New requirements for declaring the «Date of revision of the text» as per TPO4

Non-compliance with the requirements for declaring the «Date of revision of the text» in medicinal product information can lead to application delays

In order to avoid a delay in the application (as a result of receiving an interim official decision) when applying for  Type I variations to the medicinal product information, the new requirements for amending the section «Date of revision of the text» should be observed (see guidance document «Product information for human medicinal products HMV4», Annex 1, page 56 onwards): (1) For Type IA/IAIN variations, the date of implementation is the «Date of revision of the text», and the MAH must have already included this date in the medicinal product information texts at the time of submission. (2) For Type IB variations, the date of submission is to be selected as the date for the «Date of revision of the text», and again, the MAH must have included this date in the medicinal product information texts at the time of submission.

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