The Mexican regulatory compliance landscape is constantly evolving. With the challenges faced during the recent pandemic, a need for agile and simplified processes was made evident. The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) took note of the situation, and based on the practical applications of other health agencies worldwide, a plan with complementary administrative measures has been put into effect in 2023, in order to increase the efficiency of the multiple processes that the agency has to evaluate.
In this article, we will explore one of such measures known as the Immediate Service Counter, as well as explaining its purpose and application process.
What is the Immediate Service Counter?
The purpose of the Immediate Service Counter is to reduce the burden in the evaluation process. By enacting a simplified process, the Counter aims to evenly distribute evaluation burden, by focusing efforts on critical modifications (like changing the manufacturer of a product), while making simplified assessments in what is now considered as minor or moderate modifications (such as updating an address). This also helps in reducing response time across all evaluation processes.
At its initial phase, the counter handled minor and moderate modification submissions for allopathic, herbal, homeopathic and vitamin medications without narcotics and/or psychotropic substances. But recently, the counter expanded its scope of operation to include the following types of modifications:
- Sanitary Registrations of Medical Devices, Class I, II and III, as stated in article 83 of the RIS (Health Supplies Regulation):
- Change of the legal and actual manufacturer name.
- Removal of codes and/or variants, national distributors, and actual manufacturers.
- Change of business name and/or address, addition, or removal of foreign distributors.
- Change of secondary packaging*.
- Spelling correction (outside the timeframe of an Internal Correction)*.
- Change of catalogue number or code of the products*.
- Sanitary Registrations of Medical Devices catalogued as low risk devices as stated in Annex One of the “Agreement by which the list of health supplies considered as low risk for the purpose of obtaining the Sanitary Registry”:
- Change of the national or foreign distributors name.
- Change of the name of the Mexican Registration Holder (except if it involves a rights transfer), manufacturer or distributor.
- Change of the authorized national distributor.
- Change of the legal manufacturer name.
- Change of the manufacturer name.
- Change of the commercial product name or catalogue number of the products.
- Change of the secondary packaging materials.
- Removal of the product codes and/or variants.
- Removal of the distributor and/or actual manufacturer.
- Spelling correction (outside the timeframe of an Internal Correction)*.
- Change of catalogue number or code of the products*.
* In February 22, 2024, there was an update within the scope of the Immediate Service Counter operations.
Important Note: Any other type of amendment not mentioned in this list, is not applicable for the immediate service counter.
Immediate Service Counter Application Process
In order to qualify for a submission applicable to the Immediate Service Counter, the user must submit their request under classification COFEPRIS-2022-022-003-A. Taking into account the following elements:
- The Sanitary Registration must be valid, and the modification cannot be linked to extensions, rights transfers, or other pending modifications.
- The user will submit, in both physical form and in digital editable form contained in a USB:
- The registration project.
- The modification form.
After the submission, the user will receive an official document on security paper within a maximum period of 24 hours, without the need to schedule an appointment for its collection.
Conclusions
By expanding its scope of operations, the Immediate Service Counter now includes medical devices. This provides to the industry a channel to address regulatory certainty. Even though, the type of modifications applicable for this counter is still limited to specific cases, it is expected that this will allow COFEPRIS to relieve backlogged processes.
If you have any inquiries about the Immediate Service Counter, or if a modification process is applicable for this pathway, please feel free to contact us at contact@veraqueconsulting.com.
