Controlled drugs
- Document symbol
- G/LIC/N/3/GBR/3
- Original language
- English
- Published on
- 07/12/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
The Controlled Drug system allows the United Kingdom to meet its international treaty obligations under the 1961 UN Single Convention on Narcotic Drugs and the 1971 UN Convention on Psychotropic Substances.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Regulations require that all imports, exports and intermediary activities involving controlled drugs be documented by operators.
Substances are listed in Parts I, II, III and IV of Schedule 2 to the Misuse of Drugs Act 1971 and in Schedules 1 to 5 to the Misuse of Drugs Regulations 2001, and the Misuse of Drugs (Northern Ireland) Regulations 2002. A list of the most commonly encountered drugs currently controlled under those provisions can be found in the following link: https://www.gov.uk/government/publications/controlled-drugs-list--2/list-of-most-commonly-encountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation
Q3. The system applies to goods originating in and coming from which countries?
All countries whereby the substance being imported is controlled in either one of the countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
Licences are issued to manage the volumes of controlled drug movements worldwide, in accordance with our international obligations. Monetary value is of no relevance to these considerations. Licences enable trade which would otherwise be prohibited because of the danger posed by the substances and their risk of diversion. Controlled drugs are potentially harmful to health, and all imports must be made to a holder of a domestic controlled drugs licence, or to an exempt body (such as healthcare providers in respect of drugs in schedules 2-4).
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
i) The Misuse of Drugs Act 1971
ii) The Misuse of Drugs Regulations 2001
iii) The Misuse of Drugs Regulations (Northern Ireland) 2002
The substances subject to licensing are set out in legislation. The substances subject to licensing are not left to administrative discretion.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
People can ship any time during the validity of the licence. Import licenses are valid for three months and export licences are valid for up to two months or in line with the permit of the importing country, whichever expires first. Home Office service standard is seven-ten working days in addition.
Depending on the Drugs and Firearms Licensing Unit resource, a same day licence could be issued. If goods arrive at the port without a licence, a retrospective licence would not be issued as the offence has already occurred.
Q7.b. Can a licence be granted immediately on request?
The process is not automatic, so it cannot be immediately granted. However, a licence could potentially be granted on the same day, if the company already hold a valid Domestic licence and have set up the products and foreign trade establishments on the NDS system.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
There are no limitations as to the period of the year during which application for licence and/or importation may be made.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Consideration of licence applications is affected by a single administrative organ, the Drugs and Firearms Licensing Unit in the Home Office. However, the Unit will have regard to information from other agencies. In the case of cannabis-based products for medicinal use which are special medicinal products (unlicensed medicines) the Unit will take advice from the Medicines and Healthcare products Regulatory Agency (MHRA), and applicants will need to show that they have notified the MHRA according to the MHRA's requirements. Operators must lodge an application for an import or export authorisation (licence) with the competent authority in which the importer/exporter is established. The Home Office serves as the "competent authority".
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
There are no specific circumstances under which an application for a licence may be refused. All applications are considered individually on their merits. The reasons for any refusal are given to the applicant. Applicants do not have a right of appeal in the event of refusal to issue a licence.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
To apply for a controlled drug import or export licence, the company would need to hold a domestic licence unless they fall under an exemption such as university research departments, hospitals, care homes and other healthcare providers who may only require a licence for certain schedules and activities.
You need to apply for a new import or export licence for each individual shipment. Licences cannot be post-dated or retrospectively issued. If you are applying for a UK export licence, you must include a copy of the import permit.
Each individual licence has a fee of £24.
There is not a published list of authorised importers due to privacy and confidentiality.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
Regulations require that all imports, exports and intermediary activities involving controlled drugs be documented by licensees. Licensees must lodge an application for an import or export authorisation (licence) with the competent authority in which the importer/exporter is established. The Home Office serves as the "competent authority". Applications must be made via the national drugs control system (NDS) in respect of each transaction (shipment).
Applications for authorisations must contain full information about the transport arrangements, name and address of all parties involved, and nature, quantity and weight of the substance being traded. It is an online application form that needs to be completed.
Q11. What documents are required upon actual importation?
The import licence is required upon actual importation.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The fee for an individual export or import licence is £24. The Home Office will process applications in date order. The expected processing time is seven working days. A domestic licence is a pre-requisite to apply for an import/export licence unless the company is exempt. The fees for a domestic controlled drugs licence:
Controlled drug domestic licences: application fees for new controlled drug domestic licences
| Licensable activity | Application fee |
|---|---|
| Possess controlled drugs | £3,133 |
| Supply, or offer to supply, controlled drugs | £3,655 |
| Produce preparations containing controlled drugs | £4,178 |
| Produce controlled drugs | £4,700 |
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No deposit or advance payment requirement. Payment is in arrears for import licensing only. All domestic licensing fees are paid before a licence is issued. It is a set fee per license which is non‑refundable and also comes with cancellation fees depending on when the company cancel. The purpose of the fee is cost recovery.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Import licences are issued for three months. Export licences are issued for two months or in line with the permit of the importing country, whichever expires first. The validity of a licence cannot be extended.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilization of a licence or a portion of a licence.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
There are no other conditions attached to the issue of a licence.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Customs declarations.