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HOMOLOGATION


Homologation (recognition of equivalence) is a useful tool for simplifying administrative processes that are repeated in different countries. Nevertheless, it is not an end in itself. Homologation cannot be fully effective unless it is based on reciprocity and mutual respect. Hedwig Lindner and Manuel Morante explain.


Homologation is viewed as (and oſten is) a useful means of facilitating governmental authorisations necessary to launch a product subject to regulation in multiple jurisdictions.


Homologation effectively transfers authority from a governmental agency in one country to its counterpart in another country. Tus, the degree of compatibility or equivalence between the regulatory systems of the countries involved must be considered if it is to be effective and legal.


Obviously, the task is more difficult when the countries involved have very different legal systems, traditions and regulatory practices. In these cases, greater effort and care are required to build a fair and functional equivalence system.


Recognising equivalence Article 161 bis of


the Regulation on Health


Products was published in the Federal Official Gazette on August 17, 2010. Tis article authorises the Secretariat of Health to issue ‘general provisions’ recognising that the requirements set by foreign health authorities for the quality, safety and efficacy of products sold, distributed or used in their jurisdictions are equivalent and regulations.


to those set by Mexican laws


Te first general provisions were published in the gazette on September 3, 2010.


Under these provisions, the Federal Commission for Protection Against Health Risks (COFEPRIS) must do the


following before equivalence resolution: issuing an


• Analyse the prerequisites, technical and scientific evaluation procedures and other requirements that the foreign health authorities set for the sale in their country of health products and ensure that they guarantee the quality, safety and efficacy of the products sold.


• Analyse the technical and scientific evaluation procedures employed by the foreign health authorities in approving the sale of health products, and ensure that they guarantee the quality, safety and efficacy of products that have been approved.


• Analyse, where applicable, the mechanisms and controls, technical and pharmaceutical surveillance undertaken by the foreign health authorities to guarantee the quality, safety and efficacy of products being sold. In this case, the reports or results must be available to COFEPRIS.


• Consider the experience derived from the technical and scientific evaluation of products sold abroad under foreign laws and regulations, for the granting, extension or modification of sanitary registrations.


• Ensure that the prerequisites, tests, evaluation procedures and other requirements of foreign authorities:


∙ Are indispensable for allowing the sale of the products in their respective countries, and


∙ Provide certainty regarding the safety, efficacy and quality of products, to the same degree or to a greater degree than the requirements established by COFEPRIS for sanitary registration in Mexico.


For these purposes, the general agreement states that foreign health authorities must grant COFEPRIS access to information showing that the technical and scientific evaluation procedures they employ guarantee the quality, safety and efficacy of regulated products.


Moreover, COFEPRIS must decide in each case whether it is necessary, before issuing a recognition of equivalence, to visit the facilities where the foreign health authorities undertake the technical and scientific evaluation of health products.


The first recognition of equivalence was published in the gazette on October 26, 2010.


An additional resolution, containing application forms for procedures before COFEPRIS under the foregoing resolution, was published in the gazette on December 13, 2010.


Recognition of equivalence for medical devices (REMD)


Te government based its decision to publish the REMD on a perceived need to expedite the entry into the Mexican market of medical devices that embody the most recent technological advances made in other parts of the world. Te essential fact is that most medical devices sold in Mexico are previously registered in the United States and Canada. On January 25, 2011, the Secretary of Health testified before the standing commission of Congress that 91 percent of all medical devices registered by COFEPRIS are foreign and that 44 percent of all Class III medical devices registered by COFEPRIS come from the US or Canada.


www.worldipreview.com


Life Sciences Intellectual Property Review 2011


73


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