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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 107f CELEX: 02001L0083-20250101 Following the assessment of periodic safety update reports, the national competent authorities shall consider whether any action concerning the marketing authorisation for the medicinal product concerned is necessary.
They shall maintain, vary, suspend or revoke the marketing authorisation as appropriate. |