On 29 July 2022, the Federal Commission for the Protection against Health Risks (COFEPRIS) published an alert regarding the existence of irregular drug distributors and issued a directive on the controls that such establishments must apply to prevent the entry of illicit supplies into the supply chain.
According to COFEPRIS, the main causes for non-compliance include:
- the lack of a correct health authorisation to sell/distribute pharmaceutical products; and
- the failure to comply with requirements relating to:
- infrastructure;
- documentation;
- personnel; and/or
- equipment.
In addition, the regulator mentions that some alleged distributors are actually companies that merely simulate operations through the issuance of invoices that are not supported by actual operations.
As a result, COFEPRIS introduced a new platform of irregular medicine distributors. According to COFEPRIS, users will be able to access the digital platform to find out whether a medicine distributor has violated health regulations, either because they lack the proper authorisations, or because they have failed to comply with the applicable regulatory requirements. This is expected to help avoid the acquisition of medicines that may be lacking in quality, safety and efficacy.
The platform will allow interested parties, establishments and institutions to consult, before acquiring medicines, a list of distributors identified as irregular. COFEPRIS points out that the platform will be continually updated with new establishments that have been identified as failing to comply with the regulations and that those which submit evidence of compliance will be removed.
The platform, rather than being a digital search engine, comprises a PDF document containing a list of establishments (individuals and legal entities) identified as "distributors of medicines that do not comply with health regulations", together with their official addresses and a brief description of the irregularity detected.
Currently, COFEPRIS has issued no information on the periodicity of the updates nor the legal and regulatory implications that may result. However, it is important for interested parties to check the listing as part of their due diligence with respect to their medicine providers.
For further information on this topic please contact Juan Luis Serrano or Rodrigo Calderón at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected] or [email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.