Package Information Leaflet

Administer medicines (RTAs). Reconstitution of parenterals is not always described in the Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL). If so this process may be called reconstitution in excess of the SmPC (see Fig. 1.2). If this is considered to be a variance from the SPmC, it results legally in off-label use and should be supported by evidence, e.g. an appropriate risk assessment including the benefits and evidence about compatibility and a possible longer shelf life (see Sect. 22.6). 

There are many successful examples of compliance packaging in the marketplace. These include oral contraceptives, unit-of-use packaging for steroids, convenience paks, and blister packaging systems that incorporate reminder and information leaflets (the MACPAC). 

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... 

Packaging materieils—drcift or printer s artwork copies of the product s inner label, outer carton, package insert (PI) (for prescription-only products) or patient information leaflet (PIL) (for pharmacy-only and general sales list products). 

C3 Product Label, Outer Carton, Package Insert, Product Information Leaflet ... 

Change of manufacturer s name Major (DRA-3) Letter issued by product owner authorising manufacturer with new name to manufacture the product GMP certificate (if not submitted previously) Amended labels, outer cartons and package insert/patient information leaflet B1... 

Change of existing manufacturer s plant address Major (DRA-3) GMP certificate (if not submitted previously) Plamt layout of new manufacturer Label, carton, package insert or patient information leaflet (if old address of mcmufactur-er is stated) Certificate of analysis for finished product and finished product specifications B2... 

Label, carton and package insert or patient information leaflet... 

Inclusion of new pack size Major (DRA-3) Label, carton and package insert or patient information leaflet for new pack size C2(f)... 

Change of product label, Major carton, package insert or (DI -3) patient information leaflet which does not fall under No. 5.10 5.11 New product label, carton, package insert or patient information leaflet with the chcmges highlighted C3... 

The new regulations will make provision for an information leaflet that is patient oriented and easy to read and understand. The current package insert that accompanies every pack will still have to be made available to prescribing professionals when a product is detailed to them for the first time, or when the insert has been modified. 

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). 

Label, containers and information leaflets (package inserts) shall be inspected and handled by a responsible person. This person shall accurately check the identity, contents and uniformity of the articles against approved originals. 

In licensed medicines this information can be printed on the outer package when there is not enough space on the actual label on the primary container. In many countries it is permitted to include part of the information in a patient information leaflet, as it will often not fit within the label. A reference to such a leaflet should be made in that case. Since 2013 the European Pharmacopoeia (Ph. Eur.) monograph on Pharmaceutical Preparations have made most of... 

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