If products with the same active substance are not available in the UK or the PI changes proposed are not applicable to UK products, no further action will be taken. only interim results from an ongoing study are available which will be assessed later in their totality

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 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. If 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. 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 information 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

Features

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. 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. the MAH intends to apply for a marketing authorisation for a paediatric indication in relation to the product. confirm that, based on the results of the study, no urgent safety update of the product information is required

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. the drug is already licensed in the paediatric population and the study does not provide new PK, efficacy or safety dataIf 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.

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 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. 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. confirm that the application will be submitted within the next 6 months, if not, provide justification for the delay including an estimated date of submissionIf 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: If proposed PI changes are not directly applicable to the UK products, the MHRA may adapt the recommendations and subsequently send requests to UK MAHs for type IB variation, where the UK adapted recommendations will be provided, within 60 days. 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. 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.

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.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: specify the UK procedure number, if available or the type of application this will be submitted under planned timings and the route of submission.