Version 1.0

Date of publication 25 October 2018

Date of implementation 9 June 2019

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Version 1.0

Saudi Food & Drug Authority

Drug Sector

For Inquiries SDR.Drug@sfda.gov.sa

For Comments Drug.Comments@sfda.gov.sa

Please visit SFDA’s website at

http://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx

for the latest update

mailto:Drug.Comments@sfda.gov.sahttp://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx

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Saudi Food and Drug Authority

Vision and Mission

Vision

To be a leading international science-based regulator to protect and promote

public health

Mission

Protecting the community through regulations and effective controls to

ensure the safety of food, drugs, medical devices, cosmetics, pesticides and

feed

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Document Control

Version Author Date Comments

- Executive Directorate of

Regulatory Affairs 25 October 2018

Draft

1.0 Executive Directorate of

Regulatory Affairs 21 May 2019

Final

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INTRODUCTION:

Saudi Food and Drug Authority seeks to implement procedures that promote the

availability of the important pharmaceutical products in Saudi Arabia, one of these

“marketing exclusivity” which is granted for a maximum two companies per product

for specific period.

CRITERIA FOR GRANTNG MARKETING EXCLUSIVITY:

1. Essential products (published list that based on WHO recommendations).

2. Non-registered product or product with no alternative.

3. The product with high demand in the market (i.e. shortage reports and import

license).

PERIOD OF MARKETING EXCLUSIVITY:

1. New pharmaceutical products: five years from the date of certificate of

pharmaceutical product (CPP)

2. Registered products: five years from the date of the marketing exclusivity

approval letter.

SUBMISSION PROCEDURE:

1. The company shall submit a request letter for a marketing exclusivity to the Drug

Sector with filling the application form (attached).

2. SFDA will review the request within 15 working days and in case of initial

approval, the company will be given three months to submit the product’s

registration file (for new products). Otherwise, the approval is considered

cancelled.

3. The company has the right to apply for “the pricing estimation before registration”

after getting the approval.

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IMPLEMENTATION PROCEDURE:

1. SFDA publish the list of the pharmaceutical products that are eligible for marketing

exclusivity:

(Link: https://www.sfda.gov.sa/en/drug/Documents/MarketingExclusivityList.pdf)

2. The company is obligated to place the product in the market within three months

from the notifying date of the decision of the registration committee. SFDA may

extend the deadline for only a similar period if the justifications are accepted.

3. The company can appeal against price after receiving the CPP, and the applicant

objection should not breach the company commitment of the product availability.

4. The marketing exclusivity is granted for a maximum of two companies, for five

years period.

5. For each product falls under marketing exclusivity: the first marketing exclusivity

will be granted for five years, and second will have the same period. However, the

total period of exclusivity for the two companies will not exceed five years.

6. The list of the pharmaceutical products and the companies granted the marketing

exclusivity will be published on the SFDA website.

7. SFDA has the right to cancel the marketing exclusivity:

If the company does not supply the product for three months within any

time of the five years period.

In case of the of quality defects.

8. SFDA may extend the period of marketing exclusivity within 6 months from end

of marketing exclusivity and the company must supply the product during this

period.

9. The company shall commit to renew the registration (if the CPP expired) and keep

supply it in the market.

10. Marketing Exclusivity is granted for both local and international companies.

https://www.sfda.gov.sa/en/drug/Documents/MarketingExclusivityList.pdf

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Request for Marketing Exclusivity

Trade name

Active ingredient(s)

Dosage form

Strength/unit

Package size

Manufacturer

Marketing authorization holder

Agent (if applicable)

Registration number (for registered

product)