This newsletter covers the recent legislation related to following matters in Brazil:
1. Pharmaceutical products; 2. Food, Beverages and Agribusiness; 3. Health services and 4. Institution information of Anvisa.
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1. PHARMACEUTICAL PRODUCTS
Communiqué CMED No. 1, of February 7, 2018
Discloses new presentations of pharmaceuticals deemed as similar to those included in the list of the Resolution No. 5, of October 9, 2003.
Post-registration of medicine
Resolution RDC Anvisa No. 219, of February 27, 2018
Provides for the guidelines for conditional approval of pharmaceutical post-registration change applications, and makes other provisions.
International Inspection by Anvisa
Resolution RDC Anvisa No. 217, of February 20, 2018
Amends Resolution RDC no. 39, of August 14, 2013, deals with the administrative procedures for issuance of Good Manufacturing Practices Certificate and Good Distribution and/or Storage Practices Certificate.
2. FOOD, BEVERAGES AND AGRIBUSINESS
Joint Normative Ruling Anvisa No. 2 of February 7, 2018
Establishes procedures for tracking the production chain of fresh vegetable products intended for human consumption, for monitoring and controlling agrochemical residues, throughout Brazil. The rule proposal had discussed with regulated industries through the Public Consultation 298, of February 08, 2017. Such rule will be gradually enforced according to the products categories at terms of 6 months, 1 and 2 years, as from February 28, 2018, pursuant to Schedule III.
Normative Ruling MAPA No. 3, of February 14, 2018
Amends the Technical Regulation on the Establishment of Identity and Quality Standards of Diet and Low Calorie Beverages, which is established by the Normative Ruling SDA/MAPA No. 30, of September 27, 1999. Manufacturers involved will have 180 days, from February 19, 2018, to meet the new requirements. Beverages produced during this iod will be commercialized its valid date until.
Normative Ruling MAPA No. 4, of February 14, 2018
Exempts, in the ambit of SDA, the registration of byproducts not intended for human food obtained from animal sources or tissues and of establishments that manufacture or process them.
3. HEALTH SERVICES
Resolution RDC Anvisa No. 216, of February 8, 2018
Amends Resolution RDC no. 11, of March 13, 2014, which provides for the Good Practices Requirements for Dialysis Services, and makes other provisions. Sets up the prohibition for an indefinite term the reuse of arterial and venous products applied to all haemodialysis procedures carried on health establishment localized in Brazil.
Resolution RDC Anvisa No. 214, of February 07, 2018
Provides for the Good Practices on Human Cells for therapeutic use and clinical research, and makes other provisions. Such rule comes into effect on April 23, 2018.
Resolution CFF No. 654, of February 22, 2018
Provides for the requirements necessary for the pharmacist to provide vaccination, and makes other provisions.
Resolution CFM No. 2,178, of December 14, 2017, published on February 28, 2018
Regulates the operation of applications that offer medical appointment at home.
4. INSTITUTION INFORMATION OF ANVISA
Amends of internal rules
Resolution RDC Anvisa No. 218, of February 21, 2018
Amends Resolution RDC no. 61, of February 3, 2016, which approves and enacts Anvisa Internal Rules.
Reorganization of health care assignments
Resolution RDC Anvisa No. 215, of February 8, 2018
Provides for the amendment of the vacation legis of Resolution RDC 207, of January 3, 2018, which provides for the organization of healthcare actions, performed by the Federal Government, States, the Federal District and Municipalities, relating to the Permit for Operation, License, Registration, Certificate of Good Practices, Monitoring, Inspection and Regulation, in the ambit of the National Public Health Control System (SNVS).
Anvisa – National Health Surveillance Agency
CFF – Federal Council of Pharmacy
CFM – Federal Counsil of Medicine
CMED – Medications Regulation Chamber
MAPA – Ministry of Agriculture, Cattle Breeding and Supply
SDA – Agricultural and Stockbreeding Defense