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List of documents subject to submission for licence for parallel import in respect of a medicinal product, and the conditions and procedure for processing of applications

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List of documents subject to submission for licence for parallel import in respect of a medicinal product, and the conditions and procedure for processing of applications - content
Issuer:Minister of Social Affairs
Type:regulation
In force from:24.04.2010
In force until: In force
Translation published:28.03.2016

List of documents subject to submission for licence for parallel import in respect of a medicinal product, and the conditions and procedure for processing of applications

Passed 17.02.2005 No. 18
RTL 2005, 22, 299
Entry into force 01.03.2005

Amended by the following legal instruments (show)

PassedPublishedEntry into force
15.04.2010RTL 2010, 20, 36524.04.2010

This Regulation is established on the basis of clause 65 (12) 2) of the Medicinal Products Act.
[RTL 2010, 20, 365 - entry into force 24.04.2010]

§ 1.  General provisions

 (1) This Regulation establishes the list of documents subject to submission for licence for parallel import in respect of a medicinal product, including the form for the application for a licence for parallel import, and the conditions and procedure for processing of applications.

 (2) For the purposes of this Regulation, the following definitions shall be used:
 1) parallel import - the import, from an EEA Member State, of a medicinal product which has a valid marketing authorisation in Estonia, by an importer other than the importer designated by the holder of the first marketing authorisation;
 2) directly imported medicinal product - a medicinal product that has a valid marketing authorisation in Estonia and serves as the reference medicinal product for the parallel-imported medicinal product;
 3) source country - an EEA Member State from where the parallel-imported medicinal product originates and where the medicinal product has a valid marketing authorisation.

§ 2.  Documents subject to submission for licence for parallel import in respect of a medicinal product

 (1) To apply for the licence for parallel import, the following documents shall be submitted to the State Agency of Medicines:
 1) an application in the form provided in the Annex to this Regulation, filled out in Estonian or English;
 2) a copy of the contract complying with the requirements stipulated in the rules for manufacture of medicinal products established on the basis of subsection 16 (8) of the Medicinal Products Act, if the re-packaging and labelling is carried out by another company serving as a contractor;
 3) a sample of the parallel-imported medicinal product, along with a copy of the package leaflet from all source countries and, if the product is to be re-packaged into a new inner or outer packaging, a sample of the re-packaged product;
 4) a summary of the product characteristics complying with the requirements established on the basis of clause 65 (12) 1) of the Medicinal Products Act, draft design of the packaging and the package leaflet on a hard copy and in electronic form, in both Estonian and English.
[RTL 2010, 20, 365 - entry into force 24.04.2010]

 (2) The application for a licence for parallel import in respect of a medicinal product shall be submitted separately for each proprietary medicinal product and source country.

 (3) For renewal of the licence for parallel import, an application shall be submitted in the form provided in the Annex to this Regulation.

§ 3.  Processing of application for licence for parallel import

  The application for a licence for parallel import shall be processed on the conditions and pursuant to the procedure provided in clause 65 (12) 3) of the Medicinal Products Act.
[RTL 2010, 20, 365 - entry into force 24.04.2010]

§ 4.  Entry into force of the Regulation

  This Regulation shall enter into force on 1 March 2005.

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