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 firstname.lastname@example.org.