1 May 2011AmericasHedwig Lindner and Manuel Morante

Recognising equivalence, reciprocity and respect

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 often 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. Thus, 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. This 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 to those set by Mexican laws and regulations.

The 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 issuing an equivalence resolution:

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