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Consultation for product registration

Are you seeking to increase the value of your product?

Before you introduce your product in the market, it is mandatory to register your product for sale and distribution within the nation. Product registration confirms the product’s quality, safety, and adherence to Saudi regulatory requirements. This process may seem complicated, but don’t let this be a hindrance to your business. Getting a consultation can make the process easier. A product must be submitted to the appropriate government authorities for approval along with comprehensive product information, testing results, and other essential documents.

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The procedure for product registration in Saudi Arabia involves several steps:

Online Application Filing: 

  • Fill the appropriate application form in the SDR system.
  • Payment via SADAD is necessary for form submission.
  • A reference number is assigned upon submission.

Acceptance of Drug Application:

  • Check application for completeness.
  • Two cases: Without Deficiencies (acknowledgment and further processing) or With Deficiencies (notification of deficiencies and a 90-day window to complete).

Phase II Validation:

  • Validate application materials for suitable quality.
  • Two cases: submission of requested information within 90 days (further processing) or incomplete information (possible extension of 30 days).

Assessment of Application:

  • Assess applications for quality, safety, and efficacy.
  • Address issues through electronic Inquiry Forms, with a response required within 90 days.

Pricing:

  • Calculate pricing according to guidelines.

Testing:

  • Conduct appropriate testing based on application and dosage form.

Inspection:

  • Schedule inspection if needed, and issue an inspection report.

Stop-Clock:

  • The clock starts with an Inquiry Form and ends upon receiving a complete and acceptable response from the applicant.

Decision Process:

  • Approval, More information needed, or Rejection based on application assessment.

Appeal Process:

  • Applicants have a 60-day window to appeal SFDA decisions.
  • For more detailed information, refer to the original document.

Why is product registration essential in Saudi Arabia?

Product registration is crucial in Saudi Arabia to ensure compliance with local laws and regulations, guaranteeing product safety, quality, and efficacy. It facilitates traceability, consumer protection, and efficient market control. Failure to register a product can result in legal penalties and market exclusion, making registration a vital step for businesses entering the Saudi Arabian market.

How long does it take to register a product in Saudi Arabia?

The time duration for product registration in Saudi Arabia varies depending on the product type and the registration process. Whether it is Pharmaceutical products, medical devices, or importers, each product type has a different processing period. Contacting an expert advisor for in-depth information would be better, depending on your requirements.

Why Helpline Group?

Helpline Group is here to streamline and assist you with the product registration process in Saudi Arabia. With 25 years of Global experience in this field, we are known for our fast and accurate consulting services. We understand the importance of a smooth registration process to ensure compliance with local regulations and successful market entry. If you have any inquiries or need assistance regarding product registration in Saudi Arabia. Contact us!