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Kuwait: New Guidelines for Pharmaceutical Registration

March 2, 2020

Following the issuance of Ministerial Decree no. 361 of 2019 that was published on January 5, 2020, the Ministry of Health (MOH) in Kuwait updated the regulations regarding the registration of pharmaceutical products.

In line with local legislation, pharmaceutical products must be registered with the MOH before being imported into the Kuwaiti market by local agents. The local agents, should in turn be authorized and licensed by the Ministry of Commerce and MOH to import and distribute such products in Kuwait.

In order to apply for marketing authorization, a common technical document must be submitted to the MOH for assessment and approval. It is worth noting that registration is allowed for biological products and biosimilars, which must satisfy the technical and product class specific provisions set out in the Gulf Health Council guidelines and must be registered with a competent authority, such as the United States Food and Drug Administration or the European Medicines Agency.

The Decree lists, among other things, the requirements for registration of pharmaceutical products, registration of marketing authorization holders with the MOH, and bilingual (Arabic and English) product labelling. Furthermore, registration certifications are valid for five years from the date of issuance and renewal files must be submitted six months prior to pharmaceutical registration certificate expiry.

With regard to language, the regulatory requirements in Kuwait call for the use of the mark in Arabic on the package and/or the leaflet. Hence, protection of the mark in the Arabic script is recommended, although the registration of a trademark in English should, in general, provide protection against the registration of another mark with a prominently featured or at least confusingly similar Arabic transliteration that could cause public confusion.

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