MINSA: EXTENSION OF HEALTH EMERGENCY
Through Supreme Decree No. 027-2020, the State of Health Emergency was extended until December 7.
During this period, the “Plan of Action – Surveillance, containment and care of cases of the new COVID-19 in Peru” and the list of “goods or services required for COVID-19 health emergency activities” remain in force.
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DIGEMID: WITHDRAWAL OF COVID-19 RAPID TEST
The authority has been carrying out quality control of the rapid tests and determined the withdrawal from the market of lots of 5 rapid tests (medical devices) whose results do not comply with health requirements.
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DIGEMID: SANCTIONS FOR OBSERVATORY OF PRICES OF GOODS USED IN THE TREATMET OF COVID -19
Through Supreme Decree No. 025-2020-SA, the sanction of 4UIT for not complying with reporting the stock and sales price of the essential goods used in the treatment of COVID-19 to DIGEMID was included in the table of infractions and sanctions of the Regulation of Pharmaceutical Establishments (DS No. 014-2011-SA), as indicated in Emergency Decree 059-2020.
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DIGEMID: NARCOTICS AND PSYCHOTROPICS REGULATIONS ARE AMENDED
Through Supreme Decree No. 024-2020-SA, the Regulations on Narcotics, Psychotropics and other substances subject to health control (D.S. 023-2001-SA) were amended.
The amendment indicates that a supervisor shall be appointed, at the request of the company, to proceed to verify the effective incorporation of the controlled inputs into the respective medicines as an exclusive service. In addition, the service is specified in the exclusive distribution of special prescriptions, as well as details of the process of destruction of controlled products that have suffered deterioration or loss of effectiveness.
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DIGEMID: CRITERIA FOR PROMOTION AND ADVERTISING
Through Ministerial Resolution No. 474-2020-MINSA, published on July 9, Health Technical Standard No.162-MINSA/2020/DIGEMID was adopted, which establishes ethical criteria for the promotion and advertising of pharmaceutical products, medical devices and health products.
The entry into force of this standard shall be in 90 calendar days, that is to say, on October 7, 2020, and shall be applicable to public and private health establishments, pharmaceutical and non-pharmaceutical establishments, including also health professionals involved in the prescription, dispensing and sale of the aforementioned products.
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DIGESA: DRAFT REGULATION OF CLEANERS AND PESTICIDES FOR DOMESTIC AND INDUSTRIAL USE
Through Ministerial Resolution No. 439-2020-MINSA, the draft of the “Regulation and Control of Hazardous and Similar Substances for Domestic, Industrial and/or Public Health Use” applicable to cleaners, degreasers and descalers for surfaces of industrial use, as well as disinfectants and pesticides for domestic, industrial and public health use, was published.
The aforementioned draft includes clear and specific requirements for this type of products that to date do not have a special regulation. The private sector may send their comments or recommendations to the document during the next 90 calendar days (until September 30, 2020), via email: webmaster@minsa.gob.pe.
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DIGESA: SIMPLIFIED PROTOCOL FOR FOOD CERTIFICATION
Through Board Resolution No. 035-2020/DIGESA/SA, the simplified health protocol was adopted, on a temporary basis, for the certification procedures of prior evaluation of food and inspection records of digital and face-to-face application.
The entity arranged the inspections in a simplified way so that the inspection times could be shortened in order to maintain social distance and to be able to attend to the files that are pending. The application shall be until the culmination of the declared Health Emergency.
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For further information, please do not hesitate to contact Maritza Reátegui (mreategui@estudiorodrigo.com) and Solange Noriega (snoriega@estudiorodrigo.com).
