Following the requests by trade associations and taking into account the statements thereof, in particular the fact that some MAHs have already submitted the information requested by Step 1 in other ways than those established by AIFA and notified on 26 February 2021, in order to reconcile the different needs, the decisions referred to herein have been adopted to update the communication issued on 26 February 2021.

Therefore, the following updates are provided on how to send the information requested by the call for review Step 1.

A) If the information requested by Step 1 has already been submitted to AIFA:

1. for medicinal products registered under national or EU procedure (DC/MR), which show no risk of nitrosamine contamination, the PDF template requested by AIFA may be submitted by 31 May 2021;
2. for medicinal products registered under EU procedure in which Italy acts as CMS, where there is a risk of nitrosamine contamination, the PDF template requested by AIFA may be submitted by 31 May 2021;
3. for medicinal products registered under national or EU procedure in which Italy acts as RMS, where there is a risk of nitrosamine contamination, the information must be re-submitted using AIFA’s PDF template by 31 March 2021.

The table below summarises the above indications:

Type of procedure /role of IT	Risk (YES/NO)	Deadline for submitting the PDF template
DC/MR (IT-RMS, IT-CMS), N	NO	31/05/2021
DC/MR (IT-CMS)	YES	31/05/2021
DC/MR (IT-RMS), N	YES	31/03/2021

B) If the information requested by Step 1 has not been already submitted to AIFA, but it is ready to be submitted in other ways from those established by AIFA:

1. for medicinal products registered under national or EU procedure in which Italy acts as RMS, the information needs to be submitted by 31 March 2021, using the PDF template provided by AIFA;
2. for medicinal products registered under EU procedure in which Italy acts as CMS, the information may be submitted by 31 March 2021 in a format other than the PDF template provided by AIFA. However, such information still needs to be provided by 31 May 2021 using the PDF template made available by AIFA.

The table below summarises the above indications:

Type of procedure /role of IT	Deadline for submitting the PDF template
DC/MR (IT-RMS), N	31/03/2021
DC/MR (IT-CMS)	31/05/2021, provided that the information is submitted in other formats, by 31 March 2021

Additionally, the following is clarified:

• In the “Contamination root cause description (if identified)” field, the root cause can be briefly described;
• The fields must be filled in by providing the required information (they cannot be used to provide information other than those requested);
• If the risk is limited to certain packages, select YES in the “Risk Identified” filed and specify the 9-digit packages with risk in the “Notes” field;
• The "Notes" may be used to provide additional information that is deemed useful or that cannot be provided in any other predefined field.

Finally, please be informed that in the course of the following weeks further explanations will be provided on the national management of the call for review Step 2 (https://www.hma.eu/620.html).

Published on: 09 March 2021