Market-access intelligence for life sciences — a weekly scan of DE, AT and CH regulatory changes, with what each means for pricing, reimbursement and getting paid.
No new binding Austrian rule in this window. The items below are news from 7–13 October plus one catch-up decision from 1 October, each with its date.
Reimbursement mechanics move: tenders, Annex XIIa, and still no AMNOG draft.
The coalition factions revised their amendments to the Notfallreform before the Bundestag vote: tenders for compounded cytostatics at pharmacy level were removed, while the reintroduction of tenders by statutory health insurers for Hilfsmittel stays in the package. The amendments also extend a limited dispensing right for doctors to home visits.
Why it matters: Manufacturers selling medical aids (Hilfsmittel) through homecare providers face renewed price pressure once insurers can tender again. Review contract structures and margins with your German channel partners now.
Sources: PZ: Zyto tenders dropped · PZ, 13 Oct 2026: dispensing right at home visits
The G-BA replaced Annex XIIa of the Pharmaceuticals Directive (AM-RL) following the change to the benefit-assessment rules under the GKV contribution-stabilisation act (BStabG). Not covered in our previous edition.
Why it matters: Annex XIIa feeds into how assessment results are applied in price negotiations. Check whether ongoing or upcoming dossiers are affected by the new version.
Sources: G-BA decision, 1 Oct 2026 (PDF)
The Federal Administrative Court (BVerwG) confirmed that doctors may manufacture medicines for an individual patient, but only with substances that meet recognised pharmaceutical rules.
Why it matters: Relevant for suppliers of starting materials and for companies whose products compete with physician-made preparations: quality rules apply to the doctor as well.
Sources: PZ, 8 Oct 2026
A quiet week; the EUDAMED transition is the date to plan around.
BASG confirmed the first four EUDAMED modules became mandatory on 28 May 2026, after Commission Decision (EU) 2025/2371 triggered a six-month transition under Regulation (EU) 2024/1860.
Why it matters: Austrian manufacturers and authorised representatives should have actor and UDI/device data complete before the transition ends. Confirm the exact date with BASG.
Sources: BASG notice
Swissmedic eases GMP evidence for foreign sites and sets an SMS deadline.
At an extraordinary GMP/GDP round table on 13 August, Swissmedic and industry associations agreed specific solutions on how GMP compliance of foreign manufacturers is assessed in authorisation applications. Swissmedic published the minutes on 9 October as an exception.
Why it matters: Non-Swiss manufacturers planning Swiss filings should read the minutes (German only): they set out what evidence Swissmedic now accepts and should shorten back-and-forth during review.
Sources: Swissmedic, 9 Oct 2026
From 15 November 2026, prior registration of active substances in the EMA Substances Management Services (SMS) database is mandatory for their inclusion in Swiss establishment licences and GMP certificates.
Why it matters: API makers and Swiss licence holders should check SMS entries now; missing entries will block licence and certificate updates.
Sources: Swissmedic, 1 Oct 2026
The consultation on the revision of the Therapeutic Products Act (HMG), including a supervision fee for medical-device manufacturers and importers, ends on 16 October 2026.
Why it matters: Last days to submit input, directly or through industry associations.
After the Council adopted its first-reading position on 28 September, the European Parliament must still approve it in plenary. A law-firm update points to autumn 2026, with November as an indicative month; no date is confirmed.
Why it matters: Keep gap analyses on regulatory data protection and orphan exclusivity running; the formal clock starts with Official Journal publication.
Parliament and Council reached a provisional agreement on 12 May 2026, including resilience criteria in public procurement of critical medicines. We found no confirmation of formal adoption yet.
Why it matters: Generic and essential-medicine suppliers to German hospitals should prepare for tender criteria that reward supply-chain resilience, not just price.
We advise life-sciences companies on pricing, reimbursement and regulatory strategy across Germany, Austria and Switzerland. Book a call to work through what these changes mean for your portfolio.
Book a session →Disclaimer. This digest is prepared by BCA (bcaun.de) for general information only and is not legal advice. Regulatory positions change quickly: every item marked Transition, Watch or In ratification is not settled law, and dates, scope and entry-into-force can shift. Confirm any such item directly with the competent regulator — BfArM, PEI, G-BA or GKV-Spitzenverband in Germany; BASG/AGES in Austria; Swissmedic in Switzerland; the European Commission or EMA at EU level — before acting. This edition covers 7–13 October 2026 and was issued on 13 October 2026.