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Regulatory Affairs European Union

Difficulty in readability testing

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The Difficulty in Readability Testing

Since readability testing became a necessity for better patient understanding of leaflets, there has been a plethora of ways to test a leaflet.   To the outsider, presenting a leaflet to a participant, asking a set of preset questions and recording the responses could appear to be enough to gauge the user friendliness of a Package Leaflet (PL).  However, a simple yes/no dichotomic approach quickly yields an unforeseen variable which can aptly be demonstrated in the following hypothetical situation.

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Change of Access

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Romania - Notice on change of access to information on centrally authorised medicinal products

The NMA hereby informs you on replacement of PDF files in the “Useful Information” section of the main menu, containing the Romanian version of the Summary of Product Characteristics (SPC) of centrally authorised medicinal products, with a table in Excel format including the following data: name of centrally authorised medicinal products, medicinal product registration number in the Community Register of centrally authorised medicinal products and the marketing authorisation holder (MAH).

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NMA of Romania News Flash

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Important notice to the attention of Marketing Authorisation Holders

The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 16th 17th February 2009 (http://www.hma.eu/186.html)


 

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NMA of Romania News Flash

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Romania - Important notice to the attention of Marketing Authorisation Holders

The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 19th and 20th January 2009 (http://www.hma.eu/186.html)

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NMA of Romania News Flash

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Romania - Important notice to the attention of Marketing Authorisation Holders

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- Name of the medicinal product;
- International Non-Proprietary Name (INN) of the active substance contained in the respective medicinal product;

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