Reporting adverse effects of medicinal products having marketing authorisation (Spontaneous report of adverse effects)
Physician, pharmacist
Physician prescribing the medicine or pharmacist handing out the medicine have to report the suspicion or the fact of severe or adverse effects of a medicinal product immediately or at least within 15 days to the National Institute of Pharmacy. The report should be made on the announcement sheet – „yellow sheet” - brought into service by the National Institute of Pharmacy (download from the website of NIP), however it also may be reported by letter (Országos Gyógyszerészeti Intézet, 1372 Budapest, Pf. 450), by fax (+36-1-88-69-472) or by email in light of personal rights (adr.box@ogyi.hu).
Report is valid only if it contains the following information: 1. identification of th announcer, 2. identification of the patient (name or monogram + birth date or age + sex), 3. suspected medicinal product, 4. supposed adverse effect. In the couse of the fact the report to be the most valuable the above mentioned data should be completed with some other pieces of information (medicines given simultaneously, treatment, conditions of time of appearance of the adverse effects, disease, dependence of an effect upon a cause, outcome of the adverse effect, etc.).
Report is valid only if it contains the following information: 1. identification of th announcer, 2. identification of the patient (name or monogram + birth date or age + sex), 3. suspected medicinal product, 4. supposed adverse effect. In the couse of the fact the report to be the most valuable the above mentioned data should be completed with some other pieces of information (medicines given simultaneously, treatment, conditions of time of appearance of the adverse effects, disease, dependence of an effect upon a cause, outcome of the adverse effect, etc.).
Marketing Authorisation Holder
A properly qualified expert (qualified person of pharmacovigilance) must be interested in collecting, assessing and announcing the supposed adverse effects towards the National Institute of Pharmacy concerning the medicinal product that is the marketing authorisation holder of. They should be in contact and cooperation with the National Institute of Pharmacy personally or through a delegate.
They have to keep records of all adverse effects having been coming to their knowledge, independently of the fact if they have been experienced in Hungary or in any foreign country. This activity has to be extended to monitoring of determinant elements of the risk-benefit rate of the medicinal product (inappropriate use, abuse, results of non-clinical and clinical trials).
The serious adverse effects have to be reported electronically immediately – or not later than within 15 calendar days - to the National Insitute of Pharmacy independently of their expected or non-expected nature.
All non-clinical, clinical or information from other publications which may have an influence on the estimation of the risk-benefit rate of a medicinal product have to be reported immediately to the National Institute of Pharmacy.
The above mentioned facts and other (Hungarian or foreign) adverse effects have to be included in the Periodic Safety Update Report by the Marketing Authorisation Holder.
They have to keep records of all adverse effects having been coming to their knowledge, independently of the fact if they have been experienced in Hungary or in any foreign country. This activity has to be extended to monitoring of determinant elements of the risk-benefit rate of the medicinal product (inappropriate use, abuse, results of non-clinical and clinical trials).
The serious adverse effects have to be reported electronically immediately – or not later than within 15 calendar days - to the National Insitute of Pharmacy independently of their expected or non-expected nature.
All non-clinical, clinical or information from other publications which may have an influence on the estimation of the risk-benefit rate of a medicinal product have to be reported immediately to the National Institute of Pharmacy.
The above mentioned facts and other (Hungarian or foreign) adverse effects have to be included in the Periodic Safety Update Report by the Marketing Authorisation Holder.
National Institute of Pharmacy
The announcements are judged and assessed and the appropriate actions are taken by the National Institute of Pharmacy.
The announcer, the Marketing Authorisation Holder and the EMEA (European Medicines Agency) are informed about the reports and the following actions by the National Institute of Pharmacy.
One copy of the reports on adverse effects and on any suspected adverse effects concerning immunological preparations are sent to the National Center for Epidemiology.
Participants in health provision (National Publications, NIP Publications, Official Gazette) are all being informed about the result of a report and the necessary actions.
The announcer, the Marketing Authorisation Holder and the EMEA (European Medicines Agency) are informed about the reports and the following actions by the National Institute of Pharmacy.
One copy of the reports on adverse effects and on any suspected adverse effects concerning immunological preparations are sent to the National Center for Epidemiology.
Participants in health provision (National Publications, NIP Publications, Official Gazette) are all being informed about the result of a report and the necessary actions.
