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Brazil proposed Technical Resolution n. 374, 2 August 2017

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Brazil proposed resolution provides for claims of use for registration and notification of dynamised drugs

Brazilian Health Regulatory Agency (Anvisa) proposed resolution provides for claims of use for registration and notification of dynamised drugs.

Determine the publication of the "Table of claims of use for registration and notification of dynamised drugs", in the form of the annex of this Normative Instruction and procedures for requests for change, inclusion or exclusion in the Table.

The allegations of use in the Annex of this Normative Instruction were defined according the homeopathic, anthroposophical or antihomotoxic literature, since, for these associations, no clinical studies of efficacy were conducted.

Products covered: Medicines

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: 08-10-2017

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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