Detailed guide: Controlled drugs: import and export licences

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Detailed guide: Controlled drugs: import and export licences

 

 

Controlled drugs are prescription drugs named in the misuse of drugs legislation. You can check for the most common ones on the controlled drugs list. You can also read the full lists in both the Misuse of Drugs Act 1971 and schedules 1-5 of the Misuse of Drugs Regulations 2001.

This guide should not be used in place of the law and, if in doubt, you should take your own independent legal advice.

If your company or organisation intends to import or export controlled drugs or precursor chemicals, you need to apply for a licence.

If you are trading in prescription-only medicines which do not contain controlled drugs, please contact the Medicines and Healthcare Regulatory Authority for guidance.

Before you apply

You need an NDS account to apply for an import or export licence. You can read the user guide for more information on what to do.

You will need a domestic licence before you can apply for an NDS account. If you do not have a valid domestic licence your request will be cancelled.

Once your account is approved you will need to tell us about your overseas trading partners and details of your controlled drug preparations.

Apply for an import or export licence

Valid applications are normally processed in 10 working days.

Import licences are valid for 3 months. Export licences are valid for either 2 months or in line with the permit of the importing country, whichever expires first. 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.

Channel Islands

The Channel Islands (Jersey and Guernsey) have their own licensing rules for controlled drugs. If you export controlled drugs from mainland UK to the Channel Islands you will be issued a specific licence.

Frequent exporters

If your company or organisation is making 24 or more shipments in 12 months you can apply for a time-limited frequent export licence. This licence is only available for the export of medicines in finished dose form from the UK to the Channel Islands.

Frequent export licences are valid for a maximum of one year. If you renew your licence the following applies:

  • your renewal should be made at least one month before the existing licence expires
  • your licence will not be renewed automatically
  • your application will be assessed as a new one

You must submit a monthly return form to dflu.ie@homeoffice.gov.uk detailing exactly what drugs have been shipped.

If you have not shipped for a month or more you will need to provide a return sheet showing zero, to avoid your licence being suspended.

Contact dflu.ie@homeoffice.gov.uk for details on how to apply.

Export restrictions on specific drug substances

The European Union has adopted a new EU-wide control on the export of certain drugs usable in execution by lethal injection.

These controls, which came into force on 21 December 2011, were adopted as an amendment to annex 3 of Council Regulation (EC) 1236/2005 concerning trade in certain goods which could be used for capital punishment, torture or other cruel, inhuman or degrading treatment or punishment.

You can download the full text of Council Regulation (EU) No 1352/2011 from the Europa website.

Exporters need to seek appropriate permission from national export control authorities to export to any destination outside the EU ‘short and intermediate acting barbiturate anaesthetic agents including, but not limited to’ the following:

  • amobarbital (CAS RN 57-43-2)
  • amobarbital sodium salt (CAS RN 64-43-7)
  • pentobarbital (CAS RN 76-74-4)
  • pentobarbital sodium salt (CAS 57-33-0)
  • secobarbital (CAS RN 76-73-3)
  • secobarbital sodium salt (CAS RN 309-43-3)
  • thiopental (CAS RN 76-75-5)
  • thiopental sodium salt (CAS RN 71-73-8), also known as thiopentone sodium

Exporters should read the guide on torture goods when exporting these drugs.

Regulations may exist to prevent the export of drugs or chemicals to certain countries, for example during conflicts. Exporters must check the current regulations for the country they are exporting to.

Annual statistical returns

If you are a wholesaler, manufacturer, producer or supplier of controlled drugs you must send a completed annual returns form each year, to annualdrugreturns@homeoffice.gov.uk. Read the guidance about annual statistical returns.

Endorsements

A condition of all import and export licences issued by the Home Office is for an immediate online endorsement of the actual shipment amounts to be made on the NDS web portal, once they have been shipped.

If you do not regularly submit timely endorsements your NDS account may be suspended.

 

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