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Letter format for MAH to do Gate way registration with Swissmedic
Q: What is registration via PV Gateway of Swiss and how to do?
A: Companies that are interested in using the Gateway solution and that fulfil the above requirements should send a letter of intent to pvgateway@swissmedic.ch After examining the letter, Swissmedic will contact the company to its involvement in detail.
Letter template
To
- Swissmedic
- Pharmacovigilance
- Hallerstrasse 7
- 3012 Bern Switzerland
dd.mm.yyyy
Letter of intent to access the PV Gateway solution for reporting ICSR originated from Switzerland
Dear Sir or Madam,
Company XY declares its intention to submit Individual Case Safety Reports (ICSR) electronically to Swissmedic. Our preferred date for initiating the process of the implementation of the Gateway solution would be dd.mm.yyyy.
- We agree to pay the external activation costs of CHF 10,000 ahead of the initiation process.
- We will allocate the necessary resources to enable the integration of the gateway solution within 3 months.
- We are technically able to exchange ICSR electronically via AS1 or AS2 protocols
Mr. ABC will be the person responsible for coordination with the following contact details:
- Mr.ABC, Safety Manager
- Email:
- Tel:
Yours faithfully,
Mr. Z
Itís difficult to find educated people about this topic, but you seem like you know what youíre talking about! Thanks