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Commission Delegated Regulation (EU) 2016/161Show full title

Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)

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CHAPTER XI TRANSITIONAL MEASURES AND ENTRY INTO FORCE

Article 48Transitional measures

Medicinal products that have been released for sale or distribution without the safety features in a Member State before the date in which this Regulation becomes applicable in that Member State, and are not repackaged or relabelled thereafter, may be placed on the market, distributed and supplied to the public in that Member State until their expiry date.

Article 49Application in Member States with existing systems for the verification of the authenticity of medicinal products and for the identification of individual packs

1.Each of the Member States referred to in Article 2, paragraph 2, second subparagraph, point (b), second sentence, of Directive 2011/62/EU shall notify the Commission of the date from which Articles 1 to 48 of this Regulation apply in its territory in accordance with the third subparagraph of Article 50. The notification shall take place at the latest 6 months before that application.

2.The Commission shall publish a notice of each of the dates notified to it in accordance with paragraph 1 in the Official Journal of the European Union.

Article 50Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 9 February 2019.

However, the Member States referred to in Article 2, paragraph 2, second subparagraph, point (b), second sentence, of Directive 2011/62/EU shall apply Articles 1 to 48 of this Regulation at the latest from 9 February 2025.

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