For the past years, the registration of new medicines in Mexico has been a very slow process. The regulation establishes a deadline of 240 calendar days to obtain the register once it has been submitted. However, the process is always much longer than this.
The Minister of Health in Mexico, recently published an Agreement that allows registering generic allopathic drugs, biological products, new molecules, and vaccines in no more than 60 business days, speeding up the registration process in the country.
The Agreement also establishes that generic drugs and new medicines without a sanitary registration in Mexico can and will be imported without a previous registration. This is due to a lack of supply from the industry that caused huge demands in the sector. In this case, the process of requesting registration must start within a period of five business days after the import has been fulfilled. The request will be resolved by COFEPRIS (Mexican Food and Drug Regulatory Agency) in 60 business days top, while the medicines are already being distributed in the country.
The requirements for these drugs are simple: firstly, they must come from countries with regulatory agencies recognized by COFEPRIS*, secondly, they should have a sanitary registration in the country of origin, and finally, they must have already been used by their population. All of these means that they comply with the requirements and tests that demonstrate the quality, safety and efficacy of the product, in accordance with the provisions of the General Health Law, its regulations, and other applicable legal provisions.
*The regulatory agencies recognized in the Agreement are:
- Swiss Agency for Therapeutic Products (Swissmed)
- European Medicines Agency (EMA)
- U.S. Food and Drug Administration (FDA)
- Health Canada
- Australian Therapeutic Goods Administration (TGA)
- Reference Regulatory Agencies PAHO (https://www.paho.org/hq/index.php?option=com_wrapper&view=wrapper&Itemid=2005&lang=es) /WHO ( https://extranet.who.int/prequal/)
*Similarly, those “drugs that are prequalified by WHO or Regulatory Agencies that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), https://picscheme.org/en/members, are considered.”
TESIS is an authorized company by the regulatory agency in Mexico (COFEPRIS), we have obtained about 2,000 sanitary registrations for 5 years by certified personnel, trained by COFEPRIS, and we are sure that we are the best option to obtain the Sanitary registration of your products with the health authority under the protection of the published Agreement.