Q&A Regarding Procedures before the Chilean Public Health Institute and the Power to Set Prices for Certain Pharmaceutical Products, Medical Devices, Etc. is Established
March, 2020 - Ignacio Gillmore, José Ignacio Mercado, Cristina Busquets, Alejandra Del Rio and Javiera Péndola
Q&A procedures before the Public Health Institute (ISP)
May I file for sanitary registrations?
Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds.
How may I file manual [sic] procedures for the modification of sanitary registrations?
The ISP has set up the e-mail address [email protected] for manual procedure requests. The foregoing e-mail shall include:
1. Code and name of the service requested in the REF. 2. Applicable form or cover letter. 3. Background information or attached schedules required in the service. 4. Copy of the electronic transfer of funds in the amount of the tariff published in the website. 5. In the event of requiring an invoice, please include the Chilean Taxpayer Number [RUT].
Will the OIRS Platform continue to work?
The OIRS Platform will continue to work for information, complaints and suggestions.
How may I inform the ISP about sanitary charges notices?
Send an e-mail to [email protected]
How may I stamp pharmacy books, sending of prescriptions and list of sales of controlled drugs?
The ISP has suspended the stamping of pharmacy books, and it is not receiving, either, prescriptions or lists of sales of controlled drugs.
How am I to pay the official tariffs after filing the procedure with the ISP through the GICONA portal?
The ISP has informed that e-transfers of funds must be made to:
Instituto de Salud Pública de Chile Chilean Taxpayer ID No. 61.605.000-1 Banco Estado Current Account No. 9507256 E-mail address: [email protected]
Link to article: https://www.carey.cl/en/qa-procedures-before-the-public-health-institute-isp/
Amendment to Decree No. 4/2020: Sets power to establish prices
An amendment to Decree 4 was published on 25 March 2020 in the Chilean Official Gazette, allowing the Undersecretariat of Public Health to set prices and limit purchases:
Thus:
1. The following are incorporated into Article 2, which grants extraordinary powers to the Undersecretariat for Public Health:
- To set the maximum price to be paid by the population in general for certain pharmaceutical products, medical devices, health elements and supplies, as well as for healthcare benefits and services, and all goods and services necessary to meet health needs.
- To limit the maximum number of the aforementioned goods and services which may be sold and delivered to each individual by retail establishments or service providers in the required dose for up to 3 months, provided that conditions for dispensing, storing or supplying the medicine so permit.
In this regard, yesterday, 26 March 2020, Exempt Resolution No. 209 was published in the Official Gazette. The resolution aims at setting the first maximum prices in the following aspects:
- A ceiling price of CLP$25,000 is set to be charged by health care providers to perform the test "Real-time Polymerase Chain Reaction (P.C.R), influenza virus, herpes virus, cytomegalovirus, hepatitis C, mycobacterium TBC, SARS CoV-2, each ( including nasopharyngeal swab sample)", code 0306082 of the exempt resolution No. 176 of 1999 of the Ministry of Health, who approved the Fee.
Link to article:https://www.carey.cl/en/amendment-to-decree-no-4-2020-sets-power-to-establish-prices/