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7.
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Objective and rationale, including the
nature of urgent problems where applicable:
Republic Act (RA) No. 9711, otherwise known
as the "Food and Drug Administration (FDA) Act of 2009", mandates
the FDA to regulate and subsequently issue appropriate authorizations to
establishments engaged in the manufacture, distribution, importation,
exportation and retailing of health products, among others.
Article I Section 6 (Requirements for Every
Incoming Shipment of Health Products) of the Book II of the Implementing
Rules and Regulation (IRR) of RA No. 9711, states that "The FDA in coordination with the Bureau of Customs,
Bureau of Quarantine and other concerned agencies is mandated to undertake
and adopt measures relating to importation of health products such as, but
not limited to, sampling and examination, in accordance with relevant
existing laws and regulations, of every incoming shipment of health
products". The FDA hereby issued FDA Memorandum Circular
(FMC) No. 2013-032 wherein a valid License to Operate (LTO) and Certificate
of Product Registration (CPR) are required for the release of drug products.
However, there is a need to strengthen market control within the distribution
chain through additional measures to ensure that the public only receive
quality-assured drug products. The infiltration of substandard and falsified
drug products into the supply system shall be prevented through risk-based
surveillance scheme and rigorous control. Therefore, as part of the FDA's
powers and functions under RA No. 9711, issuance of appropriate authorization
such as import/export clearance is necessary to strengthen the FDA's overall
market surveillance and control regulatory function.
In the interest of public health,
import/export activities related to drug products need to be controlled and
under the proper oversight of the FDA. Issuance of this guidelines is
imperative to ensure the consistency and effectiveness of these regulatory
activities.
Protection of human health or safety
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