BETA

Subject "4.20.04 Pharmaceutical products and industry"

Dossiers (99)

Phasing out of derogations for certain medicinal products in Cyprus, Ireland, and Malta. Report
Vulnerabilities of the global supply chains of medicines - Structured Dialogue on the security of medicines supply
Supplementary protection certificate for medicinal products and creation of a supplementary protection certificate for plant protection products. Evaluation. Executive summary
Supplementary protection certificate for medicinal products and creation of a supplementary protection certificate for plant protection products. Evaluation
Pharmaceutical strategy for Europe. Synopsis report. Accompanying document
Evaluation of the European Medicines Agency's fee system. Executive summary. Accompanying document
Evaluation of the European Medicines Agency’s fee system
Update on competition enforcement in the pharmaceutical sector (2018-2022) - European competition authorities working together for affordable and innovative medicines. Report
Addressing medicine shortages in the EU
EU strategy on Covid-19 therapeutics
Pharmaceutical Strategy for Europe
Examination of variations to the terms of marketing authorisations for medicinal products for human use
Medicine shortages and strategic healthcare autonomy in the EU
Adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
Medicinal products for human use
Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency
Compulsory licensing of patents in crisis situations
Unitary supplementary certificate for medicinal products
Specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland
Labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use
Adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
European Medicines Agency (EMA): appointment of four members of the Management Board
Fees and charges payable to the European Medicines Agency
Derogation from the obligation of wholesalers to decommission the unique identifier of medicinal products exported to the United Kingdom
Evaluation of notifications by national competent authorities to the Commission and inclusion of cicatrizants with ATC code D03AX and pharmaceutical form fly larvae in the list of medicinal products that shall not bear the safety features
Examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
Homologation and distribution of transparent masks
Derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom
EU global strategy on COVID-19 vaccinations
A Pharmaceutical Strategy for Europe
Derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom with respect to Northern Ireland as well as in Cyprus, Ireland and Malta
Derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland, as well as in Cyprus, Ireland and Malta
Pharmaceutical strategy for Europe
Adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
European Medicines Agency
Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease
Resolution on a strategic approach to pharmaceuticals in the environment
Adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
Supplementary protection certificate for medicinal products
Adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
Principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections
European Medicines Agency (EMA): location of the seat
Safety features appearing on the packaging of medicinal products for human use
Drug precursors and trade in drug precursors
Principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
Situations in which post-authorisation efficacy studies may be required
Medicinal products for human and veterinary use
Avoiding trade diversion into the EU of certain key medicines. Codification
Innovative Medicines Initiative 2 Joint Undertaking (IMI2 Joint Undertaking)
Medicinal products for human use: fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities
EU/Russia agreement: drug precursors
Resolution on defective silicone gel breast implants made by French company PIP
Mobilisation of the European Globalisation Adjustment Fund: redundancies in the pharmaceutical sector in Sweden
Declaration on continued and increased support for vaccinations in developing nations
Monitoring intra-EU trade in drug precursors
Monitoring EU/third country trade in drug precursors
Clinical trials on medicinal products for human use
Medicinal products for human use: transparency of measures regulating the prices and their inclusion in the scope of public health insurance systems
Pharmacovigilance: transparency and efficiency of the system. Directive
Pharmacovigilance: transparency and efficiency of the system. Regulation
Resolution on Petition 0473/2008 by Christoph Klein (German), concerning the failure of the Commission to take action regarding a competition case and the harmful impact of this on the company concerned
Duty-free treatment: specified pharmaceutical active ingredients and products
Pharmaceutical products package
Medicinal products for human use: prevention of the entry into the legal supply chain of falsified medicinal products
Medicinal products for human use: pharmacovigilance of products
Medicinal products for human use: pharmacovigilance of products
Medicinal products for human use: information on products subject to medical prescription
Medicinal products for human use: information on products subject to medical prescription
Supplementary protection certificate for medicinal products. Codification
Medicinal products for human and veterinary use: marketing authorisations
Colouring matters for medicinal products. Recast
Establishment of the Innovative Medicines Initiative Joint Undertaking
Resolution on counterfeiting of medicinal products
Declaration on pharmaceutical active substances
Community code relating to medicinal products for human use: implementing powers of the Commission
Medicinal products for paediatric use: implementing powers conferred on the Commission
Resolution on the strategy against an influenza pandemic
Medical devices and active implantable medical devices
Advanced therapy medicinal products
Fees payable to the European Medicines Agency
Pharmaceutical products: compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
Medicinal products for paediatric use
Resolution on authorisation of generic medicines at WTO level
Chemical substances: tests, good laboratory practice (repeal. Directive 87/18/EEC). Codification
Traditional herbal medicinal products
Resolution on access to drugs for HIV/AIDS victims in the Third World
Health implications of the Directive 93/42/EEC of 14 June 1993 on medical devices
Medicinal products for human use: Community code
Authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Environment: substances depleting the ozone layer, metered dose inhalers and medical drug pumps
Medicinal products for human use: Community code. Codification
Pharmaceutical industry: products single market
Orphan medicinal products
Fees payable to the European Agency for the Evaluation of Medicinal Products
Homeopathic medicinal products: application of directives 92/73/EEC and 92/74/EEC. Commission report
Medicinal products for human use: implementation of good clinical practice in the conduct of clinical trials
In vitro diagnostic medical devices: security requirements
Pharmaceutical industry: outlines of an instrustrial policy for the pharmaceutical sector
European Agency for the Evaluation of Medicinal Products: fees payable