It is possible to issue an export licence for an authorisation number (5-digit Swissmedic number) and as such for all dose strengths of a product included therein (2-digit dose strength number), but it is also possible to issue an export licence for individual dose strengths of a product only. This means that dose strengths within a product can either have an export licence or a regular authorisation (= main authorisation, intended for the Swiss market). In so doing, the marketing authorisation holder must ensure that all indications and dosage recommendations from the main authorisation can be implemented with the respective dose strengths. If this is not possible, the Information for healthcare professionals must be amended accordingly with an application. A separate basic product information must also be submitted for the dose strengths with an export licence.
Dr. Katharina Oehler
Scientific and Managing Director
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