Basic information
Outline of the system
The licensing of imports of medicinal products is regulated by the Regulation of the Minister of Social Affairs Nos. 28 of 9 April 1998, 17 of 29 April 1996 and 50 of 16 May 2001, and is administered by State Agency of Medicines. The licensing does not cover goods under HS headings 3001, 3002, 3003, 3004 and 3006 which are used only in veterinary medicine, and goods under HS heading 3002 which are used in controlling sterilisation.
Product coverage
See Product coverage.
Nature of licensing
Automatic
If Automatic, administrative purpose
Imports of medicinal products are subject to automatic licensing.
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The licensing is intended to protect the consumers who use the goods covered by the Regulation of the Minister of Social Affairs No.50 of 16 May 2001.
Questions for products under restriction as to the quantity or value of imports
No quantitative restrictions.
The system applies to products originating from which country?
The system applies to the goods originating in and coming from all countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The licensing of trade in medicinal products is based on Medicinal Products Act and is maintained under the Regulation No. 50 of 16 May 2001, which has been published in Riigi Teataja Lisa 2001 No. 61, 837, 1998 No. 153/154, 574, 1999 No. 109 and the Regulation of the Minister of Social Affairs No. 17 of 29 April 1996, which has been published in Riigi Teataja Lisa 1996 No. 56.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
All persons, firms and institutions, which have an activity licence issued by the Ministry of Social Affairs of Estonia, are eligible to apply for import.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
An importer is required to submit the following information with the application:
- The brand name of medicinal product;
- the form of medicinal product;
- active substance(s) and its content;
- size of package;
- the manufacturer;
- ATC code of medicinal product;
- the number of packages;
- the exporter and the importer;
- the border station and mode of transportation.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Application for a licence must be made at least five working days in advance of importation.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
There are no limitations as to the period of the year during which application for licence and/or importation may be made.
Issuing the license
Can a licence be granted immediately on request?
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Which administrative body is responsible for approving application of licences?
An importer has to approach only one administrative organ in connection with an application.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
There are no other conditions attached to the issuance of a licence.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
There is no licensing fee or administrative charge.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
There is no deposit or advance payment requirement associated with the issuance of licences.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
None.
Are the reasons for any refusal given to applicants?
In the event of refusal to issue a licence, the applicant has a right of appeal pursuant to the procedure provided by law.
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
Upon actual importation, an importer is required to submit the approved import licence.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other administrative procedures, apart from import licensing required prior to importation.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
A licence is a non-recurrent certificate issued for a certain period.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilization of a licence or a portion of it.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Foreign exchange is automatically provided by the banking authorities for the goods to be imported.