Step 1: Risk evaluationĬonduct a risk evaluation to identify active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome by: They should also assess the immediate risk to patients and take appropriate action to avoid or minimise the exposure of patients to nitrosamines.Īt all steps, timelines should be shortened and marketing authorisation holders should immediately inform authorities if findings indicate an immediate risk to public health. Marketing authorisation holders should inform the national competent authorities for nationally authorised products or EMA for centrally authorised products as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected. The European medicines regulatory network encourages marketing authorisation holders to submit the outcome of step 1 before the deadlines if they complete the risk evaluation or identify a risk in their products. Further details and guidance are available below. To allow marketing authorisation holders enough time to implement the Article 5(3) opinion, the European medicines regulatory network agreed new deadlines. This complements the review of chemically synthetised active substances, which has been ongoing since September 2019. The call for review was extended to biological active substances in July 2020, as an outcome of CHMP's Article 5(3) opinion. Marketing authorisation holders should review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities. Submitting a post-authorisation application.Q&A: Article 31 non-pharmacovigilance referrals.Q&A: Article 31 pharmacovigilance referrals.Q&A: Article 20 non-pharmacovigilance procedures.Q&A: Article 20 pharmacovigilance procedures.Q&A: Urgent Union Procedures (Article 107i).
Post-authorisation efficacy studies (PAES).
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