{"product_id":"lakemedel-avloppsdirektivet-2028-substansmassor-producentansvar","title":"Medicines \u0026 Wastewater Directive 2028 – substance masses, 1-ton test and PRO basis | Word\/PDF\/Excel","description":"\u003cp\u003e\u003cstrong\u003eDoes your pharmaceutical company need to start gathering evidence ahead of the EU's new extended producer responsibility for wastewater treatment?\u003c\/strong\u003e Under \u003cstrong\u003eDirective (EU) 2024\/3019\u003c\/strong\u003e, Member States must ensure extended producer responsibility for relevant products by \u003cstrong\u003e31 December 2028\u003c\/strong\u003e at the latest. Article 9 and Annex III cover, among other things, medicinal products for human use. This Swedish specialist package helps companies \u003cstrong\u003eassess their producer role, inventory substance quantities, request supplier evidence, and document potential exemptions\u003c\/strong\u003e – before Swedish legislation and the fee model are fully implemented.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRead the guide:\u003c\/strong\u003e \u003ca href=\"https:\/\/mallbutiken.se\/en\/blogs\/foretag\/avloppsdirektivet-producentansvar-lakemedel-kosmetika-2028\"\u003eWastewater Directive 2028 – producer responsibility for medicines and cosmetics\u003c\/a\u003e. It explains the rules and practical assessments.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuick facts:\u003c\/strong\u003e 7 Word documents, 7 searchable PDF versions, 1 Excel workbook with 9 tabs; a total of \u003cstrong\u003e15 actual delivery files\u003c\/strong\u003e. Five Swedish working templates, one Swedish guide, and one English user guide. Word and Excel files are editable. The PDF files are searchable and printable but not interactively fillable. The product is intended for digital ZIP delivery following separate Shopify publication.\u003c\/p\u003e\n\u003cdiv style=\"border:2px solid #245A8A;border-radius:8px;background:#ECF4FA;padding:17px 20px;margin:18px 0\"\u003e\n\n\u003ch2\u003e01. Package contents\u003c\/h2\u003e\n\n\u003cp\u003eFive separate Swedish working templates for role assessment, supplier letters, substance mass calculation, exemption assessment, and PRO\/annual data. Also a Swedish user guide and an English User Guide. Seven DOCX files with seven corresponding searchable PDFs, plus one Swedish XLSX workbook. \u003cstrong\u003e15 files in total\u003c\/strong\u003e, not 15 separate legal documents.\u003c\/p\u003e\n\n\n\u003c\/div\u003e\n\u003cdiv style=\"border:2px solid #245A8A;border-radius:8px;background:#ECF4FA;padding:17px 20px;margin:18px 0\"\u003e\n\n\u003ch2\u003e02. What the files contain\u003c\/h2\u003e\n\n\u003cp\u003eEditable information fields, actual supplier requests, substance and market data, chain of evidence, checks of potential grounds for exemption, manual decisions, and registers for the forthcoming Swedish producer responsibility organisation (PRO). Excel performs mathematical calculations but \u003cstrong\u003edoes not calculate legally binding fees, official reports, or exemption decisions\u003c\/strong\u003e.\u003c\/p\u003e\n\n\n\u003c\/div\u003e\n\u003ch2\u003eWhy is the documentation needed?\u003c\/h2\u003e\n\u003cp\u003eArticle 9.1 of the Directive states that relevant producers must ensure, through their systems, that they cover \u003cstrong\u003eat least 80%\u003c\/strong\u003e of certain costs for quaternary treatment and for the collection\/verification of relevant product data. This is \u003cstrong\u003enot\u003c\/strong\u003e a pre-determined percentage of an individual pharmaceutical company's turnover. Article 9.3 describes collective producer responsibility and annual data on substance quantities, the hazard of substances in wastewater, and biodegradability.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe timeline:\u003c\/strong\u003e The Directive entered into force on \u003cstrong\u003e1 January 2025\u003c\/strong\u003e. According to the Swedish Environmental Protection Agency's guidance, Sweden has until \u003cstrong\u003e31 July 2027\u003c\/strong\u003e to transpose it. The specific deadline for a functioning extended producer responsibility is \u003cstrong\u003e31 December 2028\u003c\/strong\u003e. As of 10 November 2026, the details of the Swedish administrative process, Swedish fee model, and exact evidence format have not been conclusively verified. TLV and the Swedish Medical Products Agency have an ongoing investigation mandate, with an interim report planned for 16 November 2026.\u003c\/p\u003e\n\u003ch2\u003eComplete file list\u003c\/h2\u003e\u003cdiv style=\"overflow-x:auto\"\u003e\u003ctable style=\"width:100%;min-width:720px;border-collapse:collapse\"\u003e\n\n\u003cthead\u003e\u003ctr style=\"background:#DBEAF7\"\u003e\n\n\u003cth scope=\"col\" style=\"padding:8px;text-align:left\"\u003eDocument\u003c\/th\u003e\n\n\u003cth scope=\"col\" style=\"padding:8px;text-align:left\"\u003eFunction\u003c\/th\u003e\n\n\u003cth scope=\"col\" style=\"padding:8px;text-align:left\"\u003eLanguage\u003c\/th\u003e\n\n\u003cth scope=\"col\" style=\"padding:8px;text-align:left\"\u003eFormat\u003c\/th\u003e\n\n\n\u003c\/tr\u003e\u003c\/thead\u003e\n\n\u003ctbody\u003e\n\n\u003ctr\u003e\n\n\u003cth scope=\"row\" style=\"text-align:left;padding:8px;border-bottom:1px solid #c7d7e8\"\u003e01 – Role and applicability assessment\u003c\/th\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eAssess producer role, medicinal products for human use, EU markets, and overlapping responsibilities.\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eSwedish\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eDOCX + searchable PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003cth scope=\"row\" style=\"text-align:left;padding:8px;border-bottom:1px solid #c7d7e8\"\u003e02 – Supplier letter – substance data\u003c\/th\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eRequest substance quantities, product identities, hazards, biodegradability, and evidence references.\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eSwedish\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eDOCX + searchable PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003cth scope=\"row\" style=\"text-align:left;padding:8px;border-bottom:1px solid #c7d7e8\"\u003e03 – Substance masses – control memo\u003c\/th\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eDefine the relevant substance scope, avoid double counting, and document the calculation basis.\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eSwedish\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eDOCX + searchable PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003cth scope=\"row\" style=\"text-align:left;padding:8px;border-bottom:1px solid #c7d7e8\"\u003e04 – Exemption assessment\u003c\/th\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eInvestigate under 1 tonne according to Art. 9.2 a or evidence of biodegradability according to Art. 9.2 b.\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eSwedish\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eDOCX + searchable PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003cth scope=\"row\" style=\"text-align:left;padding:8px;border-bottom:1px solid #c7d7e8\"\u003e05 – PRO data and final check\u003c\/th\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003ePrepare product\/substance lists, open evidence chain, annual data, and actual proof of payment.\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eSwedish\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eDOCX + searchable PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003cth scope=\"row\" style=\"text-align:left;padding:8px;border-bottom:1px solid #c7d7e8\"\u003e06 – Swedish user guide\u003c\/th\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003ePractical workflow, fictitious examples, limitations, and legal sources.\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eSwedish\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eDOCX + searchable PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003cth scope=\"row\" style=\"text-align:left;padding:8px;border-bottom:1px solid #c7d7e8\"\u003e07 – English User Guide\u003c\/th\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eInstructions for the Swedish templates, not English legal agreements.\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eEnglish\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eDOCX + searchable PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003cth scope=\"row\" style=\"text-align:left;padding:8px;border-bottom:1px solid #c7d7e8\"\u003e08 – Excel – substance register (9 tabs)\u003c\/th\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eCalculation of indicative quantity, role register, exemption assessment, environmental evidence, and action log.\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eSwedish\u003c\/td\u003e\n\n\u003ctd style=\"padding:8px;border-bottom:1px solid #c7d7e8\"\u003eXLSX\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\n\u003c\/tbody\u003e\n\n\n\u003c\/table\u003e\u003c\/div\u003e\n\u003ch2\u003eExcel: nine practical register tabs\u003c\/h2\u003e\n\u003cp\u003eThe workbook contains \u003cstrong\u003eOverview, Actor Roles, Products, Substance Masses, Market per Year, Exemption Assessment, Environmental Evidence, PRO \u0026amp; Actions, and Read Me \u0026amp; Sources\u003c\/strong\u003e. In the substance register, the company can enter the substance quantity per unit in milligrams, the number of units on the EU market, the source reference, and a double-counting check. The indicative calculation is \u003cem\u003emg per unit × units \/ 1,000,000,000 = tonnes\u003c\/em\u003e. It is a mathematical unit conversion, \u003cstrong\u003enot a legally binding method established by authorities\u003c\/strong\u003e for all substances, products, and markets.\u003c\/p\u003e\n\u003cp\u003eA test with 250 mg × 1,200,000 units yielded 0.300 tonnes at both the product and overview levels. An incomplete entry and a flagged duplicate signal \u003cem\u003eEVIDENCE MISSING\u003c\/em\u003e. At exactly 1,000 tonnes, \u003cem\u003eINDICATIVE AT LEAST 1 TONNE\u003c\/em\u003e is displayed. No Excel status automatically grants an exemption or claims that the product and substance scope is complete.\u003c\/p\u003e\n\u003ch2\u003eHow do exemptions work under Article 9.2?\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eGround A:\u003c\/strong\u003e Producers shall be exempt if they can show that the quantity of substances contained in the products they place on the \u003cstrong\u003eUnion market is less than one tonne per year\u003c\/strong\u003e. Exactly 1,000 tonnes is therefore not “less than one tonne”. Which substances and volumes are included must be assessed against the original law and current methodology – \u003cstrong\u003eonly active pharmaceutical substance, sales value, or the product's gross weight may be chosen without evidence\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eGround B:\u003c\/strong\u003e Article 9.2 b covers special cases where the substances contained are rapidly biodegradable in wastewater or do not generate micropollutants at the end of the life cycle. Such a claim must be supported by relevant studies and current criteria. The package records evidence but neither certifies biodegradability nor issues exemptions.\u003c\/p\u003e\n\u003ch2\u003eWho should buy – and who should not buy?\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eTypical case 1:\u003c\/strong\u003e A company that professionally places medicinal products for human use on the Swedish market needs to decide which legal entity will collect data from multiple manufacturers. \u003cstrong\u003eTypical case 2:\u003c\/strong\u003e An importer does not receive complete substance data and needs a concrete supplier letter, a follow-up log, and a traceable decision on missing evidence. \u003cstrong\u003eTypical case 3:\u003c\/strong\u003e A producer wants to prepare a documented assessment of the one-tonne limit without incorrectly claiming that the exemption has already been granted.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eNot the right product\u003c\/strong\u003e if it only concerns cosmetic products, veterinary medicinal products without separate legal assessment, registration that already requires an official national form, technical environmental measurements, the wastewater treatment plant's own operational reporting, or an actual application for an official exemption. For cosmetic products, there is our separate \u003ca href=\"https:\/\/mallbutiken.se\/products\/kosmetika-avloppsdirektivet-2028-producentansvar-amnesregister\"\u003eCosmetics \u0026amp; Wastewater Directive 2028\u003c\/a\u003e package.\u003c\/p\u003e\n\u003ch2\u003eHow to use the product in seven steps\u003c\/h2\u003e\u003col\u003e\n\n\u003cli\u003eIdentify the responsible legal entity and investigate whether it is actually a producer according to Article 2.19; distinguish between manufacturer, importer, distributor, and marketing authorisation holder.\u003c\/li\u003e\n\n\u003cli\u003eReview which products are medicinal products for human use according to Annex III point 1 and the medicinal products Directive 2001\/83\/EC.\u003c\/li\u003e\n\n\u003cli\u003eSend the supplier letter and collect product, substance, and market data with source references.\u003c\/li\u003e\n\n\u003cli\u003eDocument the legal substance definition and all relevant product\/substance lines. Check for duplicates between units and markets.\u003c\/li\u003e\n\n\u003cli\u003eUse Excel for indicative quantities and flags; let the responsible function determine whether the quantity calculation truly represents the correct product scope.\u003c\/li\u003e\n\n\u003cli\u003eGather scientific evidence when assessing biodegradability and document separately whether a potential exemption can be invoked at all.\u003c\/li\u003e\n\n\u003cli\u003eVerify Swedish implementing legislation, the recognised PRO, and reporting requirements when established; record only actual official decisions and proof of payment.\u003c\/li\u003e\n\n\n\u003c\/ol\u003e\n\u003ch2\u003eLegal limitations and data protection\u003c\/h2\u003e\u003cp\u003eThe product is a preparatory documentation package. It is \u003cstrong\u003enot an official authority form, registration, or approval\u003c\/strong\u003e. The Member States' future requirements may entail additional fields and limitations. The register should not contain personally identifiable patient data; protect commercially sensitive formulations and studies in the company's own authorisation-controlled system. An actual national fee cannot be calculated based on the template's mathematical mass formula.\u003c\/p\u003e\n\u003ch2\u003eFrequently asked questions\u003c\/h2\u003e\n\u003ch3\u003eDoes producer responsibility for medicinal products already apply in Sweden in 2026?\u003c\/h3\u003e\u003cp\u003eThe EU Directive is in force, but the Swedish implementation process is ongoing. The Member States' specific producer responsibility must be in place by 31 December 2028 at the latest. Treat this as preparation and check current Swedish law when using it.\u003c\/p\u003e\n\u003ch3\u003eIs the one-tonne exemption automatic when Excel shows 0.99 tonnes?\u003c\/h3\u003e\u003cp\u003eNo. Excel only calculates based on the data entered and the limitations chosen by the company. If any substance, product, or EU market is missing, the total sum may be incorrect. A claim of exemption requires a correct legal assessment and supported evidence.\u003c\/p\u003e\n\u003ch3\u003eDo I only calculate the active substance?\u003c\/h3\u003e\u003cp\u003eNot without legal and methodological assessment. Article 9.2 refers to substances contained in the products; which substances are relevant in final application must be supported by legal sources and future criteria.\u003c\/p\u003e\n\u003ch3\u003eDo I already have to pay 80% of our sales?\u003c\/h3\u003e\u003cp\u003eNo. The Directive refers to the financing of at least 80% of certain costs for quaternary treatment via producer responsibility. It is not 80% of an individual company's turnover.\u003c\/p\u003e\n\u003ch3\u003eIs this a legally reviewed official form?\u003c\/h3\u003e\u003cp\u003eNo. It is a private document package with AI-assisted source control. No independent external legal review or official certification has been performed.\u003c\/p\u003e\n\u003ch3\u003eAre the PDF files editable forms?\u003c\/h3\u003e\u003cp\u003eNo. They are searchable and printable. Word is used for editing; Excel is used for registers and calculations.\u003c\/p\u003e\n\u003ch3\u003eDoes the package contain English contract templates?\u003c\/h3\u003e\u003cp\u003eNo. The five operational templates and Excel are in Swedish; the seventh Word\/PDF file is an English User Guide for the Swedish templates.\u003c\/p\u003e\n\u003ch2\u003eOfficial legal sources and verification\u003c\/h2\u003e\n\u003cp\u003e\u003ca href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SV\/TXT\/?uri=CELEX:02024L3019-20241212\"\u003eDirective (EU) 2024\/3019, Articles 2, 9–10, and Annex III\u003c\/a\u003e · \u003ca href=\"https:\/\/www.naturvardsverket.se\/amnesomraden\/avlopp\/aktuellt\/eus-forslag-till-reviderat-avloppsdirektiv-diskuteras-i-ministerradet\/\"\u003eSwedish Environmental Protection Agency on the Directive's entry into force and transposition\u003c\/a\u003e · \u003ca href=\"https:\/\/www.naturvardsverket.se\/om-oss\/regeringsuppdrag\/pagaende-regeringsuppdrag\/genomfora-eus-reviderade-avloppsvattendirektiv\/\"\u003eSwedish Environmental Protection Agency's ongoing implementation mandate\u003c\/a\u003e · \u003ca href=\"https:\/\/www.tlv.se\/press\/nyheter\/arkiv\/2026-05-13-tlv-ska-analysera-hur-eus-nya-avloppsvattendirektiv-kan-paverka-tillgangen-till-antibiotika-och-andra-lakemedel-i-sverige.html\"\u003eTLV\/Swedish Medical Products Agency's impact assessment\u003c\/a\u003e.\u003c\/p\u003e\n\u003cp\u003e\u003csmall\u003eProduct version 1.0 • AI-assisted source control performed 2026-11-10 • No external legal review • VAT\/shipping\/Google Shopping data should follow the store's existing routines.\u003c\/small\u003e\u003c\/p\u003e","brand":"Svenska Dokumentmallar","offers":[{"title":"Default Title","offer_id":56573733568854,"sku":"AVLOPP-LAKEMEDEL-EPR-2028-V1","price":79.0,"currency_code":"SEK","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0827\/2373\/3846\/files\/lakemedel-epr-huvudbild-1600.jpg?v=1794339388","url":"https:\/\/mallbutiken.se\/en\/products\/lakemedel-avloppsdirektivet-2028-substansmassor-producentansvar","provider":"Mallbutiken","version":"1.0","type":"link"}