1 Tebogo Banda Department of Agriculture, Forestry and Fisheries AFMA workshop for registration and renewals 16 August 2011 REGISTRATION PROCESS

2 CONTENT Regulatory mandate Types of applications Administration process –New applications –Amendments of registrations –Reinstatement of registration –Advertisements –Import permit Administration process –Free Sale certificate –Renewal registrations –Cancellation of registration Appeals Complaints Contact details Banking details Additional information

3 REGULATORY MANDATE DAFF Act No. 36 of 1947 Fertilizers Animal Feeds Raw Materials Additives Supplements Complementary Complete feed Agricultural Remedies Stock Remedies

4 TYPES OF APPLICATIONS Registration of new products Amendment of registered products –Label amendment –Change of registration holder or company name –Product name change –Change of product composition or guaranteed analysis –Product line extension –Additional manufacturer –Administrative amendment Advertisement Renewal of registrations Cancellation of registrations Import permit Free Sale Certificate

5 Applicant Technical Advisor : Technical Evaluation Receipt and acknowledgement of application Payment Verification Screening and capturing of info into register Registrar: Signature Allocate Reg. Number and Prepare registration documents Verification by Admin Supervisor Registration Process

6 NEW PRODUCTS …1 Application must be –Made by person residing in South Africa or has a registered office in South Africa –Made by an authorised person on behalf of applicant Application must be accompanied by –A covering letter –Application form appropriate for the product in duplicate –Proof of payment –Certificate of analysis –Product label –Proof that the formulator is registered as an animal scientist –Two samples of 100g or 100 ml each (when required by Registrar)

7 NEW PRODUCTS …2 –For additives Description of production method Manufacturing and intended use Method of analysis of additive Method of analysis to determine residues or metabolites –Animal feed manufactured in facilities that are being used for the first time Inspection report of the facility Facility accreditation (facilities outside the Republic of South Africa) –Manufacturing facility that has changed ownership Inspection report Registration is valid for three (3) years Process takes up to four (4) months

8 REGISTRATION AMENDMENTS Application to amend may be made by registration holder or authorised person, during registration period Application must be accompanied by –Proof of payment –Documents related to the amendment If significant technical changes are made, application shall be treated as new. A written request must be made to retain old registration number If registration holder changes due to changes in company ownership –Inform Registrar by affidavit on or before change –Products will be given a new registration number –New registration holder must submit labels with new contact details within two (2) months Registrar may waive payment if amendment –Was effected in the insistence of Registrar –Is in the public interest Process takes up to two (2) months.

9 RE-INSTATEMENT OF REGISTRATION Application must be –Made by the former registration holder or authorised person Application must be accompanied by –A covering letter –Application form appropriate for the product in duplicate –Proof of payment –Certificate of analysis –Product label –Two samples of 100g or 100 ml each (when required by Registrar) Process takes up to three (3) months

10 ADVERTISEMENTS Application must be –Made by the registration holder or authorised person Application must be accompanied by –A covering letter –A copy of the advertisement script –Proof of payment –Application must be accompanied by The approval is valid for one year Process takes up to one (1) month

11 Registration Holder Renewal notice sent to reg. holder Verify reg. status and capture info into register Receipt and acknowledgement of application Approval by Admin Supervisor Payment Verification Prepare renewal certificate and documents Renewal Process

12 REGISTRATION RENEWAL Application must be made by registration holder Apply not later than 31 March of the year registration lapses Application must be accompanied by –Form AForm A –Form CForm C –Proof of payment –Two copies of labels (when required by Registrar) –Certificate of analysis (when required by Registrar) Applications received 30 days after expiry date are not considered Process takes up to four (4) months.

13 CANCELLATION OF REGISTRATION Registrations cancelled by registration holder during the period of registration Application shall be accompanied by: – a covering letter stating reasons for cancellation – a completed Form BForm B – a completed Form C – the current original registration certificate Process takes up to four (4) months.

14 IMPORT PERMIT Import permits are issued for products –Trials purposes, –Own use –Commercial purposes (registration in progress) Application for an import permit shall be accompanied by: –a covering letter stating reasons for the importation, type of product, quantities of the product(s), the origin of the products and port of entry –label of the product –product specification sheet –certificate of analysis –proof of payment Permit is valid for one (1) consignment per product Process takes up to one (1) week.

15 FREE SALE CERTIFICATE Free Sale Certificate is issued to a registration holder who intends to export a registered product to other countries for sale. Application shall be accompanied by: –a covering letter stating the company name product name product registration number –proof of payment The certificate is valid for a single use The process takes up to one (1) week

16 APPEALS …1 Appeals can be made against refusal of, determination of conditions or cancellation of registration by the Registrar Submit appeals to the Minister within 60 days If appellant is represented by a third party, power of attorney is required The appeal must be –in the form of a sworn or affirmed written statement reference number date of the notification by which the person or applicant has been informed of that decision indicate the grounds for appeal –Also be accompanied by documents relating to the subject of the appeal an applicable fee

17 APPEALS Appeals should be submitted to: Physical address The Minister Department of Agriculture, Forestry and Fisheries, Agriculture Building 20 Beatrix Street Arcadia Pretoria Postal address The Minister Department of Agriculture, Forestry and Fisheries Private Bag X 250 Pretoria 0001

18 COMPLAINTS Complaints about registration delays should be brought after the stipulated processing period. Complaints can be directed to Mr Lindinkosi Lembethe 012 – If not satisfied with outcome, can be escalated to Registrar: Mr Jonathan Mudzunga 012 –

19 COMMON MISTAKES Incomplete documents Commissioner of oath did not sign Label not submitted Certificate of analysis not submitted No Free Sale Certificate

20 CONTACT DETAILS PHYSICAL ADDRESS The Registrar: Act 36 of 1947 Department of Agriculture, Forestry and Fisheries Agriculture Building Beatrix Street 20 Pretoria Animal Feeds Office No. LB-FF-09 or LB-FF-10 ATT: Sana Magolela or Patrick Modika POSTAL ADDRESS The Registrar: Act 36 of 1947 Department of Agriculture, Forestry and Fisheries Private Bag X 343 Pretoria 0001

21 BANKING DETAILS All fee shall be paid in favour of the Director-General Department of Agriculture, Forestry and Fisheries : Account name:NDA-Act 36 of 1947 Account number: Reference:11F4 and Name of Company/Name of applicant Branch code: Branch name:Arcadia Bank name:Standard Bank

22 ANIMAL FEEDS PERSONNEL NameTelephone number address ADMINISTRATION Mr Lindinkosi Lembethe012 – 319 Mr Patrick Modika012 – 319 Ms Sana Magolela 012 – 319 Mr Clement Zulu012 – 319 Mr David Kabini012 – 319 TECHNICAL Mr Siyabonga Mbambo012 – 319 Ms Tebogo Banda012 – 319 Facsimile: 012 –

23 ADDITIONAL INFORMATION STOCK REMEDIES PERSONNEL NameTelephone number address ADMINISTRATION Ms Khabonina Chauke012 – 319 Ms Tsakane Nukeri012 – 319 Ms Happiness Nhlumayo 012 – 319 TECHNICAL Dr Ernest Mokantla012 – 319 Facsimile: 012 –

24 Thank You