Last update: 02/2004
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What is IMP?
Objectives
How does it work?
Achievements
Who benefits?
The role of IDABC
Background information
Technical information
Documentation
What is IMP?
IMP provides data processing and dissemination of medicinal products authorised by the European Commission for use within the EU to national authorities, the companies concerned, and the public. IMP manages and tracks all legal procedures related to pharmaceutical products (e.g. authorisations). It is a back-office database mainly for internal use of the European Commission, notably for the Enterprise Directorate General, Pharmaceuticals Unit.
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Objectives
IMP aims to facilitate the efficient and rapid exchange and sharing of information between the Commission and the other competent authorities and industries concerning the pharmaceutical products and their authorisation.
It is designed to electronically perform the regulatory procedures regarding marketing authorisation of medicinal products and their follow-up, as well as residue evaluations of veterinary medicinal products.
It tracks and monitors the procedures with a generic tracking system that may be applicable to other regulatory sectors.
Finally, IMP aims to promote the harmonisation of electronic information on medicinal products and the adoption of internationally agreed medical dictionaries.
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How does it work?
IMP automatically generates regulatory documents, both Decisions and Regulations, for authorising the marketing of medicinal products.It manages the information related to the status of:
For instance, when a new authorisation is requested:
- IMP automatically gathers information from EMEA - European Medicines Evaluation Agency - which is in charge of the scientific evaluation;
- Through its tracking system IMP prepares a complete file including background information and all relevant information on a product (annexes);
- The complete file is automatically translated by IMP allowing the dissemination of the information in all the 11 official EU languages plus those of the Acceding Countries;
- The file is then sent to the Member States which are requested to react by a given time. Being of a highly confidential nature, the transfer of the information is made through the secure network EUDRANET;
- After the deadline, IMP automatically generates the final decision.
Information about regulatory procedures and centrally approved medicinal products is made available electronically to EMEA, the relevant authorities in the Member States, the laboratories and the public. The type and amount of information shown to the different target groups depends on the level of confidentiality (e.g. before an authorisation is approved, the information is strictly confidential). This is why IMP is not only used for 'internal' purposes, but interacts with the public pharmacos website, where 80% of the information is generated automatically from IMP. The pharmacos website provides a wide range of information such as the Community register of medicinal products or Eudralex, the collection of the 'Rules Governing Medicinal Products in the European Union'.
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Achievements
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The IMP system currently operates on a local area network (LAN) using stand-alone architecture. All products, procedures and document definitions are available.
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Work is now continuing on the maintenance of the IMP system. Particular attention is being paid to the use of interoperable building blocks and to the delivery of generic solutions, which may have applications in other sectors.
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Who benefits?
Citizens: The IMP project refers to the principles of freedom of information based on dissemination of information to the public, industry and stakeholders; citizens will therefore benefit from the transparency of information on the market of medicinal products.
Public Administrations: The European Commission, the EMEA and National Authorities. IMP is the strategic tool for supporting the rapid and efficient decision-making process of the European Commission. The IMP electronic communication system supplies these organisations and technical services with the relevant information for the authorisation procedure.
Policy makers: They enjoy improved efficiency in authorising the marketing of centralised medicinal products as well as greater control of centrally approved medicines on the European market.
Businesses: The IMP system allows better collaboration in pre-marketing and post-marketing activities in the pharmaceutical sector in the European Union.
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The role of IDABC
IDABC has co-financed the implementation of the project. Special emphasis has been placed on the use and production of common tools for the generation of multilingual official documents and the tracking of regulatory procedures.
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Background information
In the last decade the EU has developed legislation to govern the pharmaceutical sector in the dual interest of protecting public health while completing the single market for pharmaceuticals. Particularly two Directives (75/318/EEC2 and 75/319/EEC3) sought to bring the benefits of innovative pharmaceuticals
to patients across the European Community, by introducing a procedure for the mutual recognition by Member States of their respective national marketing authorisations.
In addition, in 1995 a new European system for authorising medicinal products was set up. This consists of two main procedures:
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A 'centralised' procedure for authorising biotechnologyderived and high technology medicines, as laid down in Council Regulation (EEC) No 2309/936 and Directive 93/41/EEC7. Applications are made directly to the EMEA leading to the grant of a European marketing authorisation by the Commission.
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A 'mutual recognition' procedure. To be eligible for this procedure, a medicinal product must already have been authorised for marketing in one Member State, and sufficient data on it must be available. Applications are made to the Member States selected by the applicant and the procedure operates by mutual recognition of national marketing authorisations. The mutual recognition has been compulsory since 1998 for the EU Member States.
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Technical information
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Project start date
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1995
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Project completion date
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1999
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Project status
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Implementation
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IDA budget
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€ 762,000
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Responsible service
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DG Enterprise and Industry
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Project coordinator
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Rochus de Raat
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Contact
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idabc@ec.europa.eu
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Countries involved
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All EU Member States
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Public website
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http://pharmacos.eudra.org/
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Documentation: |
Print
IMP GIP - March 2000 (PDF)
