MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices The period of validity of any MA for pharmaceu- ticals and medical devices is five years. After this period, MAs may be renewed every five years. In contrast, a recognition letter for orphan drugs (the equivalent of an MA) lasts for two years only. Also, any authorisation may be revoked by COFEPRIS at any time – for instance, when a new risk to human health is found, if an infringer repeatedly disregards safety measures, or if false information is submitted. MAs may be cancelled if companies fail to submit renewal applications on time. A recent change to the RIS means that the sec- ond and subsequent renewals of MAs – both for medicines and for medical devices – will only be subject to a notification, not to an authorisation. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices In general, the procedure for obtaining an MA for pharmaceuticals includes filing the MA applica- tion form at COFEPRIS, along with evidence of the following: • the payment of governmental fees; • a manufacturing licence or equivalent; • notice of appointment of a qualified sanitary officer; • draft labels; • the information to prescribe; • certificates of good manufacturing practices for the finished product, its active ingredients and its additives; • the draft distinctive name; • the quantitative and qualitative formula; • quality information; and
tic agents, supplies for dental use, surgical and healing materials, and hygienic products” . Initially, any product that falls into this definition should be considered a medical device. It is also important to remember the list of prod- ucts that, due to their nature, characteristics and uses are not considered medical devices. Prod- ucts included on this list are excluded from the medical devices regulation. There are other categories that are recognised in practice (eg, combination products) but not for- mally regulated through mandatory instruments. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products In general, there is only one type of MA for phar- maceuticals for human health and for medical devices, which is granted by COFEPRIS. The same requirements of quality, safety and effi- cacy apply, regardless of whether the product is allopathic, homeopathic, herbal or a vitamin pharmaceutical. However, there is a significant difference between the extent and scope of safety and efficacy data that would be required for an innovator product compared with a subsequent product, and a specific requirement for releasing biologic prod- ucts after importation. Biotech drugs are also subject to a pre-submission regulatory meeting with the COFEPRIS’ New Molecules Committee. Please also note that a new class of approvals was introduced during the COVID-19 pandemic (albeit without a legal basis therefor): emergency authorisations. These expired once the health emergency was declared to be over, with regu- lar market authorisations subsequently being required instead.
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