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Regulation (EC) No 1901/2006 Article 50

Regulation (EC) No 1901/2006 Article 50

Article 50

1.   On the basis of a report from the Agency, and at least on an annual basis, the Commission shall make public a list of the companies and of the products that have benefited from any of the rewards and incentives in this Regulation and the companies that have failed to comply with any of the obligations in this Regulation. The Member States shall provide this information to the Agency. 2.   By 26 January 2013, the Commission shall present to the European Parliament and the Council a general report on experience acquired as a result of the application of this Regulation. This shall include in particular a detailed inventory of all medicinal products authorised for paediatric use since its entry into force. 3.   By 26 January 2017, the Commission shall present a report to the European Parliament and the Council on the experience acquired as a result of the application of Articles 36, 37 and 38. The report shall include an analysis of the economic impact of the rewards and incentives, together with an analysis of the estimated consequences for public health of this Regulation, with a view to proposing any necessary amendments. 4.   Provided that there are sufficient data available to allow robust analyses to be made, the provisions of paragraph 3 shall be fulfilled at the same time as the provisions of paragraph 2.

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Other provisions in Section 1 — Fees, community funding, penalties and reports

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 50 of Regulation (EC) No 1901/2006 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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