IMPLEMENTATION PLAN OF THE NATIONAL REGISTRY OF ELECTRONIC MEDICAL RECORDS (RENHICE)
On July 8, the Ministerial Order approving the Technical Document: Implementation Plan of the National Registry of Electronic Medical Records (RENHICE) was published.
This plan aims to implement the technological infrastructure specialized in health allowing the patient or his legal representative and health professionals being previously authorized by them, to access to the medical data contained the electronic medical records. The plan shall be implemented progressively.
The use of the Electronic Medical Records will favorably contribute to provide quality health care services in benefit of patients. It should be mentioned that any person managing the information contained in RENHICE is liable to non-disclosure.
NEW IMAGE REGULATION FOR CIGARETTES AND OTHER TOBACCO PRODUCTS
On Friday, July 19, 2019, Ministerial Order No. 654-2019/MINSA was published, whereby it is set forth to approve the “Image regulation for health warnings use and enforcement in packages, and cigarette and other tobacco products advertisements”. This regulates fonts (information of carcinogenic substance, preventive stage, health warnings, etc.), colors, photography data and disposition of graphical material.
Moreover, it is set forth as first health warnings graphics from pages 20 and 21 which shall appear in packages, and cigarette and other tobacco products after 6 months upon publication of the Order, that is, as of January 19, 2020.
Furthermore, the Ministerial Order No. 469-2011/MINSA, “Image regulation for health warnings use and enforcement in packages, and cigarette and other tobacco products advertisements” is repealed upon completion of a 6-month term.
SIMPLIFYING REQUIREMENTS AND ELIMINATING PROCEDURES IN THE CONSOLIDATED TEXT OF ADMINISTRATIVE PROCEDURES (TUPA) OF THE GENERAL MEDICINE, INPUT AND DRUG ADMINISTRATION (DIGEMID)
On August 3, 2019, the Ministerial Order No. 668-2019/MINSA was published, whereby it is set forth to simplify DIGEMID administrative procedures. This administrative simplification is given as a result of a regulatory quality analysis.
The aforementioned Order provides for the following:
In addition, 60 procedures shall adequate in the Foreign Trade One-Stop Shop (VUCE) within a 45-calendar day term expiring on September 17, 2019. During said term, such procedure formalities shall be submitted to reception desk.
INCLUDING AUSTRIA AS A HIGH HEALTH STANDARD CONTROL COUNTRY
Pursuant to Supreme Executive Order No. 018-2019-SA published on July 24, 2019, it is set forth to amend the Regulation on the Registry, Control and Health Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products; and the Drug Establishments Regulation. Such amendment is referred to the inclusion of Austria as a High Health Standard Control Country.
ESSENTIAL MEDICAL DEVICES LIST
On July 24, 2019, the Ministerial Order No. 670-2019/MINSA was published in the Official Gazette “El Peruano”, whereby it is set forth to approve the Technical Document: Peruvian Unique Essential Medical Devices List of the Ministry of Health in order to contribute to improve the access of medical devices identified as essential in prevention, treatment and control of prevailing disease within the country for population.
The list includes 119 medical devices and 20 in-vitro medical devices, and it describes common names, use as per attention stage and general description according to type of medical devices.
RATIFICATION OF THE FIRST AMENDMENT PROTOCOL – PACIFIC ALLIANCE
Pursuant to Supreme Executive Order No. 030-2019-RE, it is set forth to ratify the “First Amending Protocol to the Additional Protocol to the Pacific Alliance Framework Agreement” signed in 2015.
It should be mentioned that the amending protocol includes the deletion of technical barriers to trade of cosmetics, whereby it is set forth the market surveillance system, the removal of certificate of free sale, ingredient review system, and harmonization of product labeling based on international standards and good manufacturing practices.
GENERAL MEDICINE, INPUT AND DRUG ADMINISTRATION (DIGEMID)
LIST OF FOREIGN LABORATORIES WITH PENDING GMP CERTIFICATION BY DIGEMID
The DIGEMID Inspection and Certification Division published on its website the List of Foreign Laboratories of Pharmaceutical Products with pending Good Manufacturing Practice Certification by DIGEMID.
The list comprises the following:
INFORMING CHANGES IN DRUG ESTABLISHMENTS
The DIGEMID Inspection and Certification Division published on its website a press announcement referred to changes in drug establishments:
Said changes shall be previously informed by the requested party or by forms given by the Authority, attaching a document supporting this change. The process is automatic and does not require any Authority’s resolution.
Click here to read the document.
PERUVIAN ADMINISTRATION OF FISHERY HEALTH (SANIPES)
REGULATION OF ACT No. 30063 “PERUVIAN ADMINISTRATION OF FISHERY HEALTH (SANIPES) CREATION ACT”
Pursuant to Supreme Executive Order No. 010-2019-PRODUCE published on Sunday, July 14, 2019, it is set forth to approve the Regulation of Act No. 30063 “Peruvian Administration of Fishery Health (SANIPES) Creation Act” comprising seven (7) chapters and thirty-one (31) sections.
The Regulation aims to set adequate instruments in order to protect public health and ensure the sanitary status in the area and/or compartment where the hydrobiological resources are.
It is set forth, within a term no more than 180 business days from the effective date of the regulation, to approve the regulations in terms of health and safety whereby it is included the creation of administrative procedures within its scope to apply related issues established and previously complied with the regulation of the World Trade Organization and the Andean Community regarding sanitary and phytosanitary measures, and technical barriers to trade, as appropriate.
For further details, please contact Maritza Reategui (firstname.lastname@example.org and/or Solange Noriega (email@example.com).