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The Conditions and Procedure for the Import and Export, Carrying for Personal Use and Sending by Post of Goods Requiring Special Authorisation of the State Agency of Medicines, the Forms of Special Authorisations and the List of Goods Requiring Special Authorisation of the State Agency of Medicines

Issuer:Minister of Social Affairs
Type:regulation
In force from:01.01.2012
In force until:12.05.2013
Translation published:08.10.2014

The Conditions and Procedure for the Import and Export, Carrying for Personal Use and Sending by Post of Goods Requiring Special Authorisation of the State Agency of Medicines, the Forms of Special Authorisations and the List of Goods Requiring Special Authorisation of the State Agency of Medicines

Passed 18.02.2005 No. 31
RTL 2005, 23, 316
Entry into force 01.03.2005

Amended by the following legal instruments (show)

PassedPublishedEntry into force
07.10.2005RTL 2005, 105, 160421.10.2005
13.12.2007RTL 2007, 96, 161621.12.2007
19.12.2008RTL 2008, 102, 145701.01.2009
26.02.2010RTL 2010, 10, 18208.03.2010
11.11.2011RT I, 18.11.2011, 101.01.2012

This Regulation is established on the basis of subsection 17 (1) and subsection 19 (5) of the Medicinal Products Act.

§ 1.  Scope of application

  This Regulation establishes:
 1) the list of goods requiring special authorisation of the State Agency of Medicines (hereinafter goods requiring special authorisation);
 2) the conditions and procedure for the import and export of goods requiring special authorisation of the State Agency of Medicines (hereinafter special authorisation), including the conditions and procedure for applying for special authorisation for import or export, for the issue of special authorisation, for notification of import or export, and the conditions under which special authorisation or notification of the State Agency of Medicines is required for the import or export of cells, tissues and organs of human or animal origin used for medical or research purposes;
[RTL 2008, 102, 1457 – entered into force 01.01.2009]
 3) the conditions for carriage, by travellers, of medicinal products to be used, for medical reasons, personally by the travellers or on animals accompanying the travellers, and the conditions for sending by post of medicinal products;
 4) the form for the application for the use of unauthorised medicinal products by a doctor, a veterinarian or a professional organisation of doctors or veterinarians.
[RTL 2010, 10, 182 – entered into force 08.03.2010]

§ 2.  The list of goods requiring special authorisation

  The following goods shall require special authorisation:
 1) the goods listed in Annex 9;
 2) the active substances used for the preparation of medicinal products;
 3) cells, tissues and organs of human or animal origin used for medical purposes for the prevention, diagnosis or treatment of a disease or for the relief of a disease condition in a human.
[RTL 2008, 102, 1457 – entered into force 01.01.2009]

§ 3.  The conditions for the import and export of goods requiring special authorisation

 (1) Special authorisation is required for the import and export of the following goods requiring special authorisation:
 1) medicinal products imported under section 21 of the Medicinal Products Act, including medicinal products imported as foreign aid;
 2) medicinal products used in clinical trials;
 3) imported and exported medicinal products, including active substances;
 31) imported and exported cells, tissues and organs of human or animal origin used for medical purposes;
[RTL 2008, 102, 1457 – entered into force 01.01.2009]
 4) other imported and exported goods requiring special authorisation.

 (2) Notification of the State Agency of Medicines is required for the import and export of the following goods requiring special authorisation:
 1) medicinal products imported from and exported to a Member State of the European Economic Area, including active substances, unless these have been granted authorisation for export or import;
 11) cells, tissues and organs of human or animal origin used for medical purposes, imported from and exported to a Member State of the European Economic Area, unless these have been granted authorisation for export or import;
[RTL 2008, 102, 1457 – entered into force 01.01.2009]
 2) samples to be presented for applying for marketing authorisation.

 (3) The quantity and list of the imported and exported goods shall not exceed the special authorisation. The goods shall correspond to the accompanying documents and the special authorisation.

 (4) Where the marketing authorisation holder has designated one or several persons holding appropriate activity licences who will import the medicinal product, the medicinal product shall be imported only by the designated person.

 (5) Medicinal products that have been granted a licence for parallel import may not be imported, if the marketing authorisation of the medicinal product has been revoked or has expired in the source country of the medicinal product that has been granted a licence for parallel import.

 (6) A special authorisation of the State Agency of Medicines shall be applied for the import and export of cells, tissues and organs of human and animal origin used for research purposes, if the purpose of the research to be conducted on the cells, tissues and organs is their use for medical treatment of humans.
[RTL 2008, 102, 1457 – entered into force 01.01.2009]

§ 4.  Application for authorisation for import or export

 (1) A special authorisation of the State Agency of Medicines shall be applied for each consignment of goods requiring special authorisation. The application shall specify the name, address and contact data of the consignor (hereinafter exporter) and consignee (hereinafter importer) of the goods requiring special authorisation, the border crossing point and means of transport of the consignment, and data on the medicinal products and other goods requiring special authorisation.

 (2) The following data shall be presented on the medicinal products:
 1) name of the medicinal product;
 2) pharmaceutical form;
 3) active substance(s) and content thereof;
 4) quantity in the packaging;
 5) marketing authorisation holder and manufacturer;
 6) ATC-code of the medicinal product;
 7) number of packages.

 (3) If the imported medicinal products are not intended for use in Estonia, the corresponding confirmation shall be provided in the application.
[RTL 2010, 10, 182 – entered into force 08.03.2010]

 (4) The application for authorisation for import of unauthorised medicinal products shall specify the number of the authorisation granted by the State Agency of Medicines for the use of the unauthorised medicinal product.
[RTL 2010, 10, 182 – entered into force 08.03.2010]

 (5) The following data shall be presented in order to apply for special authorisation for import and export of medicinal products intended for clinical trials:
 1) reference number provided by the State Agency of Medicines for the conduct of a clinical trial;
 2) name of the medicinal product;
 3) pharmaceutical form;
 4) active substance(s) and content thereof;
 5) quantity in the packaging;
 6) number of packages.

 (6) The following data shall be presented on other goods requiring special authorisation:
 1) name of the goods requiring special authorisation;
 2) quantity in the packaging;
 3) number of packages;
 4) specification of the purpose of use of the goods requiring special authorisation;
 5) certificate on the cells, tissues and organs of human or animal origin, signed by the competent person of the handler of cells, tissues and organs.
[RTL 2008, 102, 1457 – entered into force 01.01.2009]

 (7) The application for special authorisation shall specify the date, as well as the name and contact data of the applicant.

 (8) The application for special authorisation for import or export of narcotic drugs or psychotropic substances shall contain the name and signature of the person responsible for the handling of these substances. The application shall specify the data on the payment of the state fee (name of the payer, bank, date of payment) or include a document verifying payment of the state fee.

§ 5.  Notification of the import or export of goods requiring special authorisation

 (1) In the case stipulated in clause 19 (1) 2) of the Medicinal Products Act, the importer or exporter of medicinal products shall submit the following data to the State Agency of Medicines:
 1) date of import or export;
 2) name, address and contact data of the consignor and consignee;
 3) name of the medicinal product;
 4) pharmaceutical form;
 5) active substance(s) and content thereof;
 6) quantity in the packaging;
 7) marketing authorisation holder and manufacturer;
 8) ATC-code of the medicinal product;
 9) number of packages;
 10) code of the coding center.

 (11) When notifying of the import or export of cells, tissues and organs of human or animal origin, the handler of cells, tissues and organs shall submit to the State Agency of Medicines the data required in subsections 4 (1), (6) and (7).
[RTL 2008, 102, 1457 – entered into force 01.01.2009]

 (2) The notifier shall specify in the notification the number of the notification, the name and contact data of the notifier and the date of preparation of the notification.

 (3) If the medicinal products imported on the basis of clause 3 (2) 1) are not intended to be used in Estonia, the corresponding confirmation shall be provided in the notification.

 (4) The State Agency of Medicines shall inform the notifier of receiving the notification.

§ 6.  Application for the use of unauthorised medicinal products

 (1) In the case stipulated in subsection 21 (1) of the Medicinal Products Act, the application to be submitted to the State Agency of Medicines for the use of unauthorised medicinal products shall contain the following data:
 1) active substance(s);
 2) pharmaceutical form and the content of active substance(s);
 3) route of administration of the medicinal product;
 4) quantity of the medicinal product for a maximum of 12 months;
 5) number of the prescription;
 6) code of the diagnosis and/or indication; where the medicinal product is to be used for veterinary purposes, the species and the indication;
 7) medical justification for the application;
 8) the patient’s surname, if the medicinal product is applied for a single patient, or the name of the health care or social welfare institution, if the medicinal product is applied for the patients of the institution.

 (2) In the cases stipulated in subsections 21 (7) and (8) of the Medicinal Products Act, the application for the use of unauthorised medicinal products shall contain the data specified in clauses 1-4, 6 and 7 of subsection (1) of this section.

 (3) In the case stipulated in clause 21 (7) 1) of the Medicinal Products Act, the medical justification for the use of the medicinal product shall specify all forms of treatment of the diagnosed condition as well as the efficiency and safety of the medicinal product concerning which the application is submitted, compared to other therapies. The medical justification shall contain references to research publications. Copies of the research publications shall be submitted at the request of the State Agency of Medicines.

 (4) The application shall specify the name and contact data (position, address of the place of work, doctor’s code, number of the activity licence of the veterinarian, telephone, e-mail) of the doctor or veterinarian. The application shall be signed and dated. In the case stipulated in clause 21 (7) 1) of the Medicinal Products Act, the application shall be approved by a person with the right of representation of the professional organisation.

 (5) In the case stipulated in subsection 21 (1) of the Medicinal Products Act, the application shall be submitted in the form provided in Annex 7 or 8 of the Regulation; in the cases stipulated in subsections 21 (7) and (8), the application shall be submitted in the form provided in Annex 13 or 14 of the Regulation.
[RTL 2010, 10, 182 – entered into force 08.03.2010]

§ 7.  Formalisation of the authorisation for import and export

 (1) The authorisation for import and export of goods requiring special authorisation shall be printed on the yellow document form of the State Agency of Medicines in the form provided in Annexes 1 and 2.

 (2) The authorisation for import and export of medicinal products used in clinical trials shall be printed on the yellow document form of the State Agency of Medicines in the form provided in Annexes 3 and 4.

 (3) The authorisation for import of narcotic drugs and psychotropic substances and medicinal products containing such substances shall be printed on the pink document form of the State Agency of Medicines in the form provided in Annex 5.

 (4) The authorisation for export of narcotic drugs and psychotropic substances and medicinal products containing such substances shall be printed on the green document form of the State Agency of Medicines in the form provided in Annex 6.

 (5) The State Agency of Medicines shall prepare the authorisation for import of narcotic drugs and psychotropic substances and medicinal products containing such substances in two copies: the first copy shall be submitted by the importer to the customs administration for customs clearance during import; the second copy shall be issued by the State Agency of Medicines for submission to the competent authority in the source country.

 (6) The State Agency of Medicines shall prepare the authorisation for export of narcotic drugs and psychotropic substances and medicinal products containing such substances in three copies: the first copy shall be submitted by the exporter to the customs administration for customs clearance during export; the second copy shall be attached by the exporter to the accompanying documents and the third copy shall be sent by the State Agency of Medicines to the competent authority in the destination country for approval.

(7) The special authorisation for other goods shall be prepared by the State Agency of Medicines in a single copy, which shall be submitted by the importer or exporter for customs clearance during import or export.

 (8) If no goods were imported or exported on the basis of the special authorisation prepared and issued by the State Agency of Medicines, the importer or exporter shall return the special authorisation to the State Agency of Medicines immediately upon expiry of the special authorisation.

§ 8.  Medicinal products for personal use

 (1) Travellers arriving to or departing from Estonia have the right to carry medicinal products to be used, for medical reasons, personally by them or on animals accompanying them.

 (2) A maximum of five different pharmaceutical preparations, a maximum of five retail packages each, may be carried for personal use of a traveller, and a maximum of five different pharmaceutical preparations, a maximum of three retail packages each, may be carried for animals accompanying the traveller without the authorisation of the State Agency of Medicines.

 (3) The size of the retail package shall be a maximum of 100 units of solid dosage forms, 500 g of powder for solution, 50 g of homeopathic granules, 500 ml of solution for infusion and oral solution, 10 ampoules or vials of injectable dosage forms, 200 ml or 200 g of medicinal products for external use, 100 g of herbal substances, 120 doses of inhalation preparations, 10 units of medicated plasters.
[RTL 2010, 10, 182 – entered into force 08.03.2010]

 (4) A maximum of one retail package containing 20 units of narcotic drugs or psychotropic substances may be carried without the authorisation of the State Agency of Medicines, while the medicinal products shall be accompanied by the doctor’s or, in case of medicinal products for animals, the veterinarian’s notice on the need for the medicinal product or a copy of the prescription, except in cases stipulated in subsections (41) and (42).
[RTL 2010, 10, 182 – entered into force 08.03.2010]

 (41) If a person whose permanent residence is in Estonia wishes to travel to another Schengen State, the person may carry narcotic drugs or psychotropic substances in the required quantity for the duration of the trip, but not more than required for 30 days of treatment. A corresponding certificate of the State Agency of Medicines shall accompany each prescribed narcotic drug or psychotropic substance carried. [RTL 2007, 96, 1616 – entered into force 21.12.2007]

 (42) A person whose permanent residence is in another Schengen State shall provide a certificate issued in the country of residence in accordance with Article 75 of the Schengen Agreement for each narcotic drug or psychotropic substance carried.
[RTL 2007, 96, 1616 – entered into force 21.12.2007]

 (5) If the quantity of the medicinal products carried exceeds the quantity specified in subsection (2), (3) or (4), the authorisation of the State Agency of Medicines shall be applied for all medicinal products carried. With the authorisation of the State Agency of Medicines, narcotic drugs or psychotropic substances may be carried in the required quantity for a maximum of 30 days of treatment.
[RTL 2010, 10, 182 – entered into force 08.03.2010]

 (6) Medicinal products may be sent by post to foreign countries or Estonia only if sent by a natural person to a natural person. Without the authorisation of the State Agency of Medicines, one parcel may contain a maximum of five unopened retail packages with a size specified in subsection (3). The medicinal products shall be in the manufacturer’s packaging.
[RTL 2007, 96, 1616 – entered into force 21.12.2007]

 (7) If the quantity of medicinal products sent by post exceeds the quantity specified in subsections (3) or (6), the authorisation of the State Agency of Medicines shall be applied for all medicinal products in the parcel.

 (8) Narcotic drugs and psychotropic substances and medicinal products containing such substances, as well as full blood and blood components shall not be sent by post.

 (9) In the cases stipulated in subsections (4), (5) and (7), the following data shall be submitted in order to apply for the permit of the State Agency of Medicines:
 1) name and contact data of the applicant;
 2) data on the source country and destination country;
 3) list of medicinal products (name of medicinal product, content of active substances and pharmaceutical form, size of the packaging and total number of packages);
 4) in case of medicinal products subject to medical prescription, the doctor’s, and, in case of medicinal products designated to be used on animals, the veterinarian’s notice on the need for the medicinal product. [RTL 2007, 96, 1616 – entered into force 21.12.2007]

 (91) In order to apply for the certificate of the State Agency of Medicines in the case stipulated in subsection (41), the application in the form provided in Annex 10 of this Regulation, or a copy thereof shall be submitted for each prescribed narcotic drug or psychotropic substance. The application or its copy shall be submitted to the State Agency of Medicines by the pharmacy dispensing the medicinal product immediately after dispensing the medicinal product.
[RTL 2007, 96, 1616 – entered into force 21.12.2007]

 (92) Paragraphs A, B and C15-20 of the application stipulated in subsection (91) of this section shall be filled out by the doctor prescribing the medicinal products. Paragraphs C14 and C21 of the application shall be filled out by the dispenser of the medicinal product.
[RTL 2007, 96, 1616 – entered into force 21.12.2007]

 (93) The State Agency of Medicines shall issue the certificate stipulated in Annex 11 of this Regulation within 5 working days after receiving the corresponding application or copy thereof. The certificate shall be valid for a maximum of 30 days.
[RTL 2007, 96, 1616 – entered into force 21.12.2007]

 (10) Mail order sale of medicinal products as well as delivery by post or express service of medicinal products ordered through the Internet is prohibited.

§ 9.  Entry into force

 (1) This Regulation shall enter into force on 1 March 2005.

 (2) Clause 5 (1) 10) of the Regulation shall enter into force on 1 October 2005.

Annex 1 

Annex 2 

Annex 3 

Annex 4 

Annex 5 

Annex 6 

Annex 7 

Annex 8 

Annex 9 

Annex 10 

Annex 11 

Annex 12 

Annex 13 

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