Customs & Global Trade Flash
New Costa Rican technical regulation on pharmaceutical products and human medicinal products, whether imported or domestically produced
On November 26th the General Customs Bureau published on the Official Gazette the Executive Decree No. 39294-S, titled “RTCR 470: 2014 Pharmaceutical products, human medicinal products. Administrative provisions on bioequivalence, intellectual property, homeopathic medicines and sanitary registration and import".
This regulation extends the provisions of the Central American technical regulation "RTCA 03.11.59: 11 Pharmaceutical products. Human medicinal products. Sanitary registration requirements", by establishing national provisions on intellectual property, therapeutic equivalence and administrative requirements under which sanitary registration is granted for human medical products and homeopathic medicines.
This new regulation applies to human medicinal products sold in Costa Rica, whether imported or domestically produced, excepting the magistral formulae.
In case of biological and biotechnological medicinal products, they must be registered using the dispositions of this new regulation as well as the technical regulation "RTCR 440: 2010 Regulations for the Registration and Control of Biological Medicines", and the Central American Technical Regulation "RTCA 03.11.59 11 Pharmaceutical products. Human medicinal products. Sanitary registration requirements".
Finally, the decree repeals the Decree no. 28466-S (2000) that refers to "Regulations for the Registration, Control, Import and Advertising of Medicines", with effect from November 26th 2015.
This regulation is now in force, as it was published on the Official Gazette.
What does it mean for your company?
Costa Rican companies that export, distribute, market, prescribe and/or promote medicinal products for human use, will need to comply with the provisions of this new national technical regulation and the respective Central American technical regulations, in order to make the corresponding sanitary registration of products before competent authorities, previously the import and the customs clearance in Costa Rica.
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