Newsletter – May and June, 2018

News6This newsletter covers the recent regulation published by National Health Surveillance Agency (“Anvisa“).

Please do not hesitate to contact us should you need the legislation in English version for your convenience or any further clarification on the matter. You may contact us by email at regulatoriolifescience@gmail.com


Rules applicable to all products controlled by Anvisa

Resolution RDC no. 233 of June 20, 2018
Amends rules about procedures for transferring to ownership of registration of products subject to health control, overall transfer of responsibility for clinical trial and update of registration data relating to the operation and certification of companies, as a result of corporate and business transactions provided by Resolution RDC no. 102 of August 24, 2016.

Resolution RDC no. 228 of May 23,2018
Provides for health risk management of activities related to the control and supervision in the importation of goods and products subject to health control.


Medicines

Resolution RDC no. 234 of June 20, 2018
Provides for the outsourcing of stages of production, analysis of quality control, transportation and storage of pharmaceutical and biological products.

Resolution RDC no. 230 of June 5, 2018
Provides for the update of the list of Common Brazilian Denominations (DCB)

Resolution RDC no. 231 of June 20, 2018
Deals with the inclusion of article 4-A in Ordinance SVS/MS no. 344 of May 12, 1998, which approves the Technical Regulation on controlled substances and drugs.

Resolution RDC no. 227 of May 17,2018
Provides for the update of the Annex I (Lists of Narcotic, Psychotropic, Precursor and other Controlled Substances) of Ordinance SVS/MS no. 344 of May 12, 1998.

Resolution RDC no. 235 of June 20, 2018
Provides for the amendments and inclusions of quality control in the registration and post-registration of biological products, phytotherapic herbs, specific and dynamized drugs.


Medical Devices
Resolution RDC no. 232 of June 20, 2018
Provides for the mandatory use of linear or two-dimensional barcodes in traceability labels of conventional and pharmacological stents for coronary arteries, and hip and knee arthroplasty implants.

Normative Rulling no. 24 of May 17, 2018
Provides for the criteria for registration, change and re-evaluation relating to the analytical performance of self-testing instruments for glucose and its medical consumables.


Tobacco
Resolution RDC no. 226 of April 30, 2018
Provides for the registration of smoking products derived from tobacco


This newsletter is meant for general information purposes only and should not be relied upon as legal advice on any specific deal or matter. The material shoul be shared through social networks.