Unless the marketing authorisation specifies further duties as referred to in Section 32, paragraph 3 or 4, the marketing authorisation holder shall submit to the Institute Periodic Safety Update Reports, either forthwith upon request or at least every six months following authorisation, until the placing on the market. The Periodic Safety Update Reports shall be, furthermore, submitted forthwith upon request or at least every six months in the first two years following the initial placing on the market and once a year for the following two years. Thereafter, these reports shall be submitted in three-year intervals or forthwith upon the Institute's request.
The Periodic Safety Update Reports contain a scientific evaluation of the risk-benefit ratio of the medicinal product. For the purposes of cooperation within the Community, the Institute may change the data and periods for the submission of these reports. (Section 92, paragraph 7 of Act No 378/2007 Coll.).
For detailed guidance on submission of a Periodic Safety Update Report please refer to Volume 9A of The Rules Governing Medicinal Products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use, item 6, Requirements for Periodic Safety Update Reports (pp. 67- 86).
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