Codeine

Codeine (codeïne) is listed in Lijst I of the Dutch Opiumwet. Article 2 prohibits importing or exporting, preparing, processing, selling, supplying, transporting, possessing, and manufacturing Lijst I substances. The Opiumwetbesluit exempts preparations containing no more than 0.5 mg codeine per gram or millilitre and no other Lijst I substance from the sale and possession prohibitions.

Argentina lists codeine, identified as 3-methylmorphine, among narcotic drugs in Lista II. The resolution also includes the listed substance’s isomers and salts where they can exist.

Japan treats codeine as a narcotic under the Narcotics and Psychotropics Control Act. The Act excludes products containing no more than 1% codeine or dihydrocodeine, where no other listed narcotic or cannabis is present, from that definition.

The current official consolidated Cap. 101 record is marked In Force, has point-in-time/publication date 6 June 2025, and lists amendments through L.N. 97 of 2025. Its First Schedule expressly lists CODEINE in Part II, with isomers and salts; Part III paragraph 1 exempts only multi-ingredient preparations at or below 100 mg per dosage unit and 2.5% in undivided preparations. The Medicines Authority states that product classification is determined during marketing authorisation and depends on the specific product. Its database records Solpadeine Capsules (paracetamol 500 mg/codeine phosphate hemihydrate 8 mg/caffeine 30 mg) as OTC and authorised on 03/06/2025, while Solpadeine Soluble Tablets with the same active ingredients and 8 mg codeine are POM and authorised on 20/01/2026. For a controlled, non-exempt preparation, S.L. 101.02 rule 6 requires the official controlled prescription and that the drug be required for medical treatment; rule 8 generally requires a control card, bars dispensing without one, and permits only a marked urgent prescription for no more than seven days with notification within 48 hours. The Medicines Authority's codeine circular likewise states that Maltese codeine medicines are either prescription-only or OTC depending on the authorised indication. Article 22 of the current Cap. 101 framework applies penalties to offences against the Ordinance: Criminal Court life imprisonment for dealing or possession not for exclusive use (with a statutory alternative of 4-30 years and a EUR 2,329.37-116,468.67 fine where the proviso applies), 12 months-10 years plus EUR 465.87-23,293.73 for other offences; Magistrates Court 6 months-10 years plus EUR 465.87-11,646.87 for dealing or non-exclusive-use possession, and 3-12 months or EUR 465.87-2,329.37 or both for other offences. These penalties apply to unlawful conduct involving controlled, non-exempt codeine, not to exempt authorised medicines.

Codeine is entered in Norway’s narcotics list as N II+III. The regulation applies to manufacture, sale, import, export, dispensing, storage, possession, and use of narcotics.

South Korea’s Narcotics Control Act Enforcement Rule specifies exempt narcotic preparations containing codeine. The exemption requires, among other conditions, no more than 1 g of codeine base per 100 g and no more than 20 mg per dose, with three or more non-narcotic active ingredients.

Codeine is listed in Table II, List No. 1 of Ukraine’s national list of narcotic drugs, psychotropic substances and precursors, which classifies it as a narcotic drug whose circulation is restricted. Preparations containing no more than 100 mg of codeine per dosage unit and no more than 2.5 percent in undivided preparations are placed in Table III, List No. 1, under which exceptions from some control measures are permitted. Medicinal products containing codeine are dispensed by prescription under Ministry of Health Order No. 360.

Since February 1, 2018, all codeine-containing preparations require a prescription. Pure codeine products are classified as Schedule 8 (Controlled Drug), meaning possession without authority is illegal and subject to the strictest regulation. Prior to this date, lower-dose preparations were available over-the-counter.

Codeine is listed in Anhang II of the Suchtgiftverordnung. Pharmaceutical preparations containing codeine with non-narcotic ingredients are placed in Anhang III when they contain no more than 100 mg per dose or 2.5% in undivided preparations.

Brazil lists codeine in Lista A2 of the controlled-substances lists under Portaria SVS/MS nº 344/1998. Qualifying low-strength preparations are sold only on a special prescription retained by the pharmacy.

Chile lists codeine in Lista II of the Reglamento de Estupefacientes. Codeine products up to 10 mg per administration unit in combination require an ordinary medical prescription; products above 10 mg and below 60 mg require a retained prescription, and products of 60 mg or more require a cheque prescription.

Codeine is listed as a medical narcotic drug in China’s Medical Narcotic Drugs Catalogue (2025 edition), which applies from publication. The Regulation for the Control of Narcotic Drugs and Psychotropic Substances permits research, production, trade, use, storage, and transport only as it provides, and prohibits retail sale of narcotic drugs. Only physicians granted narcotic-drug prescribing qualifications may issue prescriptions in their medical institutions. Compound oral liquid preparations containing codeine, including oral solutions and syrups, are separately listed as Class II psychotropic drugs.

The current controlled-drug order K.D.P. 367/2025, published 5 December 2025, replaced the Law's First Schedule and expressly lists Codeine in Part II (Class B). The operative 1979 regulations list Codeine in their Second Schedule; their First Schedule preparation exemption names acetyldihydrocodeine and nicodicodine, not codeine, while Second Schedule paragraph 5 covers preparations containing Second Schedule substances unless they are First Schedule preparations. Regulations 6(2)-(3), 9(2), 11 and 12 provide the medical/prescription route: doctors or dentists may administer Second Schedule drugs, others may administer them on a doctor's or dentist's instructions, possession for medical purposes is permitted according to those directions, and a supplier may dispense a controlled drug other than a First Schedule drug only against a compliant prescription. The official 2023 mandatory-prescription product table lists Codeine Phosphate Tablet 30 mg and also a 2 mg-per-dose Dulsana with Codeine liquid as subject to medical prescription under the narcotics legislation, confirming that low-dose/formulated codeine is not a general OTC solid-dose entitlement in Cyprus. Import, unlicensed supply, and possession remain prohibited subject to the statutory professional/prescription exceptions. For Class B drugs, the Third Schedule provides up to 8 years' imprisonment or a fine (or both) for section 5(2) supply/production and section 6(2) possession offenses; section 30 caps imprisonment at two years for a qualifying under-25 first-offender personal-use case. Licensed products may have different directions or pack conditions.

Estonia's current schedule expressly lists codeine in Schedule III, while pure codeine receives special accounting. NPALS § 4(9) requires Schedule III substances and medicines containing them to be dispensed only on a medical or veterinary prescription. Separately, the State Agency of Medicines announced that all codeine-containing medicines became prescription medicines on 1 January 2023 because of misuse and dependence risks. The schedule's § 3(2) medicinal-preparation exclusions mean the narcotic classification is formulation- and use-specific; they do not restore OTC access, because the medicines agency's later prescription classification is broader. Unauthorized small-quantity use/acquisition/possession is a misdemeanour (up to 300 fine units or detention; a fine unit is currently EUR 8), while trafficking-intent/systematic small-quantity conduct and large-quantity handling are criminal offences under §§ 183-184. The schedule wording effective 14 August 2026 lists codeine in Schedule III.

Codeine is listed in Anlage III of the Betäubungsmittelgesetz as a marketable and prescribable narcotic drug. Preparations containing no other scheduled substance and no more than 2.5% codeine or 100 mg per divided dose are excepted, subject to special rules when prescribed to persons dependent on narcotics or alcohol.

Codeine (CAS 76-57-3) is a Schedule II controlled narcotic in Latvia. Schedule II permits medical and scientific use, and medicines containing Schedule II substances are dispensed to patients only on prescription. Unauthorised manufacture, acquisition, possession, transport, dispatch, and sale are criminal offences; the schedule sets 0.2 g as the small-amount threshold and 10 g as the large-amount threshold.

Regulated under national narcotic control legislation. Specific scheduling varies by formulation and concentration.

Codeine is listed as a narcotic in Lista II of the Single Convention schedules ratified by Spain, and Ley 17/1967 treats substances in Lists I and II as narcotics. Spanish law allows narcotics only for authorized industrial, therapeutic, scientific, or teaching uses, and narcotic preparations may be dispensed to the public only by legally established pharmacies on a clinician's prescription. Qualifying combination preparations containing no more than 100 mg of codeine per dosage unit and no more than 2.5% in undivided preparations fall within the Convention's Lista III but remain prescription medicines in Spain.

Regulated under national narcotic control laws. Prescription required for codeine-containing products.

Codeine and codeine phosphate are listed by the Turkish Medicines and Medical Devices Agency as raw materials for magistral prescriptions subject to a red prescription. The list, updated on 7 August 2024, permits at most 1,000 mg of codeine or 1,400 mg of codeine phosphate on one red prescription. Law No. 2313 confines retail sale of controlled narcotic substances to pharmacies and requires a prescription.

Pure codeine is Schedule II under the Controlled Substances Act. Certain combination formulations are classified as Schedule III or V depending on concentration. Some low-dose polysubstance products are available over-the-counter.

Bulgaria permits regulated non-prescription sale of certain authorized combination medicines containing codeine phosphate. The Bulgarian Drug Agency's list current to 14 May 2026 includes Paracofdal tablets and classifies them as non-prescription for adults and children over 14. The authorization is product- and age-specific.

Codeine is a Schedule I controlled substance. However, low-concentration combination products remain available over-the-counter, including formulations containing 8 mg codeine combined with caffeine and paracetamol.

Codeine is listed in List C of Denmark’s Bekendtgørelse om euforiserende stoffer, in force from 29 March 2026. Unprepared codeine is controlled for medical or scientific use, and receipt and possession are limited to authorized recipients, including patients supplied under a prescription. Dosage-unit preparations containing no more than 0.1 g of a List C substance, and other preparations containing no more than 2.5%, are excluded from the order’s controlled-drug definition; Denmark’s official medicines register lists a 9.6 mg codeine/acetylsalicylic-acid product as HA18, meaning pharmacy-only over-the-counter supply to adults subject to package limits.

Codeine and its salts are Schedule 2 controlled drugs under the Misuse of Drugs Regulations 2017, while qualifying non-injectable compounded preparations containing no more than 100 mg of codeine base per dosage unit and no more than 2.5% in undivided preparations fall within Schedule 5. Production and supply of controlled drugs are prohibited unless authorised by the Regulations, but Schedule 5 preparations are exempt from the general import and export prohibition and are subject to fewer record-keeping controls. Some authorised low-dose codeine medicines are available without prescription through pharmacies only, while other products or pack sizes require a prescription.

Codeine is listed in List II of Lithuania’s narcotic and psychotropic substance lists, which covers controlled substances permitted for medical use. The State Medicines Control Agency records an authorised 500 mg/8 mg/30 mg paracetamol/codeine/caffeine product as nonprescription, so low-dose codeine combination medicines may be supplied through the regulated medicines system.

In Poland, authorized non-prescription medicines containing codeine remain legally available through community pharmacies and pharmacy outlets. A single sale is limited to one package containing no more than 240 mg of codeine in all covered salt forms; the limit has applied since 1 January 2017. Such medicines may not be supplied to a person under 18, and pharmacy staff must refuse a sale when they believe the medicine may be used non-medically or endanger health or life.

Codeine is a Table III controlled substance under Romania’s Law No. 339/2005. Medical use and dispensing are regulated, and dispensing Table II or III substances and preparations without a prescription is generally prohibited, subject to specified exempt preparations. Certain fixed-dose codeine combinations remain authorized for nonprescription sale: ANMDMR’s official Codamin P leaflet identifies its 15 mg codeine-phosphate combination as available without prescription, and ANMDMR’s July 2025 parallel-import list classifies Nurofen Plus 200 mg/12.8 mg as OTC.

As of 2015, over-the-counter sale of codeine solid dosage forms is permitted under European Union member state regulations.

Controlled under the Misuse of Drugs Act. Prescription required for most products, though combination preparations containing less than 12.8 mg codeine per dose are available over-the-counter from pharmacies.