Legal Requirements for Parallel Import of Medicinal Products for Human Use License Issuance and Potential Barriers for Parallel Trade in the Republic of Lithuania

Abstract

Parallel import of medicinal products is being defined as an import into the Republic of Lithuania outside the distribution network of the authorised distributor of the product granted marketing authorisation in another EEA Member State, which is identical to the medicinal product already granted marketing authorisation in the Republic of Lithuania or sufficiently resembling it. The majority of parallel import of medicinal products related cases in the Court of Justice of the European Union (hereinafter – CJEU) are dealing with barriers for parallel trade that occur in license issuance procedure. Therefore, the main goal of this article is to identify and analyse regulatory peculiarities of parallel import of medicinal products licence (hereinafter – parallel import licence or licence) issuance procedure that may create barriers for the parallel trade of medicinal products in the Republic of Lithuania. In order to achieve this task, the article evaluates the necessity of parallel import licence, analyses separate elements of this procedure, identifies its regulatory peculiarities and discusses whether these regulatory peculiarities are acceptable for the EU law.
The article concludes that domestic law of the Republic of Lithuania creates challenges for a parallel trader, as the EU law and the CJEU jurisprudence were not taken into account during the implementation of sufficient similarity criteria. A lack of detailed secondary legislation together with administrative problems may reduce the accessibility of the procedure and challenge the implementation of the requirement of the CJEU that this procedure should last “a reasonable time”.