Act No 378/2007 Coll., on pharmaceuticals and on amendments to some related acts (“Act on Pharmaceuticals”) – came into force on December 31. 2007. Title V, section 90 - 96.
Decree No 228/2008 Coll., on the marketing authorisation of medicinal products, as amended; section 14-17.
SUKL guidelines: PHV 3 Non-interventional post-authorisation safety studies with Prescription-Only Medicinal Products for Human Use, PHV 4 Electronic Adverse Drug Reaction Reports and PHV 5 Plan for transfer pharmacovigilance obligations.
Volume 9 of The Rules Governing Medicinal Products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use
Definitions
Definitions stipulated by Act No 378/2007 Coll., on the Amendment of the Act on Pharmaceuticals and on Amendments to Other Acts.
An adverse reaction to a medicinal product shall mean an adverse and unintended response to the product administration which occurs at doses normally used for the prophylaxis, therapy or diagnosis of a disease or for the restoration, correction or other modification of physiological functions; this definition shall not apply to transfusion products. (Section 3, paragraph 4)
A serious adverse reaction shall mean such adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity or is demonstrated as a congenital anomaly or birth defect in offsprings (Section 3, paragraph 4, letter a)
An unexpected adverse reaction to a medicinal product shall mean such adverse reaction, the nature, severity or consequences of which are not consistent with the information laid down in the summary of the product characteristics for an authorised medicinal product or which are not consistent with available information, e.g. the investigator's brochure for a non-authorised investigational medicinal product (Section 3, paragraph 4, letter b)
A Summary of the Product Characteristics (SPC) shall mean a written summary of information about a medicinal product that forms part of the Marketing Authorisation of the medicinal product and that contain information significant for its proper use. (Section 3, paragraph1)
A serious unexpected adverse reaction shall mean such adverse drug reaction (ADR), which meets the criteria of both a serious ADR and an unexpected ADR.
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