Belize Drug Registration Process  

Application for Registration

A request to register a drug must be submitted using the form included as Form 1 in Schedule 1 and must be supported by the documents listed below:

1. valid GMP certificate
2. Valid Pharmaceutical product Certificate (CPP) based on the model established by World Health Organization or a Certificate of Free Sales (CFS) if the country of origin is nor a member of the World Health Organization certification scheme.
3. A certificate from the country of origin’s relevant health authority;
4. Authentic, genuine certificate of analysis of the completed medicine provided by the manufacturer’s quality control lab.
5. Drug’s technical information.
6. Pharmacological information of finished product.
7. Evaluation of the environmental risk for medications, including hormones, anti-cancer drugs, radiopharmaceuticals, and any other considered required by the appropriate authority.
8. A fee of $100 for every medication per importer.

Every document needed to register a medicine under the regulation must be in the English language; if it is not, the applicant must provide the appropriate authorities along with an English translation of the document that was annexed.

Grant or refusal of product license

• If the person seeking the product license has applied in writing to the competent authority and meets the conditions for drug registration under the regulation, the competent authority may give a product license for any drug.
• The competent authority must give the applicant a drug registration code if it issues a product license.
• A candidate for drug registration may take up to 6 months to complete the necessary paperwork, according to the relevant authorities.
• The relevant authorities will refuse to issue a product license if:

1.   The applicant does not meet the requirements in the time frame provided.
2.  The risk-benefit analysis is unfavorable.
3.  The effectiveness of treatment is not sufficiently supported.
4.  The drug’s quality is damaged, or its qualitative-quantitative composition is not disclosed.
5.  The information provided in the request is incorrect or fails to comply to the requirements of the Antibiotics Act, Chemists and the Druggists Act, the Misuse of Drugs Act, or
6.  The applicant does not adhere to any Act mentioned in paragraph e.

Duration and Renewal of Product License

1.   A product license can be renewed upon application in the form prescribed by Form 1 and upon payment of a $50 renewal fee by the license holder. A product license is valid until the date of expiration of the GMP certificate or the Certificate of Pharmaceutical Product, whichever expires first.
2.  A product license renewal application must be submitted 6 months before the product’s expiration date.
3. If the holder of the product license neglects to apply for renewal within the time frame specified by sub-regulation 2., the competent authority shall terminate the registration of a drug.