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Pharmaceuticals Guides

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Guides on the EU Pharmaceuticals policy.
Strategic approach to pharmaceuticals in the environment
The European Commission adopted on 11 March a Communication outlining a set of actions addressing the multifaceted challenges that the release of pharmaceuticals poses to the environment.
New safety features for medicines sold in the EU
As of 9 February 2019, the new rules on safety features for prescription medicines sold in the EU will apply.
Supplementary protection certificate for medicinal products
The EU Commission proposed on 28 May a targeted adjustment to intellectual property rules to help Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.
Bayer - Monsanto: the Commission's competition concerns
The European Commission approved on 21 March under the EU Merger Regulation the acquisition of Monsanto by Bayer. The merger is conditional on the divestiture of an extensive remedy package, which addresses the parties' overlaps in seeds, pesticides and digital agriculture.
10 years of the EU Paediatric Regulation
The European Commission presented a report on 26 October to the European Parliament and the EU Council on progress made in children's medicines since the Paediatric Regulation came into force 10 years ago.
European Banking Authority and European Medicines Agency after Brexit - Commission assessment of country offers
European Commission publishes assessment of Member State offers to host European Banking Authority and European Medicines Agency after Brexit
Fees for Pharmacovigilance activities
The European Parliament voted on 16 April in favour of an EU Regulation on fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities for medicinal products for human use, which lays down the level and structure of these fees. This Memo explains the meaning and importance of pharmacovigilance in the EU, and why this legislation is necessary.
Joint purchasing of vaccines and medicines
The European Commission has approved a Joint Procurement Agreement, which will enable all EU countries to procure pandemic vaccines and other medical countermeasures as a group, rather than individually.
EC measures to tackle biopiracy and facilitate nature-based research
Researchers and companies in the EU received a boost today with a new proposal that should provide reliable access to genetic resources from outside the Union. The proposal – a draft Regulation that would implement the 'Nagoya Protocol on Access to Genetic Resources and Benefit-sharing' – is designed to protect the rights of countries and of indigenous and local communities that allow their genetic resources and associated traditional knowledge to be used, while also giving researchers in Europe improved, reliable access to quality samples of genetic resources at low cost with high legal certainty.
Antimicrobial Resistance - guide
With about 25,000 patients dying per year in the EU from infections caused by drug resistant bacteria and related costs of over 1.5 billion euros in healthcare expenses and productivity losses , antimicrobial resistance is a growing health problem in the EU. Today, on the eve of European Antibiotic Awareness Day, the European Commission tabled a comprehensive Action Plan on Antimicrobial resistance (AMR) which unveils12 concrete actions to be implemented in close cooperation with the EU Member States.
Information to patients on prescription-only medicines - guide
The European Commission has adopted revised proposals clarifying the information that industry can supply to the public on prescription-only medicines.
The role of the European Commission is to ensure that all players on the pharmaceuticals market (EU Member States, national health services and pharmaceutical companies) respect the Treaty rules on free competition and the free movement of goods and services within the internal market.
Information Communication Technologies Policy Support Programme (ICT PSP)
The ICT Policy Support Programme (or ICT PSP) aims at stimulating innovation and competitiveness through the wider uptake and best use of ICT by citizens, governments and businesses.
EU pharmaceutical sector inquiry - briefing
Market entry of generic drugs is delayed and there is a decline in the number of novel medicines reaching the market, according to the European Commission's final report on competition in the pharmaceutical sector. The sector inquiry suggests that company practices are among the causes, but does not exclude other factors such as shortcomings in the regulatory framework. As a follow up, the Commission intends to intensify its scrutiny of the pharmaceutical sector under EC antitrust law, including continued monitoring of settlements between originator and generic drug companies. The first antitrust investigations are already under way. The report also calls on Member States to introduce legislation to facilitate the uptake of generic drugs. The report notes near universal support amongst stakeholders for a Community Patent and specialised patent litigation system in Europe.
Pharmaceuticals Unit: Contacts
Funding opportunities in the EU pharmaceutical industry
Expand your business in the pharmaceutical industry through the Entrepreneurship and Innovation Programme developed by the European Commission to support innovation and SMEs in the EU.
Priorities for the Pharmaceutical sector in the EU
The pharmaceutical sector is extensively regulated by the European Union in the dual interest of protecting public health while completing the single market for pharmaceuticals.
The Rules Governing Medicinal Products in the European Union
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication “The rules governing medicinal products in the European Union”. The basic legislation is supported by a series of guidelines that are also published in the “The rules governing medicinal products in the European Union”.
The EU and International Cooperation in Pharmaceuticals
The European Commission is an active member of the World Health Organisation’s International Medical Products Task Force (IMPACT). IMPACT counts all the major anti-counterfeiting players including international organizations, non–governmental organisations, enforcement agencies, pharmaceutical manufacturers associations and drug regulatory authorities.
Future direction of EU policy: innovation
Research and development (R&D) in life sciences is a precondition to pharmaceutical innovation. The Commission recognises the key role pharmaceutical R&D plays. Consequently, it is currently implementing various sector-specific initiatives to restore Europe's leading role as the natural home for pharmaceutical innovation.