The rules on issuing new packaging codes are being simplified, meaning that Swissmedic will issue significantly fewer new codes in the future. This simplification will apply to applications received by Swissmedic from 1 June 2024. Section 9.3 Issuing of a new packaging code in the Guidance document (WL) Variations and extensions HAM has been revised accordingly. In addition, redundancies in sections 9.1 Issuing of a new authorisation number and 9.2 Issuing of a new dosage strength number have been deleted.
With the increase of the flat fee for indication extensions to CHF 25,000 and lowering of the maximum cost cap to CHF 30,000, Swissmedic will in future not subsume fees for multiple applications. Numbers 7.8, 7.9 and 7.14 in the document Questions and answers on variations and extensions HMP have been revised or deleted accordingly. It has been clarified in section 1.1.7 Multiple application of the Guidance document Variations and extensions HAM that each variation must be ticked individually in the corresponding application submission form.
The revised Guidance document Variations and extensions HAM and the revised document Questions and answers on variations and extensions HMP will be valid with effect from 1 June 2024.