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.
To continue reading, you need a subscription to WIPR. Start a subscription to WIPR for £455.
In-house feature articles, the archive and expert comment require a paid subscription. Subscribe now.
Want to give it a try? We are offering a two week free trial to the WIPR website – register and select “Free Trial” to begin access to the full WIPR archive and read the latest news, features and expert comment. Begin your free trial here.
Is your 2 week free trial about to end? Upgrade to a 12 month subscription for £455 now.
If you have already subscribed please login.
If you have any technical issues please email tech support.
homologation, recognition of equivalence, COFEPRIS, healthcare