REPORTING OF ADVERSE REACTIONS TO MEDICINAL PRODUCTS
ON-LINE REPORTING OF SUSPECTED ADVERSE DRUG REACTIONS
REPORTING SUSPECTED ADVERSE DRUG REACTIONS ON A PAPER FORM
You may also submit paper ADR reporting form, (link) which you send to the National pharmacovigilance centre at:
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
Sektor za farmakovigilanco
Nacionalni center za farmakovigilanco
Tel: +386 (8) 2000 500
Faks: +386 (8) 2000 510
Treatment with medicinal products also brings risks related to adverse reactions to medicinal products. A perfectly safe medicinal product does not exist. Although the safety of medicinal products is thoroughly examined even before the marketing authorisation may be obtained, some adverse reactions (particularly the rare ones) and some interactions may only be detected when the medicinal product is marketed and is used in regular clinical practice (the effect of genetic factors, longer treatments than in clinical trials, population aspects, etc.). The so-called spontaneous reports (reports submitted directly by healthcare professionals and patients) are one of the ways of monitoring the medicinal product during the entire period of its use. This information and comparison with information from other sources may significantly contribute to the assessment of potential risks.
According to the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14 and 66/19) and Rules on pharmacovigilance of medicinal products for use in human medicine (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 57/14 and 27/17) reporting on suspected adverse drug reactions is mandatory for healthcare professionals. The term suspected adverse reaction is used for reporting and means that suspicion is sufficient for reporting any adverse reaction related to the medicinal product. Healthcare professionals must report to the National pharmacovigilance centre within 15 days of detecting the suspected adverse reaction.
A patient (parents, carers) may also report a suspected adverse reaction, but we advise to contact their physician, pharmacist or other healthcare professional about the suspected adverse reaction. Healthcare professional are obliged to report the suspected adverse reaction to the National pharmacovigilance centre. The physician will also be able to evaluate whether the adverse reaction to the medicinal product requires any actions regarding treatment, and will also submit additional information for evaluation the causal relation with the medicinal product.
Adverse reactions to medicinal products and their frequency are listed in a Summary of product characteristics (detailed information about the medicinal product for healthcare professionals) and in a package leaflet (patient information included in every packaging of the medicinal product). Summaries of product characteristics and package leaflets are published in the Centralna baza zdravil (Medicinal products database). For medicinal products authorised through a centralised procedure (type of the procedure is indicated in the Centralna baza zdravil) this information is available at the EMA website.
Every submitted report is important for the monitoring of medicinal product safety. Please report any suspicion that you or your patient may be experiencing an adverse reaction which might be related to a medicinal product.
For detailed instructions about reporting, see:
How to report a suspected adverse drug reaction
MARKETING AUTHORISATION HOLDER
With the launch of new EudraVigilance System on 22 November 2017, Marketing authorisation holder (MAH) should report ICSRs in line with the simplified reporting rules to EudraVigilance database only. For further details on the launch of new EudraVigilance System please see the JAZMP press release.
Serious ADRs – 15 days
Non-serious ADRs – 90 days
The list of local literature to be reviewed by MAH for the reporting of literature cases
– Zdravniški vestnik (Slovensko zdravniško društvo)
– Farmacevtski vestnik (Slovensko farmacevtsko društvo)
– Medicinski razgledi (Društvo Medicinski razgledi)
– Tavčarjevi dnevi – zbornik (Medicinska fakulteta Ljubljana)
– Simpozij o urgentni medicini – zbornik (Slovensko združenje za urgentno medicino)
– Derčevi dnevi –zbornik (Medicinska fakulteta Ljubljana)
JAZMP does not require a review of the local literature if the medicinal product is not marketed.
A copy of the relevant article should be sent upon request of the JAZMP via e-mail to the e-mail address including the E2B report identification number (EudraVigilance Safety report ID) taking into account copyright restrictions (see GVP Module VI: VI.App.2.10. Electronic submission of copies of articles on suspected adverse reactions published in the medical literature). If the article is available in the EudraVigilance database as an attachement to the report sent in E2B format, sending it to the JAZMP via e-mail is not needed.
MAH should not report the literature cases for the substances from selected literature as published by European Medicines Agency (EMA). For more details on monitoring of medical literature by EMA please see the JAZMP press release.