Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 198/2013
• Articles: 5

Article 1

The black symbol referred to in Article 23(4) of Regulation (EC) No 726/2004 shall be an inverted equilateral triangle. It shall comply with the model and the dimensions set out in the Annex to this Regulation.

Article 2

1.   Holders of marketing authorisations granted before 1 September 2013 which concern medicinal products for human use that are subject to additional monitoring shall include the black symbol in the summary of product characteristics and the package leaflet relating to these medicinal products by 31 December 2013.

2.   By derogation from paragraph 1, holders of marketing authorisations granted before 1 September 2013 which concern medicinal products for human use that are subject to additional monitoring may request a longer period of time to be granted by the competent authorities, where they can demonstrate that compliance with the date referred to in paragraph 1 may unduly affect the appropriate and continued supply of the medicinal product.

Article 3

Stocks of human medicinal products produced, packaged and labelled before 1 January 2014, which do not include the black symbol in the package leaflet may continue to be placed on the market, distributed, dispensed, sold and used until stocks are exhausted.

Article 4

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

Schedules & Appendices

ANNEX

ANNEX

1.

The black symbol referred to in Article 23(4) of Regulation (EC) No 726/2004 shall comply with the following model:

2.

The black symbol shall be proportional to the font size of the subsequent standardised text and each side of the triangle shall have a minimum length of 5 mm.