Ministerial Agreement 094-2021 of the Ministry of Economy, published in the Official Journal on March 18 of this year, released the resolution number 436-2020 (COMIECO-XCIII) dated December 10, 2020, through which it was agreed to amend by total replacement the Central American Technical Regulation RTCA 65.05.51:08 "Veterinary Medicinal Products and Related Products. Sanitary Registration and Control Requirements” approved by the resolution number 257-2010 (COMIECO-LIX) on December 13, 2010, by the Central American Technical Regulations RTCA 65.05.51:18 "Veterinary Medicines, Related Products and their Establishments, Sanitary Registration and Control Requirements". The new Regulation will enter into force on 10 August 2021.
States that are parties shall implement the Code of Good Manufacturing Practices (GMP) of Veterinary Medicinal Products of the Committee for the Americas of Veterinary Medicinal Products of the World Organization for Animal Health, as well as its Verification Guide, within 5 years from the date of entry into force of RTCA 65.05.51:18, during this period when a manufacturer of one State Party requests the Sanitary Registration or renewal of its registration in another State Party, it shall submit the official document, issued by the authority, to support the implementation of the operational plan for compliance with the GMP.
In Guatemala, the holder of the sanitary registration must comply with the codification set in Annex H of the RTCA 65.05.51:18, within 24 months, that run from the entry into force date. During this period, the holder of the sanitary registration may market the products under the current regulation and once expired, he must market them in accordance with Annex H of the RTCA 65.05.51:18.