COVID-19
NATIONAL EMERGENCY AND SOCIAL COEXISTENCE MEASURES
Supreme Decree Nº 108-2022-PCM extended the State of National Emergency until September 30, 2022.
Additionally, the use of masks in open spaces is optional throughout the country, as well as for students in educational institutions. The use of masks and the presentation of a vaccination card with three doses (over 18 years of age) in closed spaces, among others, are mandatory.
It must be noted that during the State of National Emergency, authorizations, licenses and permits issued by administrative authorities are extended for one year and only once, according to Legislative Decree Nº 1497 and in accordance with the provisions of each sector.
DIGEMID
CANNABIS: ILLEGAL SALE OF PRODUCTS
The Digemid, through communiqué Nº 011-2022, informed that it has received reports of illegal trade of cannabis products that are not authorized by it.
Likewise, it points out that the pharmaceutical establishments authorized to sell cannabis products may be found in Digemid‘s website. On the other hand, it mentions that the population may report illegal trade on the institutional website through the link:
http://farmacia-responsable.digemid.minsa.gob.pe/denunciasWeb/DefaultCI
GOOD MANUFACTURING PRACTICES OF FOREIGN LABORATORIES
During the last month, the Ministry of Health authorized Digemid officials to travel to foreign pharmaceutical laboratories to carry out inspections in order to grant the Good Manufacturing Practices (GMP) Certification.
It must be noted that the health authority restarted the GMP certification inspection trips to laboratories abroad that are not located in countries with high health surveillance. The last trips to Brazil and Chile were authorized by Ministerial Resolutions N° 574-2022/MINSA, N° 575-2022/MINSA, N° 577-2022/MINSA y N° 578-2022 respectively.
MINSA
DRAFT: REGULATION OF PENALTIES FOR CLINICAL TRIALS
By Ministerial Resolution N° 612-2022-MINSA, the draft scale of penalties for non-compliance with the provisions set forth in the Clinical Trials Regulation, adopted by Supreme Decree Nº 021-2017-SA, was published.
The referred draft regulation provides that the scope of application is for the sponsor, contract research organization, research institution and principal investigator who commit infringements of the clinical trial regulation. Infringements would be classified as follows, depending on the type of violator:
Minor infringements: reprimand or fine of up to 30 UIT.
Serious infringements: Cancellation of the clinical trial or fine of up to 60 UIT.
Very serious infringements: Cancellation of the clinical trial or a fine of up to 100 UIT.
The resolution established a period of 10 calendar days (until August 24, 2022) to receive comments and/or observations to the draft through the e-mail address: webmaster@minsa.gob.pe.
DRAFT: RICE FORTIFICATION
Ministerial Resolution N° 597-2022-MINSA published the draft Regulation of Law Nº 31348, Law that proposes the fortification of rice in Peru. The purpose of these regulations is to establish the guidelines for the line of fortified rice to be offered to the public by the producing companies. The provisions apply to domestic or foreign companies (millers, importers, suppliers of social food programs, among others) involved in the rice production and consumption chain.
Comments shall be received during the period of 90 calendar days (November 10, 2022) via email: webmaster@minsa.gob.pe.
DIGESA
FOOD ADDITIVES
Through Communiqué N° 16-2022-DIGESA/MINSA, Digesa informed that Export Certificates for Additives shall be issued upon request through the Foreign Trade Single Window (VUCE), using the DGS040 format.
Likewise, the authority confirmed that by means of Board Resolution Nº 0067-2022/DIGESA/SA (May 17, 2022), Board Resolution Nº 0775-2003/DIGESA-SAF, which adopted the Procedures Manual for Health Authorization of Food Additives, was annulled.
