Archiving of specification documents

In order to standardise document names, the published "Information sheet" (MB) are being replaced by "Guidance documents" (WL). The function and effects of the document are not changed as a result of the name change.

ZL000_00_029e_MB Authorisation of veterinary medicines already authorised in foreign countries (Art. 13 HMG) ZL100_00_001e_MB Explanations regarding Orphan Drugs
ZL101_00_003e_MB Information sheet Authorisation applications for veterinary medicines with a known active pharmaceutical ingredient
ZL101_00_007e_MB Explanation of the procedure with prior notification (PPN)
ZL104_00_001e_MB Explanations relating to the fast-track authorisation procedure
ZL112_00_001d_MB Zulassung / Änderung von Tierarzneimitteln im Meldeverfahren nach Art. 39 VAZV / Art. 10 - 12 VAM
ZL203_00_001f_MB Annonce Non mise sur le marché / Interruption de la distribution Mise sur le marché / reprise de la distribution

In order to standardise document names, the published "Administrative Ordinances" (VV) are being replaced by "Guidance documents" (WL). The function and effects of the document are not changed as a result of the name change.
ZL000_00_010e_VV Time limits for authorisation applications

ZL101_00_001e_VV Instructions Authorisation of human medicines with new active pharmaceutical ingredients and major variations

ZL101_00_002e_VV Administrative Ordinance / Instructions Authorisation of similar biological medicinal products (Biosimilars)

ZL105_00_004e_VV Meetings for applicants held with the Authorisation sector within the authorisation procedure

ZL000_00_001e_VV Instructions Authorisation of human medicinal products already authorised in foreign countries (Art. 13, TPA)

ZL000_00_003d_VV Zulassung von Medizinalgasen

ZL000_00_004d_VV Anleitung Zulassung von wichtigen und selten angewendeten Antidota

ZL000_00_008e_VV Instructions Authorisation of human medicines with known active pharmaceutical ingredients

ZL000_00_005d_VV Anleitung Vereinfachte Zulassung von Allergenpräparaten

ZL000_00_009d_VV Anleitung Zulassung Antiveninen

ZL103_00_001d_VV Zulassung von Husten- und Halsbonbons sowie Pastillen der Abgabekategorie E im Meldeverfahren

ZL302_00_001e_VV Instructions Variations related to quality changes requiring approval

Archiving of the Administrative Ordinance Requirements for product information for human medicinal products

The Administrative Ordinance Requirements for product information for human medicinal products has been archived. The content has been transferred to the Guidance Document Formal requirements and the information sheets Explanations concerning Patient information/Information for healthcare professionals.