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    Narcotic drugs and psychotropic substances and their legal handling

    08.05.2017
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    Legal framework

    What are narcotic drugs and psychotropic substances and for which purposes can they be handled?

    Handling narcotic drugs and psychotropic substances for scientific purposes

    Handling narcotic drugs and psychotropic substances by a licenced medicines wholesaler

    Manufacturing of narcotic drugs and psychotropic substances

    Handling narcotic drugs and psychotropic substances by a licenced pharmacy

    Emergency medical care providers and state rescue services

    Other handlers of narcotic drugs and psychotropic substances

    Destruction of unusable medicinal products and substances

     

    Legal framework

     

    In Estonia the field of narcotic drugs and psychotropic substances is regulated by the Act on Narcotic Drugs and Psychotropic Substances and Precursors thereof, which lays down the main handling requirements for such substances. The conditions and procedure for handling of narcotic drugs and psychotropic substances for medical and research purposes, also the conditions and procedure for maintaining records and reporting for these substances are established by regulation no 73 of the Minister of Social Affairs.

    Narcotic drugs and psychotropic substances are divided into six schedules in Estonia, depending on the effect and misuse/dependence potential (Annex 1 of regulation no 73).  The schedules of narcotic drugs and psychotropic substances are established on the basis of the 1961 United Nations Single Convention on Narcotic Drugs and the 1971 United Nations Convention on Psychotropic  Substances and also taking into account the degree of the risk of misuse and addiction of specific narcotic drugs and psychotropic substances.

     

    What are narcotic drugs and psychotropic substances and for which purposes can they be handled?

    Narcotic drugs and psychotropic substances are substances that affect the mood and behaviour of humans and their consumption is often accompanied by a heightened potential for abuse and depencence. Depending on the effect, usage profile and abuse/dependence potential narcotic drugs and psychotropic substances are divided into six schedules in Estonia. The isomers, esters, ethers and salts of these substances and medicinal products containing such substances are also considered narcotic drugs and psychotropic substances.

    The handling of narcotic drugs and psychotropic substances is prohibited except for medical or scientific purposes, to prevent, detect or combat criminal offences relating to narcotic drugs or psychotropic substances or for use for educational purposes. “Handling” in this context means the owning, possessing, mediating, use, cultivation, gathering, preparing, manufacturing, processing, packaging, preserving, storing, loading, transport, exportation or importation, the application of the customs procedure of transit, and the supplying of narcotic drugs or psychotropic substances to third persons for or without charge.  

    There are general handling requirements that apply to all legal and private persons that handle narcotic drugs and psychotropic substances in the scope of their business and professional acitivities. Main requirements involve appointing a responsible person, conducting inner handling regulations, storage, record-keeping, receipt and dispensing requirements.

    The following chapters explain any additional requirements that apply to manufacture and wholesale companies, pharmacies, holders an activity licence for provision of the healthcare and pharmacy services and for educational or research institutions.

     

    Handling narcotic drugs and psychotropic substances for scientific purposes

    Educational or research institutions that hold a licence issued by the State Agency of Medicines can handle narcotic drugs and psychotropic substances and medicines containing them for scientific purposes. In order to obtain a licence to handle narcotic drugs and psychotropic substances, please fill out and sign the application form and submit it to the email address info@ravimiamet.ee or via regular mail to Nooruse 1, 50411 Tartu.

    Where can educational or research institutions obtain narcotic drugs and psychotropic substances from for scientific purposes?

    Educational or research institutions that have the right to wholesale purchase medicines, can obtain narcotic drugs and psychotropic substances directly from holders of an acitivity licence for wholesale distribution of medicinal products.

    Educational or research institutions that do not have the right to wholesale purchase medicines, can obtain medicines containing narcotic drugs and psychotropic substances from a pharmacy. In order to do that, an application for a permit in free from has to be submitted to the State Agency of Medicines, containing data on the specific medicine and the amount needed and also the pharmacy from which the purchase will be made. State Agency of Medicines sends the issued permit to the applicant and the pharmacy that will order and dispense the medicine for scientific purposes.

    The abovementioned general requirements also apply for handling narcotic drugs and psychotropic substances for scientific purposes.

     

    Handling narcotic drugs and psychotropic substances by a licenced medicine’s wholesaler

    Holder of an acitivity licence for the wholesale distribution of medicinal products can handle narcotic drugs and psychotropic substances and medicines containing them if they have a specific condition marked on their wholesale licence.

    The abovementioned general requirements apply for handling narcotic drugs and psychotropic substances by wholesalers of medicines. In addition, the wholesalers of medicines must submit quaterly reports to the State Agency of Medicines on the receipt and dispensing of narcotic drugs and psychotropic substances. Please submit the reports via the Client Portal of the State Agency of Medicines.

    How to submit an application for the import and export of narcotic drugs and psychotropic substances?

    Please submit the applications for the import and export of narcotic drugs and psychotropic substances via the Client Portal. The applications must be signed by the person responsible for the handling of these substances. Also, there is a state fee of 10 euros for the application of a special authorisation for the import or export of narcotic drugs or psychotropic substances (http://www.ravimiamet.ee/riigiloivud). In case of export of these substances, an import authorisation of such substances granted by the competent authority of the state to which the products are to be conveyed has to be submitted for each consignment of medicinal products. In case the substance exported is not a scheduled substance in the importing country, this has to be officially confirmed by the competent authority of that country.

    To whom can wholesalers of medicines dispense narcotic drugs and psychotropic substances?

    Holder of an acitivity licence for the wholesale distribution of medicinal products can dispense narcotic drugs and psychotropic substances to pharmacies and manufacturers of medicines, also to other appropriately licenced wholesalers of medicines.

    Only substaces included on their licence can be dispensed to educational or research institutions that have the right to wholesale purchase medicines. When the wholesaler of medicines submits an application to the State Agency of Medicines for the import of the ordered narcotic drugs of psychotropic substances, a remark has to be added on the application stating that the substances are intended to be used for scientific purposes.

    If the substance intended to import has not been previously handled in Estonia or has been handled in small amounts, we recommend to contact the State Agency of Medicines prior to submitting an application for import, as there may be a need to increase the quota for that substance (e.g. the amount of the substance in grams that is allowed for medicinal and scientific purposes in Estonia).

     

    Manufacturing of narcotic drugs and psychotropic substances

    In order to manufacture narcotic drugs and psychotropic substances for medicinal purposes a legal person has to hold a licence issued by the State Agency of Medicines for the manufacture of medicinal products with the special condition of handling narcotic drugs and psychotropic substances. This licence is terminal and contains information on the amount manufactured and the period during which the manufacture has to be completed.

    Which narcotic drugs and psychotropic substances are prohibited to be manufacured?

    The cultivation of opium poppy, cannabis and mushrooms containing psilocine or psilocybine for the purpose of preparing narcotic drugs is prohibited.

    Opium poppy and cannabis may be cultivated for the purpose of agricultural production pursuant to the requirements of a relevant market measure of the European Union Common Agricultural Policy and the content of THC in agricultural cannabis herbs cannot exceed 0,2%.

    Which handling requirements apply to the handling of narcotic drugs and psychotropic substances by manufacturers?

    The abovementioned general requirements apply for to the manufacturers of narcotic drugs and psychotropic substances. Please note that all narcotic/psychotropic intermediate products that are formed during the manufacture of narcotic drugs and psychotropic substances must also be documented.

    In addition, the manufacturers must submit quaterly reports to the State Agency of Medicines on the receipt and dispensing of narcotic drugs and psychotropic substances. Please submit the reports via the Client Portal

    Which substances can manufacturers of narcotic drugs and psychotropic substances import and export?

    Holder of an activity licence for manufacture of medicinal products has the right to import and export narcotic drugs and psychotropic substances in the scope of the manufacture of their products. If the manufacturer has appointed a person responsible for the wholesale of medicines and the activity licence has the special condition of wholesale marked on it, it is also allowed to import and export medicines that the licence holder does not manufacture.

     

    Handling narcotic drugs and psychotropic substances by a licenced pharmacy

    All licenced pharmacies can handle narcotic drugs and psychotropic substances and medicinal products containing them (except in the scope of distance selling).

    The abovementioned general requirements apply for the handling of narcotic drugs and psychotropic substances by licenced pharmacies.

    Pharmacies can dispense to patients Schedule I, II and IV narcotic drugs and psychotropic substances and medicinal products containing them only on the basis a medical prescription for a narcotic medicinal product or a veterinary prescription for a narcotic medicinal product. The substances listed in Schedules III and IV and medicinal products containing them may be dispensed only on the basis of a medical or veterinary prescription.

    The amount of narcotic drugs and psychotropic substances dispensed on the basis of medical prescription for a narcotic medicinal product cannot exceed the amount needed for one month’s treatment. It is prohibited to prescribe and dispense from pharmacies injectables containing ketamine, esketamine, fentanyl, thiopental, sodium oxybate, alfentanyl, sufentanyl and remifentanyl and oral forms of buprenorphin. If these substances are prescribed, the presciption has to be withheld by the pharmacy and the State Agency of Medicines must be notified.

    On the basis of order forms narcotic drugs and psychotropic substances can be dispensed from pharmacies to legal/private persons that have the right to handle drugs and the order form must contain the name and signature of the person responsible for the handling of narcotic drugs and psychotropic substances of the legal person submitting the order.

     

    Emergency medical care providers and state rescue services

    Medicinal products containing narcotic drugs or psychotropic substances carried for first-aid purposes on ambulance cars of emergency medical care providers, state rescue services and on board of ships and aircraft engaged in international transportation are exempt from import and export restrictions (and consequently from the requirement to apply for import/export authorisations).

    In case narcotic drugs and psychotropic substances and medicinal products containing them are exported by an Estonian rescue service team, including during training, the Estonian Rescue Board has to submit a list of goods requiring a special authorisation immediately after their departure from Estonia. The list of goods re-exported must be submitted during 30 days following the arrival back to Estonia.

    If goods requiring a special authorisation are imported by a foreign rescue service team, they have to carry a list of the goods confirmed by the head of the team and the list has to be submtitted to the State Agency of Medicines upon request.

     

    Other handlers of narcotic drugs and psychotropic substances

    Holders of an activity licence for health care provision of humans or animals, also social welfare institutions may handle narcotic drugs and psychotropic substances in the scope of their professional activities. Pharmacies can dispense narcotic drugs and psychotropic substances to these persons on the basis of an order form. The abovementioned general requirements apply for to the handling of narcotic drugs and psychotropic substances by these persons.

     

    Destruction of narcotic drugs or psychotropic substances and medicinal products containing them

    Handlers who do not have the right to handle narcotic drugs or psychotropic substances or precursors in possession of such substances are required to deliver these promptly to the Police and Border Guard Board.

    Medicines containing narcotic drugs or psychotropic substances that do not comply with quality requirements, are past their expiry date, prohibited to use or do not have a lawful purpose of use for other reasons, must be delivered to the pharmacy for proper destruction. Medicinal products should be in their original packages.

    Narcotic or psychotropic substances that do not comply with quality requirements must be delivered for destruction to a waste-management company that has the right to handle hazardous waste.