Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2017 by Medicines & Healthcare Products Regulatory Agency;

Author:Medicines & Healthcare Products Regulatory Agency;
Language: eng
Format: epub
ISBN: 4860592
Publisher: Pharmaceutical Press

Controls on strategic goods and drugs useable in execution by lethal injection

The Export Control Organisation (ECO), part of the Department for Business, Innovation and Skills, issues licences for controlling the export of strategic goods. The range of goods and services covered by embargoes and sanctions is extensive, changes from time to time and includes:

•military equipment;

•dual-use goods that can be used for both civil and military purposes;

•products used for torture;

•radioactive sources.

These may apply to medical devices, finished medical products or Active Substances.

ECO also administers the European Union controls on trade in certain goods which could be used for capital punishment, torture or other cruel, inhuman or degrading treatment or punishment. This includes the control on the export of certain drugs usable in execution by lethal injection.

As a result of these EU-imposed controls, 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.

The control also applies to products containing one or more of the above. These controls are intended to apply to finished products – in other words, those that are packaged for human or veterinary use. It is not intended that they should apply to raw materials or to intermediate products (i.e. products that require further processing to make them suitable for human or veterinary use).

It is the responsibility of a wholesale dealer to ensure that they export responsibly and within the law. ECO provide training for exporters of strategic goods. Further information on training and licensing can be found on the GOV.UK website.9,10

Control of lisdexamfetamine, tramadol, zaleplon, zopiclone and reclassification of ketamine

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