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

Product Information

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 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.

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 informationthe 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) confirm that, based on the results of the study, no urgent safety update of the product information 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. 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.

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. 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. Upon finalisation of the EU procedure and availability of the final assessment report, MAHs should submit this to [email protected]. 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.

Changes over time for: Part IIA

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. In line with the regulation, the MAH must submit a cover letter. Suggested cover letter template Suggested cover letter template ( MS Word Document, 41 KB) within 6 months of completion (i.e. date of last visit of last subject undergoing the trial, unless otherwise justified in the protocol) of the concerned paediatric studies to the MHRA in eCTD format to this mailbox: [email protected]. For a paediatric study that is part of a development program including a PIP, a line listing of all relevant studies. 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 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.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.

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 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: 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: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. If the MAH holds other paediatric studies for the same active substance falling under the scope of EU Article 45 of Regulation (EC) No 1901/2006 which have not yet been assessed by a competent authority, these should be submitted along with a clinical overview clarifying the context of the data. 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. 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. specify the UK procedure number, if available or the type of application this will be submitted under planned timings and the route of submission.