Drug laws and licensing

These are already required by art 3 of Council Reg 273/04 in respect of the internal trade and by art 1 of the draft Commission in respect of the external trade.

The only requirement for a compliance officer is that he or she should be empowered to represent the operator and take decisions necessary for ensuring that the trade is in compliance with the Regulation (see 3.1 of 273 and 1 of Com Reg). The intention is to ensure that companies take the appointment seriously and make someone responsible for ensuring that the Regulations are complied, to ensure that no-one incompetent – a casually employed handling operative, for example – is appointed to the task. In the case of a small operator, the individual should be competent to be able to carry out the required tasks, either through seniority and/ or experience and qualifications.

The company would be expected to appoint a deputy or replacement.. It is accepted that a newly appointed, or temporarily appointed, officer may not have the same degree of experience as the responsible officer, but will nevertheless need to be able to carry out the required tasks effectively. Good sense must be used.

The basic requirement is unchanged from the previous requirements. In the UK, we intend to handle the declaration requirement in 2(i) of the Commission regulation by means of a declaration on the application form.

We believe that the best course of action will be a single licence with several addresses. Policing is not a requirement being placed on the operator: the system as a whole does that. The operator is asked merely to report suspicions when he has them. Where, because of the circumstances of the issue of the licence, he is not in a position to have such suspicions, blame for not reporting cannot be attached to him. In those circumstances, the system relies on the integrity and vigilance of the licence applicant and the compliance officer who should take all reasonable steps to be able to identify a suspicious transaction.

The model form suggests a very short description, such as “secured laboratory” – which would then be backed up by the simple common sense of the operator and the judgement of the authority. The “known shipper” certificate might help, but that would not apply to non-commercial organisations.

Member States have highlighted universities as a particular risk for the diversion of drug precursors. We think we can live with the onus of adding additional substances to licences for universities and will be able to develop a speedy method of doing this that will make it easy for them to submit amended licences to suppliers for verification.

It will be enough for the sending company to provide the details of the company to which the item is being sent and to receive a customer declaration from the receiving company. The sending company cannot always know what is to become of the items once they have reached the customer: the customer may not know himself. If the customer sells the item on, the control process starts again with that company and he in turn would require a customer declaration from his customers. Where a well-established company is supplying its well-established sister company, that requirement will be satisfied.

The key point is that the documentation accompanying the consignment contains sufficient information to identify the name, quantity and weight and co-ordinates of supplier, distributor consignee etc

Intra Community legislation makes this a requirement

A “scheduled substance” “excludes ….mixtures…and other preparations containing scheduled substances that are compounded in such a way that they cannot be easily used or extracted by readily applicable or economically viable means.” So the rules will not apply to many or all such substances.

The Council Regulation do not refer to either concentration or molarity in relation to mixtures. Instead they refer to quantity, weight or percentage by weight. To simplify the process for operators we have proposed a maximum percentage of the scheduled substances in the mixture. If operators wish to express the exact concentration this should be converted from mass per unit volume to a percentage for consistency reasons.

Art 5(6) allows data to be stored electronically. However it must the same appearance and accessibility as a paper version.

We are well aware of the risks of industry over-reporting. We envisage that prosecution would only be contemplated where there is clear evidence of gross neglect or collusion. We will ensure that the investigatory arm of the UK authority undertake backtracking, rather than live operations as much as possible, thus allowing trade to continue.

The operator is only required to report where he has suspicions. The Guidelines for the Chemical Trade can assist operators to identify suspicious transactions.

e.g. Excel file that can be collated with the files from other suppliers to look for patterns e.g. a single postcode buying scheduled substances from multiple suppliers, or regularly buying substances not compatible with their business.
(i). This would also highlight any small export traders who are not compliant with the export regulations of precursor substances, often through ignorance of the regulations rather than deliberate non-compliance.
(ii) Such information must be exempt from disclosure under the Freedom of Information Act.
The intra Community trade, the draft legislation requires an annual summary of the quantities of scheduled substances supplied to each third party or used by the operator themselves. This could be provided in the form of an excel spreadsheet, this is a matter for the national authorities and operators to decide. The FOI point is for the UK. (We imagine that there must surely be an FOI exemption for commercially sensitive information.

and Will it still be possible to have a simplified IEA if we are working through distributors, not with end-users?

The revised arrangements were based on the previous ones, because it was thought better just to change slightly a system that was known and understood rather than introducing a new one.

The CAS numbers are substance – specific and not dependent upon dilution or what they are mixed with. Each scheduled substance has a CAS number. Annex I to the legislation offers the operator the possibility to list the CAS number as well as the CN code, but in all cases the CN code is required.

If you require any further information, you can e-mail Licensing Enquiries or telephone 020 7035 0480/0633/0771. Alternatively, you can write to us at:

Home Office
Drugs Licensing & Compliance Unit
4th Floor, Peel Building
2 Marsham Street
London
SW1P 4DF