If a healthcare professional wants to prescribe an unlicensed medicine, or a licensed medicine off-label, they must follow their professional guide, for example for doctors the General Medical Council's good practice guidelines. These include giving information about the treatment and discussing the possible benefits and harms so that the person has enough information to decide whether or not to have the treatment. This is called giving informed consent. Accessing drugs and medicines recommended by a technology appraisal

Investigations are usually completed in 30 days. It may take longer if the case requires detailed discussion or statutory action. Medication Guides: Includes Medication Guides approved by the Center for Drug Evaluation and ResearchPediatric Labeling Information Database: Includes labeling recently updated with pediatric use information If the proposed changes don’t need to be submitted for full assessment you must register the changes using the notification scheme. Product information which needs a submission for full assessment and approval must include change codes on the application form. P1 You should use the letters CD in an inverted triangle if your product is a controlled drug. This isn’t compulsory but we encourage you to include this mark on your product’s labelling.

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. Drug Safety-Related Labeling Changes Database: Includes recent updates to safety information in labeling including labeling changes from efficacy supplements and labeling supplement approvals. These labeling changes include changes:The first thing to do is to discuss with your healthcare professional whether the treatment is right for you. If they think it is but you are still unable to obtain it, you should speak to the Patient Advice and Liaison Service (PALS) in your local NHS trust if you are being treated by hospital services. Speak to PALS in your local clinical commissioning group (also known as a CCG) if you are being treated by community services. If you are being treated in primary care, for example in a GP or dental surgery, you will need to ask NHS England for advice.

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. Changes where we inform you about the change, for which a full application is needed. These may include but are not restricted to: 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

Changes to PILs which include significant changes to content and/or design and layout and must show continued compliance with user testing or bridging data. Changes to the leaflet in line with article 62 (allowing a MA holder to include extra statutory information on the label and in the PIL) also fall into this category. P3 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. Medicines can be prescribed if they don't have a licence (unlicensed) or for 'off-label' use. Off-label means that the person prescribing the medicine wants to use it in a different way than that stated in its licence. This could mean using the medicine for a different condition or a different group of patients, or it could mean a change in the dose or that the medicine is taken in a different way. Once you have done this, you should discuss with your healthcare professional how to make a complaint about the organisation not providing you with the treatment (see making a complaint). Can I still get access to a medicine privately if NICE has not recommended it for use in the NHS?

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. inclusion of a liquid medicine in a container-closure system previously used for solid dosage forms Once 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. 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.We do not reveal the identity of the complainant to the MA holder unless they are a competitor company. UK regulation Evidence summaries explain whether a medicine has a licence and, if it does, what the licence covers. Our evidence summaries provide an overview of the best evidence that is available about specific medicines. They also give general information about: 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.