Article 25: Use of internationally agreed terminology
1. For the classification, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of pharmacovigilance and medicinal product information, Member States, marketing authorisation holders and the Agency shall apply the following terminology:
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(a) |
the Medical Dictionary for Regulatory Activities (MedDRA) as developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), multidisciplinary topic M1; |
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(b) |
the lists of Standard Terms published by the European Pharmacopoeia Commission; |
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(c) |
the terminology set out in EN ISO 11615:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of regulated medicinal product information’ (ISO/FDIS 11615:2012); |
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(d) |
the terminology set out in EN ISO 11616:2012 Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of regulated pharmaceutical product information’ (ISO/FDIS 11616:2012); |
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(e) |
the terminology set out in EN ISO 11238:2012 Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of regulated information on substances’ (ISO/FDIS 11238:2012); |
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(f) |
the terminology set out in EN ISO 11239:2012 Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation and routes of administration’ (ISO/FDIS 11239:2012); |
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(g) |
the terminology set out in EN ISO 11240:2012 Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of units of measurement’ (ISO/FDIS 11240:2012). |
2. Member States, national competent authorities or marketing authorisation holders shall request the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, the European Pharmacopoeia Commission, the European Committee for Standardisation or the International Organisation for Standardisation to add a new term to the terminology referred to in paragraph 1, where necessary. In such a case, they shall inform the Agency accordingly.
3. Member States, marketing authorisation holders and the Agency shall monitor the use of the terminology referred to in paragraph 1 either systematically or by regular random evaluation.