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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use article 118 CELEX: 02001L0083-20250101 1. The competent authority shall suspend or revoke the marketing authorization for a category of preparations or all preparations where any one of the requirements laid down in Article 41 is no longer met. 2. In addition to the measures specified in Article 117, the competent authority may suspend manufacture or imports of medicinal products coming from third countries, or suspend or revoke the manufacturing authorization for a category of preparations or all preparations where Articles 42, 46, 51 and 112 are not complied with. |