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1.11.6. Pharmacovigilance System Master File Street (MF.6) ....................................... 137<br />
1.11.7. Pharmacovigilance System Master File City (MF.7) .......................................... 137<br />
1.11.8. Pharmacovigilance System Master File State (MF.8) ........................................ 137<br />
1.11.9. Pharmacovigilance System Master File Postcode (MF.9) ................................... 137<br />
1.11.10. Pharmacovigilance System Master File Country code (MF.10) ......................... 137<br />
1.11.11. Comment (MF.11) ..................................................................................... 137<br />
2. Maintenance of medicinal product data ............................................... 138<br />
Scope and objectives ............................................................................................... 138<br />
2.1. Transition maintenance phase - Electronic submission plan .................................... 139<br />
2.1.1. Submission date for Type IA Variations ('Do and Tell') ....................................... 141<br />
2.1.2. Submission date for Type IB Variations ............................................................ 141<br />
2.1.3. Submission date for Type II Variations ............................................................. 142<br />
2.1.4. Submission date for Type II Variations (MRP/DCP) ............................................. 143<br />
2.1.5. Submission date for Type II Variations (NAP) .................................................... 143<br />
2.2. Transition maintenance phase - Business processes .............................................. 144<br />
2.2.1. Maintenance of a Qualified Person responsible for Pharmacovigilance (QPPV) ........ 144<br />
2.2.1.1. Business process to notify the change of QPPV details ..................................... 144<br />
Process map 3 – Change of QPPV details ................................................................... 144<br />
2.2.1.2. Business process to notify the change of a QPPV within the organisation ........... 145<br />
Process map 4 – Change of a QPPV ........................................................................... 146<br />
2.2.2. Maintenance of XEVMPD Controlled Vocabularies (CVs) by the MAH ..................... 147<br />
NOTE 18 ................................................................................................................ 147<br />
2.2.2.1. Maintenance of a Marketing Authorisation Holder (MAH) Organisation ............... 147<br />
Process map 5 – Maintenance of an MAH entity .......................................................... 148<br />
2.2.2.2. Maintenance of Pharmacovigilance System Master File Location (PSMFL) ........... 149<br />
Process map 6 – Maintenance of PSMFL entity ............................................................ 150<br />
2.2.3. Maintenance of authorised medicinal product (AMP) ........................................... 151<br />
Process map 7 - Overall business process to amend medicinal product information in the<br />
XEVMPD ................................................................................................................ 152<br />
2.2.3.1. Variations of marketing authorisation ............................................................ 152<br />
2.2.3.2. (Lifting of) suspension of marketing authorisation ........................................... 154<br />
2.2.3.3. Transfer of marketing authorisation .............................................................. 155<br />
Process map 8 – Transfer of marketing authorisation .................................................. 156<br />
2.2.3.4. Renewal of marketing authorisation .............................................................. 156<br />
Process map 9 – Renewal of marketing authorisation .................................................. 158<br />
2.2.3.5. Change of authorisation procedure following a referral .................................... 158<br />
2.2.3.6. Revocation/Withdrawal of Marketing Authorisation (MA) .................................. 158<br />
2.2.3.7. Nullification of medicinal product .................................................................. 159<br />
2.3. Scenarios for maintenance of medicinal products ................................................. 160<br />
2.3.1. Change of QPPV within the MAH organisation .................................................... 160<br />
Process map 10 – Amendment of an AMP entry following a change of QPPV ................... 160<br />
2.3.2. Amendment of an AMP entry following a change in the referenced PSMFL information<br />
............................................................................................................................ 161<br />
Process map 11 – Amendment of an AMP entry following a change of a PSMFL ............... 161<br />
2.3.3. Bringing AMP entries up to date and amending the referenced information ........... 162<br />
Detailed guidance on the electronic submission of information on medicinal products<br />
for human use by marketing authorisation holders to the European Medicines Agency in<br />
accordance with Article 57(2) of Regulation (EC) No. 726/2004<br />
EMA/135580/2012 Page 6/163
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