Ref.no 2712/ /2010. Guideline of the National Agency for Medicines 1/2005

Size: px

Start display at page:

Download "Ref.no 2712/ /2010. Guideline of the National Agency for Medicines 1/2005"

Brianne Robertson
5 years ago
Views:

1 Guideline 2/ (5) Ref.no 2712/ /2010 Reporting of adverse drug reactions Unofficial translation Target groups Persons authorised to prescribe or supply drugs Period of validity The guideline will enter into force on 1 January 2011 and shall be valid until further notice. Provision to be repealed Guideline of the National Agency for Medicines 1/2005 Lääkealan turvallisuus- ja kehittämiskeskus Säkerhets- och utvecklingscentret för läkemedelsområdet Finnish Medicines Agency Mannerheimintie 103b, Helsinki, Finland P.O. Box 55, Helsinki,Finland Tel kirjaamo@fimea.fi Business ID

2 2 (5) Guideline Reporting of adverse drug reactions The Finnish Medicines Agency (Fimea) maintains a national register of adverse reactions to drugs. The register of adverse reactions to drugs is stipulated on in section 30 of the Medicines Act (395/1987) as well as in the Act (556/1989) and Decree (774/1989) on National Personal Records Kept under the Health Care System. The register of adverse reactions to vaccines maintained by the National Institute for Health and Welfare is stipulated on in section 12 b of the Communicable Diseases Act (583/1986). Adverse reaction means a harmful and unintended response to a medicinal product occurring at doses normally used in man for the prophylaxis, diagnosis or treatment of disease or for the restoration, correction or modification of a physiological function. Persons authorised to prescribe or supply drugs are advised to report to Fimea any adverse reaction they find or suspect in association with the use of drugs, in the following cases in particular: when the use of a drug is suspected of having caused, or is found to have caused a serious adverse reaction. These include reactions which have caused a death been life-threatening required in-patient hospitalisation or prolongation of existing hospitalisation resulted in permanent or significant disability or incapacity, or resulted in a congenital anomaly/birth defect when the use of a drug is suspected of having caused, or is found to have caused a harmful interaction with another drug when the adverse reaction is unexpected (its nature or seriousness is not consistent with the summary of product characteristics of the drug) when the adverse reaction is caused or suspected to have been caused by a new drug that has been on the market for less than two years when, according to the person reporting the adverse reaction, its frequency appears to be increasing

3 3 (5) Contents of a report of an adverse reaction The person reporting an adverse reaction should ensure that he or she is able to submit, if necessary, information and additional details that may be required for an evaluation of the case reported. The following information is required for the evaluation of an adverse reaction: description of the adverse reaction: symptoms, diagnosis, examinations to determine the case and any treatments suspected drug or medication: dose, method of administration, date of initiation and discontinuation of medication, therapeutic indication, other concomitant medication patient data: identifiable/traceable person (age, sex, social security number), health condition before initiation of medical treatment, other illnesses and familial predisposition, other risk factors course of the event: duration of the adverse reaction, hospital treatment, recovery, effect of the discontinuation or re-commencement of the drug or medication on the adverse reaction identification information of person reporting the adverse reaction: the person authorised to prescribe or supply drugs must be identified product trade name and batch number in biological products The person reporting the adverse reaction should ensure that, in particular, severe, medically significant adverse reactions can be associated with a specific patient in order to identify the same reaction if it is reported in several different sources. It is recommended that reports on adverse reactions be submitted by using the electronic form on Fimea s website ( or the PDF form, which can be printed out, or the form designed for that purpose Ilmoitus epäillystä lääkkeen haittavaikutuksesta (No 720), which, including reply envelope, can be ordered through Edita Prima Plc. Under section 12 b of the Communicable Diseases Act (583/1986), health care professionals must report all diagnosed or suspected adverse reactions to a vaccine that come to their knowledge to the National Institute for Health and Welfare (THL) by using the form Ilmoitus epäillystä rokotuksen haittavaikutuksesta, which can printed out from THL s website. The form is available at Fimea will forward the details of all reports of adverse reactions received to the marketing authorisation holder of the suspected drug, the World Health Organization s (WHO) Register of Adverse Reactions and of all serious adverse reactions also to the European Medicines Agency (EMEA).

4 4 (5) Entry into force This normative guideline enters into force on 1 January Director General Sinikka Rajaniemi Head of Unit Kirsti Villikka

5 5 (5) Distribution Persons authorised to prescribe or supply drugs For information Ministry of Social Affairs and Health Pharmaceutical goods wholesalers Central Organisation of Health and Food Trade in Finland Pharma Industry Finland Finnish Generic Pharmaceutical Association Pharmaceutical Information Centre Finnish Parallel Drug Importers Foundation University of Helsinki Pharmacy University of Eastern Finland Pharmacy Social Insurance Institution University of Helsinki, Faculty of Pharmacy University of Helsinki, Faculty of Medicine University of Eastern Finland, Faculty of Health Sciences University of Oulu, Faculty of Medicine University of Tampere, Faculty of Medicine University of Turku, Faculty of Medicine Åbo Akademi, Department of Biochemistry and Pharmacy Association of Finnish Pharmacies Finnish Pharmacists Association Finnish Dental Association Finnish Medical Association Finnish Nurses Association Finnish Medical Society Duodecim Finnish Pharmacists Society Poison Information Centre Finnish Pharmaceutical Insurance Pool

This Administrative regulation will come into force on 1 st August 2013 and will remain so until further notice.

This Administrative regulation will come into force on 1 st August 2013 and will remain so until further notice. Administrative regulation 01.08.2013 Dnro 4000/03.01.01/2012 2/2013 UNOFFICIAL TRANSLATION Finnish Medicines Agency Administrative Regulation APPLYING FOR AND MAINTAINING A MARKETING AUTHORI- SATION AND