Narcotics quotas and estimates: how the INCB system reaches a licence holder

What the estimates are

The system is set out in the 1961 Single Convention on Narcotic Drugs. Under Article 19, each party furnishes to the INCB every year, on the Board's forms, estimates for each of its territories covering among other things:

• the quantities of drugs to be consumed for medical and scientific purposes;
• the quantities to be used to manufacture other drugs, preparations in Schedule III and substances not covered by the Convention;
• the stocks to be held at 31 December of the year concerned;
• for synthetic drugs, the number of manufacturing establishments and the quantity each will make.

Article 19 is plain about the result: the estimates shall not be exceeded. A State may furnish supplementary estimates during the year, with an explanation of the circumstances. Under Article 12, the Board examines the estimates, can ask for more information and confirms them. With the government's consent it can amend them, and if they disagree it can establish and publish its own.

The INCB publishes the confirmed totals as "Estimated World Requirements for Narcotic Drugs" and updates them during the year. In its own words, these totals enable parties to determine the maximum quantity of drugs that a State may acquire through import and/or manufacture. Since 2 July 2025 it has also published monthly updates of the estimates for the cultivation and production of cannabis.

How the estimates limit trade

Two articles of the Single Convention turn the estimates into hard limits on trade.

Article 21 limits manufacture and import. The total manufactured and imported by a country in a year may not exceed what it consumed and used for manufacture within its estimates, plus what it exported, plus what it added to stock up to the estimated level. If the Board finds an excess, the excess is deducted from the following year's quantities and estimates. If the returns show that exports to a country have exceeded its estimates, the Board may notify other parties, who then must not authorise further exports of that drug to that country during the year, unless a supplementary estimate is furnished or, exceptionally, the exporting government considers the export essential for the treatment of the sick.

Article 31 governs each shipment. Parties may not knowingly permit an export except within the limits of the importing country's estimates, plus amounts intended for re-export. Every import and export needs its own authorisation stating the drug, the quantity, the importer, the exporter and the period within which it must take place. An export authorisation is issued only against an import certificate from the importing country, and the importing country returns the export authorisation endorsed with the quantity actually imported. Governments report imports and exports to the Board quarterly, within one month of the end of each quarter (Article 20).

Psychotropic substances: assessments

Psychotropic substances under the 1971 Convention follow a lighter system. Governments submit assessments of their annual medical and scientific requirements for substances in Schedules II, III and IV on INCB Form B/P. Assessments apply for one year, a full revision is expected every three years, and a country can modify its assessment at any time with the supplement to Form B/P. Schedule I substances have their own special provisions and need no assessment. The INCB publishes the current assessments for all countries.

How the cap reaches a licence holder in Germany

In Germany the Board's figures reach the operator through three layers:

For medical cannabis, the MedCanG requires a separate BfArM authorisation for each import and export (section 12) and applies the BtMAHV procedure to them (section 14), so the same estimate checks apply. Our Germany import permit guide covers the medical cannabis procedure step by step.

How the cap reaches a licence holder in Portugal

Portugal's Decreto Regulamentar 61/94, which implements Decreto-Lei 15/93, is more direct, as compiled by INFARMED:

• Annual quantities. Every July, INFARMED sets the quantities of substances in tables I and II (except II-A) that authorised entities may manufacture or put on sale during the following year, taking account of Portugal's international commitments (article 16). The quantities can be increased during the year, INFARMED can limit manufacture at any time, and the figures are published in the 2nd series of the Diário da República.
• Cultivation surpluses. A cultivation surplus of up to 10% of the authorised quantity can be tolerated if it is reported to INFARMED within 15 days of being established, and it counts against the next year's quantities (article 14).
• Manufacturing authorisations carry conditions that let INFARMED prevent stocks building up beyond market needs (article 15).
• Each import and export needs a prior INFARMED certificate for that operation (articles 22 and following), now issued electronically through NDS.

Tracking the balance in practice

An operator does not see the national estimate being consumed in real time. What it can control is its own position against the limits that apply to it:

1. Record every limit with its source.Licence quantities, annual allocations and each import or export authorisation, with substance, quantity, unit, counterparty and validity dates.
2. Convert to one basis.Where a limit is set for the pure substance and stock is held as a preparation, keep the conversion documented and consistent.
3. Consume the balance on the right event.Import authorisations on receipt, export authorisations on dispatch, annual quantities on manufacture or sale, as the authority defines them.
4. Check the balance before releasing an order.Not after the goods have moved.
5. Watch expiry.An authorisation used after its period is as bad as no authorisation.
6. Report partial use.Where less was shipped than authorised, make sure the actual quantity is on record for the endorsement.
7. Plan ahead of the national cycle.If you will need more, tell the authority early enough for a supplementary estimate.

Where 365Phyta fits

365Phyta Licensing keeps licences, permits and quotas inside Microsoft Dynamics 365 Business Central. Quotas are tracked against what you receive, make and ship, and per-shipment import and export authorisations are checked with their remaining balance before an order is released. A sales or purchase order cannot be released without valid licences on both sides, enough permit balance and quota. Every movement posts to the controlled-substance stock book, which reconciles to the item ledger to the gram. National report formats come with the country packs for Germany and Portugal, which are in development. See controlled substances, the glossary terms quota and import and export authorisation, and pricing.

FAQ

Sources

1. UNODC, Single Convention on Narcotic Drugs, 1961, as amended, Articles 12, 19, 20, 21 and 31.
2. INCB, Narcotic Drugs Estimates (Estimated World Requirements).
3. INCB, Form B/P and supplement and Assessments of psychotropic substances.
4. Betäubungsmittelgesetz (gesetze-im-internet.de): § 9 Beschränkungen, Befristung, Bedingungen und Auflagen, § 11 Einfuhr, Ausfuhr und Durchfuhr.
5. Betäubungsmittel-Außenhandelsverordnung (BtMAHV), §§ 2 and 8 (Versagungsgründe).
6. Medizinal-Cannabisgesetz: § 12 Genehmigung zur Einfuhr und Ausfuhr, § 14 Geltung der Betäubungsmittel-Außenhandelsverordnung.
7. Decreto Regulamentar n.º 61/94 (INFARMED, Legislação Farmacêutica Compilada), articles 14, 15 and 16; INFARMED, Substâncias controladas (import and export certificates, NDS).

Last reviewed: September 2026. General information, not legal advice. Terms are defined in the glossary.