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marketing authorisation can be considered as a marketing authorisation granted in accordance with the pharmaceutical acquis for the purpose of EU legislation. Therefore the marketing authorisation of these products has to fulfil requirements provided for in, inter alia, Regulation (EU) 726/2004 and Directive 2001/83/EC. The attachment to be used for reference in a medicinal product entry is an Austrian SmPC. The data elements AP.13.1 - AP.13.6 must however be provided in German. In the Notice to Applicants (Volume 2A, Chapter 1) it is also clarified that on the basis of a bilateral agreement between Liechtenstein and Switzerland, a Swiss marketing authorisation is effective in Liechtenstein. This recognition has no effects outside the customs union between Switzerland and Liechtenstein. Consequently, a marketing authorisation granted by the Swiss authorities and recognised by Liechtenstein, while Switzerland does not apply the EU pharmaceutical acquis, cannot be considered as a marketing authorisation granted in accordance with the pharmaceutical acquis for the purpose of EU legislation and therefore falls outside the scope of, inter alia, Regulation (EU) 726/2004 and Directive 2001/83/EC. Table 1b - Requirements for AMP records and attachments for countries with more than one national language Country National language(s) AMP record required ? Attachment to be used for reference Comment Language to be used to enter data elements in fields AP.13.1 - AP.13.6 Belgium Dutch Yes SmPC Dutch French Yes SmPC French German Yes PIL Since there is no SmPC in German, the PIL is to be used German Finland Finnish Yes SmPC Finnish Swedish Yes PIL Since there is no SmPC in Swedish, the PIL is to be used Swedish Ireland English Yes SmPC English Irish No n/a Authorisations are not issued in Irish and no SmPC/PIL exists in this language n/a Luxembourg* French Yes SmPC or an equivalent document (e.g. PIL or French or Belgian SmPC/PIL in French can be French 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 20/163
Country National language(s) AMP record required ? Attachment to be used for reference Comment Language to be used to enter data elements in fields AP.13.1 - AP.13.6 similar text as authorised by used the Authorising Body) German Yes SmPC or an equivalent document (e.g. PIL or similar text as authorised by the Authorising Body) German, Austrian or Belgian SmPC/PIL in German can be used German Luxemburgish No n/a Authorisations are not issued in Luxemburgish and no SmPC/PIL exists in this language n/a Malta English Yes SmPC English Maltese No Authorisations are not issued in Maltese and no SmPC/PIL exists in this language n/a * Table 1b covers the scenario when the French as well as the German SmPC/PIL are provided to the Luxembourgish Authority. If MAH have decide to provide only the French SmPC/PIL or only the German SmPC/PIL to the Luxembourgish Authority, then only one product entry referencing the applicable document should be submitted in the XEVMPD. Where, in exceptional circumstances, the national SmPC for non-centrally authorised products (MRPs/DCPs/NAPs) is not available, a similar text (i.e. the English common text, package insert or other similar text as authorised by the Authorising Body) can be used as an attachment for the submission in the XEVMPD. The data elements AP.13.1 - AP.13.6 must however be provided in the language of the country where the marketing authorisation applies. 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 21/163
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: Table 1a- Authorised Medicinal Prod
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
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SmPC Reference XEVPRM Technical Spe
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− − where an application for a
Page 75 and 76:
Process map 2 - Referencing route o
Page 77 and 78:
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
Page 87 and 88:
(Low Amount) Denominator Prefix (PP
Page 89 and 90:
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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