Chiara Pieve -

AIFA recently published a new press release with some clarifications on the timing for the submission of variations to implement PRAC recommendations.

In particular, AIFA states that the MAHs have a legal obligation to comply with the conclusion and recommendations arising from the assessment of a signal as per Art. 107h of Directive 2001/83/EC, Art. 28a of Regulation (EC) No 726/2004 and Chapter III Commission Implementing Regulation (EU) No 520/2012.

The implementation timings are generally indicated in the PRAC recommendation published on the EMA website along with the texts to be implemented. MAHs are required to periodically check that these requirements are fulfilled. The standard deadline for submitting changes is 60 days from the date of publication on the EMA website unless a different date is expressly indicated in the text of the recommendation.

AIFA also reminds that MAHs have a legal obligation to ensure that the information on the medicinal product is up-to-date with the PRAC recommendations published on the EMA website, in line with Article 16 (3) of the Regulation (EC) n. 726/2004 and article 23, paragraph 3, of Directive 2001/83/EC.

Regulatory Pharma Net offers regulatory assistance throughout the whole drug lifecycle and is also available to provide full regulatory support  in the management of the variation applications to implement PRAC recommendations.

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