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    The import and export of goods that require a special authorisation (including medicinal products)

    03.05.2017
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    Which goods require a special authorisation from the State Agency of Medicines?

    Goods that require a special authorisation from the State Agency of Medicines are as follows:

    • medicinal products (including medicinal products that have a marketing authorisation in Estonia and those that do not; human and veterinary medicinal products; medicinal products that contain narcotic drugs and psychotropic substances; medicinal products to be used in clinical trials; medicinal gases and also unusable medicinal products)
    • the active substances of medicinal products (including active substances used for the manufacture of medicinal products and for the preparation of medicinal products in pharmacies)
    • narcotic drugs and psychotropic substances
    • cells, tissues and organs of human or animal origin used for medical purposes on humans for the prevention, diagnosis or treatment of a disease or for the relief of a medical condition
    • hormones, prostaglandins, thromboxanes and leukotrienes (natural or synthetic); their derivatives and structure analogues, including polypeptides that have a modified chain that are mostly used as hormones (including as a substance, as an ingredient in medicinal products or as an active substance used to manufacture/prepare medicinal products) (CN code 2937)
    •  natural or synthetic herbal alkaloids, their salts, ethers, esthers and other derivatives (including as a substance, as an ingredient in medicinal products or as an active substance used to manufacture/prepare medicinal products) (CN code 2939)
    • antibiotics (including as a substance, as an ingredient in medicinal products or as an active substance used to manufacture/prepare medicinal products) (CN code 2941)
    • dried glands and other organs used in organotherapy (in powder form or other); the extracts of glands, other organs and their secretions; heparine and its’ salts; substances derived from humans or animals used in the prevention, diagnosis or treatment of a disease that are not mentioned elsewhere (CN code 3001)
    • whole blood, blood components and plasma-derived products to be used in humans (CN code 3002)

    The regulations on handling drug precursors (including the import and export) can be found here.

    In case of uncertainty whether the goods handled require a special authorisation from the State Agency of Medicines, please contact us.

     

    What is considered import and export?

    The European Economic Area (EEA) is a common economic area created with the EEA Agreement, which unites the EU Member States and the three EFTA States (Norway, Iceland, and Liechtenstein) into an Internal Market governed by the same basic rules.

    The term import includes the import of goods requiring special authorisation from countries outside the EEA (placing such goods under the customs procedure of release for free circulation, i.e. import from third countries). When goods are imported from a Member State of the European Union or a member state of the European Economic Area to Estonia, it is considered conveyance of goods.

    The term export includes the export of goods requiring special authorisation to countries outside the EEA (placing such goods under export procedure, i.e. export to third countries). When goods are exported goods from Estonia to a Member State of the European Union or to a member state of the European Economic Area, it is considered conveyance of goods.  

    In case of transit procedures the consignee (importer) or the consignor (exporter) is not an Estonian company and therefore this procedure is not considered import or export in the meaning of Medicinal Products Act.

    In case of purchase or sale that takes place in the bonded warehouse,  the Estonian company involved in either transaction has to hold an activity licence for the handling for medicinal products.

     

    Who can import and export goods that require a special authorisation?

    The importer is the consignee and the exporter is the consignor of the goods that require a special authorisation. The transporter of the goods is not considered an importer of exporter.

    The importer and exporter may be:

    • a holder of an activity licence for wholesale distribution of medicinal products
    • a holder of an activity licence for manufacture of medicinal products
    • holders of an activity licence for health care provision (can import or export medicinal products used in clinical trials, radiopharmaceuticals, medicinal products used in various compassionate use or named patient programs, medicinal products for foreign aid)
    • holders of an activity licence for the acquisition or handling of cells, tissues and organs (can import cells, tissues and organs of human or animal origin used for medical purposes and handling)
    • educational or research institutions (can import medicinal products, tissues, cells and organs of human origin used for scientific or research purposes)
    • social welfare institutions (can import or export medicinal products for foreign aid)
    • other legal persons (can import or export medicinal products for research and other purposes with the prior consent of the State Agency of Medicines, for example medicinal products for scientific research and other purposes)

    If a company does not hold any of the activity licences mentioned above and wishes to convey, import or export goods that require a special authorisation that are not medicinal products (CN codes mentioned above), please contact us to specify the purpose of use of the goods, the right to import and export and the requirements for special authorisation for import or export or notification.

    Only holders of an activity licence for manufacture of medicinal products are permitted to import medicinal products directly from third countries (non-EEA) to Estonia. This requirement is valid mainly in case of importing medicinal products meant to be marketed/used in Estonia that have a marketing authorisation and also in case of medicinal products that are used in clinical trials.

    Medicinal products that do not have a marketing authorisation in Estonia are permitted to import to Estonia by a holder of an activity licence for manufacture of medicinal products or for wholesale distribution of medicinal products, who has a corresponding special condition marked on their activity licence.

    In case of first time import of medicinal products that have a marketing authorisation that are meant to be marketed in Estonia, the importer of the medicinal products has to inform the marketing authorisation holder and the State Agency of Medicines prior to the planned transaction if that importer is not designated as the importer by the holder of the marketing authorisation.

     

    What is a special authorisation and in which cases are special import and export authorisations or notifications of import and export required?

    A special authorisation is either a special authorisation for import or export or conveyance of goods (herinafter import or export) or the notification of such transactions.  

     

    Special authorisation for import or export

    Special authorisation for import or export is required in case of import or export of the following goods:

    • narcotic drugs and psychotropic substances and medicinal products containing them
    • unauthorized medicinal products intended to be marketed in Estonia (based on an application of a doctor, a health care facility or a professional organization of doctors for the use of any unauthorized medicinal product)
    • the import and export of goods that require a special authorisation from or to third countries (as an exception, the export of medicinal products used in clinical trials requires notification instead of a special authorisation for export)

    The obligation to apply for a special authorisation for import or export lays upon the consignor (hereinafter ‘exporter’) and consignee (hereinafter, ‘importer’) of the goods that require a special authorisation. A special authorisation for import or export has to be applied for every consignment of goods and multiple import and export transactions can not be conducted on the basis of one special authorisation for import or export.

    An application in compliance with the requirements established must be submitted to the State Agency of Medicines at least five working days before goods requiring special authorisation arrive at the customs frontier or the border between Estonia and a Member State of the European Economic Area.

    A separate application must be submitted for the import or export of narcotic drugs and psychotropic substances and it must contain the name and signature of 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 order to apply for the special authorisations mentioned above, we kindly ask you to register an user account for the Client Portal of the State Ageny of Medicines and submit the applications via the Client Portal.

    If the use of the Client Portal is not possible for some reason, an application form may be used. Applications that are not submitted via the Client Portal must be signed by the applicant.

    The State Agency of Medicines will decide on the granting of an import or export authorisation and a distribution permit within five working days after the receipt of a corresponding application and other requisite information and documents. During the evaluation of the application the State Agency of Medicines may ask for additional information that certifies the quality of medicinal products (including the certificate of analysis, OCABR certificate etc.). All medicinal products that are distributed in Estonia must be accompanied by a document certifying the quality of the medicinal product (certificate of analysis or a batch certificate issued by the manufacturer of the medicinal product that confirms that the medicinal product has been manufactured in accordance with existing laws in the manufacturing country, good manufacturing practices and the requirements of the marketing authorisation of the medicinal product).

    In case of import of active substances used for the manufacture of human medicines, a written confirmation by the competent authority of the state of the exporting country that confirms that the manufacturer of the active substance is acting in compliance with good manufacturing practices has to be added to the import application.

    If the conditions for applying for an import/export authorisation are not met, the State Agency of Medicines has the right to refuse to grant the import or export authorisations.

    The authorisations for the import/export of narcotic drugs/psychotropic substances are issued on paper, authorisations for other goods are issued electronically with a digital signature and the digital container can be forwarded for customs clearance.

     

    Notification of the import or export of goods that require a special authorisation

    In case the import/export of goods does not require an authorisation for the import/export, the importer or exporter must submit a notification of the import/export to the State Agency of Medicines.

    Notifying the State Agency of Medicines is required, when the following goods that require a special authorisation are conveyed to or from a Member State of the European Union or a member state of the European Economic Area to Estonia:

    • medicinal products (except narcotic drugs and psychotropic substances and unauthorized medicinal products intended to be distributed in Estonia- these require a special authorisation for import or export)
    • medicinal products used in clinical trials (as an exception, notification is also required in case of export to third countries that are not members of the EEA)
    • active substances used for the manufacture and preparation of medicinal products
    • whole blood, blood components and plasma-derived products intended to be used on humans
    • other goods requiring a special authorisation

    The obligation to submit a notification of import or export lays upon the consignor and consignee of the goods that require a special authorisation.

    Notification should be submitted as soon as possible, but not later than on the fifth working day after the goods are exported or imported.

    The notification must contain the following data on the transaction: the date of import/export, the name and address of the exporter and importer of the goods, data on the medicinal product or other goods. The name and contact details of the notifier along with the date of the notification also have to be marked on the notification (in case of notifying via the Client Portal, this data is automatically retrieved from the account details of the notifier).

    In case of import/export of medicinal products used in clinical trials, the notification must also contain the reference number assigned by the State Agency of Medicines in respect of the conduct of the clinical trial. In case of notifying on the import/export of cells, tissues and organs, a certificate of the cells, tissues and organs, signed by the competent person of the handler of cells, tissues and organs has to be added to the application.

    More information on the import and export of cells, tissues and organs is available here.

    We kindly ask to submit all notifications via the Client Portal of the State Agency of Medicines.

     

    Restrictions on the export of medicinal products

    As an extraordinary measure, the State Agency of Medicines has the right to restrict the export of a medicinal product if the incessant supply of a medicinal product is vital to the health status of a human or animal, other medicinal products containing the same active substance and strength are not marketed in Estonia or are marketed in insuffient amount. In case a decision on the restriction of export is issued, the State Agency of Medicines informs all holders of an activity licence for wholesale distribution of medicinal products.

    The export of the following medicinal products is restricted:

    Cetrotide 0,25 mg powder for injection and solvent (marketing authorisation holder Merck Serono Europe Limited) – the decision is valid until 31.08.2017.

    For additional information please contact us at eriluba@ravimiamet.ee; teavitus@ravimiamet.ee or phone 737 4140.

    Information on travelling with medicinal products and the sending of medicinal products can be found here:

    http://ravimiamet.ee/en/travelling-medicinal-products

    http://ravimiamet.ee/en/sending-medicinal-products