15.02.2021
To the attention of marketing authorisation holders
Request for assessment of the risk of the presence of nitrosamine impurities in human medicinal products containing active substances obtained by chemical and biological synthesis
Regarding the referral procedure initiated according to the provisions of Art. 5 (3) of Regulation no. 726/2004, we remind you that the deadline for marketing authorisation holders to send to the NAMMDR the result of stage 1 – Evaluation of the risk of nitrosamine impurities in medicinal products for human use containing active substances obtained by chemical synthesis is 31 March 2021, and the deadline for medicinal products for human use containing biological active substances if 1 July 2021.
The documents shall be sent to nitrozamine@anm.ro in the format established by the European Medicines Agency (EMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh)
Please consult the updated versions:
– https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities
– https://www.hma.eu

16.11.2020
To the attention of interested persons
Nitrosamines: EMA aligns recommendations for sartans with those for other medicinal products
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22.10.2020
To the attention of interested persons
EU authorities are investigating the presence of a nitrosamine impurity, 1-Nitroso-4-methyl piperazine (MeNP), in some batches of active substances used in medicinal products containing rifampicin
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20.10.2020
To the attention of interested persons
EU regulators require testing for nitrosamine impurities in metformin-containing medicinal products
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20.08.2020
To the attention of marketing authorisation holders
As part of the EU-wide measures following the outcome of the assessment carried out by the EMA Committee for Medicinal Products for Human Use (CHMP) in accordance with the requirements of Art. 5(3) (the legal basis for the so-called “referral procedure”), the process for risk assessment of the presence of nitrosamine impurities in all medicinal products for human use containing active substances obtained by chemical synthesis has been ongoing since September 2019.
In this context, in July 2020, the request for risk assessment of the presence of nitrosamine impurities was extended to medicinal products containing biological active substances.
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09.07.2020
To the attention of interested persons
EMA press release on the finalization of the opinion on the presence of nitrosamine impurities in medicinal products
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26.03.2020
To the attention of marketing authorisation holders
Information on nitrosamine impurities for marketing authorisation holders
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20.12.2019
To the attention of interested persons
QUESTIONS AND ANSWERS regarding the document “Information on nitrosamines, to the attention of marketing authorisation holders” – Consolidated version, December 2019.
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13.12.2019
To the attention of interested persons
Practical guide developed by the CMDh for the attention of Marketing Authorisation Holders (MAHs) for medicinal products authorised nationally (also through Mutual Recognition Procedures – MRP/Decentralised Procedure – DCP) in relation to the referral procedure triggered under the provisions of Article 5(3) of Regulation No 726/2004, relating to nitrosamine impurities.
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18.10.2019
To the attention of interested persons
Question and Answer Document for marketing authorisation holders in the process of evaluating the potential presence of nitrosamine impurities in manufactured medicinal products for human use and analysing medicinal products at risk
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30.09.2019
To the attention of interested persons
QUESTIONS AND ANSWERS regarding the document “Information on nitrosamines, to the attention of marketing authorisation holders”
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27.09.2019
To the attention of interested persons
EMA press release – INFORMATION ON NITROSAMINES to the attention of marketing authorisation holders
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17.09.2019
To the attention of interested persons
EMA press release on initiating the re-evaluation of ranitidine-containing medicinal products following the detection of the impurity N-nitrosodimethylamine (NDMA) impurity
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26.09.2019
To the attention of interested persons
EMA press release on EMA recommendation to companies about taking measures to avoid the occurrence of nitrosamine impurities in medicinal products for human use
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13.09.2019
To the attention of interested persons
EMA press release on EMA’s decision to provide guidance on avoiding the presence of nitrosamine impurities in medicinal products for human use
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03.05.2019
To the attention of interested persons
EMA press release on updating information on nitrosamine impurities and continuing EMA actions to prevent the appearance of impurities in medicinal products
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03.02.2019
To the attention of interested persons
EMA press release on the request addressed to pharmaceutical companies that manufacture medicinal products containing sartans, to review manufacturing processes in order to avoid the presence of nitrosamine impurities
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