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

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

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

NEW APPLICATION – CONT… Example of Application form

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

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

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  

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

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 ).

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)

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

QUESTIONS

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

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.

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

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.

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

  2.3 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

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) 319-7353 MalutaM@daff.gov.za ADMINISTRATION ISSUES Mr. David Motloi Deputy Director ( Administration Section) Tel : (012) 319-6889 DavidM@daff.gov.za

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

CONTACT DETIALS FOR STOCK REMEDY UNIT Mr Jonathan Mudzunga Registrar/Director Tel: (012) 319-7353 MalutaM@daff.gov.za Mr. David Motloi Deputy Director ( Administration Section) Tel : (012) 319-6889 DavidM@daff.gov.za . Dr Ernest Mokantla Technical Advisor (Stock Remedy) Tel: (012) 319-7271 ErnestM@daff.gov.za Ms. Khabonina Chauke Senior Administration Officer (Supervisor for Stock Remedy Unit) KhaboninaC@daff.gov.za Mr. Musawenkosi Ximba Senior Administration Clerk Tel: (012) 319-7364 MusawenkosiX@daff.gov.za

END THANK YOU