Executive Branch postpones new fees and enacts law simplifying procedures for medicines
2 junio 2021

GUATEMALA

On May 31, the Ministry of Public Health and Social Assistance (MSPAS, in Spanish) published a governmental agreement that postpones the entry into force of the regulation containing the new fees for technical services applicable to medicines, including oncological medicines. Thus, the new fees will become effective as of January 1, 2022. On the other hand, the Executive Branch enacted a law aimed at simplifying and digitalizing procedures between individuals and legal entities and State agencies, and which covers medicine licenses. It will come into force in three months.

During the week of May 24, the private sector asked President Alejandro Giammattei for the postponement. According to them, the extension of the deadline had already been verbally agreed with MSPAS authorities, so they were waiting for the Executive Branch to present a regulation supporting such commitment, which finally happened on May 31. The original text, published on November 30, 2020, establishes the fees for the services of regulation and control of pharmaceutical and food products to be paid by the private sector in order to carry out the procedures before the entity. For example, a laboratory will have to pay USD 512 to obtain a sanitary registration.

With respect to the enacted law, it establishes that documents issued in foreign territory, with prior validation in such territory, will be fully valid in Guatemala and accreditation before a public entity will not be necessary. Likewise, it also mentions that in the case of permit or license renewals, if the request is issued within the stipulated terms, the validity of the initial permit or license will be extended until the decision of the competent entity is produced and notified.

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