The Costa Rican Ministry of Well being issued an government decree to acknowledge in Costa Rica the advertising and marketing approval granted to prescribed drugs by the regulatory authorities members of the Worldwide Council for Harmonization of Technical Necessities for Pharmaceutical Merchandise for Human Use. The brand new regulation got here into impact on December 30, 2022.
What does this recognition means?
The popularity is a technical homologation by the Costa Rican Ministry of Well being of the advertising and marketing approval granted to prescribed drugs by well being regulatory authorities which can be members of the ICH and goals, in accordance with the authorities, to ensure entry to and availability of high quality, secure and efficient pharmaceutical merchandise to Costa Rican residents.
That are the regulatory authorities of the ICH?
The next is the record of the present regulatory authorities members of the Worldwide Council for Harmonization of Technical Necessities for Prescribed drugs for Human Use (ICH):
a) EMA (European Union).
b) FDA, United States.
c) MHLW/PMDA, Japan.
d) Well being Canada, Canada.
e) Swissmedic, Switzerland.
f) ANVISA, Brazil.
g) COFEPRIS, Mexico.
h) HSA, Singapore.
i) MFDS, Republic of Korea.
j) MHRA, United Kingdom.
ok) NMPA, China.
l) SFDA, Saudi Arabia.
m) TFDA, Taipei China.
n) TITCK, Turkey.
The best way to apply for the popularity?
The popularity should be requested by the celebration to the Ministry of Well being by way of its digital platform.
How lengthy does it take for an utility to be resolved?
In accordance with the brand new regulation any utility should be resolved inside 30 working days.
The Ministry of Well being issued this new regulation as a part of a method to ensure entry and availability to high quality, secure and efficient pharmaceutical merchandise to the Costa Rican inhabitants. By counting on the advertising and marketing approval granted to prescribed drugs by ICH well being regulatory authorities the Ministry of Well being makes an attempt to expedite native advertising and marketing approval with out compromising high quality, effectiveness and security as required by native laws
To perform this goal, the Ministry of Well being might undertake inspection, surveillance and management mechanisms to confirm the standard, efficacy, traceability and security of the merchandise bought in Costa Rica
When within the recognition not relevant?
Recognition might not be granted to the advertising and marketing approval of:
a) Magistral preparations.
b) Dietary dietary supplements, homeopathic merchandise, and radiopharmaceuticals.