This newsletter covers the recently legislation, published by Brazilian Health Regulatory Agency (“ANVISA”), related to following matters: 1. Pharmaceutical laboratories; 2. Industries of medical products and equipment; 3. Health services; 4. Food, agrochemicals and tobacco; 5. Customs and 6. Institutional information of Anvisa.
The legislation available bellow is in Portuguese version, please do not hesitate to contact us should you need it in English for your convenience or any further clarification on the matter. You may contact us by email at firstname.lastname@example.org
1. PHARMACEUTICAL LABORATORIES
Medicines for rare diseases
Resolution RDC no. 205, December 28, 2017
Establishes special procedure for approval of clinical trials, certification of good manufacturing practices and registration of new drugs for treatment diagnosis or prevention of rare diseases.
Resolution RDC no. 196 of December 22, 2017
Amends Resolution RDC no. 26 of May 13, 2014, which provides for registration of phytotherapic drugs, and registration of traditional phytotherapic drugs.
Resolution RDC no. 194 of December 12, 2017
Provides for the updating of the requirments to registration and post-registration changes in Manufactured Allergen Products
Resolution RDC no. 200 of December 26, 2017
Provides for the criteria and minimum requirements to grant and renew the registration of pharmaceuticals with synthetic and semi-synthetic active ingredients, classified as new, generic and similar.
Resolution RDC no. 204 of December 27, 2017
Establishes that petitions for registration, post-registration and previous consent in pharmaceutical clinical research should be classified as priority category
Resolution RDC no. 191 of December 11, 2017
Deals with the differentiated control of lenalidomide and of pharmaceutical containing it.
Resolution RDC no. 192 of December 11, 2017
Provides for the updating of the Lists of Narcotic, Psychotropic, Precursor and other controlled Substances established in the Ordinance SVS/MS no. 344 of May 12, 1998
2. INDUSTRIES OF MEDICAL PRODUCTS AND EQUIPMENT
Resolution RDC no. 211 of January 22, 2018
Provides for the extends term of the registration of medical devices
Deadline to revalidation of registration
Resolution RDC no. 212 of January 22, 2018
Amends the deadline to the revalidation request by the holder of product registration at the Anvisa provided for the Resolution RDC no. 250 of October 20, 2004.
3. HEALTH SERVICES
Resolution RDC no. 197, of December 26, 2017
Provides for the minimum requirements for the operation human vaccination services and allows the offer of vaccination at the drugstore
Resolution RDC no. 199 of December 26, 2017
Revokes Resolution RDC no. 30 of July 24, 2015 and amends Resolution RDC no. 302 of October 13, 2015, which provides for the Technical Regulation on the operation of Clinical Laboratories
Resolution no. 2,171 of October 30, 2017, published by Federal Council of Medicine
Regulates of treatment to medical clinicals of services provider of ambulatory, which carry out medical appointment, exams and procedures for short term.
4. FOOD, AGROCHEMICAL and TOBACCO
Food intended for children
Resolution RDC no. 193 of December 12, 2017
Establishes the Maximum Tolerated Levels (MTL) of inorganic arsenic, total cadmium, total lead and inorganic tin contaminants in industrializes foods intended for infants.
Resolution RDC no. 190 of November 30, 2017
Amends Resolution RDC no. 177 of September 21, 2017, which provides for the prohibition of the active ingredient paraquat in agrochemicals in Brazil and for the transitional measures to mitigate risks.
Resolution RDC no. 213 of January 23, 2018
Provides for the sale and marketing of tobacco smoking products
On December 28, 2017, Anvisa published 6 Publics Consultations for restructure of the Dietary Supplements regulation according to the table below. Any interested party can be submitted comments and suggestions until April 09, 2018 through website www.anvisa.gov.br.
Public Consultation N#
Revision of rules to registration of vitamins, minerals, amino acids and proteins for oral use, classified as specific drugs. Such changings amends on the text of current Resolutions RDC no. 24 of June 14, 2011; RDC no. 107 of September 5,2016 and Normative Ruling IN no. 11 of September 29,2016.
Proposal to establish requirements able to evidence the safety and health benefits of probiotics
Amends the Resolution RDC 27 of August 6, 2010, which deals with the categories of foods and packaging exempted from health registration and those requiring it
Updating list of nutrients, bioactive substances, enzymes and probiotics, limits of use, allegations and supplementary labeling of the food supplements
Proposal to establish health requirements of the food supplements
Proposal to provides for the food additives and technology adjuvants to be used in food supplements
Flexibilization of regulatory barriers
Resolution RDC no. 208 of January 8, 2018
Provides for streamlining of procedures for the importation of goods and products subject to Sanitary Surveillance
Imported medicines aimed for Brazilian Public Health Program
Resolution RDC no. 203 of December 203, 2017
Provides for the criteria and procedures for the importation, on an exceptional basis, of products aimed for Brazilian Public Health Program without registration with Anvisa
6. INSTITUTIONAL INFORMATION OF ANVISA
Resolution RDC no. 207 of January 3, 2018
Provides for the organization of healthcare actions, performed by the Federal Government, States, the Federal District and Municipalities, relating to the Permit for Operation, Licensing, Registration, Certificate of Good Practices, Monitoring, Inspection and Standardization in the ambit of the National Public Health Control System (SNVS)
Ordinance No. 35 of January 11, 2018
Creates the policy on granting of sponsorships through Anvisa