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?