By: Ruth Olivares
All medicines, chemical, biological and/or hygiene and beauty products for VETERINARY USE must be registered before the Sanitary Authorities of Guatemala.
The requirements and provisions for the sanitary registration of these products are established by the Central American Technical Regulation called “Veterinary Medicines and Related Products. Establishments that Manufacture, Commercialize, Fractionate or Store them. Sanitary Registration and Control Requirements. RTCA 65.05.51:08”, which has been signed by the countries of El Salvador, Guatemala, Honduras, Nicaragua and Costa Rica.
According to this regulation, the Competent Authority of each Member Country must register and control the following products:
a) Pharmaceutical or alternative medicine products for veterinary use.
b) Chemical products for veterinary use only or use in livestock facilities.
c) Biological products for veterinary use.
d) Hygiene and beauty products used in animals.
Said regulation considers 2 types of Sanitary Registration:
- Common Sanitary Registration: applies to all Veterinary Medicines and Related Products, except those that are not in the Harmonized List of Products Subject to Simplified Sanitary Registration, the details of which are mentioned below.
For this type of registration, the following documentation must be submitted:
- Application for Sanitary Registration
- Power of attorney of the manufacturer or holder in favor of the registrant.
- Certificate of Free Sale of the product
- Quali-quantitative formula
- Methodology of physical, chemical and biological analysis.
- Certificate of Analysis
- Label project
- Product samples, among others.
In the case of products with combinations of active ingredients, they must comply with certain requirements established in the RTCA and demonstrate significant pharmacological advantages, such as the synergic effect of addition or potentiation, broadening of the spectrum of action against disease-causing agents, improvements in tolerance and safety, among others.
2) Simplified Sanitary Registration: This type of registration applies to all drugs and related products included in the Harmonized List of Products Subject to Simplified Sanitary Registration, which includes:
- Absorbents
- Antacids
- Antiseptics
- Screwdrivers
- Deodorants and odorizers
- Non-pesticide repellents
- Oral electrolytes and dextrose
- Laxatives
- Hygiene and beauty products, and others.
Such sanitary registration does not imply that these products are free for sale. Interested parties must submit the documentation and comply with the following requirements:
- Application for Sanitary Registration
- Certificate of Free Sale of the product
- Quali-quantitative formula
- Physical, chemical and biological analysis methodology.
- Label project
- Analytical standard as required by the competent authority
- Proof of payment
All official documents issued must comply with legal and consular formalities. If they are written in another language, they must be accompanied by their official translation into Spanish.
The sanitary registration is valid for 5 years and is renewable for a similar period.