Any person may file for registration of a pesticide; which must be
in prescribed form addressed to the Authority and under oath, containing
complete and detailed information.
Only local companies registered by the Securities and Exchange Commission
(SEC) to do business in the Philippines and duly licensed by FPA may apply
for registration of pesticide products. For purposes of these guidelines,
a local company is a juridical person created under the Philippine law
and licensed to do business in the country. Companies operating in
the Philippines under PD 218 are excluded in this definition. Foreign suppliers
or companies registered under the SEC as regional liaison offices (PD 218)
are not allowed to register the products. In pesticide, the applicant registrant
should be the distributor or the local subsidiary of a foreign-based pesticide
company.
A separate application shall be filed for each formulated product and
active ingredient as well as for each source of the active ingredient.
A complete application, submitted in duplicate, consist of:
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Form for registrant of an Active Ingredient (P-012) or registration of
a Pesticide Product (P-022)
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Complete data required to support the registration requested as specified
in Section III of the Guidelines, particularly Table 3.3 on Data Requirements,
with a certificatin that they comply with good scientific practice, GLP's
and test protocols.
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A summary of the data submitted and an applicant's assessment of how these
data support registration for the purpose, uses and directions for use
in the label.
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Proof of registration in other countries were relevant.
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Dummy label text.
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A sample of the material to be registered must be submitted prior to registration
unless the applicant presents convincing reason to FPA as to why these
should not be submitted at that time. The following must accompany an application:
1 g. analyticial grade of the active ingredient(s), 10 g. technical
material and 500 ml or 0.500 kg of the formulation.
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Reviews of data done by other countries or international organizations,
if available.
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The appropriate fee.
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Any Authorization necessary to cite previously submitted data.
Data must be submitted in the standard 8.5 x 14 paper, indexed and bound
separately, i.e. on folder for each of the following sets of data: Specifications;
Bioefficacy; Toxicology and Residues/Environmental Fate. The dummy label
must appear as the first entry in each folder. Any additional data required
must also be submitted as prescribed. Submission that do not follows these
requirements shall not be accepted.