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Parliamentary questions
13 July 2017
E-003363/2017
Answer given by Mr Andriukaitis on behalf of the Commission

With reference to the Honourable Members' question, it should be noted that in accordance with the pharmaceutical legislation(1), a marketing authorisation for a medicinal product granted either by the Commission for the entire EU or by a Member State for its own territory, also includes the assessment and approval of its proposed packaging.

The Commission is aware of the problem encountered by older patients in opening medicines’ containers or removing pills from blister packs. The European Medicine's Agency (EMA) has a Geriatric Medicines Strategy in place since 2011(2), and one of the first areas of action within that strategy is the suitability of packaging and formulations of medicines to be used by the older population.

The EMA Quality Working Party's paper concerning quality aspects of medicines for elderly patients(3) looks at different strategies to help the elderly, e.g. using adapted container closure systems with a requirement to test ease of opening, providing additional instructions on the product label and specific and dedicated dose dispensers to avoid medication errors to older people. In May 2017, the EMA's Committee for Medicinal Products for Human Use adopted this document and it will soon be published for public consultation(4). Further information can be found on the EMA webpage on Medicines for older people(5).

(1)http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0726&from=EN
(2)http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000249.jsp&mid=WC0b01ac058004cbb9
(3)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500141560.pdf
(4)The reflection paper will be accessible via the following EMA webpage: http://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/landing/landing_page.jsp&mid=WC0b01ac05807a4176
(5)http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000249.jsp&mid=WC0b01ac058004cbb9

Last updated: 18 July 2017Legal notice