Patient information leaflet applications

An application for a marketing authorisation must be accompanied, among other items, by specified pharmaceutical, preclinical and clinical particulars and documents (the dossier ). Three important summary documents in the dossier are the SPC, a Package or Patient Information Leaflet (PIL), and the sales presentation of the product (label). The SPC has a formally prescribed structure (Box 17.1), and forms the basis for authorised chnical prescribing of the medicinal product concerned. 

Part I was a summary of the information presented in the whole dossier and included the application forms and administrative particulars on fees, various declarations and the t)rpe of application as well as particulars of the marketing authorisation (lA), proposed SPC (IBl), proposals for packaging, labels and package or patient information leaflets (IB2), and any SPCs already approved in the Member State(s) for the particular product (IB3). Also included were separate Expert Reports on chemical and pharmaceutical (ICl), pharmacotoxicological (preclinical) (IC2), and chnical documentations (IC3), as... 

The application for a licence for general use (marketing application) should include a draft Summary of Product Characteristics for prescribers. A Patient Information Leaflet must be submitted. These should include information on the form of the product (e.g. tablet, capsule, sustained-release, liquid), its uses, dosage (adults, children, elderly where appropriate), contraindications (strong recommendation), warnings and precautions (less strong), side-effects/ adverse reactions, overdose and how to treat it. 

Draw patient s attention to the patient information leaflet (PIL) and ask if she has any questions. The patient asks should she apply the cream before or after application of her E45 cream. What would be your answer You should advise the patient to apply her steroid cream (the betamethasone valerate cream) first. Allow an hour before applying the emollient (the E45 cream) to prevent the emollient from diluting the steroid cream. 

The site of application for fentanyl patches (an analgesic) depends on the brand of product used. Read the individual patient information leaflet for more details. 

The final section of the application usually contains data on the patient information leaflet (PIL), labelling, instructions for use and packaging of the final product. These data are read carefully to ensure the patient receives clear and unambiguous information. 

Module I is specific to the region in which the application is made (the EU in this case) and is, technically, not part of the CTD. It contains regional administrative information, a submission table of contents, the SmPC (i.e. the draft package insert), the patient information leaflet (PIL) (if any) and translation of the labeling into all relevant languages (in the case of a CP application this is now required in 22 languages). 

For a medicinal product classified for supply without a medical prescription, the proposed product label and leaflet are important elements of the application and will be closely examined for comprehensive information and effectiveness in protecting patients from any safety hazards. 

Non-promotional information for patients and the general public Subject to any applicable national laws and regulations, websites may include non-promotional information for patients and the general public on products distributed by the company (including information on their indications, side effects, interactions with other medicines, proper use, reports of clinical research, etc.), provided that such information is balanced, accurate and consistent with the approved summary of product characteristics (SPC). For each product that is discussed, the website must contain full, unedited copies of the current SPC and patient leaflet. These documents should be posted in conjunction with other information about the products or be connected with that discussion by a prominent link advising the reader to consult them. In addition, the website may provide a link to the full, unedited copy of any public assessment report issued by the Committee for Medicinal Products for Human Use or a relevant national competent authority. Brand names should be accompanied by recommended international non-proprietary names (rINNs). 

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