Regulation 2006/1901 - Medicinal products for paediatric use - Main contents
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Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2006/1901 |
| Original proposal | COM(2004)599  |
| CELEX number i | 32006R1901 |
| Document | 12-12-2006 |
|---|---|
| Publication in Official Journal | 27-12-2006; Special edition in Croatian: Chapter 13 Volume 064,Special edition in Bulgarian: Chapter 13 Volume 058,OJ L 378, 27.12.2006,Special edition in Romanian: Chapter 13 Volume 058 |
| Effect | 26-01-2007; Entry into force Date pub. + 30 See Art 57.1 26-07-2007; Partial application See Art 57.2 26-07-2008; Partial application See Art 57.2 26-01-2009; Partial application See Art 57.2 |
| End of validity | 05-07-2009; Partial end of validity Art. 52 Implicitly repealed by 32009R0469 31-12-9999 |
27.12.2006 |
EN |
Official Journal of the European Union |
L 378/1 |
REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 12 December 2006
on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Economic and Social Committee (1),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure referred to in Article 251 of the Treaty (2),
Whereas:
(1) |
Before a medicinal product for human use is placed on the market in one or more Member States, it generally has to have undergone extensive studies, including pre-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population. |
(2) |
Such studies may not have been undertaken for use in the paediatric population and many of the medicinal products currently used to treat the paediatric population have not been studied or authorised for such use. Market forces alone have proven insufficient to stimulate adequate research into, and the development and authorisation of, medicinal products for the paediatric population. |
(3) |
Problems resulting from the absence of suitably adapted medicinal products for the paediatric population include inadequate dosage information which leads to increased risks of adverse reactions including death, ineffective treatment through under-dosage, non-availability to the paediatric population of therapeutic advances, suitable formulations and routes of administration, as well as use of magistral or officinal formulations to treat the paediatric population which may be of poor quality. |
(4) |
This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations. These objectives should be achieved without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age populations. |
(5) |
While taking into account the fact that the regulation of medicinal products must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the free movement of safe medicinal products within the Community. The differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market. Any action to promote the development and authorisation of medicinal products for paediatric use is therefore justified with a view to preventing or eliminating these obstacles. Article 95 of the Treaty is therefore the proper legal basis. |
(6) |
The establishment of a system of both obligations and rewards and incentives has proved necessary to achieve these objectives. The precise nature of these obligations and rewards and incentives should take account of the status of the particular medicinal product concerned. This Regulation should apply to all the medicinal products required for paediatric use and therefore its scope should cover products under development and yet-to-be authorised, authorised products... |
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