Parallel import

PARALLEL IMPORT

WHAT THE PARALLEL IMPORT IS

The parallel import or parallel trade for medicines is a lawful form of trade between EU Member States based on Articles 28 and 30 of the EC Treaty.

A parallel imported medicine is subject to a parallel import license (AIP) granted by the Italian Medicines Agency ( AIFA) quite similar to a marketing authorization AIC, and it is identified by a unique ID number of the product, dosage and pharmaceutical pack, Country of Origin, marketing holder. This number AIP is written on an optical label, printed by the "Poligrafico dello Stato".

After obtaining the import authorization by AIFA, the importer can buy the drug in the Origin Country (always within the European Economic Area) and it has to make it suitable to be marketed in Italy through a repackaging in accordance with national regulations and in order to make fit the language and contents to existing homologue ones.

The medicine imported is so absolutely exactly alike to the one already marketed in the country of destination, in qualitative and quantitative composition of active ingredients, in dosage, in indications, and in side effects. The quality is guaranteed by the producer and brand holder that are the same in the different European countries.

Gekofar currently holds around 80 parallel import authorizations for medicinal products of different classes (class A, C, OTC and SOP).

The complete list of Gekofar medicines is on the page «PRODUCTS»



LEGISLATION




Ministry Decree (D.M.) in August 29th, 1997 "Procedures for parallel import license for medicinal products for human use." This D.M. was conisderated inadequate by the European Commission in the infringement procedure 2000/4410 and in the subsequent complaint no. 2006/4280/IT. In spite of it, there isn't a Law Decree yet.
Articles 28 and 30 of the EC Treaty (free movement of goods). General lines published in 2001 can not substitute a medicines import legislation.
European Commission Communication n. 839 on medicines parallel imports dated on 30/12/2003. It resumes the guidance of the European Court of Justice, but it is just a directive and it can't substitute a Italian law and even if complete and reliable it remains only a reference document.
Decree No. 219 on 24.04.2006 (Implementation of EC Directive 2001/83). It isn't specific for parallel imports and in paragraph 3 of article 99 (Title VII Wholesale distribution Medicines) the obligation seems may be misattributed to parallel importer. In support of this article 158 it is considered always valid the above DM August 29, 1997.