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Summary of changes The below sections were amended following the publication of version 3.5 on 16 June 2014: • Table 1b - Requirements for AMP records and attachments for countries with more than one national language • 1.2.12.14. Medicinal product types (AP.12.MPT.1) - Please note that the values in EVWEB to reflect the highlighted changes will be re-labelled no later than end of August 2014. • EXAMPLE 16 • EXAMPLE 17 • 1.2.13.4. Product Company Name (AP.13.4) • EXAMPLE 25 • EXAMPLE 26 • 1.2.19.1. MedDRA version (AP.IND.1) • EXAMPLE 69 - Luxembourg • NOTE 16 • 2.2.3.5. Change of authorisation procedure following a referral The below changes were made based on the comments/requests for clarification received following the publication of version 3.4 on 5 March 2014. Amendments/corrections in specific sections are highlighted. Newly added: • EXAMPLE 5 • Table 1b - Requirements for AMP records and attachments for countries with more than one national language • EXAMPLE 16 • EXAMPLE 17 • EXAMPLE 22 • EXAMPLE 26 • EXAMPLE 27 • EXAMPLE 29 • EXAMPLE 36 - Presentation name elements – vaccines • EXAMPLE 69 - Luxembourg Amended: 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 8/163
• Available operation types to be used in an XEVPRM • Table 1a- Authorised Medicinal Product – language requirements • 1.2.4. Marketing Authorisation Holder (MAH) code (AP.4) • 1.2.12.4. Authorisation number (AP.12.4) • 1.2.12.5. Authorisation/renewal date (AP.12.5) • 1.2.12.8. EU number (AP.12.8) • 1.2.13. AMP - Presentation Name element structure (AP.13) • 1.2.13.2. Product Short Name (AP.13.2) • EXAMPLE 15 • 1.2.13.3. Product INN/Common Name (AP.13.3) • EXAMPLE 25 • 1.2.13.5. Product Strength Name (AP.13.5) • 1.2.14. Authorised pharmaceutical form (AP.APT.1) • EXAMPLE 37 • 1.2.17.1. Administrable Pharmaceutical Form (PP.1) • 1.2.17.4. Active ingredient substance code (PP.ACT.1) • 1.2.18. Product ATC Code(s) (AP.ATC.1) • 1.2.19.1. • 1.2.21. AMP - Printed Product Information (PPI) Attachments • 1.4. Initial submission of an Approved Substance • 1.10. Submission of an attachment • 1.10.3. File type (ATT.3) • 2.2.3.4.1. Business process when the Authorisation number (AP.12.4) has not changed 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 9/163
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: Process map 12 - Amendment of an AM
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 and 32: 1.2. Authorised medicinal product -
Page 33 and 34: 1.2.3. New Owner ID (AP.3) This fie
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
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• If the pharmaceutical form is n
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1.2.15. Package description (AP.13.
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and ethinyl estradiol tablets and f
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SmPC Reference XEVPRM Technical Spe
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Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
− − where an application for a
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Process map 2 - Referencing route o
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Pharmaceutical Product excipient el
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− any missing translation names m
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Further guidance on how to handle a
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EXAMPLE 46 The SmPC of a medicinal
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1.2.17.6. Active ingredient concent
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(Low Amount) Denominator Prefix (PP
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EXAMPLE 55 1 dose (1 ml) contains H
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EXAMPLE 59 The SmPC of a medicinal
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1.2.17.12. Medical Device Code (PP.
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1.2.19.3. MedDRA Code (AP.IND.3) Th
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1.2.21. AMP - Printed Product Infor
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1.3. Initial submission of QPPV inf
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− If requesting that an alias is
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1.5.2. EV Code (S.2) EudraVigilance
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updated from "Pharma XYZ Limited" t
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Table 4 - Art 57(2) data elements r
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EXAMPLE: XEVPRM Acknowledgement - I
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e populated with the reason for nul
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1.7. Initial submission of an ATC C
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1.7.4. ATC Code description (ST.ATC
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1.8.1. Type Term (ST.PF.1) The type
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Following a successful insert, an E
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1.9.1. Type Term (ST.AR.1) The type
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See section 2.2.3.7. Nullification
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text as authorised by the Authorisi
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"Product Company Name" (AP.13.4) =
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1.10.1. Local Number (ATT.1) Local
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1.11. Initial submission of a Pharm
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The following case scenarios provid
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Master file location element struct
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1.11.6. Pharmacovigilance System Ma
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• Communicate efficiently with EM
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EXAMPLES of submission dates for va
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2.1.4. Submission date for Type II
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2.2.1.2. Business process to notify
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2.2.2. Maintenance of XEVMPD Contro
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Business process to notify the tran
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2.2.3. Maintenance of authorised me
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• Details of the marketing author
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• Date of the suspension must be
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2.2.3.4.2. Business process when th
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− − The date of revocation or w
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2.3.2. Amendment of an AMP entry fo
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2.3.4. Nullification of duplicated/
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