SmPC (KÜB, Summary of Product Characteristics)

The SmPC (Turkish KÜB, Kısa Ürün Bilgisi, “short product information”) is the official product information document of a licensed human medicinal product. The 2015 Regulation on Promotional Activities of Human Medicinal Products (Beşerî Tıbbi Ürünlerin Tanıtım Faaliyetleri Hakkında Yönetmelik) defines the KÜB as “the short product information found in the marketing authorization file of the human medicinal product,” and the Patient Information Leaflet (Kullanma Talimatı, KT) as “written information prepared for the user, provided with the product.” ^[1] The earlier 2011 text describes the KÜB as “a brochure prepared for health professionals containing the minimum information on the product.” ^[2]

Where is it found?

TİTCK (Turkish Medicines and Medical Devices Agency) operates a query portal for KÜB and KT documents in which a search can be made by drug name, active ingredient or marketing authorization holder. ^[3]

What does it contain?

A KÜB consists of numbered sections. For example, in the KÜB of a semaglutide product, clinical particulars, information on pregnancy and lactation (section 4), pharmacological properties, and pharmacodynamic and pharmacokinetic information (section 5) appear under separate headings; numbers such as half-life are written in the “Pharmacokinetic properties” section. ^[4]

How is it read?

The KÜB conveys the approved conditions of use and the safety information of a licensed product; it is not a personal dose or treatment instruction. Rules and time periods are product-specific: the information in one drug’s KÜB on a missed dose, stopping or the period before pregnancy does not apply to another drug. The drug guides on the site relay the dose in the KÜB only as product information aimed at physicians.

Unlicensed substances have no KÜB; therefore the phrase “according to the KÜB” is used only for licensed products. Example applications: the Semaglutide and What does half-life mean? guides.