Monday, 7 July 2008

New Mexican medicaments approvals regime: an early report

New Health Supplies Regulations came into force in Mexico on 1 February 2008, changing the previous practice for obtaining safety approvals for medicaments and addressing difficulties under the previous practice in enforcing the data protection provisions of TRIPs and the North American Free Trade Agreement (NAFTA). The new Regulations delete from Mexican law the concept of the 'interchangeable generic medicament', which rise to the market for 'grey generics' -- generic versions of medicaments that were registered on the basis of questionable data rather than on the basis of propert bioequivalence tests. On 1 February the classification 'interchangeable generic' was replaced by three new classifications: 'generic medicament', 'reference medicament' and 'new molecule'.

Further details of the new Regulations may be read in "Revised Health Supplies Regulations Promise Changes for Generics", by Héctor Elias Chagoya Cortes of law firm Becerril, Coca & Becerril, writing for International Law Office.

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