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Regulatory Offices

Operation of Regulatory Offices in Guatemala

Since the entry into force of Government Decree 05-20 on March 5th, 2020, which declares the State of Calamity in Guatemala, as well as the Presidential Decrees establishing a curfew from 4:00 p.m., to the next day at 4:00 a.m., in force until April 12th of this year, it is important to mention that the procedures for health registration of regulated products, have continued to be carried out in Guatemala, and the following Ministries are operating as follows:

  • Ministry of Public Health and Social Assistance:
  1. Food Control and Regulation Direction
  2. Department of Regulation and Control of Related Pharmaceutical Products

Both departments of the Ministry continue to work, only receiving files for procedures such as health records, among others. However, their opening hours are half a day, 7:00 a.m. – 1:30 p.m. due to the curfew, which begins at 4:00 p.m. In addition, it is important to mention that, due to the measures and protocol of sanitary security and hygiene, they only allow entrance by shifts (5 people), which must keep a minimum distance of 1.50 mts. Therefore, the admitted procedures can take a longer time than normal, to be solved.

In addition, it is important to mention that, by Presidential Decree, dated March 29th, 2020, it is established that certain companies do not have an option to close, among which are: Food and Pharmaceutical Industry, since they handle the production, transformation and processing of both human and animal consumption food, as well as medicinal chemicals and medical devices, respectively. Therefore, even though no specific provision has been issued mandating primary attention to health registration procedures for medical devices (e.g. respirators) or hygienic devices such as soap, it is understood that these are products that will help combat COVID-19 at this time.

On the other hand, the:

  • Ministry of Agriculture, Livestock and Food:

This Ministry, which is responsible for regulating products such as inputs and food for use in animals, as well as insecticides and bactericides, among others, is working half a day, receiving files for registration and trade. However, the use of masks is mandatory for entry into this entity.

Elizabeth Flores Barrios
Associate
García & Bodán
Guatemala

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