COVID-19 vaccine- Conditional health record
Supreme Decree No. 002-2021-SA adopted the regulation for granting conditional health record of the COVID-19 vaccine with phase III clinical trials with preliminary results. The General Directorate of Medicines, Supplies and Drugs (Digemid) has a maximum period of 3 months to grant the aforementioned record. The conditional health record is valid for one year and may be renewed 4 times.
The regulation provides that private individuals may be holders of the conditional health record. The figure of the health record certificate (parallel import) is not provided for.
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SINOPHARM – Vaccine shall arrive on February 9
Pilar Mazzetti, Minister of Health, through a nota de prensa (press relase) confirmed that the General Directorate of Medicines, Supplies and Drugs (Digemid) granted the first conditional health record of the COVID-19 vaccine, manufactured by the Sinopharm laboratory. The ownership of the conditional health record was granted in favor of CENARES.
Violeta Bermudez, President of the Council of Ministers, reported that the first batch of one million COVID-19 vaccines from Sinopharm would arrive in Peru next February 9, in a plane hired by DHL.
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Priority to medical oxygen production
The government declared the production and distribution of medical oxygen as a priority over industrial oxygen. Likewise, Supreme Decree No. 006-2021-SA declared medical oxygen as a strategic resource.
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Confidentiality of Vaccine Procurement Agreements
The government adopted Emergency Decree No. 003-2021, by which it was established that the Ministry of Health shall publish, on its institutional portal, the general information regarding the work carried out in relation to the COVID-19 vaccine.
In addition, the emergency decree expressly stated that the public information must not affect the confidentiality clauses that the State subscribes in the agreements and contracts for the purchase of COVID-19 vaccines.
Click aquí to access to the emergency decree.
Epidemiological Alert 001-2021
The Epidemiological Alert for the year 2021 (AE 001-2021) was published as a result of the increase of COVID-19 cases and is addressed to public and private IPRESS.
The Alert establishes provisions aimed at intensifying early detection and isolation of suspected COVID-19 cases. It is provided that samples for COVID-19 diagnosis must be processed through RT-PCR, Rapid Molecular Test (LAMP) and/or antigenic testing.
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Deadline to resolve sanctioning procedures was extended
Through Directorial Resolution No. 017-2021-DIGEMID-DICER, the Digemid extended to 12 months the deadline to resolve the sanctioning procedures initiated between January 1 and September 30, 2020. The extension was justified by the large number of highly complex administrative files and the suspension of personnel work due to the spread of COVID-19.
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TUPA DIGEMID – Amendment
By Supreme Decree No. 003-2021-SA, the Single Text of Administrative Procedures (TUPA) was amended to include the procedures for registration, re-registration and amendments of the conditional health record.
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Regulation of pharmaceutical establishments was amended
Supreme Decree No. 004-2021-SA amended the Regulation of Pharmaceutical Establishments in order to eliminate and simplify the requirements.
The amendment relates to communications concerning the resignation of technical management and quality control personnel, changes and modifications of establishments and the resumption of activities.
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Telehealth Regulations
Supreme Decree No. 005-2021-SA, Regulations of the Framework Law on Telehealth was published. Its purpose is to establish general guidelines in order to improve the efficiency and quality of telehealth and increase its coverage with the use of information technologies.
The aforementioned regulation provides that IPRESS must progressively incorporate the provision of telehealth services in its portfolio of services.
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For further information, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) and Solange Noriega (snoriega@estudiorodrigo.com).
