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20. If more than one pack size of the medicinal product has been authorised under a single authorisation number and one of the package is not marketed in sufficient amount, how will the sunset clause be applied?

As mentioned in the previous question, it is marketing authorisation and hence the MA number specified in the marketing authorisation which is being assessed for the purposes of sunset clause. Individual pack sizes have the identical MA number and for this reason the consumption of all of these packs is accumulated for the purposes of sunset clause. It is essential to comply with the quantity requirement governing the marketing authorisation number, regardless of the type of the pack size.

 

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