Slovenia becomes the seventh country in the European Union to establish a national medicinal product verification organisation.
Ljubljana, 7 October, 2016 – Medicines Verification Institute established on 6 October 2016 in Ljubljana as part of the European efforts towards increased protection of public health through combating counterfeiting of medicines.
This is the first step towards full implementation of European legislation regarding the prevention of entry of falsified medicines into the supply chain in Slovenia. The legislation in question was adopted by the European Commission in its Delegated Regulation (EU) 2016/161 and Directive 2011/62/EU.
As of 9 February 2019 each prescription medicine package will be equipped with a unique identifier in the form of a two dimensional bar code that will be verified upon dispensation of the medicine in public and hospital pharmacies. The underlying information system, to be established at national and European level, shall assure identification and verification of medicines by tracing all medicines from the manufacturer to the patient and this preventing counterfeit packages of medicines from being dispensed.
The Medicines Verification Institute – MVI was founded by representatives of all stakeholders in the medicinal product supply chain in Slovenia, namely the Forum of International Research and Development Pharmaceutical Companies, EIG, representing the innovative pharmaceutical industry, the Association of Slovenian Medicinal Product Manufacturers, representing the interests of generic medicinal product manufacturers, the Slovenian Chamber of Pharmacy, representing pharmacies, and the Slovenian Chamber of Commerce, Section of medicinal product wholesalers representing wholesalers.
The comprehensive representation of stakeholders in the MVI is a result of good collaboration on the project and full understanding of the contribution the project will make to the protection of public health. The controlling role will be assumed by Public Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. Countries which have already established their respective national medicinal product verification organisations also include Germany, Sweden, the Netherlands, Great Britain, Bulgaria and Spain.
Forum of International Research and Development Pharmaceutical Companies, EIG
Association of Slovenian Medicinal Product Manufacturers
Slovenian Chamber of Pharmacy
Slovenian Chamber of Commerce – Section of medicinal product wholesalers