Submission of applications must use the application form ( MS Word Document, 34 KB) in Word format or the portal form in PDF format. This form is not for changes accompanying a variation. See variations guidance. FDALabel: FDA’s web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods). FDALabel and DailyMed have the same database but have different search functions and different displays of search results. For the similarities and differences between FDALabel and DailyMed see Slides 42-44 in the Prescription Drug Labeling Updates presentation. Changes where we inform you about the change, for which a full application is needed. These may include but are not restricted to: Pediatric Labeling Information Database: Includes labeling recently updated with pediatric use information

You must inform us of all changes to the labelling and PIL of a product if those changes are not part of changes to the SPC. Product information which needs a submission for full assessment and approval must include change codes on the application form. P1 You should include these warnings when making an application to register labelling and/or leaflets with us. Deviations from the proposed wording must be fully justified in your submission. Braille on labelling and in PILs Technology appraisals are a special type of guidance about drugs (and occasionally other types of treatment). If NICE recommends the use of a treatment, the NHS Constitution says that it is your legal right to have it if it is right for your particular circumstances. A separate application must be submitted for each product name. The submission must also include all affected MAs, particularly when a leaflet may be shared across several MAs.Drugs@FDA does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (vaccines, allergenic products, blood and blood products, plasma derivatives, and cellular and gene therapy products) or products not approved by the FDA.

We do not reveal the identity of the complainant to the MA holder unless they are a competitor company. UK regulation inclusion of a liquid medicine in a container-closure system previously used for solid dosage forms not contain personal information that can identify an individual, including names of staff members or digital signatures The complainant and the MA holder both receive a copy of the outcome report, which details the complaint and any action taken. At NICE we do not license medicines - you can find out more about the licensing of medicines at NHS Choices. Unlicensed medicines and 'off-label' useOnce you have received approval from us, you must introduce the changes within 3 to 6 months, unless you have been told to introduce the new information early because of safety reasons. Medication Guides: Includes Medication Guides approved by the Center for Drug Evaluation and Research Yes, our remit is only to decide whether medicines can be made available on the NHS. If we do not recommend a medicine for use on the NHS a private company can still choose whether to provide a medicine or not. Questions that might be useful to ask about medicines