Orders of the Director of the State Medicines Control Agency regarding the parallel import licences

 

Parallel import is the import from the country within the EEA of a medicinal product which is identical or essentially similar to medicinal product authorised in Lithuania through other distribution channels than the ones agreed with the Marketing Authorisation Holder. For more information on the licensing of parallelly imported medicinal products please refer to Law on Pharmacy of Republic of Lithuania (only in Lithuanian) and The Rules of Parallel Import of Medicinal Products (only in Lithuanian).

 

Application form for parallel import of medicinal product is available here (only in Lithuanian).

Application form for a variation to a parallel import licence is available here (only in Lithuanian).

 

Proof of payment (originaly signed and stamped by authorized person)  should be provided with the application form submitting to State Medicines Control Agency of Lithuania together with explanation for which application the fee is paid. For more information please refer to Fees.

 

The list of parallelly imported medicinal products is available here.

 

If you have any questions regarding the parallel import of medicinal products please send them at [email protected].

 

Parallel distribution is the distribution of centrally authorised  medicinal products from one Member State to another by a pharmaceutical company independent of the Marketing Authorisation Holder.

 

Importers wishing to parallelly distribute centrally authorised medicinal products must notify the European Medicines Agency of their intention. For more details on the notification procedure see www.emea.europa.eu.

 

The list of parallelly distributed medicinal products in Republic of Lithuania is available here





 
Last Update: 2011-06-03 15:06:22

Last updated: 23-11-2023