Where no DDD has been determined for the active substance and it is not possible to determine it according to the
current WHO methodology, SÚKL will proceed in compliance with the recommendation of the European Medicines Agency and
the EC (Enterprise Directorate-General) which stipulates:
Marketing authorisation of a medicinal product shall remain valid, if:
- at least one presentation of the marketing authorisation (the form of packaging which has been allocated a SÚKL code) has been placed on the market; and
- at least one pack-size of all authorised pack-sizes is marketed.
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