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

Product Information

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. 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. For a paediatric study that is part of a development program including a PIP, a line listing of all relevant studies. only interim results from an ongoing study are available which will be assessed later in their totality

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]. 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.UK specific concern for public health issues or UK specific conditions e.g. pollen immunotherapy for pollen specific to UK only. 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. 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 information specify the UK procedure number, if available or the type of application this will be submitted under planned timings and the route of submission.

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 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. 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.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 drug is already licensed in the paediatric population and the study does not provide new PK, efficacy or safety data 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. 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. Upon finalisation of the EU procedure and availability of the final assessment report, MAHs should submit this to [email protected].