Delays in Medicine Registration

Guatemala's pharmaceutical sector is demanding delays in the authorization of medicines, since it is estimated that more than a thousand dossiers are waiting for the endorsement to be legally commercialized in the country.

Tuesday, December 11, 2018

According to authorities of the College of Pharmacists and Chemists of Guatemala, the Department of Regulation and Control of Pharmaceuticals and Related Products of the Ministry of Public Health and Social Assistance (MSPAS) has been operating irregularly since January 2017, when its former headquarters located in zone 15 of Guatemala City caught fire.

Since the beginning of last year, the MSPAS has had problems in carrying out its functions, one of which is the authorization of registers and health registrations of medicines.

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Alma Lucrecia Martinez, president of the College of Pharmacists, said to that "... of the requests made to the Department this year, approximately 1,000 dossiers are pending. Without the authorization of health records by MSPAS, medicinal products cannot be legally commercialized in Guatemala."

Martinez added that "... another aspect that has affected the delay of the dossiers is that the Department's office was moved to a place where, in her opinion, it does not meet the minimum-security guarantees for the type of procedures that are carried out in that office."

Also see "Pharmaceutical Products: Imports Increase 4%"

On the other hand, Karla Chávez, director of the Department of Regulation of the MSPAS, said that "... There are 700 dossiers pending to be solved. However, she justified that these are behind in the National Health Laboratory (LNS) because it is the users who do not comply with all the requirements requested in the Laboratory."

According to reports from CentralAmericaData, from January to June 2018, the largest purchaser of pharmaceutical products in Central America was Costa Rica, with $383 million, followed by Guatemala, with $299 million, Panama, with $277 million, Honduras, with $239 million, Nicaragua, with $209 million and El Salvador, with $179 million.

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