Prolintane

Prolintane, listed under the German INN spelling “Prolintan,” is included in Anlage 1 to the Arzneimittelverschreibungsverordnung (AMVV). Under § 1 AMVV, medicinal products consisting of, prepared from, or containing prolintane may be dispensed only on a medical, dental, or veterinary prescription; the requirement also covers corresponding salts and hydrates unless otherwise specified. Section 5 exempts qualifying homeopathically manufactured medicinal products when the final-product concentration does not exceed the fourth decimal potency. This AMVV classification concerns medicinal products, which § 1(2) NpSG excludes from that Act's scope; it does not by itself classify prolintane under the BtMG or resolve the treatment of non-medicinal products under the NpSG.

Prolintane is not listed in Annexes 1–8 of the BetmVV-EDI, whose Article 1 controls the substances in Annexes 1–6 together with the specified salts, esters, ethers, carbamates, stereoisomers and preparations. Annex 6, list e, number 315 applies to phenethylamine derivatives whose amino nitrogen is unsubstituted or substituted by alkyl or benzyl groups; unlike numbers 1, 2, 266 and 291, it does not extend that entry to an amino nitrogen incorporated into a cyclic structure. Prolintane's amino nitrogen forms part of a pyrrolidine ring, and no other entry or generic structural class in the annexes covers its verified structure, so prolintane is unscheduled under the BetmVV-EDI. This scheduling classification does not displace separate requirements under Swiss therapeutic-products, customs or product-specific law governing the importation, supply or marketing of a prolintane product.