Costa Rica advances on the ratification of the Central American Rules to regulate drugs for human consumption
Costa Rica
15 agosto 2018

Guatemala, El Salvador, Honduras, Nicaragua, Costa Rica and Panama are making progress in the process of consolidating the Central American Technical Regulations for pharmaceutical products and drugs. The aim is to establish the conditions under which a given drug is passed for human consumption. In this regard, Costa Rica began the process of ratification of the Regulations on August 13th. That is why Costa Rica opened a public consultation process with the aim of obtaining public comments and observations on the document. Contributions will be received for 60 days, until October 12th.

The regulation will cover products manufactured and imported by persons and legal institutions for marketing. The regulatory authorities of the sector will be responsible for subjecting all drugs to due registration, with a validity of five years and may suspend or cancel it for health reasons.

The regulation takes into account the controls applied in other parts of the world, along with the recommendations of the World Health Organization (WHO) and those included in the Good Manufacturing Practices (GMP). The requirements for a first health registration or for its renewal are present in the new regulation. Exceptions to the rule, post-grant modifications and reasons for failure to pass or even cancel the certification in question are also duly detailed. The annexes should be taken into account when completing the documentation and States will be responsible for implementing the legislation at national level.