NIT 2018 IN
Certain Nitisinone Capsules
Notice of Initiation of Investigation

Ottawa, September 21, 2018

The Canada Border Services Agency (CBSA) initiated an investigation, on September 21, 2018, under the Special Import Measures Act respecting the alleged injurious dumping of certain nitisinone capsules from Sweden. The investigation follows a complaint filed by Laboratoires KABS Inc. and MendeliKABS Inc.

The subject goods are usually imported under the following tariff classification numbers:

• 3003.90.00.90
• 3004.90.00.79
• 3004.90.00.90

The product definition as well as additional product information are contained in Appendix 1.

Additional information about the investigation is contained in a Statement of Reasons which will be available within 15 days on the CBSA’s website at: www.cbsa-asfc.gc.ca/sima-lmsi/menu-eng.html.

Appendix 1

Product Definition

The subject goods are defined as:

Capsules and tablets of nitisinone with a dosage of 2 mg, 5 mg, 10 mg and 20 mg, whether or not they are packaged for retail, originating in or exported from the Kingdom of Sweden.

Additional Product Information

The goods in question are commonly called nitisinone capsules (NIT). The chemical name and the active molecule of nitisinone is 2 (2 Nitro 4 Trifluoromethylbenzoyl) 1, 3 Cyclohexanedione (“NTBC”) and its molecular form is C14H10F3NO5.

Nitisinone is a drug approved for the treatment of hepatorenal tyrosinemia type 1 (HT 1). HT 1 is a rare metabolic disease affecting approximately 1000 persons worldwide. Prevalence of this disease is particularly high in Quebec, where approximately 100 persons receive NIT as treatment for HT 1.

NIT is an orally administered drug. The capsules contain a powder of nitisinone and a pharmacologically inert substance. These drugs are sold in hospital and community pharmacies by prescription.

The product definition includes nitisinone that is packaged for retail consumption at the time it is imported, that is, packaged in plastic or glass containers with an exact unit count of the capsules. In general, these containers contain sixty (60) capsule units with the same dosage. Blister pack type containers are also included, as well as containers containing more or less than 60 capsules.

The product definition also includes nitisinone that is not packaged for retail consumption at the time it was imported, that is, in bulk containers intended for bottling or packaging in Canada.

The product definition does not include nitisinone in liquid suspension.

Date modified:

2018-09-26