One-Off Launch Costs and Annual RP Fees
Separate the launch work from continuing Responsible Person coverage. Tests, translations and taxes may be additional to the service estimate.
In this guide
One-off work
One-off work can include the agreed document preparation, review, safety-assessment coordination or notification service. A headline price is meaningful only when its included scope is stated.
Annual coverage
RP coverage concerns a defined product portfolio and contractual period. Show the recurring amount separately and confirm how portfolio additions or changes are handled.
The final requirements and suitability of existing evidence are determined for the actual formula, intended use and markets.
What your quotation should separate
List exclusions, taxes subject to billing review, testing and translation costs, dependencies and the basis for timing. Do not treat unknown additional costs as zero.