Public Consultation on the Transposition of EU Directive 2011/62/EU on Falsified Medicinal Products

The views of the public and interested parties are sought on draft regulations transposing the Falsified Medicines Directive which was adopted by the European Parliament and the Council in June 2011. This legislation will be transposed into Irish law shortly. The Falsified Medicines Directive amends the EU Pharmaceutical Acquis (Directive 2001/83/EC).

The objective of the Falsified Medicines Directive is to strengthen the EU legal framework on pharmaceuticals to prevent falsified (counterfeit) medicinal products entering the legal medicines supply chain.

In summary, the Directive introduces new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. The principal new measures introduced by the Directive are as follows:

  • The inclusion of obligatory authenticity features or “safety features” on the outer packaging of the medicines to permit traceability and identification of medicines’ packs;
  • A common, EU-wide logo to identify legal online pharmacies to make it easier for members of the public to distinguish between legal and illegal online pharmacies throughout the European Union;
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
  • Strengthened record-keeping requirements for wholesale distributors;
  • New regulatory controls on previously unregulated “brokers” of medicines, who act as intermediaries in buying, selling and trading medicines, but do not physically handle or store products.

It should be noted that the purpose of this consultation is to obtain feedback from stakeholders on the proposed transposition in order to ensure that it appropriately implements the provisions of the Directive. As part of this consultation it is not possible to change the policy agreed in the Directive.

Comments in relation to this consultation should be sent to by 5pm on Friday 22nd March 2013.

Draft Medicinal Products (Control of Placing on the Market) Regulations 2013 – Consultation Draft.

Medicinal Products (Control of Manufacture) Regulations 2013 – Consultation Draft.

Draft Medicinal Products (Control of Wholesale Distribution) Regulations 2013 – Consultation Draft.