Committee publishes text that will debate on the homologation of drug registrations
22 noviembre 2021


On November 22, the International Relations Committee of the Legislative Assembly presented, through the Official Gazette of Costa Rica, the new text that will be debated regarding the bill on the homologation of sanitary registrations of medicines, supplements and foods coming from member countries of the Organization for Economic Cooperation and Development (OECD). The aim is to speed up the entry of new pharmaceutical products into the country. Since the Legislative Assembly is in extraordinary sessions, this text may only be considered and approved by the committee if the Executive Branch decides to convene it to be discussed. This has not happened so far.

In order to achieve its objective, the text states that the process of homologation of sanitary registrations will be carried out through the official digital platform Regístrelo or any other subsequently implemented by the Ministry of Health. In addition, the validity of the approved sanitary registrations will run from the date on which the approval is approved until the expiration date of the registration granted by the sanitary authority of the country of origin of the product, provided that it does not exceed five years. The initiative also mentions the documents to be submitted by the private companies to request the homologation.

Specifically regarding the homologation of medicines, the text establishes that the Ministry of Health of Costa Rica must recognize the Sanitary Registrations, renewals and post-registration changes of chemically synthesized medicines (multiorigin or innovative), which have been previously approved for their commercialization and evaluated by Regulatory Authorities of OECD countries that are Regional Reference Level IV of the Pan American Health Organization or by Strict Regulatory Authorities as defined by the World Health Organization. Likewise, Costa Rica will recognize the Sanitary Registrations of Biological, Biotechnological and Biosimilar Drugs that have been previously evaluated and approved for their commercialization by Regulatory Authorities of Strict OECD countries.