Uniunea Europeană doreşte să protejeze cât mai bine sănătatea publică a cetăţenilor săi şi să le asigure accesul la medicamente. De aceea, a stabilit reguli stricte cu privire la medicamentele care pot fi vândute pe piaţa europeană.
Înainte de a fi puse în vânzare, produsele farmaceutice trebuie să primească o autorizaţie de comercializare la nivel naţional sau european. Instituţia care emite autorizaţiile de comercializare la nivelul UE este Comisia Europeană. Deciziile sale se bazează pe evaluările ştiinţifice realizate de Agenţia Europeană pentru Medicamente.
Produsele farmaceutice continuă să fie monitorizate şi după introducerea pe piaţă. Astfel, Comisia Europeană, Agenţia Europeană pentru Medicamente şi statele membre pot să prevină efectele nedorite şi să ia măsuri în caz de necesitate. Operaţiunile de supraveghere se desfăşoară în cadrul sistemului european de farmacovigilenţă.
Iniţiative: Directiva privind combaterea medicamentelor contrafăcute (2011)All available translations.; Revizuirea sistemului de monitorizare a siguranţei medicamentelor (2010)All available translations.
Alte informaţii pe tema produselor farmaceutice:
John Dalli, European Commissioner for Health and Consumer Policy, attends the Dialogue on Human Health between Traditional Chinese Medicine Culture and Western Medicine at the University of Bologna, Italy, 10 May 2012
Distilbène, Mediator, Isomeride: they are all drugs once sold legally in Europe but now believed to have provoked serious side effects including hundreds of deaths
Scandalul provocat de Mediator, când medicamente cu potenţial fatal au rămas pe piaţă, a adus la iveală lacune în legislaţia UE. Eurodeputaţii votează controale farmaceutice mai stricte
The adverse effects of medicinal products will be better monitored in future, to prevent the recurrence of cases like the French diabetes medicine "Médiator" (benfluorex), which led to many deaths
European Medicines Agency publishes reflection paper with practical guidance on the assurance of ethical and GCP standards in the conduct of clinical trials included in marketing authorisation applications submitted in the EU.
Amsterdam, the Netherlands. Conference about how partnership with patient organisations can contribute to more efficient drug development.
The goal of the seminar is to provide a comprehensive overview on the law enforcement practices of member states in the fight against counterfeit medicines, and find the relevant points with the aim of developing methods, recommendations, proposals to fight more effectively against medicine counterfeiting.
Budapest, Hungary. In an era when increasing demands are being made on Europe’s health services, generic medicines provide a major benefit to society as they ensure patient access to quality, safe and effective medicines while reducing the cost of pharmaceutical care.
Une réunion stratégique de haut niveau organisée avec la coopération de la Commission européenne visant à tirer des conclusions sur la manière d’améliorer l’accès aux médicaments.
How to move from agreed principles to good practice and positive change across Europe Conference co-organised by the European Commission and the European Patient's Forum. 25 March 2009, Brussels, Belgium
In its Conclusions on Medical Products and Public Health of 2000, the Council of Ministers underlined the importance of identifying innovative medicines with significant added therapeutic value to attain both industrial and public health sector goals.
John Dalli, European Commissioner for Health and Consumer Policy, attends the Dialogue on Human Health between Traditional Chinese Medicine Culture and Western Medicine at the University of Bologna, Italy, 10 May 2012
Distilbène, Mediator, Isomeride: they are all drugs once sold legally in Europe but now believed to have provoked serious side effects including hundreds of deaths
Scandalul provocat de Mediator, când medicamente cu potenţial fatal au rămas pe piaţă, a adus la iveală lacune în legislaţia UE. Eurodeputaţii votează controale farmaceutice mai stricte
The adverse effects of medicinal products will be better monitored in future, to prevent the recurrence of cases like the French diabetes medicine "Médiator" (benfluorex), which led to many deaths
European Medicines Agency publishes reflection paper with practical guidance on the assurance of ethical and GCP standards in the conduct of clinical trials included in marketing authorisation applications submitted in the EU.
EMA lists the opinions adopted at the April 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
This is the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union and submitted in marketing authorisation applications to the EU regulatory authorities.
Deadline: 1 June 2012. The consultation is on the draft template for the written confirmation for active substances imported into the EU for medicinal products for human use
The Commission is preparing a proposal for the revision of the Clinical Trials Directive for later this year.
John Dalli, European Commissioner for Health and Consumer Policy, attends a joint event organised by the European Federation of Pharmaceutical Industries and Associations and the Roche Group; Brussels, Belgium, 07 March 2012.
Medicamentele ar trebui să intre mai repede pe piață. Cu această intenție, Comisia Europeană a propus astăzi să se eficientizeze și să se reducă durata deciziilor naționale privind stabilirea prețurilor și rambursarea medicamentelor.
The European Medicines Agency has published a guideline advising pharmaceutical companies how to integrate studying the role of genetic variability between patients during the development of medicines.
On the occasion of the Commissioner's visit to EMA, the European Commission is launching a video to explain to citizens the system of authorisation for all medicines circulating in the European Union.
This short video describes the work of the European Commission to ensure the safety and quality of medicines in all EU Member States.
IMI-funded 'European Patients Academy on Therapeutic Innovation' aims to educate patient advocates and lay public about therapeutic innovation.
The Innovative Medicines Initiative Joint Undertaking (IMI JU) is a pan-European public private partnership aiming to foster collaboration between relevant stakeholders, from large and small biopharmaceutical and healthcare companies to regulators, academia and patients.
The guideline was revised to take into account developments in the storage and distribution of medicinal products in the European Union and to meet new requirements for wholesale distributors and brokers established in the new Directive 2011/62/EU on falsified medicines. Comments and suggestions are invited by 31 December 2011.
The European Medicines Agency has published its plans for granting public access to the information held in its databases of the potential side effects of human and veterinary medicines.
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, which will be applicable on 2 January 2013, is the outcome of the legal proposal that the Commission put forward in December 2008. It 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.
Vizionaţi materialul video pe tema pericolelor asociate ingerării de medicamente falsificate şi a măsurilor pe care le ia UE pentru a le garanta cetăţenilor săi o sănătate cât mai bună
The European Medicines Agency is working with its European and international regulatory partners to monitor and evaluate the possible risk of radioactive contamination of medicines manufactured in Japan following the radiation leak from the Fukushima Daiichi nuclear power plant.
From tomorrow, EU citizens can be reassured that the traditional herbal medicines they buy in the EU are safe and effective. The expiry of the 7 year transition period set out in the 2004 Herbal Directive (2004/24/EC) means that only medicinal products which have been registered or authorised can remain on the EU market after 1 May 2011.
On 30 April 2011, the period granted for herbal medicines to be registered will expire. This deadline brings to an end a seven year period allowed by a Directive adopted in 2004. The Director General of the European Commission for Health and Consumers explains the situation in order to address certain concerns expressed by citizens in the European Union.
This report reviews the differences in the prices of pharmaceuticals among Member States
The European Medicines Agency has released recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products for a three-month public consultation period
The European Commission has launched a public consultation in view of modernising rules on the transparency of Member States’ decisions regarding the pricing and reimbursement of medicines.
The European Medicines Agency is responsible for the evaluation and marketing recommendation of medicines within the European Union. In a bid to be transparent, the Agency is widenning the scope of its interaction with patients organisations.
The EU Clinical Trials database gives the public access to information on the thousands of authorised pharmaceutical clinical trials that are underway in the EU.
Producţia şi comercializarea medicamentelor falsificate constituie o ameninţare majoră la adresa sănătăţii publice. Termenul „falsificat” este utilizat pentru a face distincţia faţă de medicamentele care încalcă drepturile de proprietate intelectuală, cunoscute sub denumirea de medicamente „contrafăcute”.
The Innovative Medicines Initiative (IMI), currently the largest public-private partnership in the biopharmaceutical sector, launches its second wave of research projects which address key areas including cancer, immune-mediated diseases, infectious disorders and electronic health.
Viagra, anti-malarial tablets, painkillers are all increasingly being purchased via the Internet. However there is a risk that what you buy may not be what it appears. So what is being done to stop the sale of fake medicines?
Now a new version of the database has been developed that offers public access to information on manufacturing inspection by regulatory authorities from all the European Economic Area countries.
News quoted in the Orpha News Europe. Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients was adopted by the Committee of Ministers of the Council of Europe on 19 January.
Medicamentele contrafăcute ajung până şi în farmacii. Eurodeputaţii speră să stopeze acest trafic ilegal printr-o nouă serie de măsuri.
Membrii Parlamentului European au aprobat la 16 februarie o nouă legislație care va preveni intrarea medicamentelor contrafăcute în lanțul legal de aprovizionare. Vânzările pe Internet sunt acoperite de noua legislație, care introduce, de asemenea, noi măsuri de siguranță și trasabilitate, precum și sancțiuni pentru falsificatori, pentru a preveni vânzarea medicamentelor falsificate cetățenilor UE.
What are falsified medicines and why are they a problem in the EU? What is the difference between falsified and counterfeit medicines? What is the aim of this Directive?
A new EU law on falsified medicines was adopted today in the European Parliament.
What are Traditional Herbal Medicinal Products? Why did the EU decide to adopt specific legislation on traditional herbal medicinal products? What does the deadline of 30 April 2011 represent for manufacturers of traditional herbal medicinal products? Does the Herbal Directive impose new requirements for the placing on the market of traditional herbal medicinal products? Would these requirements be too burdensome for small and medium-sized enterprises and reduce access for Chinese and Ayurvedic medicinal products?
Pacienții trebuie să aibă acces la informații mai bune privind medicamentele eliberate pe bază de rețetă, au solicitat deputații europeni, care au votat miercuri o legislație referitoare la acest subiect. Aceasta presupune informații obiective privind caracteristicile medicamentelor și bolile pentru care sunt recomandate, precum și prevenirea informațiilor nesolicitate sau a publicității mascate.
Patients must have better access to high quality information on prescription drugs in the future, MEPs decided on Tuesday. Objective information on a drug's characteristics and the health conditions it is intended to treat should be among the details given, said the EP Environment Committee. At the same time, MEPs want to protect patients from unsolicited information on medicines.
On the occasion of the Belgian Presidency’s ministerial conference on innovation and solidarity in the field of pharmaceuticals held today, Commission Vice-President Antonio Tajani announced the launch of a process on corporate responsibility in the pharmaceutical industry.
The Process on corporate responsibility in the field of pharmaceuticals should facilitate discussions on ethics and transparency of the sector but also on non-regulatory conditions for better access to medicines after their marketing authorisation.
Pacienţii europeni vor fi mai bine protejaţi și informaţi cu privire la utilizarea medicamentelor și a efectelor lor nedorite după ce PE a votat o nouă legislaţie, rezultat al acordului între deputaţi și Consiliu. Vor fi create website-uri naţionale și europene, care pot oferi mai multe informaţii pacienţilor, aceștia având posibilitatea să informeze autorităţile naţionale, organizaţiile pacienţilor sau profesioniști din domeniul sănătăţii cu privire la efectele adverse ale medicamentelor.
Din ce în ce mai mulţi oameni achiziţionează medicamente de pe internet - viagra, medicamente împotriva cancerului, malariei sau calmantele -, dar adeseori acestea sunt contrafăcute. Comisia PE responsabilă cu sănătatea publică a votat în favoarea introducerii unor noi norme de siguranţă obligatorii pentru medicină în general, incluzând vânzările pe internet, pentru a reduce numărul medicamentelor contrafăcute în UE.
To combat fake medicines, internet sales should be included in draft EU legislation to prevent "falsified" medicines from entering legal supply chain, and mandatory safety features should be introduced for prescription medicines, said Environment Committee MEPs on Tuesday. The committee also approved measures to improve pharmacovigilance in the EU.
Vă amintiţi tot ce v-a spus doctorul despre medicamentele pe care vi le-a prescris? Probabil că nu. Aveţi întrebări şi prospectul nu vă ajută. Noi reguli europene în curs de negociere cer publicarea pe internet şi în reviste de specialitate - dar nu la radio sau televizor - a unor broşuri ne-publicitare cu informaţii complete despre medicamente.
Uniunea Europeană a pierdut teren în ceea ce privește inovarea farmaceutică. Pacienții europeni încă se confruntă cu inegalități în ceea ce privește disponibilitatea informațiilor cu privire la medicamente, în timp ce medicamentele contrafăcute se răspândesc.
Medicinal products contribute considerably to the health of EU citizens. They can, however, also have adverse effects.
There is an alarming increase of medicinal products detected in the EU which are falsifications in relation to their identity, history or source. These products usually contain sub-standard or false ingredients, or no ingredients or ingredients in the wrong dosage, including active ingredients, thus, posing an important threat to public health.
EU citizens have become more empowered and proactive consumers of healthcare, increasingly seeking information about medicines and treatments.
Parliament adopted a report on a first-reading agreement concerning a Commission proposal to harmonise the regulatory system used to change marketing authorisations for medicinal products (changes subsequent to the placing on the market, such as change in the production process, change in the packaging or change in the address of the manufacturer, update of patient information leaflet).
The final report of the Pharmaceutical Forum was presented today in Brussels setting out principles and recommendations on three key challenges in the pharmaceutical landscape.
Medicines for erectile dysfunction and weight-loss drugs. Substances for lowering cholesterol levels and silicone breast implants. These are some of the products people order online in Greece. Healthcare professionals stress that ordering such products over the Internet is highly risky and could even be life-threatening.
A misunderstood, widely unknown, distressing disease. "No matter where I went, I regretted leaving home. Everyone was afraid they would catch the disease and moved away. They would tell one another ‛Look at her!’", says a psoriasis patient.
All you have to do is believe in it, be desperate and ready to pay. And pay a small fortune: between 7 and 36 thousand euros. "Healing clinics" promise unproven therapies for Alzheimer's, Parkinson's, depression and multiple sclerosis using cells derived - in some cases - from animal foetuses. Panorama submitted a number of fake medical records to 4 such centres. The results border on the incredible.
