Following an increase in falsified medicines detected within the EU in recent times, Directive 2011/62/EU has been adopted at EU level to tighten the control of distribution chains for medicinal products by introducing strengthened requirements for EU and non-EU manufacturers of active substances, as well as for wholesale distributors of medicinal products.
For some time now, industry groups have been active in lobbying the EU to strengthen its laws on the distribution of falsified medicines. The new Directive is designed to do just that and to protect consumers from falsified medicines. New safety features will be required on the outer packaging of products, designed to ensure the authenticity of prescription products. The manufacture of active substances intended for use in medicinal products is required to follow good manufacturing practice regardless of whether these ingredients are manufactured in the EU or imported. The Directive also provides that the manufacture in third countries of active substances which are intended for export to the EU must provide for a level of protection of public health equivalent to that provided by EU law. The European Commission recently published draft Guidelines on Good Distribution Practice of Medicinal Products for Human Use which are currently the subject of a public consultation process until 31 December 2011.
In order to strengthen the protection of the legal supply chain, importers, manufacturers and distributors of active substances must be registered with the competent authority as "brokers of medicinal products". Furthermore, the manufacturers of medicinal products must verify that the manufacturer and the distributor of the respective active substances comply with good manufacturing practice and good distribution practices. They must also ensure that the excipients used are suitable for use in medicinal products. Wholesale distributors must verify that their supplying wholesale distributors are authorised.
The Directive entered into force on 21 July 2011 and EU countries must implement the legislation into their own domestic laws by 2 January 2013.
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