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 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.
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homologation, recognition of equivalence, COFEPRIS, healthcare
