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Nitrosamine contamination

UPDATE – NEW DEADLINE for step 1

Information on nitrosamines for marketing authorisation holders


The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) as described in information on nitrosamines for marketing authorisation holders (see below) to 1 October 2020.

The European medicines regulatory network will provide further information on Friday 27 March 2020.

This follows reports of the challenges encountered in meeting the original deadline of 26 March 2020, and the impact of the severe restrictions in place to combat the COVID-19 pandemic.

The European medicines regulatory network encourages marketing authorisation holders to submit the outcome of step 1 before 1 October 2020 if they complete the risk evaluation or identify a risk in their products.

Marketing authorisation holders should inform the national competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected. They should also assess the immediate risk to patients and take appropriate action to avoid or minimise the exposure of patients to nitrosamines.


CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines

Call for Marketing Authorisation Holders

EMA advises companies on steps to take to avoid nitrosamines in human medicines

Information on nitrosamines for marketing authorisation holders

Questions and answers on “Information on nitrosamines for marketing authorisation holders”

Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities

Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

Ranitidin

Metformin

Templates

European Pharmacopoeia

OMCLs

Last updated: 2020.03.26 14:46