Germany published the ordinance amending the Pharmacy Operating Regulations and other regulations on 21 September 2026. Most provisions have applied since 22 September 2026; the new on-call availability rules enter into force on 1 January 2027. Public pharmacies now need to update quality management, delivery, shipping, workforce planning and procurement processes.
What pharmacies need to implement
The ordinance amends the Pharmacy Operating Regulations, the German Medicines Price Ordinance and PTA training rules. Owners should treat the changes as one operating programme covering SOPs, responsibilities, training evidence, contracts, transport planning and liquidity. This article is an operational summary, not individual legal advice.
QMS must explicitly cover crisis situations
Section 2a now requires pharmacy QMS procedures for crisis situations, expressly including short-term energy shortages. A robust pharmacy QMS should cover accountability, backup communication, refrigeration and IT failure, power continuity, medicine and workforce shortages, and restart controls.
Pharmacy delivery: connect temperature, advice and evidence
The pharmacy manager must ensure reliable delivery and compliance with medicine-specific temperature requirements until handover. Depending on whether the prescription was available and counselling occurred before dispatch, delivery by pharmaceutical staff may be required. Counselling may also be provided remotely by the pharmacy.
Section 35c: risk-based medicine shipping
Mail-order pharmacies must define risk-based transport planning, packaging and logistics instructions in the QMS. Staff require documented qualification and recurring training. Temperature-sensitive medicines need suitable active or passive cooling, valid monitoring where necessary and a maximum transport time. Delivery through unattended fixed parcel lockers is excluded for cold or cold-chain medicines.
New availability rules from 1 January 2027
The revised Section 23 reorganises emergency and partial emergency service and exemptions. Pharmacies should align opening hours, workforce plans, regional cover and patient information with the decisions of their competent authority.
Rx cash discounts and pharmacy remuneration
The price ordinance now expressly permits customary cash discounts granted in return for payment before the due date. Pharmacies should assess the real euro return after financing cost, fees, product mix and supply reliability, and connect liquidity planning with procurement.
Seven-step implementation checklist
- Assign every amendment to an owner and an SOP.
- Update and test crisis procedures.
- Review delivery counselling, temperature control and handover evidence.
- Qualify products, packaging, routes and providers for shipping.
- Train staff and retain evidence.
- Prepare workforce and opening-hours planning for 2027.
- Model cash discounts against liquidity and total return.
tiger.PHARMA implementation support
tiger.PHARMA turns the new rules into auditable operations: gap analysis, QMS and SOP updates, training plans, delivery and shipping concepts, logistics-provider assessment, and procurement and liquidity models. Discuss your implementation requirements.
FAQ: the 2026 pharmacy rules
When do the changes apply?
Most provisions apply from 22 September 2026. The revised Section 23 on availability enters into force on 1 January 2027.
Does every pharmacy need to change its QMS?
Yes where current procedures do not adequately cover crisis situations, especially short-term energy shortages. Delivery and shipping procedures should also be reviewed.
Are Rx cash discounts generally permitted?
Customary cash discounts granted for payment before the due date are permitted. Each commercial model still requires legal and economic assessment.
Where is the official text?
The complete original PDF is embedded in this article and linked to the Federal Law Gazette.
Official original
Regulatory text in the Federal Law Gazette
The complete ordinance is embedded here as an unmodified PDF.