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South Africa - Apply for Registration of Veterinary Medicine

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ProcedureEdit

Apply In-Person:

  1. To Apply for Registration of Veterinary Medicine, the applicant must go to the South African Health Products Regulatory Authority (SAHPRA) office. Contact Link
  2. The application form must be obtained from the authorities at the SAHPRA office, or else it can also be downloaded from the official website linked here. Application Form Link
  3. Make sure that you have all the documents that are mentioned in the “Required Documents” section of this page.
  4. The application form must be filled with all the necessary details, and along with the required documents, it must be submitted to the respective officials in the SAPHRA department.
  5. The veterinary medicine application and the details submitted will be verified on various factors.
  6. After complete verification if all the details and documents submitted are legitimate then the Veterinary Medicine Registration will be approved by the SAHPRA.
  7. The registration certificate for the medicine will be issued to the applicant, and the registered product will be added to the SAHPRA webpage list for the public view.
  8. The complete fee details for the registration application are given in the “Fees” section of this page.
  9. The processing time to get the veterinary medicine registration certificate will be intimated to the applicant after filing the application.



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Required DocumentsEdit

  • Application Form Link
  • Owner Consent Form Link
  • A letter of authorisation signed by the Managing Director/Chief Executive Officer.
  • A copy of Registration Certificate.
  • Copy of the Source of Active Pharmaceutical Ingredient.
  • Stability data and shelf-life of active pharmaceutical ingredient
  • Certificate of Analysis of two batches.
  • Proof of physical and chemical equivalence (more than one manufacturer)
  • Identification and assay of the active raw material, irrespective of the possession of a certificate of analysis from the supplier.
  • Identification of the inactive raw material, irrespective of the possession of a certificate of analysis from the supplier.
  • Any other tests not included in a valid certificate of analysis.
  • Copy of payment receipt.



Office Locations & ContactsEdit

SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
HEAD OFFICE
Physical Address: Building A, Loftus Park,
402 Kirkness Street, Arcadia, Pretoria.
Postal Address: South African Health Products,
Regulatory Authority, Private Bag X828, Pretoria: 0001.
Tel: 012 501 0300
Email: [email protected]

RADIATION CONTROL
2nd Floor Louwville Place Building,
Cnr Kort- and Vrede Streets. Bellville 7535.
Address & Contact Link
Location Link

EligibilityEdit

  • Any citizen/resident in South Africa is eligible to apply for the Registration of Veterinary Medicine application at SAHPRA.



FeesEdit

  • For complete fee details for the registration application, refer to the official website linked here. are given in the link.
  • Fee Link
  • Payment Guideline



ValidityEdit

  • The Veterinary Medicine Registration Certificate is valid forever.



Documents to UseEdit



Sample DocumentsEdit

Please attach sample completed documents that would help other people.



Processing TimeEdit

  • The processing time to get the veterinary medicine registration certificate will be intimated to the applicant after filing the application.



Related VideosEdit

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.



InstructionsEdit

Please provide other instructions related to the certificate/documents.
e.g., The state office holds birth records since January 1908.


Required InformationEdit

APPLICATION FOR REGISTRATION OF A VETERINARY MEDICINE
APPLICATION NUMBER PART 1 A.
(a) PARTICULARS OF APPLICANT / PROSPECTIVE HOLDER OF THE CERTIFICATE OF REGISTRATION (PHCR)

  • Name
  • Business Address
  • Postal Address
  • Telephone No
  • Fax No
  • Email Address
  • Site/Applicant Master File Number
  • Person responsible/ authorised to communicate with Authority
  • Business address
  • Telephone no
  • Fax No
  • Email


PARTICULARS OF THE VETERINARY MEDICINE

  • Proprietary name
  • Pharmacological Classification
  • Dosage form
  • Active pharmaceutical ingredient(s) and strength(s) per dosage unit
  • Indicate with an X in the appropriate block if the application is for a
    • New product with new active
    • New product with existing active
    • Amendment to existing product.
    • Registration no
    • Parallel product
    • Daughter product
    • Multi – source product
    • Veterinary biological
  • Route of administration
  • Pharmacological classification
  • Manufacturer
  • Business address
  • Site Master File reference number
  • Packer
  • Business address
  • Site Master File reference number
  • Final product release control (FPRC)
  • Business address
  • Site Master File reference number
  • Final product release responsibility (FPRR)
  • Business address
  • Site/Applicant Master File number(s)
  • Signature of Responsible Person
  • Name in block letter
  • Date of application
  • Designation
  • Date of current amendment


UPDATE HISTORY (For Variations Only)

  • Letter date of application for variations
  • Summarised details of variations
  • Date of approval by authority
  • Identification
  • Presentation
  • Storage instructions
  • Registration number
  • Name and business address of the holder of the certificate of registration
  • Date of notification of approval of this scientific professional information


Reference Product/Formulation Applied For

  • Name of product
  • Batch no
  • Holder of certificate of registration
  • Country where purchased
  • Assay results
  • Source of Active Pharmaceutical Ingredient


PART 3 - QUALITY CONTROL

  • International Nonproprietary Name (INN) or approved name and chemical nameSHARE CAPITAL – Voting/Non-voting/Other (Specify)
  • Structural formula, empirical formula, molecular mass
  • Solubility
  • Storage requirements
  • Re – test period


PART 3 B - FORMULATION

  • Approved name
  • Quantity per dosage unit
  • Active or inactive
  • Purpose of inactive


FORMULATION OF THE FINAL FILLING LOT FOR VETERINARY BIOLOGICALS

  • Approved name or chemical name of constituent
  • Quantity per unit
  • Purpose
  • Purpose of inactive


FORMULATION OF THE RECONSTITUTING LIQUID FOR THE FINAL FILLING LOT FOR BIOLOGICAL VETERINARY MEDICINES

  • Approved name or chemical name of constituent
  • Quantity
  • Purpose


SPECIFICATIONS AND CONTROL PROCEDURES

Pharmacopoeial ingredients

  • Pharmaceutical Ingredient
  • Specifications and Pharmacopoeial reference
  • Limits
  • Additional Tests (e.g., particle size)


Non-pharmacopoeial ingredients. In – house specifications and control procedures for these ingredients should be included.

  • Pharmaceutical Ingredient
  • Specifications and Pharmacopoeial reference
  • Limits
  • In-House Control procedures


SPECIFICATIONS AND LIMITS FOR PACKAGING MATERIALS

  • Specification
  • Limit
  • Name of Manufacturer/Pack of the final product


SPECIFICATIONS AND LIMITS

in - process control

  • Specification
  • Limits
  • Responsible Laboratory ies)


Final product control

  • Specification
  • Limits
  • Responsible Laboratory (ies)


Stability studies

  • Specification
  • Limits
  • Responsible Laboratory (ies)


Reconstituted/diluted final product

  • Specification
  • Limits
  • Responsible Laboratory (ies)


TABLE OF TESTS TO BE PERFORMED

  • Title of Specification



Need for the DocumentEdit

  • In order to supply veterinary medicine products in the South African market, the product must be registered with the SAHPRA. Only registered products and medicines will be sold in the market for the welfare of animals.



Information which might helpEdit

Enter other information which might help.


Other uses of the Document/CertificateEdit

Please explain what are other uses of obtaining this document/certificate.
E.g., Birth Certificate can be used as proof of identity.


External LinksEdit



OthersEdit

More information which might help people.



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