MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
charge of the facility. The typical activities cov- ered by the notice of operation are the manufac- ture 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 prac- tice 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 covered by the Manufactur- ing Industry, Maquiladora, and Export Service ( Industria Maquiladora, Manufacturera y de Ser- vicios 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 opera- tion 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 phar- maceuticals (eg, psychotropic and narcotics) and/or biological products for human use, which are subject to a licence. 6.2 Different Classifications Applicable to Pharmaceuticals Pharmaceuticals are divided into the following six sections in relation to their prescription sta- tus: • 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 registra- tion in the pharmacy 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 prescription, 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 establishments other than pharmacies (eg, OTC products). 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies A vast body of law, including secondary regu- lations, technical standards and administrative decrees, controls the area of foreign trade and customs law. These are not necessarily co-ordi- nated with the health regulation, creating fre- quent 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 clas- sified from a customs perspective as a cosmetic
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