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June 26, 2018

ANVISA publishes four new major resolutions on june 25, 2018

Life Sciences & Healthcare


Linear barcode will be mandatory in traceability labels of certain implantable medical devices

On June 25, 2018, the Brazilian Health Regulatory Agency (ANVISA) published a new resolution (RDC ANVISA No. 232/2018) making mandatory the use of linear or two-dimensional (2D) barcodes in traceability labels of conventional and pharmacological stents for coronary arteries, as well as of hip and knee arthroplasty implants. 

The linear or two-dimensional barcodes must be in compliance with the standards issued by the International Medical Device Regulators Forum, but the new Resolution also provides for the possibility of recognizing codification standards issued by other international agencies.

The RDC ANVISA No. 232/2018 will come into force in two (2) years after its publication.


New rules on the outsourcing of drugs and biological products

RDC ANVISA No. 234/2018 updates regulation concerning outsourcing of drugs and biological products manufacturing stages, quality control, transportation and warehousing.

Such new regulation opens new possibilities for outsourcing structures, as some relevant restrictions previously provided for in the revoked RDC ANVISA No. 25/2007 are no longer in place, such as: (a) prohibition against the outsourcing of all manufacturing stages; (b) prohibition against the outsourcing of all drugs registered by one company; (c) obligation on MA (marketing authorization) holders to have their own warehousing, among others.

Other aspects of RDC ANVISA No. 234/2018 should also be highlighted, such as:

(i) Mandatory provisions for outsourcing agreements;

(ii) Subcontracting by the outsourced company is now allowed; and

(iii) Lifting of the requirement to notify ANVISA before the beginning of the outsourcing activities.

In order to adapt the health regulation to the new outsourcing rules, ANVISA also published RDC No. 235/2018 to amend RDCs No. 38/2014, No. 76/2016 and No. 49/2011. These changes present specific rules on the updating of MAs whose products are to be outsourced.


Changes to the MA transfer rules

ANVISA also changed RDC No. 102/2016, which establishes the procedures for MA transfer, global transfer of responsibility for clinical trials and updating of ANVISA’s databases as a result of corporate transactions or commercial transactions. 

RDC ANVISA No. 233/2018 amended the item VII of Article 4 of the RDC No. 102/2016, in order to give a broader concept to the definition of commercial transactions, now defined as: "a transaction between companies resulting in the transfer of assets or a group of assets, without the occurrence of any corporate transaction between them." Such definition was previously limited to transactions involving the purchase and sale of assets.


Update on the regulation for substances and medicines subject to special control

Ordinance SVS/MS No. 344/1998, which provides for the technical regulation for substances and medicines subject to special control, was also updated through RDC ANVISA No. 231/2018. According to the new wording of Art. 4-A, facilities duly licensed before ANVISA may build stocks of special controlled chemical substances used as a standard in analytical tests, for later distribution to establishments carrying out laboratory analyses and research and educational activities.




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