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 use the following terminology:
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(a) |
the Medical Dictionary for Regulatory Activities (MedDRA) as developed by the International Council for Harmonisation of Technical Requirements for 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 11615:2017 Health Informatics, Identification of Medicinal Products (IDMP) standard, Data elements and structures for the unique identification and exchange of regulated medicinal product information; |
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(d) |
the terminology set out in EN ISO 11616:2017 Health Informatics, Identification of Medicinal Products (IDMP) standard, Data elements and structures for unique identification and exchange of regulated pharmaceutical product information; |
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(e) |
the terminology set out in EN ISO 11238:2018 Health Informatics, Identification of Medicinal Products (IDMP) standard, Data elements and structures for the unique identification and exchange of regulated information on substances; |
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(f) |
the terminology set out in EN ISO 11239:2023 Health Informatics, Identification of Medicinal Products (IDMP) standard, Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging; |
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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 the unique identification and exchange of units of measurement. |
2. Member States, national competent authorities or marketing authorisation holders shall request the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the European Pharmacopoeia Commission, the European Committee for Standardization, or the International Organization for Standardization 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.