CMDh Practical guidance for Marketing Authorization Holders -Update questions

Last December… CMDh/412/2019, Rev.15: CMDh Practical Guidance for MarketingAuthorisation Holders of Nationally Authorised Products (incl. MRP/DCP) in Relation to the Art. 5(3) Referral on Nitrosamines, Dec-2021(European Union) was updated with additional questions.

  • How should I submit the outcome of the risk evaluation to the competent authorities?
  • Can we combine several MAs in one template of the risk evaluation step 1 outcome?
  • Is the risk evaluation also required for products that are currently not marketed or is it sufficient to give a commitment that the risk evaluation will be performed before placing the product on the market?
  • Are homeopathic medicinal products, excluded from the call for review?
  • What is the approach for new and ongoing marketing authorisation applications (MAA)?
  • When in the step 1 template a potential risk for nitrosamines is identified as not all relevant data were available and later on it is clarified that there is actually no risk, may I submit updated templates, i.e. replace the “risk identified” template by a “no risk identified” template?
  • What should I do when I detect a nitrosamine risk after the evaluation in the MAA or after the call for review is finalized?
  • What kind of data is expected in the case of (traditional) herbal medicinal products?
  • How should I submit the outcome of the confirmatory testing to the competent authorities?

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it is very intriguing to see this extended to Herbals - having explored such products in the past for mutagenic impurities in a more general sense this could prove interesting !

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