence for, that drug from the competent authority"¹. The competent authority is the Director of Health Services or his nominee in the Ministry responsible for health¹. The Minister may exempt a person or a drug, but without an exemption the offence carries a fine of up to $10,000¹.

Regulation 4 lists the file. An application must include¹:

• a valid GMP certificate (good manufacturing practice);
• a valid Certificate of Pharmaceutical Product (CPP) on the World Health Organization model, or a Certificate of Free Sale if the country of origin is not in the WHO certification scheme;
• a valid certificate from the health authority of the country of origin;
• an original certificate of analysis of the finished drug from the manufacturer's quality control laboratory;
• a summary of product characteristics, samples of the final package, labels and insert, and pharmacological information;
• a fee of one hundred dollars for each drug per importer.

Documents must be in English or come with an English translation¹. The CPP is the core document of a voluntary WHO arrangement meant to give importing countries assurance "about the quality of pharmaceutical products" that cross borders⁹. A product licence comes with a registration code and lasts only until the GMP certificate or the CPP expires, whichever comes first; renewal must be filed six months ahead or the registration is cancelled¹. The labels and insert must stay the same as those submitted, again on pain of a $10,000 fine (regulation 9)¹. Drugs for rare diseases are exempt from registration but still need written import authorization (regulation 5)¹.

Why paperwork stands in for testing

Belize has relied on certificates because it has had little capacity to test. Asked in 2019 about complaints over generic drugs, the then Director of Health Services, Dr. Marvin Manzanero, told News 5: "we ask for a GMP, a CPP and a COA because we don't have the mechanisms in place to do testings"². He added that "FDA approved is for a U.S. market, that is different situation from what happens in Belize"². The weakness of a paper system is that papers can be wrong. In 2018 the Ministry denied import approval to a shipment whose invoice named a supplier in England while the port of loading was Ankara; at inspection, all labels and leaflets were in Turkish, and the names, manufacturer, batch numbers and expiry dates differed from the documents³. The importer supplied an inventory of more than 160 non-compliant products already in the country³. A 2016 notice had already said that importers must be licensed by the Ministry's Licensing and Accreditation Unit, and Dr. Manzanero warned: "If there is a new product that is not in our database we will simply say no to it"⁴. The database matters: when falsified Tylenol appeared in 2023, Chief Drug Inspector Dr. Crystal Samouge said the batch had not been seen "in our importation database"¹⁴.

Cabinet votes to replace the 2017 rules

On 8 October 2024 Cabinet "approved the repeal of the Food and Drug (Registration, Licensing, and Inspection) Regulations," to be replaced with modernized legislation meant to meet current needs and ensure the safety and efficacy of the medicines Belizeans use⁵. Prime Minister John Briceño, asked how drug safety was assured without a drug inspector at the Ministry, said: "We had millions in drugs rejected because they didn't meet standards" and that the appointment "will happen soon"⁶⁸. A month later Greater Belize Media reported that the Chief Drug Inspector had resigned to join the private sector and that Health Minister Kevin Bernard said a replacement was being considered; he credited the inspectorate: "If it was not because of them, we would not have been able to pick up on many of these issues"⁷. We could not find the text of the replacement legislation published as of this writing.

Who checks: inspectors and the new surveillance system

The 2017 rules give inspectors broad powers: to enter any place where drugs are stored or sold, take samples, examine records, seize drugs that contravene the Act, and, with the competent authority's permission, temporarily close an establishment (regulation 20)¹. Inspectors must also "regularly promulgate the results of sampling examinations and inspections on the quality of pharmaceuticals" (regulation 21)¹. In 2026 that inspection work gained a wider system around it. Belize became a full member of the WHO Programme for International Drug Monitoring, which, according to Dr. Javier Zuniga, also lets the country buy medicines through PAHO from WHO-certified suppliers¹³. In August 2026 the Ministry and PAHO/WHO began building a National Post-Market Surveillance System that covers quality problems, suspected substandard and falsified products and unregistered products¹².

What it means for GLP-1 and other peptide products

For peptide drugs the three certificates are not formalities. In a study of semaglutide bought online without a prescription, measured purity ranged from 7.7 % to 14.37 % against the 99 % claimed on the labels, and endotoxin was found in every sample¹⁰. PAHO warned in March 2026 that GLP-1 agonists marketed through "unofficial channels, including the internet and social media" may be falsified, unauthorized or substandard, and asked countries to limit their use to "indications approved by the national regulatory authority"¹¹. In Belize, the only way to know whether a GLP-1 product has passed the registration file described above is to ask whether it has a product licence and registration code from the Ministry¹.