Por: Andrea Castillo
The Regulation and Control of Pharmaceutical and Related Products Department has published on February 6, 2023, Communiqué UAS-03.2023 on the procedure for the submission of dossiers for joint evaluation. The above applies for the time being to synthetic chemical drugs for human consumption.
General
the users may request an evaluation prior to the submission of their dossier BY THIS mechanism for the new registration of chemically synthesized drugs for human consumption. It evaluates the technical compliance with the requirements according to the Central American legal harmonization of the RTCA.
The verification is completed by specialists in sanitary regulation commission. This seeks to facilitate the preparation of the requirements and reduce the observations issued by technical documentation, leaving only compliance according to the legislation of each country.
The countries involved in this procedure are: Guatemala, El Salvador, Honduras, Nicaragua, Costa Rica and Panama. Once a favorable opinion is obtained, the registration process can be initiated in the aforementioned countries, attaching the corresponding proof.
Admission procedure
In Guatemala, this procedure is free of charge and is carried out through the PRAIS platform of the World Health Organization (PAHO).
The entry of the dossier is done at the window located in the building of the General Directorate of Health Regulation, Surveillance and Control, in Guatemala’s Z8, however, it must be submitted only in digital format (USB, CD, DVD).
The application form corresponds to document CO2-RS-03-UR PF.HER01, current version. Once completed, it must be scanned and signed by the owner/legal representative and the pharmacist responsible for the product.
The digital dossier must be assembled in documents requested in the form order, according to the respective sub-files (folders). The requirements correspond to what is indicated in the Central American Technical Regulations (RTCA), current version. In addition, they must be numbered in the lower right corner of each page.
Opinion
Joint Evaluation results is a single consensus opinion, with the objective of standardizing the technical review process with the States Parties. Additionally, it aims to strengthen the safety, quality and access to medicines for the Central American population.
Once the dossier has been submitted, an opinion will be issued within approximately three months, as follows:
Unfavorable opinion: Observations will be issued on the dossier, where users will have 10 working days to correct them. This procedure applies only once. If the deadline is not met or the notes are not corrected, the file will be archived.
Favorable opinion: The user may initiate the registration process in all participating countries, attaching the corresponding resolution.”