Wikiprocedure

Rwanda - Registration of a Human Medicinal Product

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ProcedureEdit

Apply In-Person

  1. Visit the bank to pay the registration fee as explained in the “Fee” section below and obtain the payment receipt
  2. Visit the Rwanda Food and Drugs Authority (FDA) office to obtain the application form for registration or download directly via this link: Link and fill it correctly
  3. Write an application letter addressed to the FDA requesting registration of the human medical product
  4. Prepare the required documents for registration as explained in the” Required Documents” section below and attach them in a single file
  5. Visit the Rwanda FDA office, Pharmacovigilance and Food Safety Monitoring unit to submit your complete application to the officer located at the reception
  6. The officer will verify the application and forward it to the responsible authority for assessment and approval
  7. The FDA may deem it necessary to conduct an inspection to verify the information you have provided in your application. In this case you will be called and notified of the inspection date
  8. On the inspection date, the FDA will send an inspection officer to conduct inspection pertaining to your application and submit the findings to the FDA for assessment and decision making. Note that the inspection will be based on-site inspection and causal inspection of the non-clinical studies, clinical trials, bio-studies and production site, for the inspection to confirm the authenticity, precision and integrity of information and data submitted.
  9. The FDA will assess the application and the inspection results and if it meets the required standards, they will approve the application and prepare the certificate of registration
  10. A scanned copy of the certificate will be sent to you through your email address and you will need to go to the FDA office to obtain the original certificate.

NOTE:

  1. All applications and supporting documents shall be in English.
  2. You can also submit your application via email through this address: [email protected]


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Required DocumentsEdit

  • Payment receipt
  • Application letter - med registration dated and signed by company representative
  • Application form - med registration dated and signed by company representative
  • CD-ROM with Common Technical Document (CTD) for registration (2 simple copies)application should be submitted in a virus free CD-ROM or external hard drive; any document in any language other than English must be accompanied by a certified or notarized English translation; document format allowed are: PDF, QOS, QIS, MS-Word; PDF documents should be in OCR (Optical Character Recognition), selectable and searchable
  • Medical product commercial sample (2 original) per type of product
  • Certificate of analysis (laboratory analysis results) (original)


Office Locations & ContactsEdit

RWANDA FOOD AND DRUGS AUTHORITY
KK 15 St, Kigali
Tel: +250 788 890 738
Email: [email protected]
Website:Rwanda food and drugs Authority

EligibilityEdit

  • A company intending to manufacture, import or export a human medicinal product



FeesEdit

  • Registration fee for human medicine RWF 400,000
  • Payment methods: cash, credit cards, check
  • Payment can be made on any of the following bank accounts in RWF or USD:National Bank of Rwanda (RWF):1000047658 - Rwanda FDANational Bank of Rwanda (USD):1000047666 - Rwanda FDABank of Kigali (RWF):00040 06972093 63 - Rwanda Food and Drugs AuthorityBank of Kigali (USD): 00040 06972094 64 - Rwanda Food and Drugs Authority


ValidityEdit

  • A certificate of registration is valid for a period of 5 years from the date of issuance and may thereafter be renewed.



Documents to UseEdit



Sample DocumentsEdit



Processing TimeEdit

  • Within one month



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

  • A separate application must be submitted for each medicinal product with different active ingredients, strengths, and dosage forms, site of manufacture or proprietary names.



Required InformationEdit

  • Names
  • Product details
  • Company details
  • Addresses
  • Declaration
  • Signature
  • Stumps



Need for the DocumentEdit

  • This certificate proves that the human product has been registered with the FDA as required by Rwanda polices



Information which might helpEdit

  • Guidelines on submission of documentation for registration of human medicinal products: Guidelines


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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