HP CE278A 78A Original LaserJet Toner Cartridge, Black, Single Pack
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HP CE278A 78A Original LaserJet Toner Cartridge, Black, Single Pack
- Brand: Unbranded
Description
If review of the data is required (when the MAH proposes a PI update or when MHRA concludes after the initial appraisal, that a full assessment is needed to robustly conclude on prospective PI updates), MHRA will notify the MAH to submit the paediatric data within 60 days as a type II variation application (change code C.I.13 - complex type II variations fees will be applicable). The MAH should submit the following: In accordance with the Microsoft Silicon Support Policy, HP does not support or provide drivers for Windows 8 or Windows 7 on products configured with Intel or AMD 7th generation and forward processor The MAHs should state whether as a result of the paediatric study there is a need to update the product information and if there are any urgent safety of efficacy updates to the product information. If one or more of the above criteria are met, the MAH should submit the study report and a short clinical overview including justification why PI changes are not necessary. A variation application will not be requested if MHRA agrees with the MAH’s justification not to update the PI. Limited evaluation of the study data may be undertaken if the MAH provides robust justification that the study data are unlikely to warrant product information ( PI) changes. The MAH will need to state in the cover letter that one or more of the following criteria are met:
HP calculations based on ENERGY STAR® normalised TEC data comparing the HP LaserJet 300/400 series and 500 series monochrome printers introduced in spring 2019. HP 58/59/76/77A/X compared to HP 26A/X, and HP 89A/X/Y compared to HP 87A/X. only interim results from an ongoing study are available which will be assessed later in their totalityIf the proposed PI changes are directly applicable to UK products, if not already submitted, the MHRA will send a request to the UK MAHs to submit a type IB variation within 60 days. HP Inc UK Limited is authorised and regulated by the Financial Conduct Authority (FCA FRN 973346) and acts as a credit intermediary and not a lender, offering credit products provided by a limited number of finance providers. Such credit products may not be suitable for everyone. Borrowing more than you can afford or paying late may negatively impact your financial status and ability to obtain credit. If the study has been submitted to EU, the MAH should provide the final EU Assessment Report when available. Also we are asking the companies to inform us of any urgent safety or efficacy or updates identified during the EU assessment if on-going. If the study has been or will be submitted to the EU, the MAH must provide the final EU assessment report when available and inform us of any urgent safety or efficacy updates identified during the EU assessment if on-going. The final EU outcome (together with cover letter information) will determine further MHRA action e.g. no further action, proceed to variation. the study has been conducted in populations and/or diseases that are not applicable to UK (for example hay fever to specific seasonal pollen found in non-UK countries)
On receipt of the cover letter, MHRA will carry out an initial appraisal of whether an assessment procedure is required at this stage. One of the following may apply: The MAH should state whether the study(ies) have been or will be submitted in the UK as part of a variation/extension or any other application including this paediatric study. If this is the case, the MAH should:confirm that, based on the results of the study, no urgent safety update of the product information is required MHRA will monitor the published Public Assessment Reports ( PAR) of Article 45 PdWS procedures. Once a new PAR is identified, any proposed ( PI) changes and their applicability for UK products with the same active substance will be reviewed. MAHs are not required to submit to the MHRA information on paediatric studies completed by 26 January 2007 and which fall under the remit of Article 45 of Regulation (EC) No 1901/2006 work sharing procedure.
the MAH intends to apply for a marketing authorisation for a paediatric indication in relation to the product. Assessment of the data is not required at this stage and MHRA will maintain records including justification for the decision, e.g. that a regulatory submission to vary the Marketing Authorisation is planned in the next 6 months, the MAH plans to submit the data directly as a variation or any other agreed reason(s) to defer the procedure.
What Version
A short clinical overview clarifying the context of the data, including information on the pharmaceutical formulation used in the study, the existence of a suitable paediatric formulation and if relevant, conditions for an extemporaneous formulation. Regulation 78A(13) and (14) of the Human Medicines Regulations 2012, as inserted by the Human Medicines (Amendment etc.) ( EU Exit) Regulations 2019, requires that holders of a UK marketing authorisation who sponsor a study which involves use in the paediatric population in respect of the medicinal product to which that authorisation relates must submit to the Medicines and Healthcare products Regulatory Agency ( MHRA) results of the study within the period of six months beginning with the day on which the trial ended. A Summary of Product Characteristics/ Patient Leaflet ( SmPC/PL) proposal to update the paediatric information, or when none is considered required, justification that changes are not necessary. the same data have been reviewed in another regulatory procedure by MHRA or another competent authority and the review has not led to PI changes confirm that the application will be submitted within the next 6 months, if not, provide justification for the delay including an estimated date of submission
- Fruugo ID: 258392218-563234582
- EAN: 764486781913
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