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
List of interchangeable medicinal products
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
Forms
Zaščitni elementi
Načrt uvedbe zaščitnih elementov
Pogosta vprašanja in odgovori
Gradiva
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
List of 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
Reporting of incidents
Safety related notifications
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
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
Obvestila
Home
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Veterinary medicines
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Medicinal product information and datasets
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SPC and PIL texts
Please see the SPC, PIL
here
. The documents are in Slovene language.
here. The documents are in Slovene language.here. The documents are in Slovene language.