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

Product Information

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. 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 UK specific concern for public health issues or UK specific conditions e.g. pollen immunotherapy for pollen specific to UK only.

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].

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

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. 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: 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 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 confirm that, based on the results of the study, no urgent safety update of the product information is required

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 MAH intends to apply for a marketing authorisation for a paediatric indication in relation to the product. 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.

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 informationMHRA 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. 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: