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

2. SECTION C 3. AMENDMENT TO EXISTING REGISTRATIONS 3.1Change of Registration Holder 3.2Change of Product Name 3.3Change/Addition of Manufacturer 3.4Change of Pack Sizes 3.5Change of withdrawal period 3.6 Additional/Change of Shelf – Life 3.7Change/addition of Source of Active Ingredient 3.8Change of formulation 3.9Change of label for ease of use 3.10Additional Claim 3.11Regulatory Contact person 3.12Complaints to Inspections and Anti Corruption Hotline 2

3. 3.1 CHANGE OF REGISRATION HOLDER a) Covering letter in duplicate (one with original signature) b) Proposed labels in triplicate c) In case the approved applications are outdated (New Application forms will be required) d) Affidavit /declaration e) Proof of payment f) Return of original certificate 3

4. 3.2 CHANGE OF PRODUCT NAME a) Covering letter in duplicate (one with original signature) b) Proposed labels (with the new name) c) Affidavit /declaration. a) Proof of payment b) Return of original certificate 4

5. 3.3 CHANGE /ADDITION OF MANUFACTURER a) Covering letter in duplicate (one with original signature) b) Application Form in duplicate c) Proof of payment d) Affidavit (No change in manufacturing procedure) 5

6. 3.4 CHANGE/ADDITIONAL PACK SIZES a) Covering letter in duplicate (one with original signature) b) Application Form in duplicate c) Proof of payment d) Stability data 6

7. 3.5 CHANGE OF WITHDRAWAL PERIOD a) Covering letter in duplicate (one with original signature) b) Application Form in duplicate c) Proof of payment d) Residue Data 7

8. 3.6 CHANGE OF SHELF-LIFE a) Covering letter in duplicate (one with original signature) b) Application Form in duplicate c) Proof of payment d) Stability Data 8

9. 3.7 CHANGE OF SOURCE OF ACTIVE INGREDIENT a) Covering letter in duplicate (one with original signature) b) Application Form in duplicate c) Proof of payment 9

10. 3.8 CHANGE OF FORMULATION a) Covering letter in duplicate (one with original signature) b) Application Form in duplicate c) Data if necessary d) Proof of payment 10

11. 3.9 CHANGE OF LABEL FOR EASE OF USE a) Covering letter in duplicate (one with original signature) b) Label with track changes c) Proof of payment 11

12. 3.10 Additional Claim a)Covering letter in duplicate (one with original signature) b) Application Form in duplicate c) Data e.g new species d) Proof of payment 12

13. 3.11 REGULATORY / CONTACT PERSON  Authorization letter on a bona fide letterhead of the Registration Holder, signed by the chief executive/manager, indicating who the contact persons are, with their ID number(s) 13

14. 3.12 COMPLAINTS AND ANTI CORRUPTION HOTLINE Complaints relating to sell of unregistered products and any other contravention of the Act (i.e. the use of labels and advertisements that have not been approved by the Registrar’s office etc) should be brought to the attention of the following officials: Mr. Gift Moncho (Head of Inspections) 012 – 319 7169 GiftM@daff.gov.za Ms. Iris Mathebula 012 – 319 7174 IrisM@daff.gov.za Anti Corruption Hotline 0800 701 701 14

15. END THANK YOU 15