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"EU Number" (AP.12.8) = "Package Description" (AP.13.7) = EU/1/03/000/001 1 vial AMP entry 2: 'Full Presentation Name' field = "Authorisation Number" (AP.12.4) = "EU Number" (AP.12.8) = "Package Description" (AP.13.7) = TRADENAME XYZ 100 U/ml Concentrate for solution for infusion EU/1/03/000/002 EU/1/03/000/002 10 vials AMP entry 3: "Full Presentation Name" (AP.13.1) = TRADENAME XYZ 50 U/ml Concentrate for solution for infusion "Authorisation Number" (AP.12.4) = EU/1/03/000/003 "EU Number" (AP.12.8) = EU/1/03/000/003 "Package Description" (AP.13.7) = 1 vial AMP entry 4: "Full Presentation Name" (AP.13.1) = TRADENAME XYZ 50 U/ml Concentrate for solution for infusion "Authorisation Number" (AP.12.4) = EU/1/03/000/004 "EU Number" (AP.12.8) = EU/1/03/000/004 "Package Description" (AP.13.7) = 10 vials 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 18/163
Table 1a- Authorised Medicinal Product – language requirements Medicinal Product Authorisation Procedure (AP.12.2) Medicinal Product Data Elements (AP.13.1-AP.13.6) Substance Name* (PP.ACT.1, PP.ADJ.1, PP.EXC.1) Summary of Product Characteristics (SmPC) (attachment) (AP.PPI.1) Centralised Procedure (CAP) English All official EU languages English (Other languages available at the Agency) Mutual Recognition Procedure (MRP) National language(s) of the country of authorisation National language(s) of the country of authorisation National language(s) of the country of authorisation (Common approved English text acceptable only if national SmPCs are not available)** Decentralised Procedure (DCP) National language(s) of the country of authorisation National language(s) of the country of authorisation National language(s) of the country of authorisation (Common approved English text acceptable only if national SmPCs are not available)** National Procedure (NAP) National language(s) of the country of authorisation National language(s) of the country of authorisation National language(s) of the country of authorisation * Plant Latin binominal names or Latin herbal preparation names of authorised medicinal products if reflected in the SmPC are also acceptable ** When the SmPC in the national language becomes available, it must be provided in the context of the data maintenance, i.e. when the variations lead to changes as listed in section 2.2.3.1 Variations of marketing authorisation. Submission of medicinal products authorised in Liechtenstein It is clarified in the Notice to Applicants (Volume 2A, Chapter 1) that on the basis of a bilateral agreement between Liechtenstein and Austria automatic recognition of the Marketing Authorisations granted via Mutual Recognition Procedure (MRP) or Decentralised Procedure (DCP) is operational. This allows Liechtenstein to use Marketing Authorisations granted by Austria provided that the applicants have identified Liechtenstein as CMS in the application form submitted with MRP or DCP applications. At the end of the procedures, Austria grants authorisations that are recognised by Liechtenstein. This 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 19/163
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: AMP entry 2 (capsule): "Full Presen
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
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 67 and 68: SmPC Reference XEVPRM Technical Spe
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SmPC Reference XEVPRM Technical Spe
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SmPC Reference XEVPRM Technical Spe
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− − 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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