JAZMP
Agency for Medicinal Products and
Medical Devices of the Republic of Slovenia
   
  • About us
    • Mission, Vision, Strategy
    • Board & Committees
    • Facts about the agency
    • Customer Service
    • Organisational structure
    • Integriteta
    • JAZMP 2007-2017
  • Human medicines
    • Description
    • Data on medicinal products
      • Medicinal products database
      • Marketed Medicinal Products
      • List of interchangeable medicinal products
      • List of essential and indispensable medicines
    • Regulatory information
      • Marketing authorisation
      • Mutually Interchangeable Medicinal Products
      • Advertising of medicinal products
      • DIFFERENT LABELLING OF MEDICINAL PRODUCTS
      • Paediatric use
      • Scientific advice
      • INDIVIDUAL DEVIATION FROM THE TERMS OF MARKETING AUTHORISATION (OOS)
      • Exemptions from the application of the sunset clause
      • Issuing of certificates on the quality of medicinal products
      • PARALLEL IMPORT AND DISTRIBUTION OF MEDICINAL PRODUCTS
      • IMPORT OR ENTRY OF MEDICINAL PRODUCTS WITHOUT MARKETING AUTHORISATION
      • THE ISSUANCE OF A MARKETING AUTHORISATION PURSUANT TO ARTICLE 54
    • Product classification
    • ILLICIT DRUGS
    • Pharmacovigilance
      • National pharmacovigilance centre
      • Reporting suspected adverse drug reactions
      • Notifications for Marketing authorisation holders
      • Post-authorisation safety studies
    • Clinical trials and compassionate use of medicinal products
      • Clinical trials of medicinal products
      • Compassionate use of medicinal products
    • Pricing of Medicinal Products
      • Maximum allowed prices of medicinal products (MAP)
      • Exceptional Higher Allowed Prices (EHAP)
    • Health Technology Assessment
    • Corporate donations of medicinal products
    • Forms
    • Zaščitni elementi
      • Načrt uvedbe zaščitnih elementov
      • Pogosta vprašanja in odgovori
      • Gradiva
      • Seznam nacionalnih identifikatorjev s šiframi proizvodov (PC)
  • Veterinary medicines
    • Description
    • Medicinal product information and datasets
      • Lists of medicinal products
      • SPC and PIL texts
      • Medicinal products with temporary marketing authorisation or with entry/import authorisation
      • Essential and indispensable medicinal products
      • Medicinal products on the market
      • ATC(VET) classification
    • Marketing authorisation
      • NATIONAL PROCEDURE
      • MUTUAL RECOGNITION PROCEDURE AND DECENTRALISED PROCEDURE
      • CENTRALISED PROCEDURE
      • HOMOEOPATHIC MEDICINAL PRODUCTS
      • ADVERTISING OF MEDICINAL PRODUCTS
      • USE OF FOREIGN-LANGUAGE-LABELLED PACKAGING WITH A SLOVENE LABEL ATTACHED
      • APPROVAL OF INDIVIDUAL EXCEPTIONS
      • CERTIFICATION OF QUALITY OF MEDICINAL PRODUCTS
    • PARALLEL IMPORT AND PARALLEL DISTRIBUTION
    • Pharmacovigilance
      • Reporting on adverse effects to medicinal products
    • Forms
  • Medical devices
    • General information on Medical devices
      • Legislation
      • Forms
      • Registers and lists
    • Regulativa dejavnosti medicinskih pripomočkov
      • Register proizvajalcev medicinskih pripomočkov s sedežem v RS
      • Register poslovnih subjektov, ki opravljajo promet z medicinskimi pripomočki na debelo
      • Register specializiranih prodajaln, ki opravljajo promet z medicinskimi pripomočki na drobno
    • Registration of medical devices
      • Register of medical devices
    • Certificate of Free Sale
    • Vigilance of medical devices
      • Filed safety notices
      • Reporting of incidents
    • Clinical investigations and performance evaluation studies
    • Information on notified bodies
      • Information on notified bodies ZMedPri
    • Classification of a product as a medical device
    • Information on expert advice
  • Blood, tissues and cells
    • Blood procurement
      • Description
      • Forms
      • Lists
    • Tissues and cells supply
      • Description
      • Forms
      • Register
      • Lists
    • Advanced therapy medicinal products prepared on a non-routine basis
  • Regulation of activities
    • Description
      • Regulation of medical product activities
      • Regulation of active substances
      • Regulation of brokerage
      • Regulation of medical device activity
    • Zakonodaja
    • Forms
    • Registers
    • Lists
    • Obvestila v zvezi s postopki
    • Pristojbine in takse
  • Inspection
    • Manufacturing, marketing, and brokerage of medicinal products and active ingredients
      • Manufacturing of medicinal products and active ingredients
      • Wholesale distribution and brokerage of medicinal products and active ingredients
      • Specialised shops for the retail trade of medicinal products
    • Clinical trials of medicinal products for human use
      • Vprašanja in odgovori
    • Pharmacovigilance of human and veterinary medicinal products
    • Quality defects and recall of medicinal products
    • Market surveillance and reports of violations
      • Obrazec za prijavo kršitve
    • Supervision on the implementation of the Act on Medical Devices
    • Supply of blood, human tissues and cells and hospital exemptions
      • Blood
      • Tissues and cells
      • Hospital exemptions
Home / Medical devices / Vigilance of medical devices / Filed safety notices / 2015

2015

Initiates file downloadVarnostna obvestila v letu 2015.

    • Filed safety notices
      • 2019
      • 2018
      • 2017
      • 2016
      • 2015
    • Reporting of incidents

Jazmp

Javna agencija RS za zdravila in medicinske pripomočke

Slovenčeva ulica 22, 1000 Ljubljana,
tel: +386 (0)8 2000 500,
faks: +386 (0)8 2000 510,
e-pošta: info@jazmp.si

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      © Agency for Medicinal Products and Medical Devices of the Republic of Slovenia 2017

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