Wednesday, June 12, 2024 6:42:53 PM
Hello William, I'm sort of in agreement but I think it's a case of wondering what the minimum possible time could theoretically be versus the most likely or normal timeline.
The 7 months intention to submit before submission seems to read as more of a "minimum time before submission" rule whereas the guidelines for the submission time after rappateur selection reads more like a "maximum time before submission" rule.
"EMA recommends providing the eligibility request preferably, at the earliest, 18 months before submission of the marketing authorisation application (MAA) and, at the latest, 7 months before the MAA is filed with the EMA, at which point it could be submitted as part of the “letter of intent to submit”. For Eligibility requests submitted as part of the “letter of intent to submit”, Rapporteurs will be automatically appointed following the confirmation of the eligibility to the centralised procedure provided that the planned submission date is within 6-7 months."
As you say though I suppose it would appear the latest would be 7 months after Feb 7th so Sept 7th. However they could have submitted just after Jan 10th which would mean mid August.
As I said though I don't think it gives a minimum in regards to the rappateurs even if normally 6-7 months would be expected.
They can apply later but have to write in to request a later date if they aren't going to meet the planned date.
The 7 months intention to submit before submission seems to read as more of a "minimum time before submission" rule whereas the guidelines for the submission time after rappateur selection reads more like a "maximum time before submission" rule.
"EMA recommends providing the eligibility request preferably, at the earliest, 18 months before submission of the marketing authorisation application (MAA) and, at the latest, 7 months before the MAA is filed with the EMA, at which point it could be submitted as part of the “letter of intent to submit”. For Eligibility requests submitted as part of the “letter of intent to submit”, Rapporteurs will be automatically appointed following the confirmation of the eligibility to the centralised procedure provided that the planned submission date is within 6-7 months."
As you say though I suppose it would appear the latest would be 7 months after Feb 7th so Sept 7th. However they could have submitted just after Jan 10th which would mean mid August.
As I said though I don't think it gives a minimum in regards to the rappateurs even if normally 6-7 months would be expected.
They can apply later but have to write in to request a later date if they aren't going to meet the planned date.
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