Peru's General Directorate for Medicines, Input, and Drugs (Digemid) granted a conditional health registration to the COVID-19 vaccine developed by Pfizer, the
Ministry of Health (Minsa) reported on Wednesday.
This registration allows its importation and use across Peru in national immunization campaigns during the health emergency declared as a result of the (COVID-19) pandemic.
The conditional health registration of COVID-19 vaccines —which are in Phase 3 of clinical trials showing promising preliminary results— is possible under the recent Law that guarantees access to preventive and curative treatment against SARS-CoV-2 and other diseases that may cause a national health emergency, as well as other pandemics declared by the
World Health Organization (WHO).
This legal act amended Article 8 of Law No. 29459 (Law on Pharmaceutical Products, Medical Devices, and Sanitary Products), which is regulated by
Supreme Decree 002-2021-SA.
In case of non-compliance with the obligations set in the Digemid Resolution —which authorizes the issuance of the conditional health registration— or other cases indicated in Article 40 of Supreme Decree No. 002-2021-SA —which approves the Regulation for the Conditional Health Registration of Medicines and Biological Products— the conditional health registration issued will be suspended or canceled.
(END) NDP/LIT/RMB/MVB
Published: 2/3/2021