Administrative Resolution No. 001 /2023 issued by the National Sanitary Regulation Authority (ANRS) has entered into force, it establishes the new procedure for the processing of requests for approval of import, distribution and/or commercialization
powers, responsible professional and legal representative from abroad, as well as nationals, for medicines, medical, cosmetic and hygienic devices, handmade natural products, nutritional supplements, tobacco and its derivatives.
For this, the Pharmacy Directorate, the Medical Devices Directorate and the Health Regulation Directorate have been designated as the dependencies of the National Health Regulation Authority (ANRS), in charge of evaluating and approving the necessary
documents to carry out any procedure of those established in the current legal system and applicable to the regulation of medicines, medical devices and tobacco accessories, respectively.
Such resolution, in addition to providing requirements and guidelines, also includes a reference to the presentation model of import, distribution and/or commercialization powers, responsible professional and legal representative from abroad, as well as
nationals.
In fact, the model included all the categories regulated by the Authority in its different instances. However, the granting can be carried out with respect to one or more categories of products, or even on specifically detailed products, as well as granting authorization before one or more instances (Specific Directorates) of the ANRS. Additionally, it should also be considered that each country has its own formalities for the granting of instruments, for which reason you must adapt each one to the specific case.
Note that the ANRS, through its competent units, has the power to limit the number of authorizations to powers granted under the power of the responsible professional and legal representative, both national and foreign, for the different procedures that are carried out before any of the ANRS units, based on the volume (quantity) of previously approved powers with the same powers that are in force. The same will be done in evaluation of the following:
• The number of current powers of attorney that you have as attorney.
• Statistics on the behavior of health registration procedures.
• The types of procedures you carry out (registration of Cosmetics, Medical Devices,
Hygiene, Medicines, Natural Products, Nutritional Supplements)
• For this last criterion, a maximum limit of 5 approvals is established for each type of
procedure, they are cumulative for a total of 25.
As of the entry into force of the Resolution, natural and legal persons who carry out the Right for Registration, Renewal or related procedures, of Legal Powers before the Specific Directorates that make up the National Health Regulation Authority must carry out for each procedure of approval of legal powers the payment of C$ 1,819.18.
If you have any questions, please do not hesitate to contact us.