Executive Branch issues resolutions on registrations and emergency use of drugs while Legislative seeks cooperation with UNOPS
23 noviembre 2021


On November 23, the National Directorate of Pharmacy and Drugs (DNFD in Spanish) of the Ministry of Health approved a resolution that lifts the temporary extension of the period of validity of documents processed at the entity, as a result of the National State of Emergency declared in March 2020. Likewise, it issued a resolution establishing the procedure for issuing the Emergency Use Authorization (AUE in Spanish) for drugs used for the treatment of COVID-19. On the other hand, on November 17, the Health Committee of the National Assembly met with the United Nations Office for Project Services (UNOPS), to evaluate a possible cooperation to overcome the context of shortage and high price of medicines in Panama. 

The first regulation issued by the DNFD repeals Resolution 243, which had temporarily extended the validity of different documents, such as the Good Storage Practices Certification, required from drug producers. Now, the private companies are given a period of 6 months, under the aforementioned extension, to normalize the completion of the pending procedures to commercialize the products. 

The second resolution of the DNFD regulates Executive Decree 834, which allows the use and importation for emergency reasons of drugs whose registrations have been approved by international health regulators endorsed by the World Health Organization (WHO). Thus, it indicates that in order to obtain the AUE, documents must be submitted to the DNFM, such as a copy of the AUE of the National Regulatory Authorities of Regional Reference. Its provisions will remain in force as long as the National Emergency Declaration remains in force.

Regarding the Health Committee’s meeting with UNOPS, the organization’s director for Latin America and the Caribbean, Fabrizio Feliciani, said that Panama needs to achieve a transformation of the health system in a unified way, focusing especially on the overall picture of medicines in the country. In this sense, he pointed out that the organization would accompany the country in the necessary changes such as the harmonization of laws, regulations, norms for the purchase and homogenization of medicines. Likewise, he remarked that it is necessary to incorporate an abbreviated registry of medicines, a demand consolidation process, and to establish a market intelligence center with current information on drug prices and trends.