Controlled drugs

Unless specifically exempted by the Misuse of Drugs Regulations (Northern Ireland) 2002, any person or company that wishes to produce, supply or possess controlled drugs in Northern Ireland will need a domestic controlled drug licence issued by the DoH.

Conventions and international bodies

The United Nations conventions

The general aim of the conventions is to ensure through co-ordinated international action that medically and scientifically useful drugs are available for those purposes without being available for misuse.

The first of the two conventions is the 1961 Single Convention on Narcotic Drugs, which applies to opiates/opioids, cocaine and cannabis. It is called 'Single' because it was the single convention, which replaced the many that were previously in force.

The second convention is the 1971 Convention on Psychotropic Substances, which extended controls to LSD, amphetamine, barbiturates and benzodiazepines.

About 150 drugs are controlled under the two UN conventions. Inclusion of a drug under the controls reflects the principle that in general the drug has a legitimate medical or scientific use which must be protected and that its misuse gives rise to public health, social and economic problems.

International controls

The conventions also provide for United Nations’ machinery to monitor the conventions and to co-ordinate the cultivation, manufacture and supply of drugs at an international level.

At the top, the Economic and Social Council determines UN policy and makes recommendations to national governments.

It is assisted by the Commission on Narcotic Drugs, which is the central policy-making body. The commission drafts new conventions and changes to the existing one (eg the addition of new drugs or changes to the level of control on existing controlled substances).

The International Narcotics Control Board (INCB) is an independent executive body reporting to the Economic and Social Council.

Its main job is to help governments achieve a proper balance between supply and legitimate need. To this end it administers a system of forecasts (estimates) and statistical returns for most of the drugs controlled by the conventions.

Controlled drug licensing

Unless specifically exempted by the Misuse of Drugs Regulations (Northern Ireland) 2002, any person or company that wishes to produce, supply or possess controlled drugs in Northern Ireland will need a domestic controlled drug licence issued by the DoH (those operating in Great Britain or wishing to import or export controlled drugs into any part of the United Kingdom must apply for appropriate licences through the Home Office).

Please refer to the list of controlled drugs to identify your licence requirements.

Any person or company who applies for such a licence must ensure that they have read the general security guidance for controlled drug suppliers or the standard operating procedure guidance.

Once you have read the guidance you will need to fill in a licence application and apply for a Criminal Record Check enhanced disclosure for each individual named on the application form.

Please ensure you have read the guidance notes on completing a Controlled Drug Licence Application (MD29) before applying.

Criminal Records Checks

Controlled drug licensing

The Rehabilitation of Offenders (Exceptions) Order (NI) 1979 (as amended) enables the Medicines Regulatory Group (MRG) to ask questions about spent and current convictions in addition to cautions and cases pending for the purpose of assessing applicant’s suitability to obtain a licence.

This applies to anyone applying for a new or the renewal of a controlled drug licence from 1 April 2011.

Further information of controlled drug licensing

Individuals and Bodies Corporate not covered by the provisions of The Misuse of Drugs Regulations (Northern Ireland) 2002 must be licensed by the DoH to lawfully produce, supply or possess controlled drugs.

Northern Ireland operates a domestic licensing system separate to that operating in the rest of the United Kingdom (which is administered by Drug Licensing and Compliance Unit at the Home Office).

The DoH is responsible for processing applications for the production, supply and possession of controlled drugs to individuals or bodies corporate not authorised to do so under The Misuse of Drugs Regulations (Northern Ireland) 2002.

It also has a role in the inspection of licensees and responding to adverse episodes such as the theft or unaccounted loss of controlled drugs from licensed premises.

Commercial and personal import and export licensing is overseen and administered by Drug Licensing and Compliance at the Home Office 

All precursor chemical licensing and registration is carried out by the Home Office.

Import and export licensing

Commercial and personal import and export licensing is overseen and administered by Drug Licensing and Compliance at the Home Office.

Regulation 4 of The Misuse of Drugs Regulations (Northern Ireland) 2002 states that:

'Exceptions for drugs in Schedules 4 and 5 and poppy-straw 4. — (1) Section 3(1) of the Act (which prohibits the importation and exportation of controlled drugs) shall not have effect in relation to the drugs specified in Schedule 5.

(2)The application of section 3(1) of the Act, in so far as it creates an offence, and the application of sections 50(1) to (4), 68(2) and (3) or 170 of the Customs and Excise Management Act 1979, in so far as they apply in relation to a prohibition or restriction on importation or exportation having effect by virtue of section 3 of the Act, are hereby excluded in the case of importation or exportation by any person for administration to himself of any drug specified in Part II of Schedule 4 which is contained in a medicinal product.'

As a consequence, therefore, apart from Schedule 5 controlled drugs and those containing Schedule 4 Part II drugs in a medicinal product for personal use, all other imports and exports to and from the United Kingdom may only lawfully take place under a licence issued by Drug Licensing at the Home Office.

Personal import and export licensing

The importation and exportation of patients’ own controlled drugs (that is, medicines lawfully prescribed to patients who are personally taking their own controlled drugs out of or into the United Kingdom) is overseen and administered by Drug Licensing at the Home Office.

Telephone 020 7025 0484 or email licensing_enquiry.aadu@homeoffice.gsi.gov.uk

Industrial hemp licensing

A licence is required to cultivate low THC cannabis (industrial hemp) and each grower must be individually licensed.  Once issued a licence is usually valid for three growing seasons.

In addition licence holders are required to complete an Annual Licence Review - Grower Statement at the start of the growing season which must then be returned to the Medicines Regulatory Group.  

Licensing compliance information

Trading in controlled drugs - the law

The Misuse of Drugs Act 1971 provides the basis for outlawing illegal drugs and the regulatory framework for the legitimate manufacture and use of pharmaceutical controlled drugs.

The framework is expressed through The Misuse of Drugs (Northern Ireland) Regulations 2002 and the Misuse of Drugs (Safe Custody) (Northern Ireland) Regulations 1973.

Importation or exportation of a controlled drug may only take place lawfully under licence issued in accordance with Section 3(2)(b) of the Misuse of Drugs Act 1971.

Section 7 of the Misuse of Drugs Act 1971 gives the Secretary of State the power to authorise activities with controlled drugs that would otherwise be unlawful under and in accordance with the terms of a licence or other authority and in compliance with any conditions attached thereto.

Section 10 of the Misuse of Drugs Act 1971 gives the Secretary of State power to make regulations to prevent the misuse of controlled drugs.

They are expressed in The Misuse of Drugs (Northern Ireland) Regulations 2002:

  • licences to produce, supply, offer to supply and possess controlled drugs are issued under Regulation 5
  • persons engaged in their business of a carrier may possess and supply controlled drugs under Regulation 6(7)(b)
  • documents to be obtained by a supplier of controlled drugs are detailed under Regulation 14
  • record keeping requirements for Schedule 1 and 2 drugs are detailed under Regulations 19 and 20
  • record keeping requirements for Schedule 3 and 4 drugs are detailed under Regulation 22.
  • preservation of records is dealt with under Regulations 23 and 24.
  • destruction of controlled drugs is dealt with under Regulation 27.

Section 18 of the Misuse of Drugs Act 1971 makes it a criminal offence to contravene any regulation made under the Act, to contravene a condition or other term of a licence, to give false information and/or to incite another to commit such an offence.

Safe custody of controlled drugs is required by the Misuse of Drugs (Safe Custody) (Northern Ireland) Regulations 1973 (see also general guidance for controlled drug suppliers).

This is to be achieved by keeping controlled drugs under lock and key. The extent of the security for such purpose is determined by circumstances and amount.

For medical practitioners, Regulation 5 applies. For small amounts eg reference standards, testing laboratories etc a secure cabinet or small safe is sufficient, but commercial amounts need to be kept in safe custody stores such as prefabricated strong rooms.

Licensee security measures summary

Security measures recommended for full-line wholesale premises

  • perimeter fence and gates where appropriate
  • perimeter surveillance – detector-activated CCTV (monitored)
  • external doors to recommended standard (LPS 1175 SR4)
  • intruder alarm system conforming to ACPO 2000 requirements
  • CD store to appropriate standard, according to value of contents
  • protect/secure/control lower schedule CD stock
  • SOPs to cover procedural security - keys, access control, staff training

Additional measures recommended for large manufacturing sites

  • on-site security guards, preferably directly employed
  • electronic access control system with audit trail
  • internal/external CCTV monitored from guardhouse
  • senior manager responsible for guard force and site security

Requirements and recommendations for short-line wholesalers

  • external doors to recommended standard (LPS 1175 SR4)
  • intruder alarm system conforming to ACPO 2000 requirements
  • CD store/safe/cabinet (where required) to appropriate standard
  • protect/secure/control lower schedule CD stock
  • SOPs to cover procedural security - keys, access control, staff training

Further guidance is available from the Home Office.

Record keeping for controlled drugs

The Misuse of Drugs Regulations (Northern Ireland) 2002 imposes a requirement to keep records relating to controlled drug transaction in certain circumstances.

Records may also be required under the terms of a licence issued by the Department.

Destruction of controlled drugs

Regulation 27 of The Misuse of Drugs Regulation (Northern Ireland) 2002 requires the presence of an authorised person to witness the destruction of the controlled drugs in Schedules 1 to 4 held under a licence issued by the Department.

For this purpose, the authorised person may be an officer of Pharmaceutical Advice and Services at the department or a police officer.

Authorities may also be granted to nominated individuals under the conditions attached to a domestic licence to produce, supply or possess controlled drugs.

Companies and individuals are reminded that they are still bound by the requirements of relevant waste legislation and should take further advice from the relevant Government department on this.

Summary of the witnessing requirements for licensees

Category   Witness Required
Schedule 1 person holding licences to produce, supply or possess Yes
Schedule 2 person holding licence to produce, supply or possess Yes
Schedule 3 person holding licence to produce or supply Yes
Schedule 3 person holding licence to possess No
Schedule 4 Part I person holding licence to produce Yes
Schedule 4 Part II person holding licence to supply or possess No
Schedule 5 licences (any) No requirement

Safe custody guidance

Safe Custody Regulations (NI) 1973 for the current statutory requirements for the safe custody of controlled drugs require, so far as circumstances permit, certain CDs to be locked up in a safe or cabinet or other locked receptacle.

The drugs to which these Regulations apply are:-

  • all schedule 1 controlled drugs
  • all schedule 2 CDs except quinalbarbitone
  • in schedule 3: buprenorphine, diethylpropion, temazepam and flunitrazepam.

In the licensee setting, applicants should take advice from both this department when their application is being processed, as well as the relevant police contact dealing with crime prevention matters.

Standard operating procedure guidance

In the licensee setting, we consider that good operating procedure guidance is as valuable as good physical protection in preventing the loss and diversion of controlled drugs.

Home Office guidelines for Standard Operating Procedures (SOPs)

The Home Office has produced a short summary guide to the areas for licensees to consider when drawing up their SOPs.

The following headings should either form the basis of, or inform additional points for licensee SOP documents.  SOPs should take account of regulatory requirements and security practices.

  • check application of regulations
  • orders and arrangements for receipt of controlled drugs
  • acceptance of deliveries & procedures upon receipt
  • QC/QA handling
  • production and packing runs
  • procedures for accepting orders and controlled drug dispatch
  • record keeping and cross-checking processes
  • controlled drug store access, operative and management responsibilities
  • controlled drug destructions
  • theft, loss or adverse incident reporting and handling

Home Office Stanard Operating Procedure full guidance

The movement of controlled drugs in transit

Regulations 6(6) and (7) of The Misuse of Drugs Regulations (Northern Ireland) provides inter alia that:

(6) Notwithstanding the provisions of section 5(1) of the Act, any of the persons so specified may have any controlled drug in his possession

(7) The persons referred to in paragraphs (5) and (6) are -

  • (a) a constable when acting in the course of his duty as such
  • (b) a person engaged in the business of a carrier when acting in the course of that business
  • (c) a person engaged in the business of a postal operator (within the meaning of the Postal Services Act 2000) when acting in the course of that business
  • (d) an officer of customs and excise when acting in the course of his duty as such
  • (e) a person engaged in the work of any laboratory to which the drug has been sent for forensic examination when acting in the course of his duty as a person so engaged
  • (f) a person engaged in conveying the drug to a person who may lawfully have that drug in his possession

Carriers are therefore exempt from the licensing requirement for controlled drugs when acting in their capacity as such (and longer term storage is not taking place).

The Home Office may be able to assist with any queries regarding the Movement of Controlled Drugs in Transit.

Further guidance is available from the Home Office.

Paramedics

Paramedics engaged by and under the control of the Northern Ireland Ambulance Service HSC Trust (NIAS)

The department will be issuing a Group Authority [issued in accordance with Regulations 8(3), 9(3)(a) and 10(3) of The Misuse of Drugs Regulations (Northern Ireland) 2002] that will authorise registered paramedics engaged by and under the control of the Northern Ireland Ambulance Service HSC Trust (NIAS) to supply or offer to supply diazepam and/or morphine sulphate injection (to a maximum of 20mg) to any person who may lawfully have any of these drugs in their possession; and for registered paramedics to possess diazepam and/or morphine sulphate preparations as detailed above for the purposes of administration for the immediate necessary treatment of sick or injured persons in the course of that service or employment. 

Paramedics not engaged by and under the control of the Northern Ireland Ambulance Service HSC Trust (NIAS)

In order to lawfully conduct the same activity, those paramedics operating outside of NIAS engagement and control will require a licence to supply, offer to supply and possess controlled drugs issued under Regulation 5 of the MDR (NI) 2002.

The issue of these licences will be dependent upon the applicant demonstrating an immediate operational need for them.

Applicants will also need to satisfy the requirements of the Misuse of Drugs (Safe Custody) (Northern Ireland) Regulations 1973 and the ability to comply with the requirements of The Misuse of Drugs Regulations (Northern Ireland) 2002.

They will also be subject to periodic inspection by this Department.
Licences may be obtained by completing the application form and submitting it to the Department as directed.

Notification of and supply to addicts

The Misuse of Drugs (Notification of and Supply to Addicts) (Northern Ireland) Regulations 1973 SR 1973 No. 180 came into force on 1st July 1973.

Amending regulations

Below is a list of amending regulations since they came into force.

Misuse of Drugs and the Misuse of Drugs (Notification of and Supply to Addicts) (Amendment) Regulations (N.I.) 2005 - S.R.2005 NO 564

Notification

Under this, any doctor who attends a person who he considers, or has reasonable grounds to suspect, is addicted* to any drug shall within seven days of the attendance, furnish in writing to the Chief Medical Officer of the Ministry of Health and Social Services such of the following particulars with respect to that person as are known to the doctor:

  • the name
  • address
  • sex
  • date of birth
  • health service number of that person
  • the date of the attendance
  • the name of the drug or drugs concerned

(*For the purposes of these Regulations a person shall be regarded as being addicted to a drug if, and only if, he has as a result of repeated administration become so dependant upon the drug that he has an overpowering desire for the administration of it to be continued.)

It shall not be necessary for a doctor who attends a person to comply with the provisions of the above paragraph if:

(a) the doctor is of the opinion, formed in good faith, that the continued administration of the drug or drugs concerned is required for the purpose of treating organic disease or injury

(b) the particulars which, apart from this paragraph, would have been required under those provisions to be furnished have, during the period of twelve months ending with the date of the attendance, been furnished in compliance with those provisions:

  1.  by the doctor
  2. (if the doctor is a partner in or employed by a firm of general practitioners, by a doctor who is a partner in or employed by that firm
  3. if the attendance is on behalf of another doctor, whether for payment or otherwise, by that doctor
  4. if the attendance is at a hospital, by a doctor on the staff of that hospital

The above applies to the following drugs:

Notifiable drugs

1. The following substances and products, namely:

  • cocaine
  • dextromoramide
  • diamorphine
  • dipipanone
  • hydrocodone
  • hydromorphone
  • levorphanol
  • methadone
  • morphine
  • opium
  • oxycodone
  • pethidine
  • phenazocine
  • piritramide

2. Any stereoisomeric form of a substance specified in paragraph 1 or 2 above, not being dextrorphan.

3. Any ester or ether of a substance specified in paragraph 1 or 2 above not being a substance specified in Part II of Schedule 2 to the Misuse of Drugs Act 1971.

4. Any salt of a substance specified in any of paragraphs 1 and 3 above.

5. Any preparation or other product containing a substance or product specified in any of paragraphs 1 to 4 above.

Notification and supply to addicts

The Misuse of Drugs (Notification of and Supply to Addicts) (Northern Ireland) Regulations 1973 SR 1973 No. 180 came into force on 1st July 1973

Supply to addicts

A doctor shall not administer or supply to a person who he considers, or has reasonable grounds to suspect, is addicted* to any drug, or authorise the administration or supply to such a person, of any substance specified in the paragraph below, or prescribe for such a person any such substance, except:

  • (a) for the purpose of treating organic disease or injury
  • (b) under and in accordance with terms of a licence issued by the DoH in pursuance of these Regulations

*(For the purposes of these Regulations a person shall be regarded as being addicted to a drug if, and only if, he has as a result of repeated administration become so dependant upon the drug that he has an overpowering desire for the administration of it to be continued.)

This does not apply to the administration or supply by a doctor of a substance specified in the paragraph below if the administration or supply is authorised by another doctor under and in accordance with the terms of a licence issued to him in pursuance of these Regulations.

The substances referred to in paragraphs above are:

Annual returns

The submission of annual returns relating to controlled drug activity by licensees is required so that the UK’s competent body for this purpose (the Home Office) may submit data to the International Narcotics Control Board.

The submission of annual returns is a condition of licensing and failure to comply may lead to the cancellation or withdrawal of a licence.
 

Further guidance may be obtained by telephoning the Home Office on 020 7035 0467 or by email 

Annual compliance statement

Holders of controlled drug licences are required under the terms and conditions of their licence to submit an annual compliance form to the department by the end of February each year.

 

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