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

Product Information

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.

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

Possibly similar services

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. 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 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 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.

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