No. If a charge is made for considerable extra work because an application is incomplete, Swissmedic will notify the applicant of the extra charge in advance in an interim decision (ID) and set out its reasons for the charge. No separate official decision letter will be issued in this case. If the applicant requests a contestable decision after receiving the invoice, Swissmedic will issue one.
1 When Swissmedic charges for considerable extra work in accordance with Art. 5 FeeO-Swissmedic in the context of variations for human medicinal products in accordance with Art. 21 and 22 of the Therapeutic Products Ordinance, (TPO; SR 812.212.21) or in the context of “variations without assessment” or “variations with assessment, shortened time limit” for veterinary medicinal products, does it always issue an official decision?
2 Does Swissmedic always charge the full flat fee if an application for authorisation or a major variation (new application, authorisation extension, type II variation) for a human medicinal product (excluding complementary and herbal medicines) is withdrawn?
3 Complementary and herbal medicines and veterinary medicinal products: Does Swissmedic always charge the full flat fee if applications for variations or authorisation are withdrawn?
No. The amount charged as a fee is based on the stage in the procedure that has been reached when the application is withdrawn:
- Before formal control has been completed (doc. OK): 5% of the applicable flat fee, but at least four hours’ work
- After the List of Questions (LoQ) has been sent: 75% of the applicable flat fee.
- After the preliminary decision has been sent: 100% of the applicable flat fee.
It should also be noted that depending on the situation, a different fee reduction (e.g. Art. 13 TPA) leads to a higher fee reduction. In this case, only the higher fee reduction applicable in the case in question will be granted.
If several LoQs or preliminary decisions are required, an additional charge will be made for this work. Thus, the fee charged takes account of the processing work incurred up to the time the application is withdrawn.
It should further be noted that this procedure does not apply to the withdrawal of applications for a type IA, IAIN and IB variation or to applications for transfer of authorisation. The applicable flat fee (plus the cost of any additional work) is always charged for these application types.
For applications for authorisation, the amount charged as a fee is based on the stage in the procedure that has been reached when the application is withdrawn. Before formal control has been completed, a charge will be made for the work completed so far in hours. After formal control has been completed, the applicable flat fee will generally be charged.
If applications for type IA, IAIN and IB variations for complementary and herbal medicines are withdrawn, or if “variations without assessment” or “variations with assessment, shortened time limit” for veterinary medicinal products are withdrawn, the flat fee (plus the cost of any additional work, cf. FAQ 1) will be charged.
Last modification 01.09.2026