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BW690_00_002e_WL Export Certificates (PDF, 480 kB, 03.08.2026)
MU101_20_832e_MB Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway (PDF, 596 kB, 01.08.2026)
ZL112_00_002e_WL Guidance document Notification procedure for veterinary medicinal products (PDF, 276 kB, 01.08.2026)
ZL112_00_002e_FO Form New authorisation by notification procedure veterinary medicinal products (DOCX, 168 kB, 01.08.2026)
ZL102_00_004e_FO Form Recognition of orphan drug status (DOCX, 165 kB, 01.08.2026)
ZL000_00_050e_WL Guidance document Mobile technologies (PDF, 268 kB, 01.08.2026)
ZL000_00_049e_WL Guidance document Involvement of patient organisation in the review of Patient Information (PDF, 356 kB, 01.08.2026)
ZL000_00_042e_WL Guidance document Maintenance and updating of Annex 1 (PDF, 256 kB, 01.08.2026)
ZL000_00_035e_FO Form DMF (DOCX, 169 kB, 01.08.2026)
ZL000_00_035e_WL Guidance document Minimising the risk of TSE (PDF, 243 kB, 01.08.2026)
ZL000_00_032e_WL Guidance document Authorisation of allergen product (PDF, 312 kB, 01.08.2026)
ZL000_00_028e_FO Form Confirmation regarding substances from GMO (DOCX, 153 kB, 01.08.2026)
ZL000_00_017e_WL Guidance document Authorisation of veterinary medicinal products (PDF, 285 kB, 01.08.2026)
ZL000_00_012e_VZ ZL000_00_012e_VZ Directory List countries with comparable control of veterinary medicinal products (PDF, 158 kB, 01.08.2026)
MU103_10_001e_WL Guidance document RMP / ICH E2E – Information for submission of RMP HMP (PDF, 809 kB, 01.08.2026)
MU101_20_001d_FO Meldung einer vermuteten unerwünschten Arzneimittelwirkung (UAW) (DOCX, 191 kB, 01.08.2026)
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