MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
inclusion of WHO-prequalified medicines and vaccines was logical both scientifically and economically, but the reasoning for extending equivalence to members of PIC/S (the third group) is unclear. 4.2 Regulatory Reliance Regulatory reliance refers to the practice of relying on regulatory decisions made by other jurisdictions, which are recognised as trusted regulatory authorities, to approve new medical products. Regulatory reliance can be applied to the extent determined by the health regulator, either through an abbreviated process for medical products already authorised by another regula- tory authority or by directly recognising the regu- latory decision. COFEPRIS aims to use reliance as a method to improve efficiency in supervising medical prod- ucts. It has adopted the concept of reliance to achieve regulatory alignment with other regional authorities by collaborating with the Pan Ameri- can Health Organization (PAHO). This effort resulted in strategies for regulatory certainty for medicines and medical devices, as well as the modernisation of technical regula- tions such as NOM-241 on good manufacturing practices for medical devices and NOM-177- SSA1-2013 on the interchangeability of medi- cines. Additionally, several other existing tech- nical regulations are being modified, including NOM-059-SSA1-2015 on good manufacturing practices for medicines. As mentioned, COFEPRIS can legally expedite market authorisations if a company has approv- als from recognised jurisdictions. However,
expedited resolutions for such applications are rarely seen in practice.
5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices A pharmaceutical manufacturing plant is subject to a licence, and a medical device manufacturing plant must submit a notice of operation. COFE- PRIS is the authority responsible for granting the manufacturing licence and receiving the notice of operation. To secure a manufacturing licence, a certificate of good manufacturing practices ( “GMP cer- tificate” ) must be obtained. For that purpose, a COFEPRIS inspection visit to the manufacturing plant must first be requested, to review wheth- er the plant complies with Technical Standard NOM-059-SSA1-2015 on good manufactur- ing practice for pharmaceuticals. If COFEPRIS determines in the inspection visit that the facility is in compliance, it will grant a certificate, which must be included in the manufacturing licence application. Once the application is submitted, COFEPRIS will take no more than 60 business days to grant the manufacturing licence. The activities typically approved by the manufactur- ing licence are the manufacture and warehous- ing of pharmaceuticals in the same facility. The operation licence does not have an expiry date. The notice of operation for a medical device manufacturing plant only needs to be submitted to COFEPRIS and becomes valid the moment it is filed. The notice of operation requires the appointment of a sanitary officer, who shall be in
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