How many distributor in rmp
All payout is calculated on the Business Value BV of the product and not on the purchase price. The Business Value BV is a monetary figure assigned to each product and is quoted in terms of rupees.
All deduction will be made on Gross Income. The Amount been retained if any in your ID, for that purchase should happen before the FMP cutoff of the respective month, to get. If the amount has not been utilized by the Distributor, then the Amount will be made Zero and FMP Product of same amount will be sent to the Distributor.
The Product will be sent as per choice of Management. Making the Amount zero or carrying forward the balance to the next month is again up to company's discretion, so we always recommend you to kindly make the purchase from your end before the cut-off. From this detailed explanation, you can clearly understand that the RMP E-Repurchase Family Mart Plan has been specially created to bring out new income opportunities for distributors like you.
The four highly rewarding bonuses on the repurchase ensure rapid payment with the RMP Payment Gateway. Menu de navigation ouvert. Fermer les suggestions Recherche Recherche. Ignorer le carrousel. Qu'est-ce que Scribd? RMP Business Opportunity. Signaler ce document. Enregistrer Enregistrer Rmp Business Opportunity pour plus tard. Titre original : Rmp Business Opportunity. Getting the Best Prices on College Supplies Usually this is when mom and dad begin organizing their childs space and arranging to their faculty jemqm.
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Should this be the case, a revised RMP should be included as part of the regulatory application as it is the responsibility of the MAH to update the RMP whenever new information is being received that have a significant impact on the content of the RMP. An RMP update is expected to be submitted at any time when there is a change in the list of the safety concerns or when there is a new or a significant change in the existing additional pharmacovigilance or additional risk minimisation activities.
For example, a change in study objectives, population, due date of final results, a due date for protocol submission for an imposed study, or addition of a new safety concern in the key messages of the educational materials would be expected to be reflected in an updated RMP with the procedure triggering those changes. The significant changes of the existing additional pharmacovigilance and risk minimisation activities may include removing such activities from the RMP.
An update of the RMP might also be considered when data submitted in the procedure results or is expected to result in changes of routine pharmacovigilance activities beyond adverse reaction reporting and signal detection activities, or of routine risk minimisation activities recommending specific clinical measures to address the risk.
For example, an RMP update might be warranted with a significant change of the plans for annual enhanced safety surveillance routine pharmacovigilance activity , or when monitoring of renal function is added as a recommendation in the Special warnings and precautions for use section 4.
The need to update the plans to evaluate the effectiveness of risk minimisation activities should also be considered with such updates. When an emerging safety issue is still under assessment as defined in GVP Module VI , in particular in the context of a signal or potential risk that could be an important identified risk, an RMP update may be required if the emerging safety issue is confirmed and the important identified or potential risk requires to be added to the list of safety concerns in the RMP.
It is expected that for RMP updates which are consequential to the data provided in a regulatory application, the updated RMP should be provided as part of the same application see also Question 4 below.
However, if an RMP needs to be updated outside any regulatory procedure, this RMP should be submitted as a stand-alone variation. A stand-alone variation for updates of the RMP may be foreseen or requested by the Agency in particular in the following situations:.
It is essential to always strive to conclude the RMP assessment during the procedure i. However, in the situation where additional data and significant further assessment is still necessary, this requires a separate type II variation regardless of whether it is submitted as a stand-alone variation application or part of a grouped application.
All RMP changes are in principle considered as changes to the MA and therefore require the submission of a specific variation. However, when the RMP updates are consequential to the data provided in an application, the updated RMP should be included as part of the same application.
The latter is frequent for type II variations submitted under categories C. In addition, in case of changes to the Annex II conditions either proposed by the MAH or resulting from the assessment, e. Variation classification categories for stand-alone RMP updates. Note : In order for the implementation of pre-agreed RMP changes to be handled as a type IB variation , no additional data should be needed or submitted to support the proposes changes.
Note : Because no specific changes are identified by the variations classification guideline as falling by default into the type IB variation category, the above changes lead to such variation only when they constitute the reason for submitting the updated RMP.
Note : The changes to be implemented must already have been assessed by the Committee s in a previously concluded procedure; only the exact agreed wording is implemented, no additional changes are proposed and no further assessment is required. However, it should be noted that it is rare that an exact wording is pre-agreed and therefore in most cases a type IB or type II variation will be required. Regardless, the MAH should always specify in the submission whether or not the proposed changes have already been assessed, and if so, as part of which procedure.
It is in principle acceptable to take the opportunity of a regulatory application e. It should be noted that one specific type II variation is required for each scope even when submitted together with other major changes as part of a grouped variation application. The same rules apply to the grouping of major RMP changes as to the grouping of any other non clinical type II variations :.
With regard to multiple 'minor changes' which can be assessed as type IB variations if submitted on their own, these do not require a grouped application; instead it is acceptable to include these minor changes as part of one single type IB variation or type II variation without the triggering of additional type IB variation scopes i. This can be submitted as a grouped application of 2 type II variations.
Submission of a final study report for a category 3 study via a type II variation C. Changes to the due date for the provision of the final study report for two category 3 studies in the RMP. This can be submitted as a single type IB variation under category C. On the other hand, a grouped application is generally not acceptable if it creates the risk of postponing the implementation of important safety information in the RMP:. There is only one approved RMP at any time for a medicinal product.
Consequently, any time an updated RMP is approved as part of a procedure e. Therefore, MAHs should carefully consider the planning of RMP submission, to make sure that the approved RMP always contains the most up-to-date information on the pharmacovigilance planning and risk minimisation measures.
Given the content-based requirements for RMP submission, it is expected that there will be only few procedures where an RMP update should be included.
Early discussion with the regulators should facilitate the submission, to avoid unnecessary RMP submissions and assessment; parallel procedures warranting RMP updates should be avoided as much as possible. MAHs are strongly encouraged to streamline RMP amendments and submissions, in co-operation with the EMA for the centrally authorised products , in order to facilitate RMP assessments throughout the product life-cycle.
There are two alternative approaches to the handling of different RMP versions for which the assessment is overlapping, and the MAH should choose the option that facilitates the assessment taking into account anticipated timelines for the finalisation of the procedures.
Whenever separate applications affecting the RMP are submitted in parallel, in order to facilitate the review, it is generally agreed that the MAH initially and whenever appropriate during the procedure submits one joint draft RMP file as a 'working document'.
This single RMP document should include all data consequential to the concerned procedures running in parallel. To facilitate the assessment, the proposed RMP changes should be marked e. If the parallel applications reach the finalisation stage at the same time, the consolidated RMP version will be adopted by the relevant Committee and will become the approved version of the RMP.
If the applications do not reach the finalisation-stage at the same time, at the time of the first opinion for the parallel procedures, the MAH will need to provide for review and approval a final RMP version including only the agreed changes related to the scope of the variation application for which the CHMP is about to adopt an opinion.
The joint RMP 'working document' will continue to be used in the context of the remaining ongoing procedure s. Example: A safety variation is triggered whilst an extension of indication procedure is ongoing, both requiring significant changes in the RMP new safety concern in the new indication ; another safety concern and a new imposed PASS in the safety variation.
Option A: A joint RMP document including changes relevant to both procedures could be submitted with both the responses to the RSI in the extension procedure, and with the initial submission for the safety variation :.
Option B: Alternatively, it might be more appropriate when parallel procedures will follow very different assessment timetables to opt for an approach similar to the handling of parallel procedures with product information changes; the RMP submitted with each procedure should only include the changes related to that procedure:.
This RMP version includes then the changes approved as part of the recently finalised safety variation as clean text as well as the changes related to the extension of indication with track changes.
RMP versions submitted for assessment should be version controlled and dated. However, due to the fact that additional formats are required to facilitate the assessment i. Further details in this regard can be found in section 2. It is generally not necessary to include the annexes as part of the RMP 'working document' unless any of the annexes are actually revised.
If no tracked changes version can be compiled e. In general, any submitted version of the RMP should be based on the latest approved version i. However, sometimes it may be more appropriate to base the next version to be submitted on the latest RMP 'working document' version, especially when several procedures affecting the RMP are ongoing in parallel see Question 7 above.
Regardless, the submitted RMP version should be seen as a draft, until approved. The revised RMP should always get a new version number every time an updated RMP version is submitted for assessment see recommendations on document versioning in the Guidance on the format of the risk management plan RMP in the EU — in integrated format. When relevant, a discussion of the proposed RMP changes should be included in the non- clinical overview addendum.
It should be noted that the provision of a non- clinical overview addendum is mandatory as part of a non- clinical type II variation application which includes a revised RMP regardless of the fact that there may be no impact on the product information.
In this case the non- clinical overview addendum should discuss and justify the proposed RMP changes. On the other hand, a non- clinical overview addendum is never required as part of type IA and type IB variation applications.
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