Falsified Medicines Directive

The European Commission's Directorate for public health and risk assessment have issued Directive 2011/62/EU| and guidance from 2001. The Directive’s main aim is to protect patients from the threat of falsified medicines. As the risk to public health and safety increases every year, the European Council has introduced a comprehensive harmonised, pan-European strategy across all member states.

On the 1st July 2011 a further guidance and deadline was set out in the in Official Journal of the European Union|. Each member state must transpose Directive 2011/62/EU before 2 January 2013 outlining laws, regulations and administrative provisions necessary to comply with the Directive. By 22nd July, 2013 member states must notify the Commission of any subsequent amendment of the provisions.

The new legislation comes into force on 2nd January, 2013 to those carrying out manufacturing, importing, placing on the market, and the wholesale distribution of medicinal products in the European Union, as well as the new rules relating to active substances. In most cases companies have three years to be fully compliant with the Directive. Registration forms to the competent authority must be submitted by 2nd March 2013.

The Directive’s primary aim is to protect all high risk prescription medicines; however, if assessed to be at low risk of falsification, against the criteria set out these medicines maybe excluded from compliance. Furthermore, any non prescription medicines that have been deemed at high risk once assessed by the Commission, can be brought inline with other prescription medicines.

Who it effects:

• Manufacturers
• Importers
• Re-Packagers
• Wholesale distribution of medicinal products in the Union 
• Active substances manufactures supplying companies within the EU

Dates

• 1st July, 2011 new legislation introduced in the Official Journal of the European Union
• 2nd  January, 2013 transposed into member state law, implementation requirement to begin 
• 2nd January, 2016  EU members to be fully compliant (excluding Belgium, Italy and Greece)
• 2nd January, 2019 Belgium, Italy and Greece to be compliant

What we can expect

• An obligatory authenticity feature on the outer packaging of the medicines 
• Tamper evident security features
• A common, EU-wide logo to identify legal online pharmacies
• Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients  
• Strengthened record-keeping requirements for wholesale distributors

What do I need to do

If you are unsure or have questions about how Falsified Medicines Directive will affect your business, please contact Domino|.