Published: Jan 13, 2020

Kuwait’s New Pharmaceutical Registration Guidelines

In January 2020, Kuwait’s Ministry of Health (“MOH”) issued Ministerial Decree No. 361 of 2019 (“Decree”) regarding the registration of pharmaceuticals. The Decree supplements the pharmacy laws and provides an update to the various MOH decrees regarding the registration of pharmaceutical products.

In line with the local laws, a foreign pharmaceutical product may only be imported into the market (i) following appointment of a local agent who is duly authorised and licensed by the Ministry of Commerce and MOH to import and distribute such products in Kuwait, and (ii) registration of the pharmaceutical product with the MOH.

The Decree sets forth the requirements of the local agent, who is responsible for carrying out the pharmaceutical product and foreign manufacturer registration and obtaining the necessary importation approvals. It continues to be a requirement that a foreign marketing authorisation holder (“MAH”) produces a legalised letter of appointment detailing that the appointed local agent is the sole and/or exclusive agent in Kuwait; however, the Decree does still provide a pathway for the MAH to transfer the product registrations to a new local agent.

Registration pathways are provided for biological products and biosimilars, which must satisfy the technical and product class specific provisions set out in the Gulf Health Council (“GHC”) guidelines and must be registered in one of the reference authorities, such as the European Medicines Agency or the US Food and Drug Administration.

Product registration files continue to be required to conform to the common technical document (“CTD”) structure adopted by the GHC. Further, registration certifications are valid for five years from the date of issuance and renewal files must be submitted six months prior to pharmaceutical registration certificate expiry.

The Decree also addresses, among others, the requirements for: registration of locally manufactured pharmaceutical products; registration of marketing authorization holders with the MOH; and bi-lingual (Arabic and English) product labelling.

Al Tamimi’s specialist healthcare lawyers in Kuwait regularly advise on legal and regulatory matters concerning the pharmaceutical and medical device sector in Kuwait. For more details on our offering and how we can assist you, please contact us at healthcare@tamimi.com.

 

Key Contacts:

Lulwa Al Hammad
Associate, Corporate Commercial
l.alhammad@tamimi.com

Christina Sochacki
Senior Associate, Healthcare
c.sochacki@tamimi.com

back Chat with us

Disclaimer: This chat service should not be relied upon as a substitute for professional advice which takes account of your specific circumstances and any changes in the law and practice. No warranty is made as to the accuracy or completeness of the information provided via this service and no liability is accepted by Al Tamimi & Company Limited, its affiliates, partners or employees for any loss arising as a result of reliance upon the information provided.

I Agree   

Kindly accept the disclaimer to proceed to a live chat.

Please choose one of the following options below:

Thank you for your inquiry. We will connect you to one of our agents now.

Thank you. Which service are you looking for?

Thank you for your interest in working with Al Tamimi & Company. Please click here to view our latest job openings.

Please click here leave a message and we will get back to you shortly.

Chat