Article 116
The competent authorities of the Member States shall suspend or revoke an authorization to place a medicinal product on the market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking, or where its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the medicinal product. An authorization shall also be suspended or revoked where the particulars supporting the application as provided for in Articles 8, 10(1) and 11 are incorrect or have not been amended in accordance with Article 23, or where the controls referred to in Article 112 have not been carried out.