Ministry of Health of Chile
Agencia Nacional de Medicamentos (ANAMED)
https://www.ispch.gob.cl/anamed/
5 Years
Other pharmaceuticals
Not specified in regulation
Not specified in regulation
The following conditions must be met to import and utilize experimental drugs:
The proper marketing authorization of a pharmaceutical product contains the following information:
A stamped attachment or several must contain the following: approved graphic labeling, the patient information sheet or insert, the healthcare professional information leaflet, the specifications, and the testing methodology of the final product. These attachments are regarded as part of the registration certificate.
Depending on the type of pharmaceutical product, an application may be denied if it does not comply with the above-mentioned conditions and any additional restrictions. The ISP will notify the applicant of any information needed to complete the authorization processes. The ISP will either move on with additional evaluation of the application or ultimately reject it if the applicant does not submit within 5 working days.
The following situations might result in the marketing authorization application being denied:
The ISP requests the Ministry of Health to order the registration’s rejection if the required supplementary information is not provided within the allotted time frame, or if the requested information is provided within the time frame but is again found to be insufficient. The Ministry of Health then provides the ISP with a report on the registration refusal within ten business days of it being issued. The applicant will receive notification from the ISP after the resolution has been passed based on this.
Not specified in regulation
Within 6 months from the date of payment of the corresponding fees.
The following general administrative requirements should be fulfilled by a marketing authorization application, together with the accompanying details:
Regarding the pharmaceutical product’s technical details, the application for marketing permission must satisfy the following general requirements:
The following general requirements must be satisfied for the marketing permission application to attest to the product’s pharmaceutical quality:
1) Japanese Pharmacopoeia.
The application for marketing authorization is required to include information on the safety and efficacy of the product:
Not specified in regulation
Within 6 months from the date of payment of the corresponding fees.
Depending on their kindness and nature, all pharmaceutical goods that need a marketing license should adhere to the same standards. Regarding the generic medications, please refer to the different specifications listed in the preceding section.
Products |
Fees |
General approval of pharmaceutical products |
$279.125 |
General registration of pharmaceutical products |
$837,375 |
Approval of simplified application of pharmaceutical products |
$216,195 |
Simplified registration of pharmaceutical products |
$646.555 |
General approval of phytodrug or other pharmaceutical products (Art. 53) |
$216,195 |
Approval of simplified application of pharmaceutical products or other phytodrug (Art. 52) |
$194,492 |
Simplified registration of pharmaceutical product or other phytodrug (Art, 52) |
$571,480 |
General approval of of homeopathic pharmaceutical product (Art. 53) |
$114,970 |
General registration of homeopathic pharmaceutical product |
$343,495 |
Approval of simplified application of homeopathic pharmaceutical product (art 54) |
$20,358 |
Simplified registration of homeopathic pharmaceutical product (Art. 54) |
$94,758 |
Abbreviated application of pharmaceutical product registration |
$216,195 |
Short pharmaceutical product registration |
$646,555 |
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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