New Framework for Importing Health SuppliesBy Rodrigo Brugada | Fri, 06/25/2021 - 19:39
This week, the Ministry of Health published in the Official Gazette of the Federation (DOF) an agreement establishing several regulatory modifications that will allow the Health Institute for Welfare (INSABI) to directly import supplies and medications for public hospitals.
The Ministry announced that it will coordinate the importation of medicines and supplies necessary for the appropriate and timely provision of health services, in cooperation with the Ministry of National Defense, INSABI, IMSS, ISSSTE and Birmex. Furthermore, the Ministry specified that only medicines and supplies intended to cover the supply needs of public health and social security institutions will be eligible for importation. Import procedures will also be eased and extended to those medicines and supplies that do not have a health registration in Mexico.
For the importation of medicines, these concessions will be extended to those that have already been registered and approved by the corresponding international bodies in Switzerland, the EU, the US, Canada, Australia and those endorsed by the WHO/PAHO in their prequalification programs for medicines and vaccines. As for supplies, these facilities extend to those authorized by the US, Canada, EU, UK, Japan, Korea, Australia and Brazil. Medicines and supplies that are imported and do not have sanitary registration in Mexico, but do have registration from the appropriate agencies in these countries, will have a term period of ten business days after importation to initiate the sanitary authorization process with COFEPRIS. COFEPRIS, in turn, will have a maximum of 45 business days to issue the corresponding resolution. It is also stated that the drugs and supplies that have been imported without registration in Mexico and do not initiate the registration process within ten business days will not be granted a second import permit.
The agreement establishes that the Ministry of Health, through COFEPRIS, will issue the corresponding import permits and may specify the status of the sanitary registration of those drugs and supplies. Furthermore, if necessary, it will deploy its powers to avoid any potential health risk, especially for those imports without prior sanitary registration in Mexico. Likewise, COFEPRIS, through the Sanitary Operation Commission, may take samples of the imported inputs for the Analytical Control and Coverage Expansion Commission to perform the corresponding analysis or be analyzed by another authorized testing laboratory.
The regulation specifies that the importers and medical units that administer these drugs are obliged to carry out intensive pharmacovigilance and technovigilance in accordance with the applicable NOMs in force.
Although these changes take place amid multiple controversies and difficulties to ensure access to therapies, the expansion of the import capacity may represent one more path to increase availability. Furthermore, these changes may speed up the approval process by COFEPRIS.