Az Európai Unió arra törekszik, hogy területén minél jobb legyen a közegészség-védelem. Ezért, illetve annak érdekében, hogy az uniós polgárok hozzájuthassanak azokhoz a gyógyszerekhez, amelyekre szükségük van, az EU az uniós piacon értékesített gyógyszerekre vonatkozóan szigorú szabályokat vezetett be.
Ahhoz, hogy egy gyógyszert forgalomba lehessen hozni az uniós piacon, tagállami vagy uniós szinten kibocsátott forgalombahozatali engedélyre van szükség. Az uniós szintű engedélyt az Európai Bizottság állítja ki. Az intézmény a döntését az Európai Gyógyszerügynökség által készített tudományos értékelésre alapozza.
Ezenkívül – a gyógyszer uniós piacon való forgalmazásának engedélyezését követően – az Európai Bizottság, az Európai Gyógyszerügynökség és az uniós tagállamok biztonsági ellenőrzéseket végeznek a gyógyszer nemkívánatos hatásainak kivédésére, és szükség esetén megteszik a szükséges lépéseket. Ez a felügyeleti tevékenység az uniós farmakovigilancia rendszeren keresztül zajlik.
Kezdeményezések: A hamisított gyógyszerekkel szembeni küzdelmet célzó 2011-es irányelvRendelkezésre álló fordítások.; A gyógyszerbiztonság ellenőrzésére szolgáló uniós rendszer megerősítése, 2010Rendelkezésre álló fordítások.
A gyógyszerkészítményekről bővebben
The European Medicines Agency has published the first list of active substances contained in authorised medicines for which a lead Member State has been appointed to monitor data in EudraVigilance, in order to validate and confirm signals on behalf of the EU regulatory network.
As of January 2013, all imported active substances will have to be manufactured in compliance with standards of good manufacturing practices (GMP). As of July 2013, this compliance will have to be confirmed in writing by the competent authority of the exporting country.
The European Commission has informed the French pharmaceutical company Servier and several of its generic competitors of its objections against practices potentially delaying the generic entry of perindopril, a cardio-vascular medicine
The European Commission has relaunched its call for expressions of interest from representatives of patient and healthcare-professional organisations who wish to sit on the Committee for Advanced Therapies (CAT) and the Pharmacovigilance Risk Assessment Committee (PRAC)
This means better protection of public health through strengthened EU system for medicines safety
This workshop is organized in the framework of the EPIRARE project (“European Platform for Rare Disease Registries”, co-funded by the European Commission
The conference will be hosted by Elena Oana Antonescu, Member of the European Parliament and EUROCAM, (the European stakeholder group for Complementary and Alternative Medicine). It is organised with the support of the European Public Health Alliance
Amsterdam, the Netherlands. Conference about how partnership with patient organisations can contribute to more efficient drug development.
A tagállami nyomozási módszerek és tapasztalatok cseréje a gyógyszerhamisítás elleni hatékony fellépés érdekében.
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.
The European Medicines Agency has published the first list of active substances contained in authorised medicines for which a lead Member State has been appointed to monitor data in EudraVigilance, in order to validate and confirm signals on behalf of the EU regulatory network.
As of January 2013, all imported active substances will have to be manufactured in compliance with standards of good manufacturing practices (GMP). As of July 2013, this compliance will have to be confirmed in writing by the competent authority of the exporting country.
The European Commission has informed the French pharmaceutical company Servier and several of its generic competitors of its objections against practices potentially delaying the generic entry of perindopril, a cardio-vascular medicine
The European Commission has relaunched its call for expressions of interest from representatives of patient and healthcare-professional organisations who wish to sit on the Committee for Advanced Therapies (CAT) and the Pharmacovigilance Risk Assessment Committee (PRAC)
This means better protection of public health through strengthened EU system for medicines safety
The European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices
The European Medicines Agency has launched its website on suspected side-effect reports for medicines authorised in the European Economic Area (EEA) in the remaining 22 official European Union (EU) languages.
John DALLI, European Commissioner for Health and Consumer Policy delivers speech on the occasion of the 18th European Generic Medicines Association (EGA) Annual Conference, Malta, 15 June 2012
New breach of trust procedure for Management Board members completes Agency’s rules on dealing with potential conflicts of interests
John Dalli, European Commissioner for Health and Consumer Policy, attends the 53rd Annual Meeting of the European Association of Full Time Wholesalers (GIRP) Lisbon, Portugal, 04 June 2012
The European Ombudsman, P. Nikiforos Diamandouros, has called on the European Medicines Agency (EMA) to increase the transparency of its procedures for ensuring that children can benefit from new medicines
European Medicines Agency boosts EU transparency with online publication of suspected side effect reports
Data confirm positive benefit-risk balance of anticoagulant medicine, but modifications to product information for clearer guidance needed
New medicine offers therapeutic innovation for treatment of cystic fibrosis; review under accelerated assessment
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP). This month's highlights introduce changes based on feedback from journalists and other stakeholders over the last seven months
The European Medicines Agency has published information on research activities on medicine safety that may be funded by the European Commission's Seventh Framework Programme
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. Hosszú ideig legálisan árulták ezeket a gyógyszereket Európában, ám feltételezések szerint súlyos mellékhatásokat, sőt betegek halálát is előidézték
A Mediator-botrány, melynek során potenciálisan végzetes gyógyszerek a piacon maradtak, rávilágított az uniós joghézagokra. EP-képviselők szigorúbb gyógyszerészeti ellenőrzésekről szavaznak
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.
Az Európai Bizottság ma javasolta a gyógyszerek ármegállapítására és ártámogatására vonatkozó tagállami döntések összehangolását és felgyorsítását annak érdekében, hogy az új gyógyszerek gyorsabban forgalomba kerülhessenek.
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.
A videó a hamis gyógyszerek okozta veszélyeket, valamint az Európai Unió azon intézkedéseit ismerteti, amelyek biztosítják a polgárok egészségének a megőrzését.
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.
A hamisított gyógyszerek gyártása és kereskedelme komoly veszélyt jelent a közegészségre. A „hamisított” kifejezésbe nem tartoznak bele a szellemi tulajdonjog megsértésének számító, más típusú hamisítások.
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.
A hamisított gyógyszerek a gyógyszerészek pultjaira kerülnek. Az EP-képviselők abban bíznak, hogy a szigorúbb ellenőrzések, a kötelező pecsétek és a jóváhagyott internetes oldalak segíthetnek megállítani ezt az illegális kereskedelmet.
A képviselők február 16-án 569 igen, 12 nem és 7 tartózkodás mellett megszavazták a hamisított gyógyszerek legális ellátási láncba való bekerülésének és forgalmazásának megakadályozásáról szóló új jogszabályt. Az új irányelv az internetes értékesítés szabályozására is kiterjed valamint új biztonsági és ellenőrzési rendszert, a gyógyszerhamisítók ellen pedig keményebb szankciókat vezet be.
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?
A szerdán megszavazott jogszabály értelmében a betegek könnyebben hozzáférhetnek a vényköteles gyógyszerek minőségi tájékoztatásához. A jogszabály előírja a gyógyszer jellemzőinek valamint a gyógyszerrel kezelt betegségek és állapotok objektív tájékoztatását, elkerülve a fölösleges információkat vagy rejtett reklámot.
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.
Fokozottabban védené az európai betegeket a gyógyszerek káros mellékhatásaitól az a jogszabály, amelyet a Tanáccsal folytatott egyeztetések után a parlament egésze is elfogadott szerdán. A jobb tájékoztatás érdekében nemzeti és európai honlapokat hoznának létre, és a betegek is bejelenthetnék a nem kívánt mellékhatásokat.
Legyen szó potencianövelőkről, rák vagy malária elleni gyógyszerekről, netán fájdalomcsillapítókról – tény, hogy egyre többen vásárolnak gyógyszert az interneten. Sajnos azonban ezek nagyon gyakran hamisítványoknak bizonyulnak. A februári plenáris ülés során az EP megvitatja a biztonsági szabályok bevezetését, köztük a gyógyszerek online értékesítésének szigorítását, hogy csökkentjen az EU-ban forgalmazott hamis gyógyszerek száma. A február 15-i vitát követően másnap szavaznak is a témáról.
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.
Minden megjegyzett, amit a rendelőben eltöltött néhány perc alatt az orvos elmondott Önnek a felírt gyógyszerrel kapcsolatban? Valószínűleg nem, és a gyógyszeres dobozban található leírás mintha kínaiul lenne... A vényköteles gyógyszerekkel kapcsolatos tájékoztatás hatékonyabbá tételéről vitáztak a képviselők március 4‑én az EP‑ben.
A gyógyszeripari innováció terén az EU az utóbbi időben háttérbe szorult. Az orvosságokra vonatkozóan az európai betegek még mindig egyenlőtlenül jutnak információkhoz, miközben a gyógyszerhamisítás egyre gyakoribb jelenséggé válik.
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.
Egyszerűsíteni és egységesíteni szeretnék az EP-képviselők az olyan gyógyszerek újraengedélyeztetését, amelyek már forgalomban vannak, de kisebb vagy nagyobb mértékben módosították őket.
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.
