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

Forms

ISSUING, VARIATIONS AND RENEWAL OF MARKETING AUTHORISATIONS

Guidelines for Applicants (see: “Electronic Application Form”):
http://ec.europa.eu/health/documents/eudralex/vol-6/index_en.htm
http://esubmission.ema.europa.eu/eaf/index.html

Applicants are requested to follow the instructions regarding formats and other information on submissions for veterinary products and also take notice at new developments that occur in this website:
http://esubmission.ema.europa.eu/tiges/vetesub.htm

IMPORT/ENTRY

Forms are available in Slovene language only: https://www.jazmp.si/veterinarska-zdravila/obrazci/

REPORTING OF ADVERSE EFFECTS

Form for reporting of adverse effects (word)

CLINICAL TRIALS

Forms are available in Slovene language only: https://www.jazmp.si/veterinarska-zdravila/obrazci/ (subheader Klinična preskušanja).

MARKETED MEDICINAL PRODUCTS

Form for submission of data on launch, disruption of medicinal products

CERTIFICATES OF QUALITY OF MEDICINAL PRODUCTS ENTERING THE INTERNATIONAL MARKET

CPP: Obr. 299-10
Statement of licensing status of pharmaceutical products: Obr. 363-07

Details

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