DPP-Pesticides Section Final

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Government of Pakistan

Ministry of National Food Security & Research


Department of Plant Protection, Malir Halt, Jinnah Avenue, Karachi

GOVERNMENT PROCEDURES – EASE OF DOING SERVICES

(Part-2-Pesticides Registration) INDEX

SR.
TITLE PAGE NO.
NO.
1 Department of Plant Protection 2
2 Services catered by DPP 2
3 Procedure for Import Permit/ Registration of permitted Pesticides under Form-1 3
4 Procedure for Import Permit / Registration of permitted Pesticides under Form-16 7
5 Procedure for Import Permission/ Registration of Permitted Pesticides under Form-17 11
6 Procedure for certification of Manufacturing / Formulation / Re-packing Plants of Registered Pesticides 15

1
Ministry of National Food Security and Research Department Of Plant Protection

1. Introduction:

1) Pakistan Agricultural Pesticides Ordinance 1971 and Pakistan Agricultural Pesticides Rules 1973 were enacted by the Government to regulate the
import, manufacturer, formulation, sale, distribution and use of Pesticides for eradicating and preventing augmentation and spread of indigenous
and exotic pests and diseases which could be destructive to field crops, horticulture, floriculture and forests.

2) The Department of Plant Protection, (herein after referred as DPP) is an attached Department of Ministry of National Food Security and
Research. This Department is responsible to import, manufacturer, formulation of Pesticides in Pakistan besides quarantine functions whereas,
function to regulate inspection, testing, distribution, use, sale and storage has been shifted to the Provincial Agriculture Departments after 18 th
Constitutional Amendment.
2. Services Catered by DPP

The DPP provides following services to its clients (importers, manufacturer, formulators, re-packers/ re-fillers of registered Pesticides).
1. Certificate of Registration (Import Permit) for import of permitted pesticides under Form-1.
2. Certificate of Registration (Import Permit) for import of notified pesticides under Form-16.
3. Certificate of Registration (Import Permit) for import of New Chemistry Pesticides under Form-17.
4. Certificate of Registration to Manufacturing / Formulation / Re-filling Plants for manufacturing/ Formulation / Re-filling Plants of permitted
pesticides.
5. Reference laboratory for pesticides testing and analytical standards.
Activity-1 (ANNEXURE-
FLOW CHART I)
Procedure for Certification of Registration for import of Pesticides under Form-1

Submission of Application

Incomplete Application
Legal and Technical
Evaluation of application &
documents

Timeline: Within 60 days


Testing of pesticides sample in FPTL

Request by DPP for


Bio-efficacy trials for two crop season and
standardization of pesticides to standardization of pesticides by Provincial
Provincial & Federal Research and Federal Research Institutes

Legal and Technical Evaluation Timeline: Two Crop Season (two year)
in Sub-APTAC &
Recommendation

Timeline: 3 months Legal and Technical Evaluation &


Approval in APTAC

Issuance of Certification of
Registration

Timeline:
3 Within two and half years
PROCEDURES FOR CERTIFICATION OF REGISTRATION FOR IMPORT OF PERMITTED PESTICIDES UNDER FORM-1

Sr. NATURE OF STEPS OF OFFICIAL


DOCUMENTS REQUIRED TIMELINE REMARKS
No. CERTIFICATE PROCEDURE
1 Certificate of Application on Form-1 duly filled, signed Submission of Application. Incomplete applications are
Registration and stamped by the executive of the firm. liable to be returned with re-
under Form-1 submission after supply of
complete documents and
information.
2 Original Letter of Authorization (LOA) Legal and technical evaluation of Certificate of Registration is
from the Manufacturer with name Application and documents required under Section 4 of
&designation of the signing person having Agricultural Pesticides
seal, signature, telephone, fax and email Ordinance 1971 for import,
address. manufacturer, formulation,
re-packing, distribution,
60 days
sale, advertise of permitted
pesticides under Form-1
3 Recipe and specification of formulated Testing of sample in Federal
product analyzed by internationally Pesticides Testing and reference Lab,
accredited lab/GLP certified lab. along DPP for verification of information
with proof of accreditation. specified in application.
4 composition and specification of technical Request to more than two Provincial
grade material in accordance with and Federal Research Institutes to
composition and specification registered carryout bio-efficacy trials for two
with registration authority in the country crop seasons and standardize the
of origin product.
5 Toxicological, Eco-toxicological &
stability data of Technical grade material Bio-efficacy trials and standardization
More than
(TC)from international accredited of product by the two Provincial and
two years
lab/GLP certified lab. along with proof of Federal Research Institutes.
accreditation.
6 Toxicological study data of Formulated Legal and technical evaluation of the
product from international accredited product in notified Sub-Agricultural
lab/GLP certified lab. along with proof of Pesticides Technical Advisory
accreditation. Committee (sub-APTAC) for
recommendation of registration or
rejection.
7 MRL data & PHI period from Legal and technical evaluation of the
international accredited lab/GLP certified product in notified Agricultural
lab. alongwith proof of accreditation. Pesticides Technical Advisory
Committee (APTAC) for approval of
certificate of registration or rejection
of registration.
8 Original Copy of paid challan for Rs. Issuance of Certificate of Registration
40,000/- as registration fee. on Fom-2
9 Original copy of paid challan for Rs.
10,000/- as analysis fee of formulated
product
10 Original copy of paid challan for Rs.
10,000/- as fee of technical grade material
11 Valid registration certificate of the
formulated product in the country of
manufacture.
12 Valid registration certificate of the
technical grade material of pesticide in the
country of manufacture.
13 Sealed sample of formulated product and
TC, submitted in the Federal Pesticides
Testing &Reference Laboratory
(FPT&RL) directly from the manufacturer
along with proof of shipping documents.
14 Draft label of the product
15 Trial schedule of the product with crop
pest/weeds/diseases & dosage on desired
crops and in the desired area.

5
16 Certificate of Storage facilities on judicial
stamp paper with solid documentary proof
e.g., ownership deed, rental agreement.
17 Copy of valid distribution certificate or
contractual agreement with the registered
distributor.
18 Copy of NTN certificate
19 Copy of registration of firm / partnership
deed / Article of Association.
20 Proof of registration of trade name issued
by IPO.
21 A copy of registration of formulation plant
/ registered valid contractual agreement
signed by executives of both the firms
with name and designation.

6
Activity-2 (ANNEXURE-
FLOW CHART II)
Procedure for Import Permission (Registration) for import of Pesticides under Form-16

Submission of Application

Legal and Technical Evaluation of application & documents Incomplete Application

Timeline: Within 60 days Testing of pesticides sample in FPTL

Approval and Issuance of Certification of Registration

Timeline:
Within 60 days

7
PROCEDURE FOR IMPORT PERMISSION FOR IMPORT OF NOTIFIED PESTICIDES UNDER FORM-16

Sr. NATURE OF STEPS OF OFFICIAL


DOCUMENTS REQUIRED TIMELINE REMARKS
No. CERTIFICATE PROCEDURE
1 Import Application on Form-16 duly filled, Submission of Application Incomplete applications are
Permission signed and stamped by the applicant. liable to be returned with re-
Certificate of submission after supply of
pesticides under complete documents and
Form-16. information.
2 Letter of Authorization (LOA) of Legal and Technical evaluation of Certificate of Registration is
manufacturer (in original) with name & Application and approval required under Section 4 of
designation of the signing person, seal Agricultural Pesticides
& signature, telephone, fax & email Ordinance 1971 Read with
address. Rule 9 A (5) of APR 1973
for import of permitted
pesticides under Form-16.
60 days
3 100% break up / recipe and Testing of sample in Federal
specification of formulated product Pesticides Testing and reference Lab,
analyzed by internationally accredited DPP for verification of information
lab/ GLP certified lab. along with proof specified in application.
of accreditation.
4 100% break up / composition and Approval and issuance of Import
specifications of technical grade Permission (Certificate of
material provided by the manufacturer, Registration)
in accordance with composition and
specifications registered with
registration authority in the country of
origin.
5 Toxicological, MRL data & PHI period
from international accredited lab /GLP
certified lab. along with proof of
accreditation.
6 Original Copy of paid challan for Rs.
40,000/- as registration fee.
7 Original Copy of paid challan for Rs.
10,000/- as analysis fee of formulated
product.
8 Original Copy of paid challan for Rs.
10,000/- as analysis fee of technical
grade material.
9 Proof of manufacturing having valid
registration certificate of the formulated
product in the country of manufacture.
10 Valid registration certificate of the
technical grade material of pesticide in
the country of manufacture.
11 Sealed sample should be submitted in
the FPT&RL directly from the
manufacturer along with proof of
shipping documents.
12 Draft label of the product bearing all
information required under rule 14 /
SRO 21(1)/2004.
13 Certificate of storage facilities on
judicial stamp paper with solid
documentary proof e.g., ownership
deed, rental agreement.
14 Undertaking on judicial stamp paper
according to Rule 9A(c).
15 Copy of valid distribution certificate or
contractual agreement with the
registered distributor.
16 Copy of NTN certificate.
17 Copy of registration of firm /
partnership deed / Article of
Association.

9
18 A copy of registration of formulation
plant / valid registered contractual
agreement signed by executives of both
the firms with name and designation.
19 All the documents with Serial No. 2-5,
9, 10 duly verified by CCPIT China or
Pakistan Embassy in the country of
origin.

10
Activity-3 (ANNEXURE-
FLOW CHART III)
Procedure for Import Permission (Registration) for Import of Branded Pesticides under Form-17

Submission of Application

Legal and Technical Evaluation of application & documents Incomplete Application

Timeline: Within 60 days

Approval and Issuance of Certification of Registration

Timeline:
Within 60 days

11
PROCEDURE FOR IMPORT PERMISSION FOR IMPORT OF BRANDED PESTICIDES UNDER FORM-17

Sr. NATURE OF STEPS OF OFFICIAL


DOCUMENTS REQUIRED TIMELINE REMARKS
No. CERTIFICATE PROCEDURE
1 Import Application on Form-17 duly filled and Submission of Application. o Incomplete applications
Permission signed by Applicant. (Appendix-A) are liable to be returned
Certificate of with re-submission after
branded supply of complete
Pesticides under documents and
Form-17 information.
2 Letter of authorization (LOA) of Legal and technical evaluation of
60 days o Certificate of
Manufacturer (in original) with name & Application and documents.
designation of signing person, seal & Registration is required
signature, telephone, fax & email under Section 4 of
address. Agricultural Pesticides
3 Documentary proof of formulated Approval and issuance of Import Ordinance 1971 read
product under trade name registration Permission Certificate with under Section 4 of
in the country of manufacturer. APO 1971 read with
4 Registration of technical grade material Rule 9 A (5) (j) of APR
in the country of manufacturer. 1973 for import of
5 Documentary proof of use of pesticides branded pesticides under
in OECD countries, China or India. Form-17.
6 Documentary proof of extensive use
against pests of crop in the country of
origin, OECD countries, China or India.
7 100% break up / recipe and
specifications of formulated product
provided by the manufacturer, in
accordance with composition and
specifications registered with
registration authority in its country and
analyzed by internationally accredited
lab. along with proof of accreditation.
8 100% break up / composition and
specification of technical grade material
provided by the manufacturer, in
accordance with composition and
specifications registered with
registration authority in the country of
origin.
9 Toxicological study data by
international accredited/ GLP lab. along
with proof of accreditation.
10 MRL data & PHI period by
international accredited/ GLP lab. along
with proof of accreditation.
11 Original Copy of paid challan for
Rs.40,000/- as registration fee.
12 Draft label of the product
13 Certificate of storage facilities on
judicial stamp paper with solid
documentary proof e.g. ownership
deed, rental agreement.
14 Undertaking on judicial stamp paper
according to Rule 9A(c).
15 Copy of valid distribution certificate or
contractual agreement with the
registered distributor.
16 Copy of NTN certificate.
17 Copy of registration of firm /
partnership deed / Article of
Association.
18 A copy of registration of formulation
plant / valid registered contractual
agreement signed by executives of both
the firms with name and designation.

13
19 Proof of registration of trade name from
Trade Mark Registry in the country of
origin.
20 All the documents with Serial No.2-10
and 20 duly verified by CCPIT China
or from Pakistan Embassy from the
country of origin.

14
Activity-4 (ANNEXURE-
FLOW CHART IV)
Procedure for Registration of Manufacturing, Formulation, Repacking Plants of Pesticides

Submission of Application

Timeline: Within 10 days Legal and Technical Evaluation of application & documents Incomplete Application

Timeline: Within 15 days Testing of Plants by Committee

Timeline: Within 15 days Approval and Issuance of Certification of Registration

Timeline:
Within 40 days

15
PROCEDURES FOR CERTIFICATION OF MANUFACTURING / FORMULATION/ RE-FILLING PLANTS OF REGISTERED PESTICIDES
Sr. NATURE OF STEPS OF OFFICIAL
DOCUMENTS REQUIRED TIMELINE REMARKS
No. CERTIFICATE PROCEDURE
1 Certificate for Application duly filled in by the executive of the Submission of Application Incomplete applications are
registration of firm with name and designation on Form-18. liable to be returned with re-
Pesticides submission after supply of
Manufacturing, complete documents and
Formulation, information.
Refilling plants.
2 List of major processing equipment. Legal and technical 10 days
evaluation of application.
3 List of technically qualified staff. Inspection by the inspection 15 days
committee.
4 List of semi-skilled/non-technical staff. Approval and issuance of 15 days
Registration certificate
5 Agreement on company letter head with hospital
or doctor along with employee’s health record.
6 In-house incinerator or agreement with approved
incinerator facility (Detail of obsolete pesticides
incinerated).
7 Laboratory detail/ agreement with well-
established lab.
8 List of Laboratory staff and List of Lab.
Equipment.
9 Detail of samples analyzed.
10 Detail of warehouse and storage facilities
11 Fee challan of RS. 500000/= in case of fresh
application and of RS. 100000/= in renewal case
after 5 years.

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