1naEqka

Recommendations

Info

1.2.1. Local Number (AP.1) Unique reference number for an AMP entity in an XEVPRM following an operation type 'Insert' (1) must be assigned. When an authorised medicinal product is submitted in an XEVPRM with the operation 'Insert' (1), a local number must be assigned to this product. When the XEVPRM Acknowledgement is received and providing that the submission was successful, this local number should be used to identify the corresponding EV Code. EXAMPLE: XEVMPD - Insert of an AMP EXAMPLE - XEVPRM Acknowledgement received following an insert of an AMP 1.2.2. EV Code (AP.2) EudraVigilance (EV) Code of the authorised medicinal product must be specified if the operation type is NOT an 'Insert' (1). I.e. if maintenance related operations are performed on an authorised medicinal product entry successfully inserted in the XEVMPD, the EV Code of the AMP entry must be referenced in this data field. Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004 EMA/135580/2012 Page 32/163
1.2.3. New Owner ID (AP.3) This field is reserved for EMA use only. New Owner Identifier (ID) field is used to identify the new Owner of the XEVMPD medicinal product entry when 'Change ownership' is performed by the EMA. 1.2.4. Marketing Authorisation Holder (MAH) code (AP.4) Marketing Authorisation Holder code corresponding to the legal entity of the medicinal product in a given country as indicated Marketing Authorisation Holder organisation stated in section 7. Marketing Authorisation Holder of the SmPC of the authorised medicinal product must be specified. • If the MAH organisation was previously successfully submitted in the XEVMPD and an MAH organisation EV Code has been assigned, the MAH can be selected from the available EudraVigilance look-up table (EVWEB users). Gateway users should populate the 'MAH code' field (AP.4) with the assigned organisation EV Code received in the XEVPRM Acknowledgement. List of available MAH organisations with their assigned EV Codes can be found in the XEVMPD lookup table and in the Controlled Vocabulary (CV) lists published on the Agency's website - see "eXtended Eudravigilance Product Dictionary (XEVMPD) organisations". See also section 1.6. of this document for related information. NOTE 1 The MAH XEVMPD look-up table and the published Organisation CV list are different from the list of organisations registered in EudraVigilance. The list of organisations registered with Eudravigilance is the list of all the registered stakeholders (Regulators, Pharmaceutical Industry and Sponsors) and is accessible to registered users in the restricted area of the EudraVigilance Human website. The "Extended EudraVigilance product report message (XEVMPD) Organisations" list available as part of the Controlled Vocabularies published on the Agency's website contains details of the marketing authorisation holder organisations available in the XEVMPD. These organisation entities should be referenced as applicable in the medicinal product information submitted. • If the MAH organisation entry does not exist in the XEVMPD, the MAH information can be added using the Organisation section of the XEVPRM. See section 1.6. of this document for further information on how to submit an MAH organisation in the XEVMPD. 1.2.5. Qualified Person responsible for Pharmacovigilance (QPPV) code (AP.5) The QPPV code of the QPPV responsible for the authorised medicinal product must be specified. • The EU QPPV, and where such does not exist, the local QPPV/Responsible person (e.g. for purely national authorisations) should register with EudraVigilance. Following the registration, a QPPV Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004 EMA/135580/2012 Page 33/163
Page 1 and 2: 08 July 2014 EMA/135580/2012 Proced
Page 3 and 4: NOTE 5 ............................
Page 5 and 6: 1.7.2. ATC Code (ST.ATC.2) ........
Page 7 and 8: Process map 12 - Amendment of an AM
Page 9 and 10: • Available operation types to be
Page 11 and 12: Background information New pharmaco
Page 13 and 14: • Detailed information related to
Page 15 and 16: EXAMPLE 1 In the UK, a marketing au
Page 17 and 18: AMP entry 2 (capsule): "Full Presen
Page 19 and 20: Table 1a- Authorised Medicinal Prod
Page 21 and 22: Country National language(s) AMP re
Page 23 and 24: Authorised Product M - Authorisatio
Page 25 and 26: AP.APF authpharmform M 1.2.14. The
Page 27 and 28: PP.ADJ.6 lowamountdenomvalu e Low A
Page 29 and 30: PP.EXC.14 highamountdenomuni t High
Page 31: 1.2. Authorised medicinal product -
Page 35 and 36: The contact information for Pharmac
Page 37 and 38: NOTE 2 • For United Kingdom, the
Page 39 and 40: • Not valid - Expired due to Suns
Page 41 and 42: Authorisation Procedure" (AP.12.2)
Page 43 and 44: 1.2.12.9. Orphan drug status (AP.12
Page 45 and 46: corresponds to the legal basis in t
Page 47 and 48: symbol must also be included in the
Page 49 and 50: EXAMPLE 17 The SmPC of a medicinal
Page 51 and 52: "Full Presentation Name" (AP.13.1)
Page 53 and 54: EXAMPLE 25 The SmPC of a medicinal
Page 55 and 56: "Full Presentation Name" (AP.13.1)
Page 57 and 58: 1. Name of the medicinal product VA
Page 59 and 60: • If the pharmaceutical form is n
Page 61 and 62: 1.2.15. Package description (AP.13.
Page 63 and 64: and ethinyl estradiol tablets and f
Page 65 and 66: SmPC Reference XEVPRM Technical Spe
Page 73 and 74: − − where an application for a
Page 75 and 76: Process map 2 - Referencing route o
Page 77 and 78: Pharmaceutical Product excipient el
Page 79 and 80: − any missing translation names m
Page 81 and 82: Further guidance on how to handle a
Page 83 and 84:
EXAMPLE 46 The SmPC of a medicinal
Page 85 and 86:
1.2.17.6. Active ingredient concent
Page 87 and 88:
(Low Amount) Denominator Prefix (PP
Page 89 and 90:
EXAMPLE 55 1 dose (1 ml) contains H
Page 91 and 92:
EXAMPLE 59 The SmPC of a medicinal
Page 93 and 94:
1.2.17.12. Medical Device Code (PP.
Page 95 and 96:
1.2.19.3. MedDRA Code (AP.IND.3) Th
Page 97 and 98:
1.2.21. AMP - Printed Product Infor
Page 99 and 100:
1.3. Initial submission of QPPV inf
Page 101 and 102:
− If requesting that an alias is
Page 103 and 104:
1.5.2. EV Code (S.2) EudraVigilance
Page 105 and 106:
updated from "Pharma XYZ Limited" t
Page 107 and 108:
Table 4 - Art 57(2) data elements r
Page 109 and 110:
EXAMPLE: XEVPRM Acknowledgement - I
Page 111 and 112:
e populated with the reason for nul
Page 113 and 114:
1.7. Initial submission of an ATC C
Page 115 and 116:
1.7.4. ATC Code description (ST.ATC
Page 117 and 118:
1.8.1. Type Term (ST.PF.1) The type
Page 119 and 120:
Following a successful insert, an E
Page 121 and 122:
1.9.1. Type Term (ST.AR.1) The type
Page 123 and 124:
See section 2.2.3.7. Nullification
Page 125 and 126:
text as authorised by the Authorisi
Page 127 and 128:
"Product Company Name" (AP.13.4) =
Page 129 and 130:
1.10.1. Local Number (ATT.1) Local
Page 131 and 132:
1.11. Initial submission of a Pharm
Page 133 and 134:
The following case scenarios provid
Page 135 and 136:
Master file location element struct
Page 137 and 138:
1.11.6. Pharmacovigilance System Ma
Page 139 and 140:
• Communicate efficiently with EM
Page 141 and 142:
EXAMPLES of submission dates for va
Page 143 and 144:
2.1.4. Submission date for Type II
Page 145 and 146:
2.2.1.2. Business process to notify
Page 147 and 148:
2.2.2. Maintenance of XEVMPD Contro
Page 149 and 150:
Business process to notify the tran
Page 151 and 152:
2.2.3. Maintenance of authorised me
Page 153 and 154:
• Details of the marketing author
Page 155 and 156:
• Date of the suspension must be
Page 157 and 158:
2.2.3.4.2. Business process when th
Page 159 and 160:
− − The date of revocation or w
Page 161 and 162:
2.3.2. Amendment of an AMP entry fo
Page 163:
2.3.4. Nullification of duplicated/
show all

1naEqka

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?