Medicinal products for human use
Falsified medicines (the term "falsified" is used to distinguish the issue from IP violations, so-called "counterfeits") are a major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level.
Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of bad quality or in the wrong dose – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy - as required by strict EU authorisation procedures - this could be detrimental to your health. Falsified medicines are a major threat to public health (the term "falsifie" refers to all forms of falsification, while the term "counterfeit" specifically refers to an infringement to intellectual property rights). As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.
Following adoption by the Council and the European Parliament, the Falsified Medicines Directive (Directive 2011/62/EU) was published on 1 July 2011 in the Official Journal of the European Union. This legislation is the outcome of the legal proposal that the Commission put forward in December 2008. The Falsified Medicines Directive applies since 2 January 2013.
The Directive introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. To this end, these new measures include:
- Obligatory safety features on the outer packaging of the medicines, to be detailed via a delegated act;
- A common, EU-wide logo to identify legal online pharmacies. This would make it easier 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.
Member States had to transpose Directive 2011/62/EU into national law by 2 January 2013. The transposition process is now complete. An overview of the transposing national laws is here.
Directive 2011/62/EU provides the basis for a number of legislative implementation measures to be carried out by the Commission. An overview is here.
Safety features for medicinal products for human use
The delegated act (Commission Delegated Regulation (EU) 2016/161) detailing the characteristics of the safety features, how medicine authenticity should be verified, and by whom, was adopted on 2nd October 2015 and published, after scrutiny by the European Parliament and the Council, on 9th February 2016.
The delegated Regulation, and the new medicine verification system it lays down, will apply as of 9th February 2019.
The Commission presented the key elements of the delegated Regulation at a stakeholders' workshop held on 26 February 2016 in Brussels. The Commission presentation is available here. The minutes of the workshop can be found here.
To facilitate the implementation of the delegated Regulation and the new rules on medicine verification, the Commission has prepared a "Questions and Answers" document (version 5.0 June 2016).
In addition, the regulatory requirements to be followed to notify the EMA of the placing of the unique identifier and/or the anti-tampering device on centrally authorised products are detailed in an implementation plan developed by the EMA and the European Commission and published in the "product information templates" section of the EMA website.
The regulatory requirements for nationally authorised products have been made available by the CMDh.
Background to the delegated Regulation
Directive 2011/62/EU introduces obligatory "safety features" – a unique identifier and an anti-tampering device - to allow the verification of the authenticity of medicinal products subject to prescription and protect patients and business alike from the risks of falsified medicines. The Directive places the Commission under an obligation to adopt a delegated act setting out the details of the safety features, including how medicine authenticity should be verified and by whom. A concept paper has been rolled out for public consultation in 2011 with a view to facilitate an impact assessment of the possible policy options and prepare the delegated act. The replies to this consultation can be found here.
The information gathered during the public consultation was taken into account when performing the assessment of the benefits, costs and cost-effectiveness ("impact assessment") of the possible policy options for the unique identifier and its verification, as requested by Directive 2011/62/EU. The impact assessment report can be found here.
The options identified by the impact assessment as the most cost-effective constitute the core elements of the delegated act and are outlined below:
- The composition, format and carrier of the unique identifier should be fully harmonised across the EU. The unique identifier should be placed in a 2D barcode and contain the product code, a serial number, the national reimbursement number (if requested by Member States), the batch number and the expiry date.
- Medicine authenticity should be guaranteed by an end-to-end verification system supplemented by risk-based verifications by wholesalers. Medicines should be systematically verified at the point of supply to the public (e.g. at pharmacy level). Medicines at higher risk of falsification (returned medicines or medicines not being distributed directly by manufacturers, marketing authorisation holders or people acting on their behalf) should additionally be checked at wholesaler level.
- The repositories system containing the legitimate unique identifiers should be set up and managed by stakeholders. National competent authorities should however be able to access and supervise the repositories system.
Common logo for websites of legally-operating online pharmacies/retailers
Directive 2011/62/EU introduces a "common logo" for websites of legally-operating online pharmacies/retailers. This logo has to be clearly displayed on every page of the website offering the medicinal products. The common logo shall be recognisable throughout the Union, while enabling the identification of the Member State where the online pharmacy/retailer is established.
The Commission was under an obligation to adopt implementing acts regarding:
- The technical, electronic and cryptographic requirements for verification of the authenticity of the common logo;
- The design of the common logo.
The Commission adopted on 24 June 2014 the "Implementing Regulation on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity".
More information on the logo can be found here.
Importation of active substances
Moreover, Directive 2011/62/EU introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements.
A concept paper was rolled out for public consultation in 2011 with a view to preparing this implementing act. The responses to this consultation can be found here. The implementing Decision is available here.
Regarding the written confirmation, a template and a "Questions and Answers" document have has been published to allow for preparation of the incoming rules. More information is available here.
An information leaflet on the new rules on importing active pharmaceutical ingredients into the EU is available here.
Good manufacturing practice ("GMP") for active substances
Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ("GMP") for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paper was released for public consultation in 2012 with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.
The Commission delegated Regulation (EU) No 1252/2014 on "principles and guidelines of good manufacturing practice for active substance for medicinal products for human use" was published in the Official Journal (OJ L337, 25.11.2014, p.1). It applies as of 25 May 2015.
Medicinal products introduced into the Union
Directive 2011/62/EU has provided for the obligation for Member States to take the necessary measures in order to prevent medicinal products that are introduced into the Union, but are not intended to be placed on the market of the Union, from entering into circulation if there are sufficient grounds to suspect that those products are falsified.
The Directive also foresees that the Commission may set up in a delegated act the criteria to be considered and the verifications to be made when assessing the potential falsified character of those products.
Following consultation with stakeholders and Member States, adoption of this delegated act is not going to be pursued for the time being (NB: adoption is not mandatory - "may provision").
On 10 December 2008 the Commission adopted a legislative proposal to amend Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. The aim of this initiative is to address, in particular, the risk of falsified medicines entering the legal supply chain of medicines in the EU. The legal proposal was adopted as part of the pharmaceutical package.
For more information on the legal proposal, see below:
The Commission "proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source", was adopted on 10 December 2008.
A public consultation on combating counterfeit medicines was launched by the Commission on 11 March 2008.
A summary of the responses to the public consultation is contained in Annex 9 to the impact assessment report.
Impact assessment report
The Commission carried out a study to asses the economic, environmental and social impacts of the proposals. The final impact assessment report was adopted by the Commission on 10 December 2008.