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Costa Rica’s Ministry of Health has issued an executive order approving marketing authorizations granted to medicinal products in Costa Rica by regulatory agencies that are members of the International Council for the Harmonization of Technical Requirements for Medications for Human Use. The new regulation came into force on December 30, 2022.
What does this recognition mean?
This accreditation is a technical approval by the Ministry of Health of Costa Rica for a marketing authorization granted to a drug product by a health regulatory authority that is a member of the ICH and, according to the authority, guarantees access and availability of quality, safety and efficacy. It is intended to Medicines to Costa Rican citizens.
Who are the ICH regulatory authorities?
Below is a list of current regulatory members of the International Council for Harmonization of Technical Requirements for Human Medicines (ICH).
a) EMA (European Union).
b) FDA, USA.
c) MHLW/PMDA, Japan.
d) Health Canada.
e) Swissmedic, Switzerland.
f) ANVISA, Brazil.
g) COFEPRIS, Mexico.
h) HSA, Singapore.
i) MFDS, Republic of Korea.
j) MHRA, UK.
k) NMPA, China.
l) SFDA, Saudi Arabia.
m) TFDA, Taipei China.
n) TITCK, Turkey.
How do I apply for certification?
Approval must be requested from the Ministry of Health by interested parties through an electronic platform.
How long will it take for my claim to be resolved?
According to the new rules, claims must be resolved within 30 business days.
The Department of Health has issued this new regulation as part of its strategy to ensure access and availability of high-quality, safe and effective medicines for Costa Ricans. By relying on marketing approvals granted to drugs by ICH health regulators, the Ministry of Health will seek to expedite local marketing approvals without compromising the quality, efficacy and safety required by local regulations. I’m doing it.
To achieve this goal, the Ministry of Health may employ inspection, monitoring and control mechanisms to verify the quality, efficacy, traceability and safety of products sold in Costa Rica.
When does not fall under recognition?
Approval may not be granted for the following marketing approvals:
a) Preparation of magistrates;
b) dietary supplements, homeopathic products, radiopharmaceuticals;
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