Marketing authorisation
- Cover letter templates (new MA, renewal, variations) in English
- Cover letter templates (new MA, renewal, variations) in Slovenian
- Application forms for obtaining, renewal and variation a marketing authorisation (in English – eAF)
- Application form for obtaining a marketing authorisation for a homeopatic medicinal product (in Slovenian)
- Application form for transfer of a marketing authorisation (in Slovenian)
- Application form for withdrawal of a marketing authorisation (in Slovenian)
- Request form for SI to act as RMS in a decentralised procedure (in English)
- Application form for obtaining the blue-box data (for the centrally authorised medicinal products) (in Slovenian and Engish)
- Form for obtaining a procedure number (national procedures) (in Slovenian)
- Proof of receipt of the documentation (to be signed by JAZMP) (in Slovenian)
- Form for Braille format on packaging (in English)
Forms used in the process of providing of the Package leflet for the blind and partially sighted (in Slovenian only)
- Zahtevek za posredovanje navodila za uporabo v obliki primerni za slepe in slabovidne
- Potrdilo o prejemu zahtevka za posredovanje navodila za uporabo v obliki primerni za slepe in slabovidne
Issuing of certificates on the quality of medicinal products that are entering the international market
- Certificate of a pharmaceutical product (CPP) (Obr. 299-12),
- Statement of licensing status of pharmaceutical products (Obr.363-09).
