psychotropic substances Rules, 2003

L.N. 279 of 2003

DANGEROUS DRUGS ORDINANCE

(CAP. 101)

Substances used in the illicit manufacture of narcotic drugs and

psychotropic substances Rules, 2003

IN exercise of the powers conferred by articles 22 (1D)(b) of the

Dangerous Drugs Ordinance, the Minister of Health has made the

following rules>-

(1) The title of these rules is substances used in the illicit

manufacture of narcotic drugs and psychotropic substances Rules, 2003

(2)

These rules shall come into force on April, 2004.

In these rules, unless the context otherwise requires -

“consignee” means any natural or legal person to which the

scheduled substances are delivered in the country of destination,

and such person may be different from the end-user<

“International Narcotics Control Board” means the Board

established by the Single Convention on Narcotic Drugs, 1961, as

amended by the 1972 Protocol amending the Single Convention

on Narcotic Drugs, 1961<

“operator” means any natural or legal person engaged in the

manufacture, processing, trade or distribution of scheduled

substances or involved in other related activities such as the

brokering and storage of scheduled substances<

“the Ordinance” means the Dangerous Drugs Ordinance<

“placing on the market” means any supply against payment

or free of charge to third parties of scheduled substances

manufactured or put into free circulation<

“scheduled substance” means any substance specified in

Table I of the Third Schedule to the Ordinance, including mixtures

and natural products containing such substances. This excludes

medicines, pharmaceutical preparations, mixtures, natural products

or other preparations containing scheduled substances that are

compounded in such a way that such substances cannot be easily

used or recovered by readily applicable or economically viable

means<

“Superintendent” means the Superintendent of Public

Health.

The Superintendent shall be the competent authority Competent

authority.

responsible for the implementation of theserules.

(1) The manufacture, importation, exportation, wholesale Registration and

dealing, trade, distribution and use of the scheduled substances in the licensing of

operators.

Third Schedule to the Ordinance shall be subject to the possession of a

licence issued by the Superintendent. The supply of such substances

will be authorised only where the persons to whom they are to be

supplied are specifically authorised, either generally or individually, to

be supplied with, possess or handle such substances.

(2)

When considering whether to grant a licence, the

Superintendent shall in particular take into account the competence and

integrity of the applicant. The licence may be suspended or revoked by

the Superintendent whenever there are reasonable grounds for belief

that the holder is no longer a fit and proper person to hold a licence, or

that the conditions under which the licence was issued are no longer

fulfilled.

(3) Any operator holding the licence referred to in sub-

rule (1) shall supply scheduled substances specified in all categories of

the Third Schedule to the Ordinance only to persons specifically

authorised to be supplied with, possess or handle such substances.

(4) Operators engaged in the manufacture, import, export

or placing on the market of scheduled substances in all categories of

Table I of the Third Schedule to the Ordinance shall be required to

register and update with the Superintendent the addresses of the premises

from which they manufacture or trade in these substances.

Duties of operators.

It shall be the duty of operators>

(a) to immediately notify the Superintendent of any

circumstances, such as unusual orders and transactions involving

scheduled substances, which suggest that such substances intended

for import, export or transit may be diverted for the illicit

manufacture of narcotic drugs or psychotropic substances<

(b) to provide the Superintendent with such information

about such transactions involving scheduled substances as the

Superintendent may require.

(1) Exportation of scheduled substances listed in Category

1 of Table I of the Third Schedule to the Ordinance shall be subject to

an authorisation for each individual substance, issued by the

Superintendent. The customs export declaration is to be lodged in the

form prescribed under Annex V hereto.

(2) Applications for authorisations referred to in paragraph

(a)(i) shall contain the following information>

(a) the name and address of the exporter, of the importer

in the importing country, of any other operator involved in the

export operation or shipment, and of the consignee,

(b) the name of the scheduled substances as given in

Category 1 of Table I of the Third Schedule to the Ordinance,

(c) the quantity and weight of the scheduled substance

and, where it consists of a mixture, the quantity and weight of the

mixture as well as the quantity and weight or the percentage of

any substance or substances listed in Table I of the Third Schedule

to the Ordinance which are contained in the mixture,

(d) details as to the transport arrangements, and in

particular the expected date of dispatch, method of transport, name

of the customs office where the customs export declaration is to

be lodged, and, in so far as such information is available at this

stage, identification of the means of transport, itinerary, expected

point of exit from Malta and the point of entry into the importing

country.

In the case of paragraph (7), a copy of the import permit

issued by the destination country must be attached to the

application.

(3) A decision on the application shall be taken within a

period of fifteen working days from the date on which the Superintendent

considers the file to be complete. This period shall be extended if the

authorities are obliged to make further enquiries in order to satisfy

themselves that the importation of the substances has been properly

authorised.

(4) Without prejudice to any possible implementation of

enforcement measures, the export authorisation referred to above shall

be refused, if>

(a) there are reasonable grounds to suspect that the

information supplied in compliance with paragraph 6 (2) is false

or incorrect<

(b) in the cases referred to in paragraph 7 it is established

that the importation of the scheduled substances has not been

properly authorised by the competent authorities of the country of

destination<

(c) there are reasonable grounds for suspecting that the

substances in question are intended for the illicit manufacture of

narcotic drugs or psychotropic substances.

(5) If the particulars concerning the itinerary and means

of transport are not provided in the application referred to in paragraph

(7), the export authorisation shall state that the operator must furnish

these particulars to the customs or other competent authority at the point

of exit from Malta before the physical departure of the consignment. In

this case, the export authorisation shall be annotated accordingly at the

time of issue.

(6) (a) In all cases, the export authorisation shall be

produced for inspection by the customs authorities when the customs

export declaration is lodged. A copy of this authorisation shall,

furthermore, accompany the consignment to the customs office at the

point of exit of the scheduled substances from Malta. That office shall

insert, where appropriate, the particulars referred to in paragraph 5

together with any other necessary particulars and it shall affix its stamp

to the copy of the authorisation before returning it to the issuing authority.

(b)

The issue of an export authorisation does not preclude

any possible administrative or other liability of the holder of such

authorisation.

(c) The export authorisation may be suspended or revoked

by the Superintendent whenever there are reasonable grounds to

suspect that the substances might be diverted to the illicit

manufacture of narcotic drugs or psychotropic substances.

(d) ( i ) Any exportation of scheduled substances listed

in Category 1 of Table I of the Third Schedule to the Ordinance

shall be preceded by pre-export notification sent to the country of

destination in accordance with the provisions of Article 12(10) of

the United Nations Convention against Illicit Traffic in Narcotic

Drugs and Psychotropic Substances of the 19 th December, 1988,

and with Resolution 20/4 of the 1998 Special Session on drugs of

the United Nations General Assembly. The country of destination

shall be allowed a period of time in which to reply of up to fifteen

working days, at the end of which the export operation shall be

authorised by the Superintendent, unless advice to the contrary is

received.

(ii)

The Superintendent shall, prior to any export

of scheduled substances to the requesting country, supply the

information specified in paragraph (a)(ii) above, to the

competent authorities of that country.

(iii)

The Superintendent shall require that the

authority in the importing country receiving the information

shall keep as confidential any trade, business, commercial or

professional secret or any trade process referred to therein.

(7)

Whenever, under an agreement between Malta and

an importing country, exports are not to be authorised unless an import

permit has been issued by the competent authorities of the latter country

for the substances in question, the Superintendent shall assure himself

that any importation has been properly authorised, if necessary by

requesting confirmation from the competent authority of the importing

country.

(1) The exportation of scheduled substances listed in

Category 2 of Table I of the Third Schedule to the Ordinance shall be

subject to an authorisation issued in accordance with sub-rules (2) and

(3) hereof by the Superintendent in accordance with the provisions in

force.

(2)

Exports referred to in sub-rule (1) hereof shall be

subject mutatis mutandis to the provisions of rule 6, wherever they appear

to be intended, directly or indirectly, for any importing country which

has been identified to be concerned by the illicit manufacture of those

narcotic drugs or psychotropic substances by the use of such scheduled

substances. The said identification shall be based, in particular, on a

reasoned request by the importing country concerned. The provisions

of rule 6 shall also apply whenever an open individual authorisation

cannot be issued under sub-rule (3) hereof>

Provided that the provisions of rule 6 shall also apply

whenever a substance listed in Annex 1 is destined to an operator

established in a country listed in the same annex.

(3) In all other cases, the exportation of scheduled substances

listed in Category 2 of Table I of the Third Schedule to the Ordinanace

may be authorised at the request of the operators concerned on a global

basis by the issue of an open individual authorisation. The decision to

issue such an authorisation shall take into account the competence and

integrity of the applicant together with the nature, volume and pattern

of his involvement in these substances. In such cases, the holder shall

enter the details of this authorisation in the relevant customs export

declaration. In accordance with the provisions laid down by the

Superintendent, the holder of such an authorisation shall furnish

information about exports made under the authority of the authorisation.

(4)

The open individual authorisation referred to in sub-

rule (3) hereof may be suspended or revoked whenever there are

reasonable grounds for belief that its holder is not longer a fit and proper

person to hold an authorisation, or that the conditions under which the

authorisation was issued are no longer valid.

(1) Wherever the export of scheduled substances listed Specific Export

in Category 3 of Table I of the Third Schedule to the Ordinance is requirements>

Category 3 Table I.

intended, directly or indirectly, for any importing country>

(a) whose competent authority has issued an import

permit in respect of the consignment in question< or

(b) which has been identified as a country concerned by

the illicit manufacture of heroin or cocaine on its territory or as a

sensitive country as regards the possible diversion of the said

substances,

such export shall be subject to an authorisation issued in

accordance with sub-rules (2) and (3) by the Superintendent in

accordance with the provisions in force.

(2) Exports of substances referred to in sub-rule (1) hereof

shall be subject mutatis mutandis to the provisions of rule 6 hereof,

wherever, under specific arrangements agreed with the importing

countries concerned, an export authorisation and a pre-export notification

are required for each operation. The provisions of rule 6 shall also apply

whenever an open individual authorisation cannot be issued in

accordance with sub-rule (3) hereof>

Provided that the provisions of rule 6 shall also apply

whenever a substance listed in Annex II is destined to an operator

established in a country listed in the same annex.

(3)

In appropriate circumstances, the exportation of

substances in Category 3 of Table I of the Third Schedule to the

Ordinance may be authorised on a global basis by the issue of an open

individual authorisation. The decision to issue, suspend or revoke such

authorisations shall be taken by the Superintendent after the applicant

has given>

(a)

details of his qualifications and professional

experience in the field covered by these rules and, in the case of a

legal person, the name, relevant qualifications and professional

experience of the director or the person responsible for ensuring

that exports of scheduled substances are carried out in compliance

with the provisions of theserules<

(b) details in summary form of export transactions in the

scheduled substances concerned which he has made in the twelve

months preceding the application, specifying in the case of each

substance, the total number of transactions and the amounts

exported to each country for which an export authorisation is

required<

(c) details of the precautions he has taken to prevent the

diversion of scheduled substances to the illicit manufacture of

narcotic drugs and psychotropic substances, and in particular, the

arrangements for complying with rule 5 hereof.

(4) The authorisation shall be suspended or revoked or

refused, in particular, if>

(a) there are reasonable grounds for suspecting that the

information is incorrect<

(b) there are reasonable grounds for suspecting that the

precautions taken are not sufficient to prevent the diversion of

scheduled substances to the illicit manufacture of narcotic drugs

and psychotropic substances or for believing that the operator or

the person responsible in the case of a legal person, does not provide

sufficient safeguard against the risk of diversion.

(5) Notwithstanding the existence of the authorisation,

individual export operations undertaken under the cover of this

authorisation may be prohibited by the competent authorities.

(6)

Without prejudice to obligations arising under rule 4

hereof, the holder of the authorisation referred to in sub-rule (1) above

shall comply with the following obligations>

(a) enter the number of this authorisation in any relevant

customs export declaration<

(b) carry out the entry into the records at the latest when

the consignment leaves the premises of the supplier for their

exportation<

(c) whenever the previous issue of an import authorisation

by the destination country is a requirement for the issue of the

export authorisation, the entry shall contain the number, if any,

and place and date of issue of the import permit issued by the

destination country< a copy of this permit shall be retained<

(d) ensure that the consignment is accompanied at any

time during the transport by a copy of the authorisation<

(e) furnish, by the end of each quarter, summary

information on the export operations carried out under the

authorisation. The content of the summary to be determined in

detail by the Superintendent shall contain, as a minimum,

information on the number of operations, the substances, quantities,

and destination countries involved. In case that this information

is not supplied, the authorisation may be suspended or revoked<

(f) inform the Superintendent of any change occurring

with regard to the information supplied, or such of it as may be

specified by that authority for this purpose.

(7) The form of the open individual authorisation referred to in

sub-rule (1) hereof shall conform to the specifications which are given

in Annex VI hereto. Furthermore, it shall be a condition of the issue of

such authorisations that, for control purposes, the holder shall retain for

inspection by the Superintendent, where appropriate and in respect of

each export, a copy of the import permit issued by the authorities of the

importing country. In cases of doubt, the Superintendent may contact

the authorities which have issued the import permit.

(1) In order to ensure the correct application of rules 6, 7, 8 Powers of the

competent

and 11 of these rules, any person duly authorised in writing by the authority.

Superintendent shall, on production of his authorisation or credentials,

have the right at any time to -

(a)

have access to, inspect, obtain and retain information

and records, in whatever form they are held on scheduled substances

or operations involving scheduled substances<

(b)

enter any premises for the purpose of ascertaining

whether there is or has been or there is likely to be any contravention

of the provisions of these rules.

(2) Without prejudice to the measures laid down in rules

6, 7 and 8 and in sub-rule (1) of this rule, the Superintendent may prohibit

the introduction of scheduled substances into Malta or their departure

from Malta, if there are reasonable grounds for suspecting that the

substances are intended for the illicit manufacture of narcotic drugs or

psychotropic substances.

For the purpose of preventing specific risks of diversion in

free zones as well as in other sensitive areas such as bonded warehouses,

operators shall ensure that controls applied to operations carried out in

these areas are effective at every stage of these operations and not less

stringent than those applied in the other parts of the customs territory.

(1) All transactions leading to the placing on the market

of scheduled substances in Categories 1 and 2 of Table I of the Third

Schedule to the Ordinance shall be properly documented in written or

electronic records.

(2) (a) All records must be open for inspection by the

Superintendent or of any officer acting on his behalf and, in particular,

commercial documents such as invoices, cargo manifests, administrative

documents, customs documents, transport and other shipping documents

shall contain sufficient information positively to identify>

(i) the name of the scheduled substance as given

in Categories 1 and 2 of Table I of the Third Schedule to the

Ordinance,

(ii) the quantity and weight of the scheduled

substance and, where it consists of a mixture, the quantity

and weight of the mixture as well as the quantity and weight

or the percentage of any substance or substances specified in

Categories 1 and 2 of Table I of the Third Schedule to the

Ordinance which are contained in the mixture, and

(iii) the name and address of the supplier, distributor

and of the consignee.

(b)

Such documentation must furthermore contain a

declaration from the customer which shows the specific uses of the

substances. A separate declaration, as specified in Annex III hereto,

shall be required for each substance in Categories 1 or 2 of Table I of

the Third Schedule to the Ordinance.

(c)

Without prejudice to the foregoing paragraphs hereof,

a regular customer obtaining from a supplier a scheduled substance

specified in Category 2 of Table I of the Third Schedule to the Ordinance

may provide a single declaration, as specified in Annex IV hereto,

covering all transactions involving that substance over a period of one

year, provided that>

(i) the customer is one to whom he has supplied the

substance on at least three occasions in the preceding twelve

months,

(ii) the supplier has no reason to suppose that the

substance will be used for illicit purposes, and

(iii) the quantities ordered are consistent with usual

consumption for that customer.

(3) The obligations under sub-rule (1) of this rule shall

not, however, apply to transactions concerning scheduled substances in

Category 2 of Table I of the Third Schedule to the Ordinance where the

quantities involved do not exceed those indicated in Annex VII to

theserules.

(4)

Operators shall ensure that labels are affixed to

scheduled substances in Categories 1 and 2 of Table I of the Third

Schedule to the Ordinance before they are placed on the market. Such

labels must show the names of the substances as given in Table I of the

Third Schedule to the Ordinance. Operators may in addition affix their

customary labels.

(5)

Operators shall keep such detailed records of their

activities as are required to comply with their obligations under sub-

rule (1) hereof.

(6)

The documentation referred to in sub-rules (1) and

(5) hereof shall be kept for a period of not less than three years from the

end of the calendar year in which the operation referred to in sub-rule

(1) took place, and must be readily available for inspection by the

Superintendent upon request.

ANNEX I

Substance

Destination

ANNEX II

This includes the salts of the substances except for sulphuric acid and hydrochloric acid whenever the

existence of such salts is possible.

ANNEX III

Declaration form for individual transactions in category 1 or 2 substances

as specified in Table I in the Third Schedule to the Ordinance

( 1 ) Complete as appropriate

( 2 ) Combined Nomenclature code.

ANNESS IV

( 1 ) Combined Nomenclature code.

ANNEX V

ANNEX VI

Open individual autorisation for export of substances listed in categories 2 or 3

of Table I of the Third Schedule to the Ordinance

ANNEX VII

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press