NVC Netherlands Packaging Centre
NVC
Packaging is temporarily integrating an external function and a product to enable the use of the product.
ID: 42440258570-74
Lobbying Activity
Response to Evaluation and revision of the general pharmaceutical legislation
8 Nov 2023
NVC proposal for further improvements/modifications on the new EU Pharma Directive relating to medicinal products for human use with particular emphasis on: The appropriate definitions of the terminology used: packaging (verb/noun), packing, pack, filling, leaflet, patient information, labeling, label, The external functions delivered through the activity of packaging and the packaging elements used therein. Actively referencing related input(s) on the Patient Information Leaflet in sync with this input on the primary-secondary-tertiary packaging and labeling. Background information on the NVC Packaging Centre in general and for pharma: NVC (founded in 1953) is the association of 500+ companies worldwide striving to improve the activity of packaging throughout the supply chain of packaged products. The NVC membership, innovation projects, business information services and business education programmes stimulate the continuous improvement of packaging. The NVC innovation project Pharmaceutical Packaging Innovation is addressing the activity of packaging as driver for the sustainable development of medicinal products and medical devices for human use worldwide. NVC Packaging Centre was founded in 1953 and is a non-profit, non-governmental, non-subsidized business association, legally based in the Netherlands (CoC Gouda 40407316). Each year the finances and organization are audited by an external accountant. The NVC Annual Report is shared with the members and approved in the annual NVC General Meeting of Members. All info is provided at: www.nvc.nl and by Michael Nieuwesteeg MSc MEng, NVC Managing Director m.nieuwesteeg@nvc.nl Definition of packaging (verb) in general and for health care: Packaging is the activity of temporarily integrating an external function and a product to enable the use of the product. Packaging is the activity of temporarily integrating an external function and a medicine to enable the human use, i.e. the appropriate therapy. Each second, industry packages around 320,000 products resulting in the same number of products unpacked each second by users, at a different location and a different moment in time. The health care sector is estimated to represent around 5% of this. NVC*,** proposes the following modifications/improvements * with the essential support of prof. Karel van der Waarde, Graphic Design Research regarding this and related inputs on the Patient Information Leaflet ** based on two consecutive NVC member meetings, held respectively on 14 August 2023 and 27 September 2023 Provided is a list of suggestions for improvements/modifications of the text in the proposal for a Directive on the Union code relating to medicinal products for human use. The sequence follows the pages of the proposal. The input is based on intensive consultation of and interaction with the participants in the NVC innovation project Pharmaceutical Packaging Innovation. First a general considerations are given on the page below. This is followed by a systematic description where the left-handside column shows the text in the proposal and the right-hand side column shows the improvements/modifications proposed. All is elaborated in the pdf document attached.
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