Module 6

04/10/2024

References and useful links cont.

Patient Leaflet EC Guideline On The Readability Of The Labelling And Package Leaflet Of Medicinal Products For Human Use • https://health.ec.europa.eu/system/files/2016-11/2009_01_12_readability_guideline_final_en_0.pdf MHRA Guidance • https://www.gov.uk/guidance/medicines-packaging-labelling-and-patient-information-leaflets • https://assets.publishing.service.gov.uk/media/5fe09fa48fa8f51489f14374/Best_practice_guidance_labelling_and_packag ing_of_medicines.pdf • https://assets.publishing.service.gov.uk/media/5a748da340f0b61938c7e5e9/Always_Read_the_Leaflet___getting_the_be st_information_with_every_medicine.pdf • Kent Surrey Sussex Academic Health Science Network (KSS AHSN), Pfizer, and UK National Innovation Centre for Ageing (NICA) and VOICE (2023) One size doesn’t fit all: reimagining medicines information for patients .

Linguistic Review • https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/linguistic-review

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References and useful links cont.

EDUCATIONAL MATERIALS • MHRA guidance - https://www.gov.uk/guidance/educational-materials-and-associated-distribution plans#:~:text=MHRA%20will%20endeavour%20to%20assess,educational%20materials%20receive%20final%20approv al. • HPRA guidance - https://www.hpra.ie/homepage/medicines/safety-information/educational-material EPARS • https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-and-when/european-public-assessment-reports background-and-context • https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-preparation-european-public assessment-report-human-medicinal-product-following-positive-or-negative-opinion_en.pdf Patient Organisations EMA Patients’ and Consumers’ Working Party (PCWP) • https://www.ema.europa.eu/en/documents/other/engagement-framework-european-medicines-agency-and-patients consumers-and-their-organisations_en.pdf EMA stakeholder engagement • https://www.ema.europa.eu/en/documents/report/stakeholder-engagement-report-2022-2023_en.pdf

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