Ministry of Health’s Drug and Food Control Administration
Link for RA:
Resolution number 97/200
Who can register :
Data to be communicated :
- Original letter of appointment from the manufacturer or distributor for the sole agency of products legalized by the Arab Chamber of Commerce and Kuwait Embassy in the country of origin.
- Free Sale Certificate (F.S.C)
- A copy of the manufacturing license and GMP certificate or ISO certificate legalized by the Health authorities or the Chamber of Commerce & Industry and the Kuwait Embassy in the country of origin
- Compositions of the products in full detail with the exact percentages of the ingredients on the manufacturer’s letterhead signed and stamped by the manufacturer.
- A certificate legalized by the health authorities in the country of origin stating that the products are free from Bovine Spongiform Encephalopathy (BSE) for any biological addictive from animal
- A safety certificate from the manufacturer mentioning that the products do not contain any cortisone, hormone or harmful substances and the products are safe for human use under normal conditions of use
- All the products must have the batch nos., dates of manufacture & expiry in every consignment.
- The product packages should carry the information in English or in Arabic, including the manufacturer’s name and the country of origin
- All the above documents must be submitted along with samples containing complete information for study and registration to the department along with a covering letter from the agent in Kuwait on their letterhead
- The invoices submitted for release should be in legible vocabulary, clear print and in English or Arabic languages or require the accurate translation of the items if the invoice is in any other language along with the packing list.
- List of countries where the products are marketed with dates.
- The invoice submitted for release must contain the following information:-
- Name and address of the agent in Kuwait, including the warehouse’s address.
- Name and address of the manufacturer and the country of origin.
Timeframe and fees:
- In the official language of the member state, products must be labelled with appropriate, clearly stated, and easily understandable warnings about the hazards they may pose (Arabic).
- The manufacturer’s name and contact information and the product reference must be included in the product or package.
- Alternatively, batch information – if available – might be displayed.
- It is necessary to display the nation of origin. The Kuwaiti Ministry of Commerce and Industry (MOCI) issued Decision No.59/2009 prohibiting the use of 1,4-Dioxane as an ingredient in make-up, cosmetics, and shampoo products.