{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T04:43:48Z","timestamp":1782794628717,"version":"3.54.5"},"reference-count":33,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["clinicalkey.fr","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Annales Pharmaceutiques Fran\u00e7aises"],"published-print":{"date-parts":[[2026,6]]},"DOI":"10.1016\/j.pharma.2026.06.004","type":"journal-article","created":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T00:00:30Z","timestamp":1781222430000},"update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"title":["Regulatory non-compliance of parallel imported medicines in Kenya and implications for public health: Evidence from Nairobi County"],"prefix":"10.1016","author":[{"given":"Val\u00e9rie","family":"Faillat","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Epaphrodite","family":"Twahirwa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.pharma.2026.06.004_bib0170","unstructured":"World Trade Organisation, Understanding the WTO\u00a0\u2013\u00a0Overview: a navigational guide. https:\/\/www.wto.org\/english\/thewto_e\/whatis_e\/tif_e\/agrm1_e.htm (accessed February 27th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0175","unstructured":"World Trade Organisation (WTO), parallel imports. https:\/\/www.wto.org\/english\/thewto_e\/glossary_e\/parallel_imports_e.htm#:\u223c:text=When%20a%20product%20made%20legally,allow%20this%2C%20others%20do%20not (accessed February 27th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0180","unstructured":"Shyamolima Sengupta, NV Saisunder, Concept of Parallel Imports and the Principle of Territorial Exhaustion of Rights under the Indian Trademarks Act, 1999\u00a0\u2013\u00a0Lexology, Lexology, March 30, 2020. https:\/\/www.lexology.com\/library\/detail.aspx?g=7c49f769-c8f9-49fa-beb3-778c7af78add (accessed February 27th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0185","unstructured":"International Trademark Association (INTA), Parallel Imports\/Gray Market. https:\/\/www.inta.org\/topics\/parallel-imports\/ (accessed February 27th, 2026)."},{"issue":"3","key":"10.1016\/j.pharma.2026.06.004_bib0190","doi-asserted-by":"crossref","first-page":"185","DOI":"10.2471\/BLT.17.199364","article-title":"Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001\u20132016","volume":"96","author":"Hoen","year":"2018","journal-title":"Bull World Health Organ"},{"issue":"2\u20133","key":"10.1016\/j.pharma.2026.06.004_bib0195","doi-asserted-by":"crossref","first-page":"287","DOI":"10.1163\/17087384-12342030","article-title":"Pharmaceutical patents in developing nations: parallel importation and the doctrine of exhaustion","volume":"6","author":"McKeith","year":"2014","journal-title":"Afr J Legal Stud"},{"issue":"7","key":"10.1016\/j.pharma.2026.06.004_bib0200","doi-asserted-by":"crossref","first-page":"533","DOI":"10.2471\/BLT.12.115865","article-title":"Using TRIPS flexibilities to facilitate access to medicines","volume":"91","author":"Nicol","year":"2013","journal-title":"Bull World Health Organ"},{"key":"10.1016\/j.pharma.2026.06.004_bib0205","series-title":"Access to medicines and vaccines implementing flexibilities under intellectual property law","author":"Correa","year":"2022"},{"key":"10.1016\/j.pharma.2026.06.004_bib0210","article-title":"Kenya's intellectual property bill, 2020, and its shortcomings in adopting all lawful TRIPS public health flexibilities","volume":"53","author":"Baker Brook","year":"2020","journal-title":"Joint PIJIP\/TLS Res Paper Series"},{"key":"10.1016\/j.pharma.2026.06.004_bib0215","unstructured":"The Kenya Pharmacy and Poisons Board (PPB), The Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules 2019. 2019. https:\/\/web.pharmacyboardkenya.org\/download\/parallel-importation-rules-2019\/?wpdmdl=4343&refresh=69a1dad82c5081772215000&ind=16443791100381&filename=Parallel_Importation_Rules_2019.pdf (accessed February 27th, 2026)."},{"issue":"4","key":"10.1016\/j.pharma.2026.06.004_bib0220","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1177\/1741134321999418","article-title":"Parallel importation as a policy option to reduce price of patented health technologies","volume":"17","author":"Abbas","year":"2021","journal-title":"J Generic Med"},{"key":"10.1016\/j.pharma.2026.06.004_bib0225","series-title":"Limiting counterfeit goods and parallel imports: an effective approach","author":"Richardson","year":"2006"},{"key":"10.1016\/j.pharma.2026.06.004_bib0230","unstructured":"[1Q] Scientific. ICH stability storage zones. https:\/\/q1scientific.com\/services\/ (accessed March 10th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0235","unstructured":"Ghana Food and Drugs Authority (FDA). Guidelines on The Registration Of Parallel Imported Medicinal Products. 2024. https:\/\/fdaghana.gov.gh\/wp-content\/uploads\/2024\/09\/GUIDELINES-ON-PARALLEL-IMPORTATION-OF-MEDICINAL-PRODUCTS.pdf (accessed March 10th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0240","unstructured":"UNICRI. Organized crime strategies in the production and trade of counterfeit medicines indications regarding organized crime motivations, modus operandi and strategies., Research funded by the European Union's Seventh Framework Programme (FP7\/2007\u20132013) under grant agreement No. 26171. 2019. https:\/\/unicri.org\/sites\/default\/files\/2019-11\/Organized%20crime%20strategies%20in%20the%20production%20and%20trade%20of%20counterfeit%20medicines.pdf (accessed March 10th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0245","unstructured":"Millar A. The rise of counterfeit medicines in Africa. Pharmaceutical Technology. 2020. https:\/\/www.pharmaceutical-technology.com\/features\/counterfeit-drugs-africa\/ (accessed March 11th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0250","series-title":"Pharmaceutical parallel imports: a solution or a problem?","author":"Le","year":"2015"},{"key":"10.1016\/j.pharma.2026.06.004_bib0255","unstructured":"Pharmacy and Poisons Board, Republic of Kenya, Ministry of Health. Guideline on Summary of Product Characteristics, Patient Information Leaflet, and Labelling. 2022. Version number 0. https:\/\/web.pharmacyboardkenya.org\/download\/guideline-on-summary-of-product-characteristics-patient-information-leaflet-and-labelling\/?wpdmdl=8777&refresh=69b15c509095e1773231184&ind=1698844543628&filename=Guideline-on-Summary-of-Product-Characteristics-Patient-Information-Leaflet-and-Labelling-.pdf (accessed March 11th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0260","unstructured":"Pharmacy and Poisons Board, Republic of Kenya, Ministry of Health. Compendium of guidelines on Medicines evaluation and registration in Kenya. 2022. https:\/\/web.pharmacyboardkenya.org\/download\/guidelines-on-medicines-evaluation-and-registration\/?wpdmdl=4349&refresh=69b15ec6dc94f1773231814&ind=1700161653643&filename=COMPENDIUM-OF-GUIDELINES-ON-MEDICINES-EVALUATION-AND-REGISTRATION-IN-KENYA.pdf (accessed March 11th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0265","first-page":"309","article-title":"Stability testing of active pharmaceutical ingredients and finished pharmaceutical product Annex 10","volume":"1010","year":"2018","journal-title":"WHO Tech Rep Series"},{"key":"10.1016\/j.pharma.2026.06.004_bib0270","unstructured":"International Council for Harmonisation. Q1A(R2): Stability testing of new drug substances and products. ICH Harmonised Tripartite Guideline. 2003. https:\/\/database.ich.org\/sites\/default\/files\/Q1A%28R2%29%20Guideline.pdf (accessed March 11th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0275","first-page":"227","article-title":"Guidelines on the conduct of surveys of the quality of medicines","volume":"996","year":"2016","journal-title":"WHO Techn Rep Series"},{"key":"10.1016\/j.pharma.2026.06.004_bib0280","unstructured":"Roi C, Assiago J, Gathuthi C, Kago J, Muindi M, et al. Korogocho situation analysis: a snapshot. United Nations Human Settlements programme 2010. https:\/\/habnet.unhabitat.org\/sites\/default\/files\/documents\/Final%20Report%20Korogocho%20S%20A%20a%20snapshot.pdf (accessed March 11th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0285","unstructured":"Kenya National Bureau of Statistics (KNBS) website (accessed Nov. 09, 2022)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0290","unstructured":"https:\/\/westlands.ngcdf.go.ke\/about-us\/ (accessed November 09, 2022)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0295","unstructured":"World Trade Organisation. Declaration on the TRIPS agreement and public health. Doha WTO ministerial WT\/MIN(01)\/DEC\/2. 2001. https:\/\/www.wto.org\/english\/thewto_e\/minist_e\/min01_e\/mindecl_trips_e.htm (accessed March 11th, 2026)."},{"issue":"4","key":"10.1016\/j.pharma.2026.06.004_bib0300","doi-asserted-by":"crossref","first-page":"164","DOI":"10.4103\/picr.PICR_195_18","article-title":"Drug labeling: the study of compliance of regulatory requirements for prescription drugs in India","volume":"11","author":"Shah","year":"2020","journal-title":"Perspect Clin Res"},{"key":"10.1016\/j.pharma.2026.06.004_bib0305","first-page":"310","article-title":"Joint FIP\/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services","volume":"961","author":"World Health","year":"2011","journal-title":"WHO Tech Rep Series"},{"key":"10.1016\/j.pharma.2026.06.004_bib0310","unstructured":"National Council for Law Reporting. The Trade Marks act Cap. 506, Kenya Law. 2022. https:\/\/new.kenyalaw.org\/akn\/ke\/act\/1955\/51\/eng@2022-12-31 (accessed March 11th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0315","unstructured":"National Council for Law Reporting. The Pharmacy and Poisons Act. CAP 244. Kenya Law. https:\/\/new.kenyalaw.org\/akn\/ke\/act\/1956\/17\/eng@2023-12-11 (accessed March 11th, 2026)."},{"key":"10.1016\/j.pharma.2026.06.004_bib0320","unstructured":"World Health Organization Data, Density of pharmaceutical personnel (per 10 000 population) [Indicator]. https:\/\/data.who.int\/indicators\/i\/C668579\/45CA7C8 (Accessed on 19 December 2024)."},{"issue":"100","key":"10.1016\/j.pharma.2026.06.004_bib0325","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1016\/j.socscimed.2013.08.020","article-title":"Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya","volume":"97","author":"Wafula","year":"2013","journal-title":"Soc Sci Med"},{"key":"10.1016\/j.pharma.2026.06.004_bib0330","unstructured":"Musiega A, Ogira D and Wafula F. Designing fit-for-purpose regulation for evolving healthcare systems. Country report: Kenya December 2018; https:\/\/www.lshtm.ac.uk\/sites\/default\/files\/2020-09\/Country%20Report_India_website.pdf."}],"container-title":["Annales Pharmaceutiques Fran\u00e7aises"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003450926001008?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003450926001008?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T03:47:50Z","timestamp":1782791270000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0003450926001008"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6]]},"references-count":33,"alternative-id":["S0003450926001008"],"URL":"https:\/\/doi.org\/10.1016\/j.pharma.2026.06.004","relation":{},"ISSN":["0003-4509"],"issn-type":[{"value":"0003-4509","type":"print"}],"subject":[],"published":{"date-parts":[[2026,6]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Regulatory non-compliance of parallel imported medicines in Kenya and implications for public health: Evidence from Nairobi County","name":"articletitle","label":"Article Title"},{"value":"Annales Pharmaceutiques Fran\u00e7aises","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.pharma.2026.06.004","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Acad\u00e9mie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}]}}