Health Regulation

1- Health Registration and Amendments

Sanitary Authorization that enables natural or legal persons to perform activities related to drugs and medical devices.

2- Import and/or Export Permits

Sanitary Authorization enabling a natural or legal person to import or export any raw materials, products, drugs, medical devices, foods, food supplements, alcoholic beverages and tobacco products

3- Labeling Reviews

Labeling review and modification, as well as back-labeling products in order to comply with the Official Mexican Standards

4- Ingredient Review

Analysis of product or supply ingredients to verify whether they are permitted in Mexico or not and whether they comply with limits established by the Health Authority.

5- Advertising Notices and Permits

Content authorizations or notices to advertise medicinal products, services or supplies in print media, radio, TV, and/or the Internet.

6- Operation Notices and Modifications

Notice to the site where medicinal products, health supplies or health services are manufactured, stored, marketed or provided.

7- Product Classification

Analysis of the product pursuant to Mexican Law in order to define the requirements to be met, and any other formalities required for manufacturing, import, export and/or marketing thereof.

8- Free Sale Certificates

Certificate issued by the Health Authority to export products, drugs and medical devices that comply with the current health regulations, as they are used and sold freely in Mexico.

9- Good Manufacturing Practice Certificate

Certificate issued by the pertinent authority showing compliance with the current manufacturing standards in Mexico in relation to products, drugs and medical devices.

10- Extension, Health License

Authorization granted to the site where controlled medicinal products, health supplies or health services are manufactured, stored, marketed or provided.

11- Compliance with Official Mexican Standards

Analysis of the raw materials, drugs, medical devices, products, foods, food supplements, alcoholic beverages, and tobacco products in order to ensure compliance with the Official Mexican Standards.