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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)
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