MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
6.2 Different Classifications Applicable to Pharmaceuticals Pharmaceuticals are divided into the following six sec- tions according to their prescription status: • section I – prescription pharmaceuticals that can only be acquired by a special prescription or permit issued by the regulatory authority (eg, controlled substances); • section II – prescription pharmaceuticals that require a prescription to be collected and retained in the pharmacy as well as registration in the phar- macy control books; • section III – pharmaceuticals that can only be purchased with a prescription that may not be supplied more than three times and that must be recorded in the control book and retained in the pharmacy after the third supply; • section IV – pharmaceuticals that require a pre- scription, but which can be supplied as many times as directed by the physician (eg, antibiotics); • section V – non-prescription pharmaceuticals, authorised for sale only in pharmacies; and • section VI – pharmaceuticals that do not require a prescription and can be supplied in any establish- ments other than pharmacies (eg, OTC products). 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies Medical Devices and Relevant Enforcement Bodies A vast body of law, including secondary regulations, technical standards and administrative decrees, con- trols the area of foreign trade and customs law. These are not necessarily co-ordinated with the health regu- lation, creating frequent issues for companies in the pharma and medical devices sectors. By way of example, product classifications can differ to the extent that a product may be classified from a customs perspective as a cosmetic for importing purposes and as a medical device from a regulatory perspective for commercialisation purposes. This can
cate, 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 typi- cally approved by the manufacturing licence are the manufacture and warehousing of pharmaceuticals in the same facility. The operation licence does not have an expiry date. The notice of operation for a medical device manufac- turing 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 charge of the facility. The typi- cal activities covered by the notice of operation are the manufacture and warehousing of medical devices in the same facility. The notice of operation does not have an expiry date. With the recent issuance of the new NOM-241 on good manufacturing practice for medical devices, a GMP certificate must be obtained. This new version of NOM-241 has been a source of controversy, as it also applies to manufacturing sites dedicated exclusively to exporting, which are cov- ered by the Manufacturing Industry, Maquiladora, and Export Service ( Industria Maquiladora, Manufacturera y de Servicios Exportadores IMMEX) programme. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices As a general rule, establishments involved in the wholesale of pharmaceuticals and/or medical devices are only required to submit a notice of operation to COFEPRIS. The notice of operation enters into effect at the moment of filing and does not have an expiry date. The exception to the general rule is warehouses dedicated to the wholesale of controlled pharmaceu- ticals (eg, psychotropic and narcotics) and/or biologi- cal products for human use, which are subject to a licence.
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