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Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (Text with EEA relevance ) article 21a CELEX: 02009R0469-20190701 Evaluation
No later than five years after the date referred to in Article 5(10), and every five years thereafter, the Commission shall carry out an evaluation of Article 5(2) to (9) and Article 11 in order to assess whether the objectives of those provisions have been achieved, and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. In addition to evaluating the impact of the exception of making for the purpose of export, special account shall be taken of the effects of making for the purpose of storing in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate on access to medicines and on public health expenditure, and of whether the waiver and in particular the period provided for in point (a)(iii) of Article 5(2) is sufficient to achieve the objectives referred to in Article 5, including public health. |