{"id":108079,"date":"2026-01-26T08:33:38","date_gmt":"2026-01-26T07:33:38","guid":{"rendered":"https:\/\/www.roeltgen.de\/marking-requirements-for-pharmaceutical-products\/"},"modified":"2026-03-05T10:17:50","modified_gmt":"2026-03-05T09:17:50","slug":"marking-requirements-for-pharmaceutical-products","status":"publish","type":"post","link":"https:\/\/www.roeltgen.de\/en\/marking-requirements-for-pharmaceutical-products\/","title":{"rendered":"Marking requirements for pharmaceutical products"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.27.5&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>Pharmaceutical marking is much more than just \u2018text on a package\u2019. It is the last safety net between the necessary administration of a highly effective medicine and the risk of incorrect use or confusion. <\/p>\n<p>This is precisely why national and European regulations stipulate precisely what must be stated on packaging, how it must be designed \u2013 and how each individual package can be clearly identified.<\/p>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-103052\" src=\"https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-300x131.jpg\" alt=\"Title Packaging and paper\" width=\"600\" height=\"263\" srcset=\"https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-300x131.jpg 300w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-scaled-150x66.jpg 150w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-scaled-750x328.jpg 750w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-1024x448.jpg 1024w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-768x336.jpg 768w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-1536x672.jpg 1536w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-2048x896.jpg 2048w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-1080x473.jpg 1080w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-1280x560.jpg 1280w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-980x429.jpg 980w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2023\/08\/Header-Verpackung-und-Papier-480x210.jpg 480w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>In practice, the marking acts as a two-stage protection system: firstly, it ensures that patients, pharmacies, clinics and specialist staff can clearly identify a product and use it correctly. Secondly, it protects the supply chain by making counterfeiting more difficult and speeding up recalls. <\/p>\n<p>Standardised dosage forms such as blister packs (push-through packs) in particular demonstrate how strict the requirements are: essential information must be permanently, clearly legible and unambiguously displayed in a confined space. This is not an end in itself, but a consequence of the everyday risks associated with modern pharmaceutical supply. These risks include mix-ups, incorrect dosages, parallel imports, repackaging, logistics across multiple countries \u2013 and, unfortunately, attempts to smuggle counterfeit products into legal distribution channels.  <\/p>\n<p>In addition to traditional marking requirements, the EU has therefore also established security features and serialisation, which must be implemented on a mandatory basis in most areas from February 2019 onwards.<\/p>\n<p>&nbsp;<\/p>\n<h2>What must be included on blister packs<\/h2>\n<p>For medicinal products for human use, EU law specifies the information that must appear on the outer packaging (or, if there is no outer packaging, on the primary packaging). This includes the name of the medicinal product, strength, dosage form and, depending on the product, the INN\/active ingredient. Information such as the batch number and expiry date, as well as a note that the product is only available from pharmacies and the marketing authorisation number, are also required.  <\/p>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-107248\" src=\"https:\/\/www.roeltgen.de\/wp-content\/uploads\/2026\/01\/Blister-300x200.png\" alt=\"Blister strips containing tablets must be marked.\" width=\"600\" height=\"400\" srcset=\"https:\/\/www.roeltgen.de\/wp-content\/uploads\/2026\/01\/Blister-300x200.png 300w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2026\/01\/Blister-400x268.png 400w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2026\/01\/Blister-150x100.png 150w, https:\/\/www.roeltgen.de\/wp-content\/uploads\/2026\/01\/Blister.png 402w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>In Germany, this is regulated very specifically in the Medicines Act (AMG) \u2013 including special requirements for blister packs. Section 10 AMG makes it clear that marking is not a \u2018nice to have\u2019 but a mandatory component of marketability. The following applies to blister packs: even if space is limited, key identification information must be reliably available on the blister itself \u2013 so that individual cavities do not become \u2018anonymous\u2019 once the outer packaging is removed. Because \u2018legibility\u2019 must not be a matter of interpretation, guidelines and QRD specifications supplement the legal requirements and define clear rules for design and comprehensibility.   <\/p>\n<p>With the Falsified Medicines Directive (FMD), Europe has added a digital security layer to marking. Since February 2019, many prescription medicines have carried a 2D data matrix code with a unique identifier and tamper-proofing. The code contains the serial number and other identifiers such as the product code, batch and expiry date, and is verified upon dispensing. This means that counterfeits and recalls can be identified in seconds \u2013 not in the laboratory, but directly in the process.   <\/p>\n<p>For manufacturers, this is more than just an IT project: print quality, legibility, inline verification, clean data handling and stable interfaces to serialisation and ERP systems are an integral part of regulatory compliance.<\/p>\n<p>Bottom line: Marking is not a compulsory exercise, but rather a systematic risk mitigation measure \u2013 physically (plain text), organisationally (specifications &amp; legibility) and digitally (serialisation &amp; verification). Those who consistently combine these levels achieve exactly what counts in the pharmaceutical world \u2013 trust down to the last tablet. <\/p>\n<p>You will find the <a href=\"https:\/\/www.roeltgen.de\/en\/products-for-industrial-marking\/cardboard-boxes-and-blister-packs\/\">right tools<\/a> for marking cardboard boxes and blister packs here. R\u00f6ltgen also offers <a href=\"https:\/\/www.roeltgen.de\/en\/product\/blister-punch\/\">blister punching<\/a> and regrinding services. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text admin_label=&#8221;interne Links&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; header_3_font=&#8221;||||on|||#075C97|&#8221; header_3_text_color=&#8221;#075C97&#8243; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><a href=\"https:\/\/www.roeltgen.de\/produkte-fuer-industrielle-kennzeichnung\/\">Would you like to browse our products?<\/a><\/h3>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;externe Links&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2 style=\"text-align: center;\">Further information can be found here:<\/h2>\n<p style=\"text-align: center;\"><a href=\"https:\/\/www.gesetze-im-internet.de\/amg_1976\/\" target=\"_blank\" rel=\"noopener\">BMJV &#8211; Medicines Act<\/a><\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/gesundheitsberufe.de\/news\/rechtliche-regelungen-f%C3%BCr-die-pharmaindustrie-eine-besonders-sensible-branche\/\" target=\"_blank\" rel=\"noopener\">Gesundheitsberufe.de &#8211; Legal regulations<\/a><\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/de.wikipedia.org\/wiki\/Produktkennzeichnung\" target=\"_blank\" rel=\"noopener\">Wikipedia &#8211; Product marking<\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Spare parts for machines: Learn about the advantages and disadvantages of non-OEM parts, with tips on cost savings, fast delivery and risks for industrial companies.<\/p>\n","protected":false},"author":5,"featured_media":107256,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[38],"tags":[164,163,169,167,165,168,166],"class_list":["post-108079","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-blister-pack","tag-blister-punching","tag-cardboard-boxes","tag-marking-requirements","tag-pharmaceutical","tag-pharmaceutical-industry","tag-pharmazeutisch"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Marking requirements for pharmaceutical products<\/title>\n<meta name=\"description\" content=\"Marking requirements for pharmaceutical products explained simply: legal requirements, technology and safe implementation in the pharmaceutical industry.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.roeltgen.de\/en\/marking-requirements-for-pharmaceutical-products\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Marking requirements for pharmaceutical products Kennzeichnungswerkzeuge und Kennzeichnungsmaschinen\" \/>\n<meta property=\"og:description\" content=\"R\u00f6ltgen GmbH &amp; Co. 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