Procedure for the registration of powers of attorney before the National Health Regulation Authority
On May 2nd, 2023, Administrative Resolution No. 001/2023, issued by the National Health Regulation Authority (ANRS), will come into force, establishing the procedure to apply for registration and renewal of powers of attorney granted by domestic or foreign manufacturers to carry out procedures related to medicines, medical devices, cosmetics and hygiene products, natural handmade products, nutritional supplements, tobacco, and its derivatives; in the same sense, it has also determined the forms of powers of attorney, which must be submitted for the aforementioned purpose.
Although the formats of powers of attorney for legal representatives, responsible professionals, and distributors have been established, these may be modified at the will of the grantors, if they consider that, for their benefit, there are other important elements to be included.
Despite the above, it is expressly established, in the case of powers of attorney that include products manufactured by different subsidiaries, that the list of subsidiaries of the holder or legal manufacturer must be detailed in a table attached to the power of attorney; in the case of products manufactured by maquila, in addition to attaching the maquila contract, the file of the products to be registered must be attached; and when the power of attorney corresponds to the distribution of medical equipment, it must indicate the legal commitment of the manufacturer to supply parts and components of the equipment, as well as the technical support for a minimum of 5 years, once the equipment has entered the country.
The resolution also determines that the ANRS has the competence to limit the number of authorizations for powers of attorney granted in favor of responsible professionals and legal representatives, based on the volume of powers of attorney previously authorized for them, taking into consideration the following parameters:
- The number of powers of attorney in force.
- The behavior of sanitary registration procedures.
- Types of procedures performed (registration of cosmetics, medical devices, hygienic products, medicines, natural products, or nutritional supplements).
For the last of these parameters, a limit of 5 approvals has been established for each type of procedure, cumulative for a total of 25.
Finally, as of the entry into force of Administrative Resolution No. 001/2023, the fee for registration or renewal of powers of attorney for legal representatives, responsible professionals, and distributors will accrue a fee of C$1819.18, with the maintenance of the value about the U.S. dollar.