Package leaflets

Title V Labelling and package insert Tide V Labelling and package leaflet... 

The draft text of the label and package leaflet (Annex 3). 

Cards, display cards, divisions and liners, packaging leaflets and inserts Laminates... 

If the patient has missed one or several doses there might be a need to overcompensate for the missing doses and to restore steady-state levels fast, but general rules are hard to give. Nowadays, this information is often available in the package leaflet for each medication. The information is also available on EMEA home page (EMEA 2008). Fore many medications there is no recommendation. For some medications like simvastatin, citalopram and atenolol the advice is not to compensate for missing doses. 

Many elderly have vision and co-ordination problems. This is problematic for reading and opening containers and package leaflets pour solutions, dripping eye-drops etcetera. Several aids are commercially available and sold at pharmacies. 

Sometimes a solid oral preparation needs to be divided or crushed. Normally this is not a problem and problems should be written on the package and in the package leaflet. 

Part lA Administrative data, packaging, samples Part IB SPC, package leaflets Part IC Expert reports... 

This working party considers safety-related issues at the request of the CPMP and national authorities, resulting in the harmonization of the summary of produet eharae-teristics and package leaflets of marketed products. Regular videoeonferenees are held with the U.S. Food and Drug Administration (FDA) to discuss issues of mutual interest. A pilot project has been started for the electronic transmission of individual case safety reports with a restricted number of participants from national authorities and marketing authorization holders. 

Council Directive 92/27/EEC of 31 March 1992 on labelling and package leaflets. 

Where an applicant wishes to market a product in more than one Member State, an identical dossier will be sent to all relevant Member States. If an authorisation has not been previously granted, one Member State will be appointed by the applicant to act as RMS who will prepare a draft assessment report with a draft SPC and a draft of the labelling and package leaflet. The CMSs will have the opportunity to review and approve the documents. Therefore, conceptually, the decentralised procedure resembles the centralised procedure without the involvement of CHMP, representing consultation between the Member States before even the first marketing authorisation is granted. 

Under Directive 2004/27/EC, there are various changes to the information to be included on the product label and certain provisions relating to the product s package leaflet. There is also a new requirement for the name of the medicinal product to be expressed in Braille format on the label. For products containing up to three active substances, the legislation specifies that the international non-proprietary name (INN) must also appear on the labelling. The MAH must also ensure that the package leaflet is made... 

European public assessment reports, summaries of product characteristics and package leaflets may be provided to members of the public on request. 

European public assessment reports, summaries of product characteristics and package leaflets for medicines covered by Clause 21.1 above may be included on the Internet and be accessible by members of the public provided that they are not presented in such a way as to be promotional in nature. 

Excipients in the label and package leaflet of medicinal products for human use. In The Rules Governing Medicinal Products in the European Union Guidelines Medicinal Products for Human Use, European Commission, September 1997 3B. 

Changes to package leaflets Modification of type and/or content of contcuner 30,000 12,000... 

MAs are accompeinied by a summary of the characteristics of the product and package leaflet. 

Whenever an application is granted, INFARMED shall send the applicant a copy of the summary of the product characteristics, the labelling and the package leaflet, as they were approved, and the national medicinal product registration number. 

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