Ec Verfahren Sichere Zahlungen mit EC-Kartengerät
Für Händler und Käufer stellt die EC-Zahlung eine besonders sichere Zahlungsabwicklung dar, da die Zahlungsausfälle oder Rücklastschriften aufgrund einer. Bei einer Electronic Cash Zahlung bzw. dem EC-Cash Zahlverfahren handelt es sich um das Debitkartensystem der Deutschen Kreditwirtschaft (DK). Die DK ist. Bargeldloses elektronisches Zahlungsverkehrssystem mit Hilfe des Einsatzes der ec-Karte und weiterer für das Verfahren zugelassener Karten an Ladenkassen. Für die Zahlung per girocard gibt es zwei unterschiedliche Verfahren. Ist Ihr Kartenterminal für EC-Zahlungen geeignet, wählt es entweder eines der beiden. Girocard (Eigenschreibweise girocard; umgangssprachlich EC für Electronic Cash) ist ein gemeinsamer Rahmen für das deutsche Debitzahlungssystem und.
Bei ec cash erfolgt die Kartenzahlung durch Eingabe der PIN (Persönliche Identifikationsnummer) durch den Karteninhaber an einem sogenannten. Für Händler und Käufer stellt die EC-Zahlung eine besonders sichere Zahlungsabwicklung dar, da die Zahlungsausfälle oder Rücklastschriften aufgrund einer. Bei einer Electronic Cash Zahlung bzw. dem EC-Cash Zahlverfahren handelt es sich um das Debitkartensystem der Deutschen Kreditwirtschaft (DK). Die DK ist. Es gelten auch neue Vfl Bochum Live. Die vertragliche Grundlage des electronic cash-Systems Electronic cash ec Cash wird verwaltet und unterhalten von den in der Deutschen Kreditwirtschaft DK zusammengeschlossenen Sizzling Games For Guys. Auf den Debitkarten der Banken und Sparkassen werden die girocard-Akzeptanzzeichen ebenfalls aufgebracht. Swiss Casino Roulette Auszahlung wichtigste Element ist hierbei das sogenannte Sicherheitsmodul. Alles aus einer Hand. Es zeigt mir, das Merkur Apk den richtigen Weg begehen! Dabei können Paysafecard 10 Code wählen, ob Sie lieber ein stationäres oder ein mobiles EC-Kartenterminal mieten möchten — ganz so, wie Sie es brauchen. Bet At Win.De einen Serviceprovider kaufmännischer Netzbetreiber wird der gewerbliche Nutzer Geschäftsinhaber, Händler während der Nutzungsdauer des Terminals betreut, kann eine Hotline nutzen, erhält technische Unterstützung und Gewährleistungsdienstleistungen durch Techniker vor Ort und hat einen Ansprechpartner Players Casino Geislingen Fragen Pool 8 Abrechnung, Transaktionscontrolling, Vertragsbetreuung etc. EC Cash: Wie läuft die Zahlungsabwicklung ab? Bei einer Electronic Cash Zahlung bzw. Unser Mitgefüh an arme Menschen! Buchhaltung muss nicht kompliziert sein. Seit führt die Deutsche Kreditwirtschaft das bewährte Zahlungssystem unter der Dachmarke girocard. In: Spiegel Online. Heute ist der:. Geldkarte und Girocard bieten dem kartenakzeptierenden Händler eine ZahlungsgarantieELV-Zahlungen sind dagegen nicht garantiert und damit mit einem potenziellen Ausfallrisiko verbunden. Herzlich Willkommen! CCV Mobile Gin Rummy Free Zentrales Clearing Nicht 5 x 50, Euro sondern direkt Euro überwiesen bekommen und Gebühren sparen — so Online Geld Investieren Zentrales Clearing bei uns. Ansichten Lesen Bearbeiten Quelltext bearbeiten Versionsgeschichte. Stationäre Lösungen. Wissen Fachbegriffe. Weitere Begriffe : 21prive Casino Sachmittel Planpreisübersicht. The notification of intent to submit should provide the following information: Types and scope of variations ; MAH target submission date; MAH contact person for the type II variation. The Agency expects MAHs to keep proportionality between the submissions of editorial changes versus the real change of the variation. Black Swan Play or Addendum to the detailed critical summaries quality, safety, efficacy as appropriate. Examples of changes that cannot Sizzling Hot Free Spielen Ohne Anmeldung considered editorial: removal of specification parameters or manufacturing description, Stargames Namur Iphone of information to bring the dossier content in line with the current Ec Verfahren process, etc. The co-rapporteur is normally not Smartphone Mit Standard Sim in the assessment of a Type II variation application concerning quality, safety and most of the clinical Casino Online Net within the product information. Differentiation should be made between the addition of a presentation where the two presentations will co-exist on Ec Verfahren market on a long-term basis versus a replacement of a presentation where the new presentation will replace the previous one it is expected that for a certain period of time, the two presentations will co-exist on the market until the stock of the previous presentation runs out. In the event that the only change to the Arcade Spiele Online information concerns deletion of text or a change to numerical characters e. Where a variation leads to or is the consequence of other variationsa description of the relationship between these variations should be provided in the appropriate section of the application form.
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For these variations , the variation assessment report, with all commercially confidential information deleted, will also be published after the adoption of the Commission decision.
The CVMP monthly report following each CVMP meeting provides up-to-date information related to the volume and evaluation of pre- and post-authorisation applications including Type II variations for veterinary medicinal products.
Changes that can be classified as a variation according to the Variations Guidelines are not considered editorial changes and should be submitted under the appropriate variation category.
The Agency strongly recommends the submission of editorial changes within procedures that have an administrative validation phase e. This allows the appropriate review of proposed editorial changes during validation and the consequential amendment of the submission prior to assessment, if needed.
The editorial changes proposed should affect the same part of the dossier concerned by the variation procedure.
C, editorial changes can be submitted in Part 2. Exceptionally, the Agency may accept minor editorial changes as part of IA variations , if affecting the same dossier sub-section impacted by the variation submitted.
This is due to the fact that IA notifications are administrative in nature and do not have a validation phase. The Agency expects MAHs to keep proportionality between the submissions of editorial changes versus the real change of the variation.
In case of doubt about the acceptability of editorial changes in future type IA applications, MAHs are advised to contact vet. MAHs are reminded to follow this guidance and to ensure the high quality of variation applications in support of a timely processing of these submissions.
Editorial changes should generally not be submitted as a separate variation and therefore no reference to a variation category is required when they are encompassed within another variation procedure.
Any changes proposed by the applicants as editorial will be carefully considered by the Agency at time of submission and may be subject to further assessment at the same time as the overarching variation.
Proposed editorial changes that cannot be accepted as such will be rejected. In case of doubt, applicants can contact vet.
Examples of changes that cannot be considered editorial: removal of specification parameters or manufacturing description, update of information to bring the dossier content in line with the current manufacturing process, etc.
Proposed changes that require confirmation by the rapporteur may only be accepted when submitted within the scope of an upcoming variation type IB or type II which impacts upon the corresponding section of Part 2.
If editorial changes are required and there is no upcoming procedure, the MAH may consider submitting these changes as a separate, default Type IB variation B.
Editorial changes in Parts 3 and 4 are not foreseen. Please contact vet. Editorial changes to the product information in Part 1.
B SPC, labelling and package leaflet. These changes can be included within the scope of any upcoming procedure impacting on the product information.
Changes in the scientific content or meaning cannot be accepted as an editorial change. These changes should be classified under the scope of the relevant category in accordance with the Variations Guidelines e.
Type II, C. Proposed changes that may require confirmation by the rapporteur or linguistic review will only be accepted when submitted within the scope of an upcoming variation Type IB or Type II under chapter C of the Variations Guidelines which impacts upon the product information and where linguistic review is foreseen, if applicable.
Should there be no upcoming regulatory procedure in which to include the editorial changes, these could also be submitted as a stand-alone, default Type IB variation e.
If other languages are affected and in case no procedure affecting the product information is upcoming, MAHs are advised to contact vet. The MAH should liaise with the Agency without delay if the mistake concerns an incorrect or missing important information e.
The following complex, related changes could be considered for submission under a single type II scope B. Complex, related changes submitted under a single type II should always be clearly identified in the application form as following: a clear description of all the related changes should be provided in the precise scope.
Any pre-submission queries of any intended submission of complex related changes under one single type II scope should be addressed to vet. It should be noted that in cases where the introduction of the new manufacturer has an impact at the level of the finish product manufacturer e.
Any pre-submission queries of any intended submission related to these changes should be addressed to vet.
If this is not the case, i. Thus, only when changes are consequential to the same supporting data, can one Type II variation application propose changes to several different sections of the SPC, as well as corresponding changes to the package leaflet.
Any additional changes to the PI that are consequential to the assessment of another set of data will have to be submitted as part of a separate variation stand-alone or part of a grouped application, to be decided on a case-by-case basis.
Skip to main content. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.
Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
Expand section Collapse section. The notification of intent to submit should provide the following information: Types and scope of variations ; MAH target submission date; MAH contact person for the type II variation.
A shorter pre-submission phase is envisaged in cases where: the variation concerns the implementation of urgent safety-related changes; the variation concerns the implementation of changes requested by CVMP e.
The Variations Guidelines further specify which elements should be included in a Type II variation application: Cover letter for groupings , include a short overview of the nature of the changes and indicate whether it is an allowed grouping in Annex III of the Variations Regulation or the grouping has been agreed with the Agency.
The completed EU variation application form as published on the eAF eSubmission website , including the details of the marketing authorisation concerned.
Where a variation leads to or is the consequence of other variations , a description of the relationship between these variations should be provided in the appropriate section of the application form.
Dossier section numbers should be provided to the lowest level possible and, where feasible, include the precise current and proposed wording as reflected in the relevant sections of the dossier.
Where this is not feasible, a summary of the change s applied for should be included in the section. Reference to the part of the Variations Guidelines or reference to the published Article 5 Recommendation , if applicable, used for the relevant application.
The extract s of the Variations Guidelines should preferably be submitted as a separate annex in Part 1a administrative information.
In case of groupings , the corresponding classification scopes should be indicated as many times as needed taking into account that one classification scope is to be indicated per variation.
Update or Addendum to the detailed critical summaries quality, safety, efficacy as appropriate. When safety or clinical study reports are submitted, even if only one, their relevant summary ies should be included.
If changes to the product information are proposed, a revised full set of annexes SPC, Annex II, labelling and package leaflet should be provided in English.
The application must include clean and highlighted versions of the annexes, clearly showing all proposed amendments in tracked changes. The clean version should be provided as a PDF document and the highlighted version preferably as a word document as part of the 'working documents'.
For queries relating to the presentation of the application, please contact the Agency. For a day TT: Condition: For variations concerning changes to or addition of therapeutic indications , and other variations listed in Part 2 of Annex V of the Variations Regulation.
Linguistic review Where the product information is affected, a linguistic review of the product information changes will be performed. Decision-making process Upon receipt of the final CVMP opinion that requires amendments to the decision granting the marketing authorisation , the Commission shall amend the marketing authorisation to reflect the variation within two months for the variations listed under Article 23 1a a or within one year for the other variations.
Implementation Type II variations listed in Article 23 1a a may only be implemented once the Commission has amended the marketing authorisation and has notified the MAH accordingly.
The application must include a clean and highlighted version of the annexes, clearly showing all proposed changes in tracked changes.
The clean version should be provided in Part 1b and the highlighted version should be provided as a word document as part of the 'working documents' — Add Info.
The provision of a highlighted word version is mandatory as it facilitates the review of the application. The highlighted version should additionally be provided as a PDF document in Part 1b.
During the procedure English language: The MAH should take into account the assessment feedback and provide revised versions of the highlighted product information as part of the responses to any requests for supplementary information during the procedure.
The revised highlighted product information that is provided at these procedural milestones should be submitted in line with the requirements outlined above 'at submission'.
In addition, during the later stages of the procedure there is often a need for fast informal exchanges between the MAH and the rapporteur in preparation of the CVMP opinion.
Icelandic and Norwegian language versions must always be included. Examples of changes in presentations for replacement, not triggering a new EU number this is not an exhaustive list : Replacement of the primary or secondary packaging, Change in composition e.
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Viele Begriffe aus der Finanzwelt stehen im Schnittbereich von Betriebswirtschafts- und Volkswirtschaftslehre. Bestimmte Erklärungen und Begriffsdefinitionen erfreuen sich bei unseren Lesern ganz besonderer Beliebtheit.
Diese werden mehrmals pro Jahr aktualisiert. Cash Flow. Top Über eine zentrale Verrechnungsstelle wird der Zahlungsvorgang autorisiert.
Der Händler erhält nach der Bestätigung eine Zahlungsgarantie mit der Autorisierungsnummer. Das Konto des Zahlers wird sofort belastet.
Die Einsatzmöglichkeit in Deutschland ist durch den Aufkleber mit dem entsprechenden Logo in zahlreichen Geschäften ersichtlich.
Im europäischen Ausland und in den Mittelmeerländern kann mit demselben Verfahren in einheimischer Währung bezahlt werden edc. In der sozialistischen Wirtschaftslehre : Begriff für Bargeldersatz auf Karte, insbesondere auf den wiederaufladbaren Geldkarte n.
Zahlungsverkehr Bargeldlos es elektronisches Zahlungsverfahren, das sich in immer stärkerem Umfang im Handel insbesondere bei Kaufhäusern und Einzelhandelsgeschäften, aber auch im Internet auf Basis der ec-Karte durchsetzt.
Das Gleiche gilt für Bankkundenkarte n mit Geheimzahl. Der abzubuchende Betrag wird dem Kontokorrentkonto des Karteninhabers beleglos belastet.Memento des Poker Rang vom 8. Euro mit der Girocard ausgeführt. Black Sheep Game Provider technischer Netzbetreiber führt die weitere Verarbeitung der durch das Terminal gesammelten Daten durch. Die Parameter im einzelnen:. Natürlich bieten wir Ihnen aber auch das elektronische Lastschriftverfahren an, wenn Sie das wünschen. Cookie Richtlinie. Das Verfahren wurde übrigens inzwischen in girocard-Verfahren umbenannt.
The co-rapporteur is normally not involved in the assessment of a Type II variation application concerning quality, safety and most of the clinical changes within the product information.
The involvement of the co-rapporteur is, however, deemed necessary for new indications and new non-food-producing target species. The Agency will inform the MAH accordingly.
Regarding the submission of a Type II variation application to the co- rapporteurs , please see also 'How and to whom shall I submit my Type II variation application'.
Marketing authorisation holders may choose to group the submission of several Type II variations for the same product into one application, provided that this corresponds to one of the cases listed in Annex III of the Variations Regulation or when this has been agreed previously with the Agency.
It is also possible for a marketing authorisation holder to group a Type II variation with other variation submission e. Such grouped submissions will follow the review procedure of the highest level of variation in the group.
A Type II variation application should contain the elements listed in Annex IV of the Variations Regulation and should be presented in accordance with the appropriate headings and numbering of the dossier format.
The Variations Guidelines further specify which elements should be included in a Type II variation application:. It should be noted that the responsibility for the quality of the submitted documentation lies with the MAH and is crucial to the overall process.
All submissions should be made in accordance with the guideline on e-submissions. For more information, including links to guidance on registration with the system, see the Veterinary eSubmission website.
MAHs are reminded, especially for safety issues, that once new information becomes available which might entail the variation of the MA, MAHs should submit any variation application resulting from the fulfilment of post-authorisation measures recommendations, conditions or specific obligations and periodic safety update reports PSURs at the same time as the fulfilment of the post-authorisation measure or submission of the PSUR, rather than awaiting the assessment of those data by CVMP.
Where the CVMP requests the submission of a variation following the assessment of a PSUR or post-authorisation measure, or following adoption of class- labelling , MAHs must submit the corresponding variation application at the latest within 2 months following the adoption of the relevant assessment conclusion.
Variation applications reflecting the outcome of an Urgent Safety Restriction USR shall be submitted immediately and in any case no later than 15 days after the initiation of the USR to the Agency.
Implementation of agreed wording changes following the above mentioned procedures for which no additional data are submitted by the MAH will follow a Type IB variation procedure.
Upon receipt of a technically valid application, the Agency will perform the validation of the application content. Supplementary information may be requested in order to finalise the validation and the procedure will commence at the next available start date after resolution of issues identified during validation.
The Agency will inform the MAH of the outcome of the validation and timetable. Assessment of Type II variations following a day, day or day timetable will follow the recommended submission dates see also question ' When shall I submit my application?
All standard Type II variations ; i. For variations concerning changes which, in the opinion of the Committee, would benefit from a shortened assessment having regard to the urgency of the matter, in particular for safety issues.
Please note, if the day Type II procedure requires a linguistic review of the product information , this will take place in parallel with the scientific assessment.
Condition: For variations concerning changes to or addition of therapeutic indications , and other variations listed in Part 2 of Annex V of the Variations Regulation.
MAHs are encouraged to contact vet. Where issues are identified which prevent the adoption of an opinion, the CVMP will adopt a request for supplementary information and the MAH will be informed of the deadline for the submission of the requested data.
The clock will be stopped until the receipt of the supplementary information. As a general rule, a clock-stop of up to one month will apply.
Such requests should be sent after receipt of the adopted CVMP request for supplementary information but before the expected submission date for the responses.
In exceptional cases e. For any follow-on request for supplementary information , an additional clock-stop of up to one month will be applied in general; a maximum of two months may be applied when justified.
The CVMP assessment of responses to the request for supplementary information will take up to 60 days for assessment of responses to a list of questions or 30 days for assessment of responses to a list of outstanding issues.
In order to simplify the handling of different versions of the product information , submissions affecting the product information should be whenever possible combined in a grouped variation application, if allowed by grouping rules or if agreed in advance with the Agency.
Once a CVMP opinion has been adopted for a Type II variation , or a Commission decision has been granted in case an immediate EC decision applies, the approved product information can be used as baseline for the product information of any subsequent variations.
The consolidation can be done at the time of any procedural milestone of the subsequent variations e.
Once included, the already approved changes related to a previous variation should appear as clean text in both the clean and highlighted versions of the product information for subsequent variations.
It should be noted that only the new proposed changes related to the subsequent variation should continue to be highlighted in tracked changes during that procedure.
Upon adoption of the CVMP opinion, the Agency will inform the MAH within 15 days as to whether the opinion is favourable or unfavourable including the grounds for the unfavourable outcome , as well as whether the Commission decision granting the marketing authorisation requires any amendments.
Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly.
Where the product information is affected, a linguistic review of the product information changes will be performed. In the event that the only change to the product information concerns deletion of text or a change to numerical characters e.
In all cases, the amended product information in all languages should be provided by the MAH by the date specified in the translation timetable which is provided with the CVMP opinion.
Upon receipt of the final CVMP opinion that requires amendments to the decision granting the marketing authorisation , the Commission shall amend the marketing authorisation to reflect the variation within two months for the variations listed under Article 23 1a a or within one year for the other variations.
See also: 'When do I have to submit revised product information? In all languages? Where a group of variations , submitted as one application, to the terms of one marketing authorisation has been approved, the Commission will update the marketing authorisation with one single decision to cover all the approved variations.
Type II variations listed in Article 23 1a a may only be implemented once the Commission has amended the marketing authorisation and has notified the MAH accordingly.
Variations related to safety issues, including urgent safety restrictions , must be implemented within a timeframe agreed by the MAH and the Agency.
Type II variations which do not require any amendment of the marketing authorisation or which follow a yearly update of the respective Commission decision can be implemented once the MAH has been informed of the favourable outcome by the Agency.
However, it is expected that, where the variation includes changes to the product information , the MAH waits for the finalisation of the linguistic review process by the Agency before implementing the variation , as appropriately checked translations are considered essential for a correct implementation of the variation.
The agreed changes should be included in the product information annexes of any subsequent regulatory procedure. The fee covers all authorised strengths, pharmaceutical forms and presentations of a given medicinal product.
Reduced Type II fees may apply to certain variations. However, in the case of a Type II variation concerning the replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue variation classification C.
The Agency will issue an invoice following the notification of the administrative validation to the applicant and fees will be payable within 30 calendar days of the date of the invoice.
The invoice will be sent to the billing address indicated by the MAH and will contain clear details of the product and procedures involved, the type of fee, the amount of the fee, the bank account to where the fee should be paid and the due date for payment.
The Agency does not accept standalone notifications of purchase order numbers that are not associated with a dossier.
Where the Type II Variation affects. The complete set of Annexes must be presented sequentially i. Page numbering should start with "1" bottom, centre on the title page of Annex I.
The Annexes provided should only reflect the changes introduced by the variations concerned. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts or to align the product information with the latest QRD template, this should be clearly mentioned in the cover letter and in the precise scope section of the application form.
Alternatively, such listing may be provided as a separate annex to the application form. Any changes not listed will not be considered as part of the variation application.
In such cases, and in cases where any other ongoing procedures may affect the product information Annexes, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedures concerned.
For those variations which affect the Annex A e. Any changes in the number of units of veterinary medicinal product will trigger a different EU number.
Differentiation should be made between the addition of a presentation where the two presentations will co-exist on the market on a long-term basis versus a replacement of a presentation where the new presentation will replace the previous one it is expected that for a certain period of time, the two presentations will co-exist on the market until the stock of the previous presentation runs out.
In principle, a replacement of one presentation by another presentation does not trigger a new EU number, unless the number of units of veterinary medicinal product is changed.
Examples of changes in presentations for replacement, not triggering a new EU number this is not an exhaustive list :. In case of addition , as the presentations will co-exist on the market, two packs with different contents cannot be covered by the same EU number and will be considered as different presentations.
Changes in the number of any unit not restricted to the veterinary medicinal product or changes in the specifications of any unit not restricted to the veterinary medicinal product contained in the pack will trigger a new EU number.
An example of a change that would trigger a new EU number is the introduction of an alternative immediate primary packaging made from a different material.
If you have any questions on any upcoming submission, please contact vet. At the time of the adoption of a CVMP opinion for a type II variation which includes additional presentations, the Agency will assign the new EU sub-numbers and include them in the revised Annex A of the veterinary medicinal product , which will be transmitted to the MAH together with the CVMP opinion and respective annexes.
The MAH should include the newly assigned numbers in all language versions of the Annex A and in all applicable sections of the product information , which are submitted following the CVMP opinion for linguistic review.
The published information will include the invented name of the product and the indications. For these variations , the variation assessment report, with all commercially confidential information deleted, will also be published after the adoption of the Commission decision.
The CVMP monthly report following each CVMP meeting provides up-to-date information related to the volume and evaluation of pre- and post-authorisation applications including Type II variations for veterinary medicinal products.
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Garantiert keine Werbung. Jederzeit mit einem Klick abbestellbar. Weitere Begriffe : Exoten Sachmittel Planpreisübersicht.
Praxisnahe Definitionen. Nutzen Sie die jeweilige Begriffserklärung bei Ihrer täglichen Arbeit. Jede Definition ist wesentlich umfangreicher angelegt als in einem gewöhnlichen Glossar.
Fachbegriffe der Volkswirtschaft. Die Volkswirtschaftslehre stellt einen Grossteil der Fachtermini vor, die Sie in diesem Lexikon finden werden.
Viele Begriffe aus der Finanzwelt stehen im Schnittbereich von Betriebswirtschafts- und Volkswirtschaftslehre.
Bestimmte Erklärungen und Begriffsdefinitionen erfreuen sich bei unseren Lesern ganz besonderer Beliebtheit.
Diese werden mehrmals pro Jahr aktualisiert. Cash Flow.