1. ADMINISTRACTIVE REQUIREMENTS FOR REGISTRATION OF STOCK REMEDY
MS KHABONINA CHAUKE
3 SEPTEMBER 2013

2. SECTION A 1-FULL APPLICATIONS
1.1 NEW APPLICATIONS 1.2 PARALLEL REGISTRATION 1.3 DAUGHTER REGISTRATION 1.4 RENEWALS 1.5 REINSTATEMENT OF LAPSED APPLICATIONS

3. 1.1 NEW APPLICATION
1.1.1 New Molecules :- new substance that is not yet registered within the country.
1.1.2 Generic :-contain substance that is already registered in the country.
(a) Covering letter in duplicate (one must have original signature)
Application forms in triplicate-(complete all the sections and one
must have original signature)-typed not hand written
( c) Proof of payment and reference number
(d) Proposed labels in triplicate (it must clear and legible)
(e) One copy of dossier
(f) Properly bound and easy to work through
(g) Separate volumes

4. NEW APPLICATION – CONT…
Example of Application form

5. REQUIREMENTS – CONT…
The example of the dossiers file (outside cover). APPLICATION FOR REGISTRATION OF KHABONINA SHEEP AND DRECH Volume 1 of 5 Residue data Name of the company: Magalisburg Pty Ltd Private Bag X 234 Johannesburg 2000

6. REQUIREMENTS – CONT… h) Clearly marked (i) No electronic submission
(J) Proof of payment
Dossiers / Files
Quality (pharmaceutical)
Safety
Efficacy
Residues

7. 1.2 PARALLEL REGISTRATION
Trade Name
Registration number
Covering letter
Application form in triplicate and Labels
Affidavit /declaration (signed by Commissioner of Oath)
Proof of payment and reference number allocated
NOTES: No amendment allowed before mother amended
Does not give birth
It is transferable

8. 1.3 DAUGHTER REGISTRATION
Trade name
Registration number
Registration Holder
Covering letter in triplicate (one must have original signature)
Application form in triplicate and label
Agreement form for daughter registration (valid for three years)
Affidavit /declaration.
Proof of payment and allocation of reference number
Notes : Not transferable
No amendment allowed before mother amended
Does not give birth
When mother lapsed/cancelled the daughter dies

9. 1.4 RENEWALS
Each year the renewals notices are forwarded to applicant three months prior to closing date, that is 30 June every year.
From the 1st July the payment will be company by the penalty fee.
From the 1st August submission will be treated as reinstatement.
During reinstatement no product(s) will be marketed until such approval is granted by the office of the Registrar.
Registration Renewals are renewable every three years (3 ).

10. RENEWALS – CONT… Covering letter in duplicate
Declaration Form in duplicate-(Signed by Commissioner of Oath)
Form A in duplicate-(has number of products)-issued by the office
Form C –(Company details)-issued by the office
Form B-(Cancellation of the products that are no longer in use by applicant)
During cancellation original certificate must also be submitted)

11. 1.5 REINSTATEMENT OF LAPSED APPLICATIONS
Covering letter in duplicate (one must have original signature)
Application form and label in triplicate
Affidavit/declaration
Proof of payment and allocation of reference number
Notes: No additional/ changes allowed during the submission of reinstatement
Only the Registration Holder is authorized to reinstate lapsed products.
No company shall sell the lapsed/cancelled products to other companies

12. QUESTIONS

13. SECTION B 2. OTHER MINOR APPLICATIONS
2.1 IMPORT PERMIT
2.2 FREE SALE CERTIFICATE
2.3 ADVERTISEMENT
2.4 COMPLAINTS AND APPEALS PROCESS
2.5 TOOLS
2.6 CONTACT DETAILS OF ADMINISTRATORS

14. 2.1 IMPORT PERMIT
Import application shall be done according Section 16 (1).
Covering letter in duplicate (one signed with original signature)
Signed trial protocol
Proof of payment
Notes: The applicant must submit the request prior to importation.

15. IMPORT PERMIT –CONT… Example letter of the import permit
Department of Agriculture, Forestry and Fisheries
Private Bag X 343
Pretoria
0001
Dear Registrar
IMPORTATION OF FERTILIZERS, FARM FEEDS, AGRICULTURAL REMEDIES AND STOCK REMEDIES
1. State the reason for requesting import permit
2. Indicate purpose of importation
NB: Below is the table where you fill the necessary information indicated in the columns
Name of the Product ACTIVE (Concentration) Batch Number Port of entry Manufactuctuer Quantity
Yours faithfully
Your Signature

16. 2.2 FREE SALE CERTIFICATES
Covering letter in duplicate (one with original signature);
Proof of payment
Notes: Only Registered Products can be issued with a Free Sale Certificate.

17. FREE SALE CERTIFICATE-CONT…
TO WHOM IT MAY CONCERN
CERTIFICATE OF FREE SALE
This is to certify that Khabonina Holdings (Pty) Ldt of physical address:
Khabonina Holdings (Pty) Ltd
Republic of South Africa
and of postal address:
P.O. Box 346
SUNNINGHILL, 0639
is the registration holder of the following product:
G………. Name of the Product
and where necessary the formulated product is registered for free sale in South Africa under the existing regulations governing stock remedies.
REGISTRAR: ACT 36 OF 1947
FERTILIZERS, FARM FEEDS, AGRICULTURAL REMEDIES
AND STOCK REMEDIES ACT, 1947 (ACT No. 36 OF 1947)
Example of the Free Sale Certificate

18.   ADVERTISEMENT
Regulations, Section 10 (1) No person shall publish or distribute any false or misleading advertisement relating to a Stock Remedy.
Only Stock Remedy must appear on the advert
Proposed advertisement in triplicate
Covering letter in duplicate (one with original signature)
Proof of payment.
  Notes: Company shall not advertise other Registration Holders products without authorization.
Adverts are renewed each year
Adverts must be approved before publishing

19. 2.4 COMPLAINTS & APPEALS
Act No. 36 of 1949, Section 6(1) A person who feels aggrieved by any decision, within the period and in the manner prescribed and upon payment of the prescribed fees, appeal to the Minister against such decision.
APPEAL
Ms T Joemat-Petterson, MP
Minister of Agriculture , Forestry and Fisheries
Private Bag X118
0001
COMPLAINTS REGARDING TECHNICAL ISSUES
Mr Jonathan Mudzunga
Registrar/Directo
Private Bag 343
PRETORIA, 0001
Tel: (012)
ADMINISTRATION ISSUES
Mr. David Motloi
Deputy Director ( Administration Section)
Tel : (012)

20. TOOLS Act. No 36 of 1947 Regulations of Stock Remedy Application form
Labeling requirements
Tariffs
Contact the office of the Registrar

21. CONTACT DETIALS FOR STOCK REMEDY UNIT
Mr Jonathan Mudzunga Registrar/Director Tel: (012) Mr. David Motloi Deputy Director ( Administration Section) Tel : (012) Dr Ernest Mokantla Technical Advisor (Stock Remedy) Tel: (012) Ms. Khabonina Chauke Senior Administration Officer (Supervisor for Stock Remedy Unit) Mr. Musawenkosi Ximba Senior Administration Clerk Tel: (012)

22. END
THANK YOU