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TL;DRA T-Rezept (T-prescription) is a special, numbered prescription form required in Germany for medicines containing thalidomide, lenalidomide or pomalidomide. These three substances are teratogenic: they cause severe birth defects. The T-Rezept exists so that they are prescribed only under a controlled distribution system, with a pregnancy-prevention programme behind every prescription.
The regime is narrow and deliberate. Only these three active substances, and their generics, fall under it. A T-Rezept is not a general "special prescription": it is specific to the immunomodulatory drugs (IMiDs) that share thalidomide's teratogenic risk, and it is managed centrally by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) through the T-Register.
The controlling provision is §3a of the Arzneimittelverschreibungsverordnung (AMVV), not the AMG, a distinction worth getting right. §3a Abs. 1 AMVV requires that lenalidomide, pomalidomide and thalidomide be prescribed either on the official numbered BfArM form or as a qualified electronic prescription flagged as a "T-Rezept". The pharmacy side is set in §17 Abs. 2b and 6b of the Apothekenbetriebsordnung (ApBetrO). The BfArM issues the forms, runs the T-Register, and publishes the accompanying announcements.
| Rule | Requirement | Legal basis |
|---|---|---|
| Substances | Only lenalidomide, pomalidomide or thalidomide, and their generics | §3a Abs. 1 AMVV |
| Medicines per form | At most one medicine per T-Rezept | §3a AMVV |
| Validity | Up to six days after the date of issue, or the qualified electronic signature | §3a Abs. 4 AMVV |
| Maximum supply, women of childbearing potential | A four-week supply | §3a Abs. 3 AMVV |
| Maximum supply, all other patients | A twelve-week supply | §3a Abs. 3 AMVV |
| Completeness | The form must be completed fully and correctly; the prescriber confirms the safety conditions | §3a Abs. 2 AMVV |
| Pregnancy prevention | A pregnancy-prevention programme where required, with information materials handed to the patient | §3a Abs. 2 AMVV |
Two figures are the ones most often misremembered. The prescription is valid for six days, not the 28 days of an ordinary prescription, and the maximum quantity depends on the patient: four weeks for a woman of childbearing potential, twelve weeks for everyone else. Only one medicine may be written per form.
Only physicians registered for the T-Register. Under §3a Abs. 5 AMVV the prescriber must hold the medical information materials for the product, commit in writing to the safety requirements set out in its product information, and have the necessary expertise. Forms are requested from the BfArM against an officially certified copy of the medical licence, are personal to the prescriber, and are numbered. The pregnancy-prevention programme sits behind this: for a woman of childbearing potential it requires effective contraception before, during and after treatment and a negative pregnancy test before each prescription, as set out in the product's programme.
No, and conflating the two is a common error. A BtM-Rezept covers Betäubungsmittel, substances listed in the annexes of the Betäubungsmittelgesetz, on a three-part yellow form under the BtMVV. Thalidomide, lenalidomide and pomalidomide are not Betäubungsmittel: they appear in no BtMG annex, and a T-Rezept substance is therefore never dispensed on a BtM-Rezept. The two systems share the idea of a controlled, numbered form issued by the BfArM, but they rest on different law and cover different substances for different reasons: abuse and dependence for the BtM regime, teratogenicity for the T-Rezept.
Whether an article requires a T-Rezept is a legal classification you should not have to reconstruct by hand for every PZN. On pharmazie.com it is a structured field.
One honest limitation: the flag tells you that an article is subject to the T-Rezept requirement, per PZN. It does not reproduce the T-Register workflow, the supply limits or the pregnancy-prevention programme, which live in §3a AMVV and the BfArM materials and remain the authority for how to prescribe and dispense.
