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    New Regulation Streamlines the Entry Processes for Health Related Products in Costa Rica

    Health-related products will no longer need to have the health registration issued by the Ministry of Health

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    The more than 600 companies benefiting from the Free Trade Zone Regime and the Active Improvement Regime will be able to import or re-import health-related products or their raw materials more easily, as they will no longer need to have sanitary registration from the Ministry of Health. This new regulation is the result of the coordinated inter-institutional work carried out by the Presidential Council for Foreign Direct Investment outside the Greater Metropolitan Area. (GAM).

    Through Executive Decree No. 44696-S-COMEX “Regulation for the sanitary authorization of the entry of health-related products or their raw materials into establishments under the free trade zone and active improvement regimes,” the aim is to expedite the entry and re-entry of these types of products that are essential for the operation of companies, mainly those that export or re-export the majority of their production, such as those in the life sciences sector.

    Laura López, General Manager of the Costa Rican Foreign Trade Promotion Agency (PROCOMER) – an institution that coordinates the Presidential Council outside of GAM and raises proposals for improvements in competitiveness – stated that this effort is part of the post-establishment work carried out by the institution to promote the attraction of foreign direct investment. “The improvement in regulations and the reduction of barriers to investment is a task that we have been carrying out from the after-care area of PROCOMER and from the Presidential Council outside of GAM to facilitate all establishment and operation processes for companies, so that their continuity in our country can be guaranteed.”

    Approval of health registration applications

    Before this new regulation, free trade zone and active improvement companies had to wait for the approval of health registration applications from the Ministry of Health, even to export their products, which caused delays in the effective start of their operations. In 2023, this ministry received more than 67,000 requests for sanitary registrations.

    With this regulation, companies will now be able to export without having to meet this requirement and will be able to import these products by presenting a “De-Storage Authorization Form” (FAD) through the Single Window for Foreign Trade (VUCE) of PROCOMER, which will be resolved within a period of 7 business days. It is important to consider that companies must continue to comply with the legal and administrative provisions of customs control exercised over the entry or exit of these products from the designated free trade zone areas, as well as their transportation.

    Complying with health registrations

    In the event that the products are imported, marketed, distributed, used, or consumed within the national territory, companies must comply with health registrations, as established by the General Health Law and its regulations. Likewise, this regulation establishes certain products or raw materials excluded from its application, including hazardous chemicals or unfinished chemicals.

    “This reform is the result of months of joint work and institutional coordination between the different areas of the Ministry of Health, the Ministry of Foreign Trade, and PROCOMER, being a response to a challenge identified by free zone companies,” concluded López.

    Resonance Costa Rica
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