HP CE278A 78A Original LaserJet Toner Cartridge, Black, Single Pack

Product Information

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.

MHRA will also consider the outcome of CMDh paediatric work-sharing procedures ( PdWS) reviewed under Article 45 of Regulation (EC) No 1901/2006 (as amended). If required, MHRA will request updates to the product information ( PI) for UK Marketing Authorisations. 1. Submission of informationMAHs 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. If the MAH is unable to submit the type II variation within the 60-day timeframe, they must justify the delay and propose a new submission date. 3. Studies remaining within EU framework If this is the case, the MAH should provide the study title(s) with approximate date of completion. If the study(ies) relate to a UK PIP, the MAH should provide the PIP number. 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.

only interim results from an ongoing study are available which will be assessed later in their totality 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. 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. The MAH should state whether the study(ies) have been submitted for assessment as an EU PdWS procedure under Article 46 of Reg. 1901/2006.specify the UK procedure number, if available or the type of application this will be submitted under planned timings and the route of submission. 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. The MAH should indicate whether the study(ies) are linked to other paediatric studies which have been or will be the subject of other submissions under Regulation 78A of the Human Medicines Regulations 2012, as inserted by the Human Medicines (Amendment etc.) ( EU Exit) Regulations 2019.

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 results of a paediatric study have been submitted to EMA or CMDh under Article 46 of Regulation (EC) 1901/2006 before 1 January 2021 or a decentralised procedure the process will remain within the EU assessment framework and no UK equivalent procedure will be initiated unless the MAH indicates that an urgent safety update of the product information ( PI) is required. 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.The Micro Fine 78A Toner provides highly accurate placement and control to ensure consistently sharp text and smooth grayscales while HP’s Smart Print Technology makes automatic adjustments to optimize print quality and enhance reliability. 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.

For a paediatric study that is part of a development program including a PIP, a line listing of all relevant studies. the study, due to its design, limited number of paediatric patients, discontinuation or other reason does not allow drawing conclusions on efficacy or safety that would impact on the drug’s benefit:risk ratio or be useful to prescribers and patients

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: 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