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Op 8 juni 2011 hebben de Raad en het Europees Parlement het voorstel ondertekend en kan worden overgegaan tot officiële publicatie.
officiële titel
Voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging van richtlijn 2001/83/EG om te verhinderen dat geneesmiddelen die qua identiteit, geschiedenis of oorsprong vervalst zijn, in de legale distributieketen belandenofficiële Engelstalige titel
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| COM-nummer | COM(2008)668  |
|---|---|
| extra com nummer | COM(2008)668;SEC(2008)2674;SEC(2008)2675;COM(2009)665 |
| raadsdocument | 2008/04 |
| interinstitutioneel nummer | 2008/0261(COD) |
Geneesmiddelenvervalsingen kunnen minderwaardige, vervalste of verkeerd gedoseerde - al dan niet werkzame - bestanddelen of helemaal geen werkzame bestanddelen bevatten. Zij vormen een ernstige bedreiging voor de patiënt en het Europese bedrijfsleven, en het publiek en de politiek maken zich ernstige zorgen over het in de afgelopen jaren gestaag toegenomen aantal vervalsingen dat in de EU op het spoor is gekomen.
De potentiële bedreiging van de volksgezondheid wordt ook onderkend door de Wereldgezondheidsorganisatie (WHO), die daarom de International Medical Products Anti-Counterfeiting Taskforce (IMPACT) in het leven heeft geroepen. IMPACT heeft in actieve samenwerking met de Gemeenschap beginselen en elementen voor de nationale wetgeving tegen namaakgeneesmiddelen opgesteld, die op 12 december 2007 door de algemene vergadering van IMPACT in Lissabon werden goedgekeurd. De Groep van Acht (G8) heeft de inspanningen van IMPACT in haar verklaring van 7 juni 2008 toegejuicht.
Daarbij komt nog dat het risicoprofiel veranderd is. Steeds vaker duiken vervalsingen van innovatieve en levensreddende geneesmiddelen op. Om de afzet ervan te vergroten, worden deze middelen bovendien via de legale distributieketen aan de man gebracht. Op deze manier zijn in 2007 vele duizenden verpakkingen vervalste levensreddende geneesmiddelen bij patiënten in de EU terechtgekomen.
Hoewel niet precies te zeggen valt om hoeveel gevallen het op dit ogenblik gaat of in de toekomst nog zal gaan, tekent zich een duidelijke tendens af die het hoge niveau van bescherming van de volksgezondheid in de EU bedreigt. Deze ontwikkeling kan desastreuze gevolgen hebben voor het vertrouwen van het publiek in de farmaceutische industrie en de politiek, zeer wel vergelijkbaar met de voedselveiligheidscrisis in de jaren negentig.
Dat geneesmiddelenvervalsingen in de legale distributieketen onontdekt blijven, heeft velerlei oorzaken, die echter tot vier aspecten kunnen worden herleid:
? Geneesmiddelenvervalsingen zijn niet altijd gemakkelijk te onderscheiden van de originele middelen;
? De distributieketen is zeer complex geworden en is slechts zo sterk als zijn zwakste schakel;
(...)
lees meer
| besluitvormingsprocedure | Gewone wetgevingsprocedure (COD) |
|---|---|
| stemwijze Raad | Raad besluit met gekwalificeerde meerderheid van stemmen |
| datum online publicatie | 10-12-2008 |
| datum besluit | 08-06-2011 |
| datum bekendmaking | 01-07-2011 |
| datum inwerkingtreding | 21-07-2011 |
| datum uiterste omzetting | 02-01-2013 |
| aan actor | Lidstaten Europese Unie |
|---|---|
| directoraat-generaal | Directoraat-generaal Ondernemingen en industrie (ENTR) |
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COVER NOTE
5494/1/12 REV 1 - 23 jan '12Commission Communication to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions A coherent framework for building trust in the Digital Single Market for e-commerce and online services
COVER NOTESecretary-General of the European Commission
5494/12 - 18 jan '12Commission Staff Working document Online services, including e-commerce, in the single market Accompanying the document Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Commitee of the Regions A coherent framework to boost confidence in the Digital Single Market of e-commerce and other online services
COVER NOTESecretary-General of the European Commission
5494/12 ADD 2 - 21 jun '11Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
LEGISLATIVE ACTS AND OTHER INSTRUMENTS: CORRIGENDUM/RECTIFICATIF
11884/11 - 28 feb '11Proposal 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 - Outcome of the European Parliament's first reading (Strasbourg, 14 to 17 February 2011)
NOTEGeneral Secretariat
6317/11 - 8 jun '10Proposal 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
NOTEGeneral Secretariat of the Council
9076/2/10 REV 2 - 3 jun '10Proposal 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 - Information from the Presidency
NOTEGeneral Secretariat of the Council
10469/10 - 21 mei '10Proposal 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
CORRIGENDUM TO NOTEGeneral Secretariat of the Council
9076/1/10 REV 1 COR 1 - 18 mei '10Proposal 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
NOTEGeneral Secretariat of the Council
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NOTEGeneral Secretariat of the Council
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NOTEGeneral Secretariat of the Council
5184/5/10 REV 5 - 12 mrt '10Proposal 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
NOTEGeneral Secretariat of the Council
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COVER NOTEPresident of the European Commission
17193/09 ADD 1 REV 1 - 26 feb '10Proposal 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
NOTEGeneral Secretariat of the Council
5184/2/10 REV 2 - 3 feb '10Proposal 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
NOTEGeneral Secretariat of the Council
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NOTEGeneral Secretariat of the Council
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NOTEGeneral Secretariat of the Council
17589/09 - 20 nov '09Proposal 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
NOTEGeneral Secretariat of the Council
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NOTEGeneral Secretariat of the Council
12610/2/09 REV 2 - 6 okt '09Proposal 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
NOTEGeneral Secretariat of the Council
12610/1/09 REV 1 - 18 jun '09Proposal 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
NOTEGeneral Secretariat of the Council
10377/09 - 28 mei '09Preparation of the Council (Employment, Social Policy, Health and Consumer Affairs) on 8 and 9 June 2009 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 - Progress report / Exchange of views
REPORTWorking Party on Pharmaceuticals and Medical Devices
10180/09 COR 1 - 12 mei '09Proposal 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
NOTEGeneral Secretariat of the Council
7250/2/09 REV 2 - 16 apr '09Proposal 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
NOTEGeneral Secretariat of the Council
7250/1/09 REV 1 - 17 mrt '09Proposal 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
NOTEGeneral Secretariat of the Council
7250/09 - 18 feb '09Proposal 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
NOTEGeneral Secretariat of the Council
6331/09 - 19 dec '08Commission Staff Working Document accompanying document to the 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 Impact Assessment
COVER NOTESecretary-General of the European Commission
17504/08 ADD 1 - 19 dec '08Voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging van Richtlijn 2001/83/EG om te verhinderen dat geneesmiddelen die qua identiteit, geschiedenis of oorsprong vervalst zijn, in de legale distributieketen belanden
PROPOSALEuropean Commission
17504/08 - 19 dec '08Werkdocument van de diensten van de Commissie Begeleidend document bij het voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging van Richtlijn 2001/83/EG om te verhinderen dat geneesmiddelen die qua identiteit, geschiedenis of oorsprong vervalst zijn, in de legale distributieketen belanden Samenvatting van de effectbeoordeling
COVER NOTESecretary-General of the European Commission
17504/08 ADD 2 - 19 dec '08Mededeling van de Commissie aan het Europees Parlement, de Raad, het Europees Economisch en Sociaal Comité en het Comité van de Regio's Veilige, innovatieve en toegankelijke geneesmiddelen:een nieuwe visie voor de farmaceutische sector
COVER NOTESecretary-General of the European Commission
17503/08
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