Transcript Registration Process and Requirements
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REGISTRATION PROCESS
Tebogo Banda Department of Agriculture, Forestry and Fisheries AFMA workshop for registration and renewals 16 August 2011
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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
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REGULATORY MANDATE
DAFF Act No. 36 of 1947 Fertilizers Animal Feeds Agricultural Remedies Stock Remedies Raw Materials Additives Supplements Complementary Complete feed
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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
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Registration Process
Receipt and acknowledgement of application Screening and capturing of info into register Registrar: Signature Payment Verification Technical Advisor : Technical Evaluation Verification by Admin Supervisor Allocate Reg. Number and Prepare registration documents
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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)
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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
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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.
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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
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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
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Renewal Process
Renewal notice sent to reg. holder Receipt and acknowledgement of application Verify reg. status and capture info into register Approval by Admin Supervisor Prepare renewal certificate and documents Payment Verification
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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 A – Form 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.
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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 B – a completed Form C – the current original registration certificate • Process takes up to four (4) months.
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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.
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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
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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
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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
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COMPLAINTS
• Complaints about registration delays should be brought after the stipulated processing period.
• • Complaints can be directed to • Mr Lindinkosi Lembethe • 012 – 319 6863 [email protected]
(preferable) • • If not satisfied with outcome, can be escalated to • Registrar: Mr Jonathan Mudzunga • 012 – 319 6657 [email protected]
(preferable)
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COMMON MISTAKES
• Incomplete documents • Commissioner of oath did not sign • Label not submitted • Certificate of analysis not submitted • No Free Sale Certificate
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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
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BANKING DETAILS
All fee shall be paid in favour of the Director-General Department of Agriculture, Forestry and Fisheries : Account name: Account number: NDA-Act 36 of 1947 011203102 Reference: Branch code: Branch name: Bank name: 11F4 and Name of Company/Name of applicant 010845 Arcadia Standard Bank
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ANIMAL FEEDS PERSONNEL
Name ADMINISTRATION
Mr Lindinkosi Lembethe Mr Patrick Modika Ms Sana Magolela Mr Clement Zulu Mr David Kabini 012 – 319 6863 012 – 319 6720 012 – 319 6544 012 – 319 7252 012 – 319 7071
TECHNICAL
Mr Siyabonga Mbambo Ms Tebogo Banda
Telephone number Email address
012 – 319 6728 012 – 319 6837 [email protected]
Facsimile: 012 – 319 7179
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ADDITIONAL INFORMATION STOCK REMEDIES PERSONNEL
Name ADMINISTRATION
Ms Khabonina Chauke Ms Tsakane Nukeri Ms Happiness Nhlumayo
TECHNICAL
Dr Ernest Mokantla
Telephone number Email address
012 – 319 7353 012 – 319 7898 012 – 319 6964 012 – 319 7271 [email protected]
Facsimile: 012 – 319 7179
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