- recommend a text if the testimonial try a variety however, zero particular wording are recommended from the PRAC Rapporteur / Lead Associate State,
- render an excuse in case the MAH does not go along with the fresh PRAC Rapporteur / Member County recommendation to vary, suspend otherwise revoke the fresh MA; and/otherwise
- are a lot more comments otherwise explanation deemed expected of the MAH
The new MAH’s comments is going to be registered as per the PSUR dossier submitting standards in depth throughout the matter Just how should We submit the answer to an ask for secondary pointers through the an effective PSUSA process?.
In case there is significant dispute to the PRAC Rapporteur’s/Direct Representative State’s proposed Recommendation as previously mentioned in the upgraded assessment statement, the fresh new MAH will be contact the item Head (to possess Hats) otherwise Risk Administration Expert (for NAPs merely) no after than just several working days following acknowledgment of your own statement. Contained in this interaction the fresh MAH would be to indicate whether or not they would wish to to make use of the chance of an oral need so you’re able to guard the position till the PRAC. Continue reading »
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