DIGEMID RELEASES:
The entity has issued various communiqués to users during the last week regarding the following:
• Exceptional medical device authorization may be requested by email digemidvirtual@minsa.gob.pe.
• Extension of the validity of operating permits.
• Standardized formula of Ivermectin pharmaceutical preparation is validated by Digemid.
• The obligation to report prices for the sale of essential goods for the management and treatment of Covid-19 through the Peruvian pharmaceutical products observatory.
• List of foreign pharmaceutical manufacturing laboratories that are pending certification in Good Manufacturing Practices (GMP) by the National Medicines Authority.
Additionally, Digemid issued Alert No. 16-2020 ordering the withdrawal from the market of a batch of rapid tests that came out with a critical quality control result.
Click to access the document.
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Alertas/2020/ALERTA_16-20.pdf
RULES:
LIST OF ESSENTIAL GOODS
Through Ministerial Resolution No. 315-2020-MINSA, the list of essential goods for the management and treatment of COVID-19 was published.
Initially, this list had 48 items including pharmaceuticals, medical devices (including biomedical equipment and in vitro diagnostic agents), and others. However, through Ministerial Resolution No. 419-2020-MINSA, 07 additional pharmaceutical products were incorporated.
Currently, there are 55 goods listed as essential goods for the management and treatment of COVID-19.
Click to access the document.
https://cdn.www.gob.pe/uploads/document/file/732315/RM_315-2020-MINSA.PDF https://cdn.www.gob.pe/uploads/document/file/865820/RM_419-2020 -MINSA.pdf
PRICE REPORT
Emergency Decree No. 059-2020 enacted extraordinary measures to guarantee access to medicines and medical devices for the treatment of COVID-19.
It was arranged that the public and private pharmaceutical establishments (laboratories, drugstores, pharmacies and health establishment pharmacies) operating in the country, report to the Peruvian Pharmaceutical Products Observatory of the National Information System of Prices of Pharmaceutical Products, the available stock and sale prices of essential goods for the management and treatment of COVID-19. Same as the number of units imported or manufactured in the country.
Administrative Directive No. 289-MINSA/2020/DIGEMID establishes the procedure for supplying data to the Peruvian Pharmaceutical Products Observatory of Essential Goods for the management of COVID-19 included in the list approved in Ministerial Resolution No. 315 -2015-MINSA, under the Emergency Decree D.U. No. 059-2020.
Click to access the document.
https://cdn.www.gob.pe/uploads/document/file/827266/RM_367-2020-MINSA.PDF
NEWS:
NEW HEALTH RECORDS FOR MEDICAL CANNABIS PRODUCTS
Until the end of May, there was only one Health Record of a medicine approved by the General Directorate of Medicines, Supplies and Drugs – DIGEMID. However, the authority has recently granted two health records of natural products to two drugstores.
Despite being in a State of Health Emergency at the national level due to the existence of COVID-19, the entity has been working on matters related to access to medical cannabis and also granting import and/or marketing licenses.
