Falsified Medicines Legislation

The European Union (EU) Falsified Medicines Safety Features Use and Learn to End Q12022Directive amends Directive 2001/83/EC to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and introduces new rules to more rigorously regulate the supply chain. The main provisions of the Falsified Medicines Directive are: 
  • To introduce a new obligatory authenticity feature (referred to as a safety feature) which must appear on the outer packaging of designated medicines;
  • To introduce more robust rules regarding the control on starting materials and inspection of producers of active substances and excipients contained in medicines;
  • To introduce more robust controls on the wholesale distribution of medicines, including introducing controls for the first time on entities involved in brokering medicines;
  • To introduce a common, EU-wide logo to identify legal online pharmacies and to establish a notification system for entities offering to supply medicines to the public over the internet.

The falsified medicines legislative proposal was adopted by the Council and European Parliament in June 2011.

European Commission Delegated Regulation for Safety Features on Medicinal Products for Human Use

The Commission Delegated Regulation (EU) 2016/161, that supplements Directive 2001/83/EC, with detailed rules for the safety features appearing on the packaging of medicinal products for human use, has now been adopted and was published in the Official Journal of the European Union on 9 February 2016.

The Delegated Regulation will apply in Ireland from 9 February 2019 (3 years after its publication).

The European Commission's Falsified Medicines webpage contains the link to text of the Delegated Regulation. 

The publication of the Delegated Regulation was accompanied by the publication of the following documents which can be accessed through the links provided below:-

A Q&A document on the Commission website

The Implementation Plan for Centrally Authorised Products (CAPs) on the European Medicines Agency (EMA) website

The Implementation Plan for Nationally Authorised Products (NAPs) on the Head of Medicines Agencies (HMA: CMDh) website

In addition the European Medicines Verification Organisation (EMVO) has asked competent authorities to communicate the following to manufacturers, importers and MAHs.
Letter of Announcement EMVO Notice to Future On-Boarding Partners .
Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU (issued October 2018).

Irish Legislation

The following amendment Regulations concerning placing on the market, manufacture and wholesale of medicinal products have been signed by the Minister of Health and give effect to Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (also known as the Falsified Medicines Directive) • Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (S.I. No. 162 of 2013)

• Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013
(S.I. No. 163 of 2013)

• Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013
(S.I. No. 164 of 2013)

The legislation concerning the application of fees by the HPRA has also been amended (see below) to include details of the fees which will be levied for the registration processes described in Directive 2011/62/EU.

• HPRA (Fees) (Amendment) Regulations 2013
(S.I. No. 165 of 2013)

Directive 2011/62/EC provides the basis of a number of implementation measures by the Commission. An overview is provided here.

The HPRA is working with a wide range of stakeholders, including the Department of Health, Customs and Excise, European Medicines Agency, European Commission and other national competent authorities on the implementation of the provisions contained within the new legislation.

Rules on importing active pharmaceutical ingredients into the European Union

The European Commission has published an information leaflet on the new rules on importing active pharmaceutical ingredients into the European Union.

Contact the HPRA

Compliance Department
By e-mail: inspect@hpra.ie
By phone: 01 6764971