Kuwait Drug Product Registration

Pharmaceutical /Medicine/Drug/OTC Registration for Kuwait

Territory

Middle East

Official Language

Arabic

Regulatory Authority Name

Ministry of Health Kuwait

Regulatory Authority Website

https://www.moh.gov.kw/en/Pages/default.aspx

Mail ID

kdfc@moh.gov.kw

Local Authorised

Yes

Classification of Medical Device

New Drug, Generic Drug, Biologic, Biosimilar.

Introduction

According to the Pharmacy Law in Kuwait, a pharmaceutical product can only enter the local market if it is registered by the Pharmaceutical and Herbal Medicines Registration and Control Administration. Each pharmaceutical product must be represented by a local pharmaceutical company, referred to as the Local Agent.

This Local Agent is responsible for providing the necessary documents for the registration of the pharmaceutical product and its manufacturing company, adhering to the Common Technical Document (CTD) structure as outlined in the ministerial decree.

Import Requirements

Foreign pharmaceutical products require both a local licensed agent and MOH registration.

Local Agent Responsibility

Appointed local agent handles product/manufacturer registration and import approvals.
MAHs must provide a legalized letter of appointment for the exclusive agent.
Transferring registrations to a new agent is possible.

Biological & Biosimilar Registration

Allowed with specified GHC requirements and registration in reference authorities (EMA/FDA).

Common Technical Document

CTD format remains mandatory for registration files.

Registration Validity and Renewal

Certificates valid for 5 years.
Renewals filed 6 months before expiry.

Additional Requirements

Registration for locally manufactured products.
MAH registration with MOH.
Bi-lingual (Arabic/English) product labelling.

Information Required

Reference standard with CoA.
Finished product sample.
Patient information leaflet (English and Arabic).
Source of supply of API and inactive ingredients.
Raw material specifications.
Finished products’ specifications with quality control methods.
Stability data
Long term three batches (two pilot and one production).
Accelerated studies: six months, same three batches, used for Longterm studies.
Bioequivalence study data.

Certificates

WHO-CoPP.
Certificate of suitability for TSE free product.
Legalized price list.
Certificate of alcohol content.
Composition certificate.
List of countries where product has been registered.

For the Registration of Pharmaceutical Products, the fulfilment of the following requirements is necessary:

Local Agent Requirements

If the Local Agent is a new local pharmaceutical company, the following documents must be submitted:
Copy of a valid License from the Ministry of Commerce, indicating the company’s activity includes the sale of medicines.
Copy of a valid license issued by the Drug Inspection Administration.
Copy of a valid Store License issued by the Drug Inspection Administration.
Copy of authorized personal signatures legalized by the Kuwait Chamber of Commerce and Industry.
Any other documents specified by the administration in accordance with other Ministerial Decrees (MD’s).

Marketing Authorization Holder (MAR) Registration (including manufacturing company/companies)

Legalized and original letter of appointment from the Marketing Authorization Holder (MAH) stating that the Local Agent is the sole and/or exclusive agent in the State of Kuwait.
Original legalized Manufacturing License from the country of origin for each manufacturing site, issued by the Health Authority in the country of origin.
Original legalized “Good Manufacturing Practice” (GMP) certificate from the Health Authority in the country of origin.
Site Master File containing the following:
General information and history of the company.
Capital and turnover for the past three years.
Layout and diagrams of manufacturing sites.
Quality control unit and quality management.
Personnel information, including the number of employees in each department and their qualifications.
Premises and equipment, including manufacturing sites owned by the company, manufacturing lines, and manufacturing machines.
List of products manufactured by the company and exporting countries.
Distribution problems, complaints, product defects, and recalls from any authorities worldwide.
Contract manufacturing information.
Pharmacovigilance Master File.
Recognized global approvals for the company, such as USFDA, EMA, MHRA, GCC.
The Pharmaceutical and Herbal Medicines Registration and Control Administration may request a GMP inspection visit for any manufacturing site.

Pharmaceutical product registration file must be submitted in CTD structure as per GCC guidelines:

Module 1

Regional Administrative Information; This module includes the regional required information specific to Kuwait Pharmaceutical &Herbal Medicines Registration and Control Administration, such as administrative information and certificates.

Module 2

Common Technical Document Summaries; Must reflect the information provided in modules 3, 4 and 5.

Module 3

Quality

Module 4

Non-Clinical Study Reports

Module 5

Clinical Study Reports

Variations are classified into two main categories

Minor Variations

Type IA:
- Can be implemented without prior approval (“Do and Tell”).
- Type IAIN: Immediate notification within 14 days of implementation.
- Other Type IA: Can be compiled and submitted annually by January 31st.
Type IB:
- Must be submitted before implementation (“Tell, Wait and Do”).
- 60-day waiting period for SFDA review before implementation.

Major Variations (Type II)

Have significant potential impact on quality, safety, or efficacy.
Require formal approval from SFDA before implementation.

Renewal Of Marketing Authorization

An applicant shall submit a renewal request every five years. It is possible to request for renewal within six months of the certificate expiry. Most of the registered drugs have gone through at least one renewal process or have been registered through the SDR system