Information related to the readability test

(Issued by National Institute of Pharmacy)

On the basis of the decree 30/2005 (VIII. 2) of the Minister of Health on the labeling and patient leaflet of medicinal products for human use, in order to finalize the patient information leaflet, consultation (with the widespread name readability test) must be conducted with the target groups of the patients according to the indication of the medicinal product, in order to have a well readable, unambiguous and easily usable patient information leaflet. The results of this test must be reflected by the text of the patient information leaflet. This (and all the other) requirements of the decree must be met - as regards to the medicinal preparations having already marketing authorization - by the Applicants until December 31, 2010, the latest.

In order to facilitate this, and in order to formulate the expectations of the Hungarian authorities in details, for your kind information the questions of the Applicants sent to the National Institute of Pharmacy between June 1-July 31 of 2009, and the answers of the NIP given to them, and the Bridging Application serving the office work of the Authorities, have been made available. (The Q and A part is available only in Hungarian, Pro-Pharma is glad to help in all the important questions.)

In order to meet the requirements of the decree mentioned above the Applicants have two possibilities:

- the results of the readability tests must be submitted in the form of notification until December 31, 2010, at the latest;

or

- the Bridging Application must be submitted in the form of notification until December 31, 2010.

Documents including the rules relating to the readability tests:

- decree 30/2005 (VIII. 2) of the minister of health on the labeling and patient leaflet of medicinal products for human use,

- European Commission: Guideline on the readability of the labeling and package leaflet of medicinal products for human use. Revision 1, 12 January 2009. ENTFR/F/2SF/jr (2009)D/869.

- European Commission: Guidance concerning consultation with target groups for the package leaflet. May 2006.

- CMDh: Consultation with target patient groups - meeting the requirements of article 59(3) without the need for a full test - recommendations for bridging. Revision 1, April 2009. CMDh/100/2007.