Marketing authorisation refusal

Under Article 26, the grounds for refusing a marketing authorisation have been amended under the review. The new provision allows a refusal if the risk-benefit balance of the product is not favourable, if the therapeutic efficacy is insufficiently substantiated, or if its qualitative and quantitative composition is not as declared. The application may also be refused if the documents are not submitted in accordance with the requirements set out in the Directive. The MA holder/applicant is responsible for the accuracy of the data and documentation submitted. The rmfavourable risk-benefit balance is the additional ground for refusal, although in practice this has previously been applied. 

In the European Union there have been several petitions to approve stevia and its products. In 2000, the EU Commission refused marketing authorisation for Stevia rebaudiana Bertoni plants and dried leaves as a novel food or novel food ingredient (Official Journal of the European Communities, 2000). In October 2003, the SCF rejected a request to re-examine the restrictions on the uses of extracts of stevia. Its comment, after throroughly examining the evidence, was that the committee has serious doubts about the safety of stevioside and does not consider it acceptable for use in food (European Parliament, 2003). 

Questions and Answers on Recommendation for the Refusal of the Marketing Authorisation for Ixem-pra. http //www.emea.europa.eu/pdfs/human/opinion/ IxempraQ A 60256908en.pdf (accessed August 2012). 

Phase II - studies that might be conducted to investigate environmental hazards and thus eventually lead to risk mitigation measures that could, in the most extreme circumstances, lead to the product being refused a licence, marketing authorisation, approval etc. 

Conceptually, this procedure for Community authorisations (also known as the centralised procedure) resembles a hybrid of the national procedure and the mutual recognition procedure, with the differences that first, the application is submitted to EMEA second, the dossier supporting the application undergoes a detailed assessment by the CHMP before approval in any Member State of the EU third, the applicant is provided with an opportunity to clarify any issues raised by any of the EU Member States fourth, the procedure naturally has an extended time frame but stUl with predetermined deadlines and finally, the applicant ends up with an approval or a refusal to market the product in all or any Member States of the EU. The centralised procedure is shown in Figure 17.2. 

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