The EMA’s human medicines committee (CHMP) has requested that marketing authorisation holders (MAHs) for medicines containing chemically synthesised and also biologically derived active substances review their medicines for the possible presence of nitrosamines.

This process is referred to as the “call for review” and is an ongoing exercise that started in September 2019.

Practical guidances for MAHs are available on the Heads of Medicines Agencies website (accessible through the box "Related links"). They include information on the procedural aspects to be followed for non-centrally authorised products and the deadlines to be adhered to. The deadlines for completion of the various steps differ between chemical and biological medicinal products.

In particular, for step 1 of the call for review, the deadline is set as follows:

• 31^st March 2021 for chemical medicines;
• 1^st July 2021 for biological medicines.

MAHs are therefore asked to submit the required information by the deadlines indicated above according to the following national procedural requirements:

• the requested information should be provided by filling in the pdf template attached to this communication; a single template should be used for each individual medicinal product (Marketing Authorisation Number six digits);
• the pdf templates duly filled in should be sent to the mailbox nitrosammine@aifa.gov.it;
• the subject of the mail must contain: “MODULO STEP 1”.

The templates should not to be scanned but only filled in, saved and sent back by mail, to allow automatic data extraction by the ICT Dept.

Multiple filled in pdf templates, referred to different medicinal products, can be attached to the same mail; however, in this case, the templates should be collected in a single compressed folder (.zip).

A cover letter, duly signed by the legal representative or by his/her delegate, where the medicinal products for which the outcome of the risk evaluation is declared through the relative pdf templates are listed, should be attached to each mail.

MAHs who have already forwarded the information related to the step 1, are kindly requested to send it again, following the instructions provided in this communication.

Published on: 26 February 2021