A counterfeit pharmaceutical product is one which is deliberately and fraudulently mislabelled with respect to identity and/or source (WHO).
Counterfeiting may include products with the correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with fake packaging.
The counterfeit medicines’ circulation problem exists in Armenia as well. The illegal import of medicines from the neighbor countries facilitates the mentioned phenomenon. Importing counterfeit medicines legally is almost impossible. According to the import procedure, before the customs authorization, packages and instructions of the imported samples are compared with the registered ones, also is carried out checking of the accompanying documents and laboratory control. The ministry of health grants the import certificate only in case of positive conclusion. As a result, all the manufacturers and importers have come to the conclusion, that importing counterfeit medicines legally is almost impossible in Armenia. To confirm this, it must be noted, that from 2002-2008 were found 14 cases of medicines falsification, 13 of which were illegal imports, and the one was discovered during the import expertise.
To fight against the counterfeit medicines’ circulation, have been taken the following measures:
Since 2003 has been created a computer data basis of all the medicines which have undergone import expertise (medicine’s name, dosage, form, manufacturer, importer, supplying country, invoice number, batch number, expiry date, etc).
Since February, 2003 according to the order of the minister of health, the wholesalers in the invoices must mention the batch number of each of the medicines.
Since 2005 in the website of the Scientific Centre of Expertise have been placed all the package scan versions and/or the colored mock ups of the registered medicines of RA.
Due to the changes made in the Criminal Code of RA in 2006, Armenia was the first CIS country where were taken steps to punish the counterfeit medicines’ manufacture and sale with imprisonment of 3 years, and for the same acts which negligently caused human death, with imprisonment of 5 years.
In February, 2007 in “The National Security Strategy of the Republic of Armenia” confirmed by the president of Armenian, the fight against counterfeit medicines was adopted as a national security’s factor.
In 2008 the governments of the CIS countries signed “A Convention on the Fight Against the Circulation of the Counterfeit Medicines”.