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
CLINICAL TRIALS
- Form A – notification on a clinical trial
- Form B – statement of the principal researcher
- Form C – statement of the responsible person (organization/institution)
- Form D – statement of applicant/sponsor of clinical trial
- Form E – notification on changes
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
- FSC: Obr. 362-08
- Statement of licensing status of pharmaceutical products: Obr. 363-07
- A statement that the medicinal product is manufactured in Slovenia: Obr. 364-07