Extraordinary Newsletter N°25/2017
Informativos . 21/09/17
It was published on the Official Gazette, on 09/15/2017, Interpretative Orientation 9, from 09/13/2017, clarifying that the analysis of price approval of drug object of ownership transfer will be initiated only when its registration becomes valid.
CMED, through this Orientation, suggests that DIP – Price Informative Document referent to drugs subject to ownership transfer shall be protocoled before CMED only after the beginning of the validity of its registration, as per article 47 of RDC 102/2016.
Also, this Orientation clarifies that the DIP protocoled after its publication and referent to drugs subject to ownership transfer which registration is still not valid will be archived. In the case of DIP protocoled before the publication of such Interpretative Orientation referent to drugs which registration is still not valid, those will be analyzed once the registration becomes valid. Drugs subject to ownership transfer may be commercialized once protocoled DIP before CMED, as long as its is kept the price previously approved by CMED, until the company is notified about the results of the analysis of the DIP by CMED.