Bioequivalence and Bioavailability Forum

Thanks Helmut!

❝ First of all: Are you talking about generic application (Directive 2001/83/EC, Article 10(1))? If yes, see below. Otherwise, please provide more details.

No it's not ANDA. Its an exploratory study (NDA?) with an ER formulation

❝

❝ ❝ 1. With a drug that is not approved in Europe …

❝

❝ Showstopper: “… reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted in the Union on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, as amended.”

(Sorry I updated my question, there is no question 1 and 2 anymore, just 1 question now)
An IR exists in Europe and an ER also exist in Europe but not the same as my so-called ER product. However, the other Euro ER product has safety issues and is currently off market. Euro IR is ok. I am thinking of dosing the ER of interest at a higher total daily dose than the max recommended dose of the Euro ER that is off the market.

❝ ❝ What do I need to file?

❝

❝ You need a very (very!) good justification.

Question, what's the standard turnaround time? UK? I mean after protocol approved by IRB and going thru the next approval stages(?)

Thx
John