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Quality Declaration

In practice:
- New MA legislation
- Substantial changes
- MA Renewal


General regulations from the French authorities (AFSSAPS) :

The Regulation of May 6 2008 concerning the renewal of Marketing Authorizations (MA) emphasizes the content of the first module of the MA report. It establishes that the part 1.3 of this report should contain the following information:

“A resume of the product characteristics, the patient information leaflet and the label as well as the results of the tests carried out on a group of patients, as mentioned in Article R. 5121-148 of the Public Health code, whenever this test has not been conducted before or when the amendments have been done after the time of the last test.”

Submission date of the test in the event of MA renewal
Attention is to be paid to the following:
The MAs which’ expiration date is between May 7 2008 and February 7 2009 (both dates included) are protected during 9 months (1st rule).
Concerning the MAs that expire before July 7 2009, taking into account the material impossibility it might be to conduct the tests before the submission date of the total of the concerned products, the submission date of the test results can be deferred. However, the laboratories should endeavour to provide the test results as fast as possible and this should be no more than 5 months after the submission of the renewal request (2nd rule).
Depending on the MA renewal date, determined before the publication of the regulations, three periods are defined for the calculation of the submission date of the readability tests. These three periods are outlined in the below documents:

Submission date of readability tests in the event of MA renewal
Example of submission date of readability tests in the event of MA renewal

In all cases, the covering letter of the MA renewal request should mention this further submission and the motives for the report. The results of the readability test should then be accompanied by a copy of the covering letter of the MA renewal request.

Furthermore, it is required that the owner of the MA will complete the document with an evaluation of the test results, indicating if any changes have been applied to the leaflet since the request date. This might concern changes related to the test results or to any requirement to modify the information that might have arisen in the meantime.

DPMI will be in charge of this conclusion and will provide you with a final report, ready to submit to the authorities.

The information on this page is mainly taken from the AFSSAPS website.

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