The Council of Ministers of Economic Integration (COMIECO) approved the Central American Technical Regulation RTCA 11.03.69:13 PHARMACEUTICAL PRODUCTS. NATURAL MEDICINAL PRODUCTS FOR HUMAN USE. GOOD MANUFACTURING PRACTICES and its VERIFICATION GUIDE, whose objective is to establish the principles of Good Manufacturing Practices, which regulate all procedures involved in the manufacture of natural medicinal products for human use, to ensure their efficacy, safety, and quality. It will enter into force on July 1, 2021.
The regulation indicates that a transitional period of three (3) years will be granted from the effective date of the Resolution, for the compliance of the critical and qualifiable criteria in the VERIFICATION GUIDE, according to detail:
From July 1 2021 to June 30, 2022: 80% of critical criteria and 65% of qualifying criteria.
From July 1 2022 to June 30, 2023: 85% of critical criteria and 70% of qualifying criteria.
From July 1 2023 to June 30, 2024: 90% of critical criteria and 75% of qualifying criteria.
After the transitional period, as of July 1, 2024, laboratories shall meet 95% to 100% of the critical criteria and 80% of the qualifying criteria of the VERIFICATION GUIDE. The transitional period will not apply to El Salvador and Panama, since they will have to comply with this percentage of the criteria as of the effective date of this Resolution.