Starting at Administrative Provisions No. DM-RM-0838-2020 As of March 31, 2020, the Costa Rican Ministry of Health has incorporated procedures for registration, renewal, and post-registration changes. A brief summary follows:
New registrations as of March 31: First-time applications for registration of foreign products of health interest, entered into the country after March 31, 2020, must submit all the documentation established in the current regulations for the product type. Considering that some Health Authorities have information available on health registrations for products, as well as on companies that comply with good manufacturing practices, and that these documents can be consulted online through their databases, these types of documents will be accepted provided they are presented in the following manner:
– Provide a notarized copy of the digital document, in which the Notary must record the electronic address where the document is located and the date it was consulted, for certified copies.
– Documents in a language other than Spanish must be accompanied by an official translation.
Post-registration changes submitted before March 31For post-registration change requests already submitted to the Regístrelo Platform and which have been approved, the interested party may request a 3-month extension to process documents from other Regulatory Authorities that require an apostille or legalization.
– If the apostille or legalization of the documents cannot be obtained before the end of the extension period, a digitally signed letter from the Legal Representative must be provided, committing to include the legalized documents through a post-registration change within a period of no more than six months from the approval of the change.
Post-registration changes from March 31: Applications for post-registration changes submitted after March 31, 2020, and without apostilled or legalized documents must include:
– A digitally signed letter from the Legal Representative, committing to provide the legalized documents through a post-registration change, within a period of no more than six months from the approval of the respective change.
Registration renewal: Extend the expiration of the health registration period (5 years) for all products by an additional 6 months.