Solutions Circle: Enabling Earlier Access to Medicines in Latin America by Rationalizing Legalization Requirements

Description: The legalization / apostillation1 of documents presented to regulatory authorities as part of submissions is currently a legal / regulatory requirement for most countries in Latin America. Certificates of Pharmaceutical Product (CPPs) and Certificates of Good Manufacturing Practices (cGMP) are examples of documents that importing countries commonly require are legalized / apostilled in the country of origin. However, these traditional legal methods are highly discouraged, for example, in the context of the Certification Scheme on the quality of pharmaceutical products moving in international commerce (CPP Scheme). According to the World Health Organization (WHO), authorities that request CPPs are “discouraged to introduce legalization procedures or any form of authentication procedures such as notarization, embassy legalization and apostillation that may cause the undue delay of certificates”. For the purposes of the WHO Scheme, legalization or apostillation of a CPP does not represent any value to the document, and has not proven to be an efficient method to avert the potential abuse of the Scheme or to frustrate attempts at falsification. Currently, multinational companies, when submitting dossiers to health authorities in Latin America, mainly provide documentation issued by the European Medicines Agency (EMA) and by the United States’ Food and Drug Administration (US FDA). In the case of the EMA, these documents are issued in secure electronic format and provide means to their authentication. This session will provide data on the current scenario of acceptance of electronic documentation issued by the EMA, as part of the submission requirements of regulators in Latin America, with the aim at building awareness around the consequences of these requirements and discuss the next steps that can drive the necessary changes at the local level.