By: Ruth Olivares
“The Ministry of Public Health and Social Assistance of Guatemala, through the Health Surveillance, Monitoring and Control Unit, has recently issued a new Form for the Notification of Complaints, Claims, Diversions and Withdrawals of Pharmaceutical Products and Other Products in Guatemala, as well as the respective Procedure.
Its objective is to define the types of defect that pharmaceutical and related products, as well as medical devices, may present, and to indicate the guidelines to follow to adequately notify the Directorate of Regulation and Control of Pharmaceutical and Related Products of complaints, claims. , diversions of merchandise (robbery or theft), as well as the withdrawal from the market of products subject to health surveillance.
Among the most relevant aspects of the process we highlight the following:
- All notifications received (complaints, claims, deviations, withdrawals) will be presented to the Health Surveillance, Monitoring and Control Unit, through the pharmaceutical or related establishments involved in the product supply chain (drugstores or distributors in Guatemala ).
- The withdrawal of the product from the market may be voluntary or as a result of an administrative process, such as a complaint from third parties, notifications of adverse effects, as a consequence of an inspection, post-registration sampling, or in view of a national or international alert. .
- The process to follow for the Notification will include:
- Fill out form F-AS-f-13, Various Requests and check the UVMC (Health Surveillance, Monitoring and Control Unit) box.
- Also complete the form F-UV-f-03 Notification of Complaints, Claims, Deviations and Product Withdrawals, and attach the documents requested by said form, as applicable.
- Cancel the value of the Fees for Various Certifications, in accordance with the payment slip of the current version.
- Present the above to the Document Reception Window of the Ministry of Health, who will issue the respective password that certifies the start of the process.
- Subsequently, the file will be evaluated by the corresponding Unit, who will promptly issue the Risk Report according to what happened.
- The Risk Report will be published on the website of the Ministry of Health and in other Official Media, for the knowledge of the public and consumers.
- Within the Notification Procedure, the Health Surveillance, Monitoring and Control Unit has also recorded the Classification of Quality Defects of Pharmaceutical Products, Related Products and Medical Devices, and the Time of Withdrawal from the Market of the products, as detailed:
| Defect Classification | Scope | Withdrawal Time |
| Class 1 | Defects that are potentially life-threatening or may cause serious health risks | 1 to 2 months |
| Class 2 | Defects that may cause disease or incorrect treatment, not classified in class 1 | 3 to 4 months |
| Class 3 | Defects that may not have a significant health risk | 5 to 6 months |
The new Notification Form came into effect on February 5, 2024, so it is shared, along with the Notification Procedure already mentioned.”