Vastuskiri

Dear Sofia,

Thank You for Your inquiry. Please find the answers to Your questions below.

1. If it will be submitted as a substantial modification, how many days can we expect to wait before we receive the approval from you?

The timelines regarding substantial modifications are laid out in Regulation (EU) 2017/746 Article 71 (3):

3.   The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in paragraph 1, unless:

(a) the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or of public policy; or

(b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the performance study, which, in accordance with national law, is valid for that entire Member State.

Please note that the sponsor may implement the modifications earlier than 38 days provided that the Health Board has authorised the substantial modification.

2. If it will be submitted as a notification, do we need to wait for an approval or acknowledgement of receipt before implementing the change? If yes, how many days can we expect to wait before receiving this?

There is no need to wait for an approval or acknowledgement of receipt in case of a non-substantial modification. The sponsor may implement the modifications wihtout delay.

For any further information we recommend to consult with the MDCG guidance 2021-6-Rev.1 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation as the principles described there are applicable to IVDR as well. The guidance also thoroughly describes instances which could be considered substantial.

In case of any further questions, please do not hesitate to contact us again.

All the best,

Dear Terviseamet,

I am reaching out to you with a few questions about the timelines we can expect for different IVDR submissions.

For one study, we likely need to submit an updated CPSP for an IVDR study. As it is not finalized yet, it is not clear if it will be submitted as a substantial modification or as a notification. I hope you can clarify the following:

1. If it will be submitted as a substantial modification, how many days can we expect to wait before we receive the approval from you?

2. If it will be submitted as a notification, do we need to wait for an approval or acknowledgement of receipt before implementing the change? If yes, how many days can we expect to wait before receiving this?

I would highly appreciate if you are able to respond to this before Tuesday 27AUG.

Thank you very much in advance!

Kind regards | Vänliga hälsningar 

Sofia Hogander, M.Sc. Pharm (she, her, hers)

FSP Clinical Trial Associate 2 | Nordic & Baltic Hub

Global Study Operations SM

m: +46 (0)76 136 43 11

e: shogande@amgen.com

Amgen AB

Gustav III:s Boulevard 54, 169 27 Solna, Sweden

www.amgen.com  

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