• Appeal: The right of the company or its agent in the Kingdom to submit an appeal to Drug Sector decisions. The company or its agent is allowed to submit two appeals as follows:

1- First appeal: It shall be within 60 days from the date of informing the company or its agent of the decision. The application shall be studied within 60 days of its completion.

2- Second appeal: it shall be submitted after deciding upon the first appeal, within thirty 30 days as of the date on which the company or its agent is notified of the decision on the first appeal. The appeal will studied within 30 days of its completion and is not allowed to submit requests for reconsideration.

• Reconsideration of the product’s price: It is the right of the company or its agent in the Kingdom to submit a request to reconsider the price of the registered pharmaceutical product 3 years after the last decision based on the price and the request will be evaluated within 90 days of its completion.

• Price-based decision: It is the decision issued by the Authority’s registration committees and it is either to increase, decrease or continue on the approved price

The company or its agent shall submit the justifications supporting the appeal or reconsideration request based on the relevant guidelines for each request as follows: A- Regarding the registration process decisions:

• Attach response file according to the eCTD/CTD/VNeeS requirements.

• Include the issued decision with justifications in the Responses to questions field.

• Fill out the Appeal (on technical decision) Request form (Appendix No. 1).

B- Regarding the price of the pharmaceutical product decision.

• Attach response file according to the eCTD/CTD/VNeeS requirements

• Include the following in the Responses to question filed:

1. Cover Letter.

2. Include the recent decision regarding the product’s price.

3. Updated price certificate and new proposed price.

4. Submit price Appeal/Reconsideration form, (Appendix No. 2 or 3) and certified (signed and stamped) by the agent or scientific office.

5. Include the scientific, economic, or logistical justifications for not accepting the price with other documents that are related in the technical file containing the following:

- Clinical Guideline.

- Comparative studies of the product’s safety and efficacy with registered substitutes.

- Economic studies: the economic impact of the product compared to the registered alternatives.

- The extent of the disease in the Kingdom and the number of patients targeted for treatment with the drug

- Data on the availability of the product during the past five years (for previously registered products). - Product’s market share during the past two years (for previously registered products).

- Pay the financial fee for the appeal or reconsideration study for each registered package.

C- Regarding the decision to not register or cancel a clinical study registration:

• Attach a cover letter and document (certify) it (signed and stamped).

• Include the issued decision with the request justification.

• Fill out the Clinical Trial Rejection/Revoke of Registration Appeal form (Appendix No. 4).

D- Regarding the appeal to the result of the approved inspection visit report:

• Attach a cover letter and certify it (signed and stamped).

• Include the decision with the issued report and the request justifications.

• Fill out the inspection appeal form (Appendix No.5)

The applicant must provide a clarification if one of the requirements is not provided.

• The appeal shall be submitted to the Authority with all technical requirements and its validity (Business Validation) will be verified within 5 days.

• If the requirements are not met during the Business Validation phase, a letter will be sent to the applicant to complete the requirements and deficiencies within the appeal or reconsideration remaining period, or not later than 5 days in the event that the regular period for appeal or reconsideration expires. The application will be rejected if the requirements are unmet within this period.

• If there any inquires or observations during the study phase, the company or its agent must respond within 10 days, otherwise the request is considered rejected.

Annex No. (1)

Annex No. (2)

Annex No. (3)

Annex No. (4)

Annex No. (5)