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Pharmacovigilance

What is pharmacovigilance?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.[1]

According to this general definition, the base objectives of European pharmacovigilance legislation are as follows:
→ preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure; and
→ promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.
Thus, pharmacovigilance constitutes an activity which contributes to protecting patient’s and public health.

Who can report suspected adverse reactions?
Anyone can report suspected adverse reactions, for example: patients, legal representatives of patients, carer or healthcare professionals.[2]

What are the minimum criteria for reporting?[2]
→ existence of an identifiable reporter (through name and contact details)
→ an identifiable patient (through initials, date of birth, age, gender)
→ a suspected adverse reaction
→ a suspected medicinal product

How can you report adverse drug reactions for Vim Spectrum’s medicinal products?
Vim Spectrum offers high quality products and monitors constantly the safety of their use. If you wish to report suspected adverse reactions, please choose the appropriate form: the first is for patients, legal representatives of patients, carers and the second for healthcare professionals.[3]

♦  Suspected adverse drug reactions report form for patients (available only in Romanian language)
  Suspected adverse drug reactions report form for healthcare professionals (available only in Romanian language)

By accessing the above links you can download the forms and after you have completed with the most complete information you can mail, fax or e-mail to the Pharmacovigilance Office for the company’s qualified person responsible for pharmacovigilance:

Tivadar Salló
Adress: Corunca no. 409, Postal code 547367, Mureş county, Romania
Phone: 0040 365 430 806
Mobile: 0040 744 621 407
Fax: 0040 265 266 210
E-mail: sallo.tivadar@vimspectrum.ro
or: pharmacovigilance@vimspectrum.ro

[1] European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP): Annex I (Rev 3); London: EMA/876333/2011; Rev 3

[2] European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP): Module VI (Rev 1); London: EMA/873138/2011; Rev 1

[3] Ministry of Health. National Agency for Medicines and Medical Devices: Pharmacovigilance / Report an adverse drug reaction [Internet]. [accessed 28 October 2016]. Available from: http://www.anm.ro/anmdm/med_reactie_adversa.html