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    Drug Precursors

    08.05.2017
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    What are drug precursors?

    Who controls the handling of drug precursors?

    What are the handling requirements of drug precursors?

    Legal acts that regulate the field of drug precursors

     

    What are drug precursors?

    Drug precursors are chemicals and mixtures/natural products containing them that can be used for the illegal manufacture of narcotic drugs and psychotropic substances. Drug precursors themselves generally do not have a psychoactive effect.

    The trade of drug precursors cannot be prohibited, as they have a wide range of legitimate uses in various industrial processes and in the manufacture of different products (medicinal products, perfumes, plastics, cosmetics etc). Both at international and at EU level, specific regulatory frameworks have been put in place to ensure that diversion of drug precursors is prevented through control of their legitimate trade at EU borders and in the internal market. The legislation aims to strike a balance between the necessary control to prevent diversion of drug precursors and allowing their legitimate trade without creating unnecessary administrative burdens.

    At EU level 28 drug precursors are "scheduled" (controlled) and they are divided into four categories:

    Table 1. Categories of drug precursors

    Category 1

    Most sensitive substances, from which illicit drugs can be produced most easily

     

    Ephedrine

    Ergometrine

    Ergotamine

    Lysergic Acid

    1-phenyl-2-propanone (BMK)

    Pseudoephedrine

    N- acetylanthranilic Acid

    3-4 Methylenedioxy-Phenylpropan-2-one (PMK)

    Isosafrole

    Pipreronal

    Safrole

    Norephedrine

    Alpha-phenylacetoacetonitrile (APAAN)

    Chloroephedrine

    Chloropseudoephedrine

    Category 2

    Less sensitive substances

    A

    Acetic Anhydride

    B

    Potassium Permanganate

    Phenylacetic Acid

    Anthranilic Acid

    Piperidine

    Category 3

    Bulk chemicals that can have different types of uses in the manufacturing process (feedstock, but also solvents, impurities remover, etc.)

     

    Acetone

    Ethyl Ether

    Methyl Ethyl Ketone (MEK)

    Toluene

    Hydrochloric Acid

    Sulphuric Acid

    Category 4

    Human and veterinary medicinal products that

    contain ephedrine and psedoephedrine (other

    medicinal products that contain other drug precursors

    are not considered precursors)

     

    Ephedrine in medicinal preparations

    Pseudoephedrine in medicinal preparations

     

    Who controls the handling of drug precursors?

     

    In order to prevent illicit drug manufacture from drug precursors their handling is internationally controlled and regulated.

    In the European Union the competent authorities responsible for the control of drug precursor handling are customs, police and public health agencies. They work in close cooperation with industry, as this is a core element of international drug precursor control.

    In Estonia the competent authority responsible for the supervision of the legal trade of drug precursors is the State Agency of Medicines, we issue the licences and registrations for handling precursors, import and export authorisations, collect and submit annual data on the trade of drug precursors and regularly inspect the handlers to determine that they are conducting their trade in compliance with legislation. Cases of illicit handling and trade are managed by Estonian Police and Border Guard Board and Tax and Customs Office.

     

    What are the handling requirements of drug precursors?

     

    The requirements for handling drug precursors depend on the category of any specific substance and the purpose of the handling. The main types of handling are as follows:

    Placing on the market -  any supply, whether in return for payment or free of charge, of drug precursors in the EU; or the storage, manufacture, production, processing, trade, distribution or brokering of them for the purpose of supply in the EU

    Import -  any entry of drug precursors having the status as non-EU goods into the customs territory of the Community, including temporary storage, the placing in a free zone or free warehouse, the placing under a suspensive procedure and the release for free circulation

    Export -  any departure of drug precursors from the customs territory of the EU, including the departure of drug precursors that requires a customs declaration and the departure of them after their storage in a free zone of control type I or free warehouse

    Intermediary activities - any activity to arrange purchase and sale or supply of drug precursors carried out by any natural or legal person who aims to obtain agreement between two parties or to do so through acting on behalf of at least one of these parties without taking these substances into its possession or taking control of the carrying out of such transaction; this definition also includes any activity carried out by any natural or legal person established in the Community involving purchase and sale or supply of drug precursors without these substances being introduced into the Community customs territory;

    A brief overview of requirements for handling drug precursors:

    Special licence and special registration: depending on the specific drug precursor and the purpose of the handling, the companies handling drug precursors have to obtain a special licence or register themselves. Check from this scheme wheter a licence or registration is required.

     

    Applications for a special licence and a special registration:

    Application for a licence

    Application for a registration

     

    Import and export authorisations: depending on the specific drug precursor, purpose of the handling and amount handled, the companies handling drug precursors have to obtain an export or import authorisation. Check from this scheme whether an import or export authorisation is required.

     

    Applications for import and export authorisations:

    Application for import

    Application for export

     

    Please note that state fees apply for the applications for a special licence and for an export authorisation.

    Appoint a responsible officer. In order to place on the market category 1 and 2 substances and in order to obtain a licence/registration to handle drug precursors the operator shall appoint an officer responsible for the trade in drug precursors.

    Documentation. All transactions leading to the placing on the market of category 1 and 2 drug precursors must be properly documented. This includes invoices, cargo manifests, administrative documents, transport and other shipping documents that must contain information on the drug precursor, the name quantity and weight of the drug precursor and on all parties to the transaction. The documentation and records  shall be kept for at least three years from the end of the calendar year in which the transaction.

    Customer declaration. Any operator that holds a licence/registration who supplies a customer with category 1 and 2 drug precursors, shall obtain a declaration from the customer which shows the specific use or uses of the scheduled substances.

    Labelling. Operators shall ensure that labels are affixed on any packaging containing drug precursors indicating their name and CN code, or, in the case of a mixture or a natural product, its name and the name of any drug precursor contained in the mixture or in the natural product. Operators may, in addition, affix their customary labels.

    Notification on suspicious transactions. Operators handling drug precursors must notify the State Agency of Medicines of any suspicious transactions concerning drug precursors, including unusual orders and other types of transactions that may indicate that drug precursors may be diverted from the legal supply chain in order to produce illicit drugs. In case of suspicion, please submit at least the name and the quantity and weight of the drug precursor and other relevant details of the transaction. 

    Annual reports on the handling of category 1 and 2 drug precursors must be submitted by 15th of February each calendar year. Please submit the annual reports in electronic form and signed digitally to email address info@ravimiamet.ee

     

     

    Legal acts that regulate the field of drug precursors

     

    European Union legislation on drug precursors implements the requirements of The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.

     

    There are four regulations that form the basis of drug precursor legislation in the European Union and they apply directly in all Member States:

    1. REGULATION (EC) No 273/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on drug precursors, that lays down laws on trade in drug precursors within the EU.
    2. COUNCIL REGULATION (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug Precursors.
    3. COMMISSION DELEGATED REGULATION (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors
    4. COMMISSION IMPLEMENTING REGULATION (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors

     

    The main requirements on handling drug precursors are also stated in Estonian Act on Narcotic Drugs and Psychotropic Substances and Precursors thereof