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The Pharmaceutical Package
The 'Pharmaceutical Package', is the popular name for a series of measures proposed by the European Commission impacting the pharmaceutical industry. This series included the "Communication on the future of the single market in pharmaceuticals for human use", which set out the Commissions's vision for the sector.
The 'Pharmaceutical Package' contains three important initiatives: a proposal for a directive on how to modernize pharmacovigilance in order to improve safety of medicines; a proposal to improve patient safety by reducing the infiltration of counterfeit medicines into the supply chain; and a directive on the future direction of the supply of health information to patients.
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Press releases:
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Further information on the Commission's Proposals concerning the Pharmaceutical Package can be accessed here. |
Counterfeit Medicines
The Commission's adopted legislative proposal aims at strengthening EU legislation to better protect EU citizens from serious threats posed by fake medicines. The overall principle of the proposal adopted is to protect the legal distribution chain from the infilitration of fake medicines. In particular requirements for the manufacturing, trading and distribution of medicines for human use and active substances are expected to be tightened and may include amendments to Directive 2001/83/EC on the Community code relating to medicinal products for human use; and to Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice.This will help to ensure confidence of distributors, health care professionnals and patients in the medicinal products they trade, prescribe and purchase in the legal supply chain.
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Key documents:
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Information to Patients
The adopted legislative proposal aims at ensuring that EU citizens have access to reliable information on medicines available, the grounds on which they have been authorised and how they are monitored. The overall principle of the proposal is to provide a framework for providing citizens of EU Member States with understandable, objective, high-quality and non-promotional information about the benefits and the risks of their medicines, while maintaining the ban on direct-to-consumer advertising of prescription medicines and making sure that there is a clear distinction between advertising and non-promotional information. This proposal will help empower EU citizens to make more informed decisions about their health.
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Key documents:
- Position Paper on Commission's Proposal on patient information
(October 2009)
The current lack of EU harmonisation in the area of health and medicines information has led to a patchwork of differing national approaches, unequal access of citizens to such information and legal uncertainty for manufacturers. EFPIA therefore broadly welcomes the recent legislative proposals by the EC as a unique opportunity to improve the access of all EU citizens and patients’ to high-quality information on health and prescription medicines - regardless of language, age, culture and ability to access the internet.
- Question & Answers on information to patients (October 2009)
The EC proposals on Information to Patients (ITP), as set out in the Pharmaceutical Package, seek to ensure that health information from various sources and of a suitable standard is available to all citizens of Europe. Specifically, the Commission seeks to create a clear framework of rules, as well as to determine how to ensure the available information would be of high quality, non-promotional, evidence-based, objective and up-to-date.
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Pharmacovigilance
The Commission's adopted proposal aims at better protecting patients by strengthening the EU system for the safety monitoring of medicines (pharmacovigilance). The aim is to simplify the current system with the overall objectives of better protecting public health, ensuring the proper functioning of the internal market and simplify the current rules and procedures.
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Key documents:
- Position Paper on Commission's Proposals on pharmacovigilance
(October 2009)
EFPIA welcomes the Commission proposal and all measures contributing to the rationalisation and simplification of pharmacovigilance activities in Europe. EFPIA feels that the proposals reflect the latest scientific and policy developments in this area, and that they align well with the overall objectives of better protecting public health, ensuring proper functioning of the internal market and simplifying current rules and procedures.
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