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 (the term 'falsified' is used to distinguish the infringement to intellectual property rights, so-called 'counterfeits') are a major threat to public health. 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 new legislation on falsified medicines was published on 1 July in the Official Journal of the European Union.
The new legislation will be applicable on 2 January 2013. This legislation is the outcome of the legal proposal that the Commission put forward in December 2008.
The new legislation 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:
- An obligatory authenticity feature on the outer packaging of the medicines : this feature will be decided at a later stage 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 have to transpose Directive 2011/62/EU by 2 January 2013 into national law. An overview of the transpostion status of all Member States, together with a reference to the transpoing national law, is here.
Medicinal products introduced into the Union
Directive 2011/62/EU provides the basis of a number of implementation measures by the Commission. An overview is here.
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.
A concept paper is being rolled out for public consultation with a view to preparing the implementing act. The responses to this consultation can be found here.
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").
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 is 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.
A concept paper is being rolled out for public consultation with a view to preparing the implementing act. The replies to this consultation can be found here.
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.
Safety features for medicinal products for human use
Directive 2011/62/EU introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier. A concept paper has been rolled out for public consultation with a view to preparing both the impact assessment and the delegated act.
The replies to this consultation 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 has been rolled out for public consultation with a view to preparing this implementing act.
The responses to this consultation can be found here. The implementing Decision is 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 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 is being released for public consultation 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 will be applicable as of 25 May 2015
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.