The Falsified Medicines Directive is a legal framework introduced by the

European Commission The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body ...

, to improve the protection of

public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...

within the

European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been ...

. The directive applies since 2 January 2013. The European Commission Delegated Regulation, (EU) 2016/161, supplements Directive 2001/83/EC with rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted in October 2015. Measures to counteract to fake medicines include stricter record-keeping of wholesale distributors, tougher inspections of pharmaceutical producers, an EU-wide quality mark to identify online pharmacies and obligatory safety features on packages. It requires that a unique identifier must be encoded in a two-dimensional

Data Matrix A Data Matrix is a two-dimensional code consisting of black and white "cells" or dots arranged in either a square or rectangular pattern, also known as a matrix. The information to be encoded can be text or numeric data. Usual data size is from ...

code printed on each unit of sale package which is to contain: * Product code * Randomized serial number * Expiration date * Batch or lot number * National Health Reimbursement Number if required There must be a Tamper Evident Device. When the medicine or vaccine is dispensed it must be scanned and the barcode decommissioned, so that it cannot be reused on a falsified medicine. 2,291 pharmaceutical companies with marketing authorisations to supply prescription medicines to the

European Economic Area The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Ass ...

are required to connect to the EU Hub established by the

European Medicines Verification Organisation The European Medicines Verification Organisation was established by the European Commission to administer the Falsified Medicines Directive in 2015. The legal basis is Regulation (EC) No. 726/2004 and Directive 2001/83/EC. The main stakeholders ar ...

and upload the unique identifier for each pack of medicine they manufacture or repackage before February 2019. By August 2018 only 841 companies had completed the first stage of connection, which may take up to six months. The Market Pharmacy in

Bolton Bolton (, locally ) is a large town in Greater Manchester in North West England, formerly a part of Lancashire. A former mill town, Bolton has been a production centre for textiles since Flemish weavers settled in the area in the 14th ce ...

, which is part of the Hollowood Chemists group claimed in December 2018 to be the first compliant pharmacy in the UK when it connected to the UK Medicines Verification System in December 2018. The directive ceased to apply in Great Britain, except in Northern Ireland, at the end of the Brexit transition period.

References

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External links

Official Medicinal products website of the European Commission

Official website of the European Medicines Verification Organisation (EMVO)
Health law Pharmaceuticals policy European Union directives