Commission Implementing Regulation (EU) No 520/2012Dangos y teitl llawn

CHAPTER IV Use of terminology, formats and standards

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:

(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;

(b) the lists of Standard Terms published by the European Pharmacopoeia Commission;

(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);

(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);

(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);

(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);

(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.

Article 26 Use of internationally agreed formats and standards

1. For the description, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of pharmacovigilance and medicinal product information, national competent authorities, marketing authorisation holders and the Agency shall apply the following formats and standards:

(a) the Extended Eudravigilance Medicinal Product Report Message (XEVPRM), which is the format for the electronic submission of information on all medicinal products for human use authorised in the Union in accordance with the second subparagraph of Article 57(2) of Regulation (EC) No 726/2004, as published by the Agency;

(b) ICH E2B(R2) ‘Maintenance of the ICH guideline on clinical safety data management: data elements for transmission of Individual Case Safety Reports’;

(c) ICH M2 standard ‘Electronic Transmission of Individual Case Safety Reports Message Specification’.

2. For the purpose of paragraph 1 national competent authorities, marketing authorisation holders and the Agency may also apply the following formats and standards:

(a) EN ISO 27953-2:2011 Health Informatics, Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011);

(b) 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);

(c) 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);

(d) 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);

(e) 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);

(f) 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).