ARTICLES & UPDATES

Foreign pharmaceutical companies looking to distribute their products in Kuwait must either set up a legal entity in the country or appoint a local agent in accordance with local laws. Most companies opt for the latter, leveraging the local agent’s established market presence and
connections to enhance their product’s success. However, this route involves several regulatory considerations that must be addressed before entering the market. Our article explains the regulatory considerations that foreign pharmaceutical companies must navigate when entering the Kuwaiti market.

Registration of Pharmaceutical Products

Under Kuwaiti law, the registration of pharmaceutical products with the Ministry of Health is mandatory. The registration process and approval are handled by the Department of Pharmaceutical and Herbal Medicines Registration and Control Administration department.
Distribution Agreement and Local Agent If a foreign pharmaceutical company decides to engage a local agent through a distribution
agreement, it must ensure compliance with Law No. 13 of 2016 (Agency Laws). According to this law, the local agent is obligated to register the agency agreement with the MOCI. The Agency Law defines a commercial agency as any agreement in which one party, holding the legal right, authorizes a merchant or company within the State to sell, promote, distribute goods or products, or provide services as an agent, distributor, franchisee, or licensee of the original supplier, in exchange for profit or commission. The application must include the following details:

1. Name of the agent or distributor and name of the principal and its nationality;
2. The goods, products, or services covered by the contract;
3. The rights and obligations of each of the principal and agent or distributor, and the extent
of the principal’s liability for the agent’s obligations in the field of its representation;
4. The agent or distributor’s working territory;
5. Duration of the agency and its renewal method;
6. Method of termination and expiry of the agency; and
7. Any other conditions agreed upon between the principal and agent or distributor.

It’s important to note that if the agency agreement is not registered at the MOCI, then the Kuwaiti courts will not hear any disputes arising from the agency relationship.

Registration of Pharmaceutical Products

In January 2020, Kuwait’s Ministry of Health (MOH) issued Ministerial Decree No. 361 of 2019 regarding the registration of pharmaceuticals. The decree supplements the pharmacy laws and updates the various MOH decrees regarding the registration of pharmaceutical products. For the registration of pharmaceutical product(s), the following requirements shall be fulfilled:

I. Local Agent Requirements

If the local agent is a new local pharmaceutical company, the following must be submitted:

a. Copy of a valid license Ministry of Commerce in which the company activity includes the sale of medicines.
b. Copy of valid license issued from Drug Inspection Administration.
c. Copy of valid store license issued from Drug Inspection Administration.
d. Copy of authorized personal signatures legalized by the Kuwait Chamber of Commerce and Industry.
e. Any other documents set by the administration.
II. Marketing Authorization Holder (MAH) Registration (including manufacturing
company/companies)
a. Legalized and original letter of appointment from MAH stating that the Local Agent is the sole and/or exclusive agent in the State of Kuwait.
b. Original Legalized Manufacturing License from the country of origin for each manufacturing site issued by the Health Authority in the country of origin.
c. Original legalized “Good Manufacturing Practice” (GMP) certificate from the Health Authority in the country of origin.
d. Master File: This includes details of the local agent and the manufacturer, such as general information and the company's history, premises, equipment, manufacturing sites, quality control, and any recognized global approvals like FDA, EMEA, or GCC.

III. Pharmaceutical Product Registration

Pharmaceutical product registration file must be submitted in Common Technical Document structure as per the GCC guidelines:

A. Module 1: This module includes the regional required information specific to Kuwait Pharmaceutical & Herbal Medicines Registration and Control Administration, such as administrative information and certificates.
B. Module 2: This module is concerned with the common technical document summaries and shall reflect the summary of the information provided in modules 3, 4, and 5.
C. Module 3: Quality
D. Module 4: Non-Clinical Study Reports
E. Module 5: Clinical Study Reports
(You will find the link to the modules in the footnote of our article)

Once the application is submitted by the local agent of the foreign company, reviewed, and approved by the Ministry of Health (MOH), the certificate of registration of the pharmaceutical product is granted for a period of 5 years and must be renewed 6 months before the expiration of the registration.

Transfer of Agency

In case the foreign company is desirous to transfer its agency to any other local company in Kuwait, the following documents shall be submitted to the authority:

1. Legalized original letter of appointment for the new local agent issued by marketing authorization holder.
2. Termination letter of the previous local agent mentioning the date of termination issued from MAH.
3. List of products that are affected by the transfer, including product name, concentration, dosage form, and manufacturing company.

Other Considerations for Foreign Companies:

Foreign pharmaceutical companies often prefer an agency agreement for distributing their products in Kuwait. However, they must ensure that the local agent/distributor holds the necessary licenses to import and distribute pharmaceuticals. The foreign principal should request these licenses from the local agent to confirm their capacity to enter into the agreement. The MOH requires that the foreign principal shall grant the local agent exclusivity in distributing its products. The reason behind this is to ensure compliance with drug safety requirements, in order to be able to hold the agent accountable for maintenance of information at the MOH, to handle product recalls, pharmacovigilance, etc.

Proper drafting of the agency agreement is crucial to mitigate these protections. Although Kuwaiti law provides that Kuwaiti courts will have jurisdiction over disputes arising from the agency agreement, arbitration can be agreed upon for dispute resolution. Parties can also choose a foreign law to govern the contract, provided it does not violate public order or morality in Kuwait.

Modules Link:

https://drive.google.com/file/d/103TEgE08BVhwEDR9NqrKHjzavREFV8g7/view?usp=drive_link

How Abdulrazzaq Abdullah & Partners Law Firm Can help?

At Abdul Razzaq Abdullah and Partners Law Firm, we bring extensive experience in serving both local and international clients in the healthcare sector. Our dedicated team specializes in providing tailored legal expertise to meet unique needs. Whether you require support with contract drafting, regulatory compliance, agency agreements, applications, or dispute resolution, we are dedicated to delivering solutions aligned with your business objectives.