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- disclosure of such data, unless it is necessary to protect the public and unless
measures have been taken to guarantee that the data have been protected
against unfair exploitation in trade.
This Article shall apply until the first holder no longer controls the undisclosed
data and they have been made available to the public anywhere in the world.
Article 375: It shall be prohibited for any person other than the one who has communicated
undisclosed data resulting from trials or other data, whose establishment requires
considerable effort, to rely on or mention such data in a request for authorization
for commercialization filed by a third party, in the case at hand the first holder,
within a reasonable period following the communication of the results of these
trials or data.
This period must be set by the competent authority for each good whose
commercialization has been approved, in view of the nature of the data as well
as the efforts made by the first holder and the costs of conducting trials for each
good.
Article 376: The period referred to in Article 375 must be a maximum of five years for all
goods, starting from the date of approval.
The authority responsible for approving the commercialization of the goods shall
set the term of protection for each good, in view of the nature of the data and the
efforts made to finalize these data.
When it evaluates these efforts, the authority shall take due account of all
aspects, notably the work and time needed to finalize the data in support of the
first registration of the product in all countries and territories which have
acceded to the Paris Convention or are members of WTO or when reciprocal
treatment is recognized for citizens and residents of Burundi in any other
country.
Article 377: If the applicant pays the first holder fair compensation, the amount of which is
approved by the subsequent applicant and the first holder or, failing agreement,
by the authority responsible for issuing the marketing approval, the competent
authority may, during the period mentioned in Article 376, rely on undisclosed
data resulting from trials and other undisclosed data communicated by the first
holder with a view to the approval of the subsequent application in the following
cases:
- if obtaining these undisclosed data resulting from trials or other data has
caused suffering in human beings or animals;
- in cases of extreme urgency;
- if the goods concerning the undisclosed protected data resulting from trials or
other data have not been commercialized in Burundi within a reasonable
period after such commercialization has been approved by Burundi;