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BMC Health Services Research

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Open Access 01-12-2024 | Research

Outer packaging labelling of medicines in Southern African Development Community (SADC) countries: comparative analysis of requirements and transition terms for harmonisation

Authors: K. Narsai, F. B. Masekela, H. G.M Leufkens, A. K. Mantel-Teeuwisse

Published in: BMC Health Services Research | Issue 1/2024

Abstract

Introduction

The COVID-19 pandemic highlighted an urgent need for harmonised requirements for the regulation of medicines. To fully implement harmonised medicines regulations across Africa, common technical standards of medicine regulations are needed. One such technical standard is the labelling of medicines on outer packaging. In this study, we compared outer packaging labelling requirements and transition terms for harmonization for countries in the Southern African Development Community (SADC) region.

Methods

Data on legislation and/or regulatory guidelines for medicine outer packaging labelling from National Medicines Regulatory Authorities (NMRAs) were obtained for countries in the SADC region (n = 16) by February 2023. A detailed comparative content analysis was conducted to determine alignment with the requirements of the Southern African Development Community (SADC) harmonised labelling guidelines to assess readiness levels of each country to transition to the SADC harmonised labelling guideline for outer packaging of medicines.

Results

Content analysis showed at least 11 out of 16 countries require national legal reform to transition to the SADC harmonised labelling guideline. In all cases where countries specified labelling requirements for outer packaging of medicines, these were stipulated in national medicines legislation.

Conclusion

Even though there is a high level of alignment across the countries in terms of national labelling requirements, most countries in the SADC region would still require national legislative reform to transition to regional harmonised labelling requirements and then ultimately to continental requirements of the African Medicines Agency (AMA).

Miletic N, Adam S, Acquah J, Aziz Z, Joos A, Mwangi JM. What makes Joint Assessment procedures (JAPs) attractive to the innovative industry: successes, challenges, and proposed improvements. Front Med;10:1207954.

World Health Organization. Assessment of medicines regulatory systems in sub-Saharan African countries: an overview of findings from 26 assessment reports. WHO.(Updated 2010.Accessed 11. February 2014.) Available from http://apps.who.int/medicinedocs/en/d/Js17577en 2010.

PATH. Implementing the African Union Model Law at the Regional and National Level. 2016; Available at: https://www.path.org/resources/implementing-the-african-union-model-law-at-the-regional-and-national-level/. Accessed 10 Jan, 2023.

Ndomondo-Sigonda M, Miot J, Naidoo S, Ambali A, Dodoo A, Mkandawire H. The African Medicines Regulatory Harmonization Initiative: progress to date. Med Res Archives 2018;6(2).

Ndomondo-Sigonda M, Ambali A. The African medicines regulatory harmonization initiative: rationale and benefits. Clin Pharmacol Ther. 2011;89(2):176–8.CrossRefPubMed

Sithole T, Mahlangu G, Walker S, Salek S. Regulatory authority evaluation of the effectiveness and efficiency of the ZaZiBoNa collaborative medicines registration initiative: the way forward. Frontiers in medicine 2022;9.

Sithole T, Mahlangu G, Salek S, Walker S. Evaluating the success of ZaZiBoNa, the southern African development community collaborative medicines registration initiative. Therapeutic Innov Regul Sci. 2020;54(6):1319–29.CrossRef

Sithole T, Mahlangu G, Walker S, Salek S. Pharmaceutical industry evaluation of the effectiveness and efficiency of the ZaZiBoNa collaborative medicines registration initiative: the way forward. Front Med. 2022;9:898725.CrossRef

Kenagy JW, Stein GC. Naming, labeling, and packaging of pharmaceuticals. Am J Health-System Pharm. 2001;58(21):2033–41.CrossRef

10.

Jeetu G, Girish T. Prescription drug labeling medication errors: a big deal for pharmacists. J Young Pharmacists. 2010;2(1):107–11.CrossRef

11.

Poudel RS, Shrestha S, Thapa S, Poudel BK, Chhetri M. Assessment of primary labeling of medicines manufactured by Nepalese pharmaceutical industries. J Pharm Policy Pract. 2018;11(1):13.CrossRefPubMedPubMedCentral

12.

Narsai K, Williams A, Mantel-Teeuwisse AK. Impact of regulatory requirements on medicine registration in African countries - perceptions and experiences of pharmaceutical companies in South Africa. South Med Rev. 2012;5(1):31–7.PubMedPubMedCentral

13.

Sillo HB, Masota NE, Kisoma S, Rago L, Mgoyela V, Kaale EA. Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the east African market. PLoS ONE. 2018;13(5):e0197490.CrossRefPubMedPubMedCentral

14.

Sillo HB. Comparison of medicines legislation in the East African Community. WHO Drug Information. 2016;30(4):567.

15.

Guchelaar H, Kalmeijer MD, Jansen ME. Medication error due to ambiguous labelling of a commercial product. Pharm World Sci. 2004;26(1):10–1.CrossRefPubMed

16.

Athuraliya N, Walkom EJ, Dharmaratne S, Robertson J. Assessing medication packaging and labelling appropriateness in Sri Lanka. J Pharm Policy Pract. 2016;9(1):38.CrossRefPubMedPubMedCentral

17.

Narsai K, Williams A, Mantel-Teeuwisse AK. Impact of regulatory requirements on medicine registration in African countries–perceptions and experiences of pharmaceutical companies in South Africa. South med Rev. 2012;5(1):31.PubMedPubMedCentral

18.

Guchelaar H, Colen HB, Kalmeijer MD, Hudson PT, Teepe-Twiss IM. Medication Errors Drugs. 2005;65(13):1735–46.PubMed

19.

Barton I, Avanceña AL, Gounden N, Anupindi R. Unintended consequences and hidden obstacles in medicine access in Sub-saharan Africa. Front Public Health. 2019;7:342.CrossRefPubMedPubMedCentral

20.

African Medicines Regulatory Harmonization Initiative A. SADC Concludes Draft Guideline to Harmonise Product Information and Labelling Requirements. 2019; Available at: https://www.nepad.org/publication/african-medicines-regulatory-harmonisation-programme-q4-2019-newsletter. Accessed 23/09/, 2020.

21.

SADC Secretariat. Guideline on excipients in the labelling, summary of product characteristics and patient information leaflet of medicinal products for human use. 2020; available at: www.sahpra.org.za. Accessed 6 Feb, 2023.

22.

SADC Secretariat. SADC Guideline on product information. 2018; Available at: https://www.sahpra.org.za/wp-content/uploads/2020/01/e327093bDRAFTSADCGUIDELINEONPRODUCTINFORMATION_LABELLING_version4_26Jun20191.pdf. Accessed 16th February, 2023.

23.

World Bank. World Bank Group country classifications by income level for FY24 (July 1, 2023- June 30, 2024). 2023; Available at: https://blogs.worldbank.org/opendata/new-world-bank-group-country-classifications-income-level-fy24. Accessed Dec 4, 2023.

24.

Orgao Oficial da Republica de Angola. Decreto Presidencial 315.20 Regulamento registo medicamentos. 2020; Available at: https://armed.gov.ao/wp-content/uploads/2021/12/Decreto-Presidencial-315.20-Regulamento-registo-medicamentos.pdf. Accessed Feb, 2023.

25.

Botswana Drugs Advisory Board. Guidelines on Drug Registration Applications in Botswana. 2000; Available at: https://www.moh.gov.bw/Publications/registration%20guidelines.pdf. Accessed Dec, 2021.

26.

Ministry of Health and Wellness Botswana. MRSA 2019 Regulations Botswana. 2019; Available at: https://www.bomra.co.bw/index.php/bomra-downloads/publications/category/31-regulations. Accessed Dec, 2021.

27.

Ministry of Health and Wellness, Medicines B. and Related Substances Act 2013 Botswana. 2013; Available at: https://www.bomra.co.bw/index.php/bomra-downloads/publications/category/19-mrs-act. Accessed Dec, 2021.

28.

Malawi Ministry of Health. Pharmacy Medicines and Poisons Regulations Arrangement of Regulations Malawi. 1998; Available at: http://www.rrfa.co.za/wp-content/uploads/2012/11/Pharmacy-Medicines-and-Poisons-Regulations-Arrangement-of-Regulations-Malawi-9808.pdf. Accessed Nov, 2022.

29.

Malawi Ministry of Health. Malawi Pharmacy, Medicines and Poisons Act., 1988 (No. 15 of 1988). 1988; Available at: https://leap.unep.org/countries/mw/national-legislation/pharmacy-medicines-and-poisons-act-1988-no-15-1988. Accessed Apr 24, 2023.

30.

Ministerio da Sauda M. Mozambique: Data for Complete registration. 1999; Available at: http://www.misau.gov.mz/index.php/decretos. Accessed June, 2022.

31.

Ministerio da Sauda M. Mozambique Decreto 22 99 de 4 de maio regulamento do sistema do registo do medicamento. 1999; Available at: http://www.misau.gov.mz/index.php/decretos. Accessed June, 2022.

32.

Namibia Ministry of Health & Social Services. Medicines and Related Substances Control Act 13 of 2003. 2020; Available at: https://laws.parliament.na/annotated-laws-regulations/law-regulation.php?id=146. Accessed Oct, 2022.

33.

Namibia Ministry of Health & Social Services. General Regulations to the Medicines and Related Substances Control Act 13 of 2003. 2020; Available at: https://laws.parliament.na/annotated-laws-regulations/law-regulation.php?id=146.

34.

South African Health Products Regulatory Authority. Guidance for the submission of the South African CTD /eCTD -General & Module 1. 2019; Available at: https://www.sahpra.org.za/product-registration-process/. Accessed 23 June, 2020.

35.

Ministry of Health SA. Medicines and Related Substances Act, No. 101 of 1965. 2017; Available at: www.greengazette.co.za. Accessed 23 June, 2020.

36.

Seychelles Ministry of Health & Social Development. Republic of Seychelles, Seychelles National Medicine Policy., 2009; Available at: file:///C:/Users/knars/Downloads/SEYCHELLES%20NATIONAL%20MEDICINE%20POLICY.pdf. Accessed Jan, 2023.

37.

Republic of Seychelles. Medical products and Pharmacy Operations Bill. 2022; Available at: http://www.health.gov.sc/index.php/policies/. Accessed Feb, 2023.

38.

Department of Health RoS. Seychelles National Health Policy. 2017; Available at: http://www.health.gov.sc/wp-content/uploads/National-Health-Policy_final-26062015.pdfs/0. Accessed Jan, 2023.

39.

Tanzania Food and Drugs Authority. Guidelines on Format and Content of Labels for Medicinal Products. 2015; Available at: https://www.tmda.go.tz/publications/42?page=2. Accessed 6th April, 2020.

40.

Tanzania Food and Drugs Authority. Guidelines on Submission of Documentation for Registration of Human Pharmaceutical Products. 2015; Available at: https://www.tmda.go.tz/publications/42?page=1, 2020.

41.

Ministry of Health Zambia. General guidelines for submitting applications for registration of a medicine. 2016; Available at: http://www.who.int/medicines/areas/coordination/zambia_guidelines_registrationc.pdf. Accessed 20 March, 2023.

42.

Zambia Ministry of Health. The Medicines and Allied Substances Act. 2013. 2013; Available at: http://www.rrfa.co.za/wp-content/uploads/2012/11/The-Medicine-and-Allied-Substances-Act-2013.pdf. Accessed 10 Oct, 2020.

43.

Zambia Ministry of Health. The Pharmaceutical Act 2004. 2004; Available at: http://www.rrfa.co.za/wp-content/uploads/2012/11/The-Pharmaceutical-Act-20041.pdf. Accessed 10 Oct, 2020.

44.

Government of Zambia. The Medicines and Allied Substances Act. 2019; Available at: http://www.zamra.co.zm/wp-content/uploads/2019/12/S.-I.-No.-79-of-2019The-Medicines-and-allied-Substance-Marketing-Authorisation-of-Medicines-Regulations.pdf. Accessed 10 Oct, 2020.

45.

Medicine Control Authority Zimbabwe. Guideline on submission of documentation for registration of a multisource (generic) finished pharmaceutical product (FPP): Quality part in the CTD format. 2013; Available at: http://www.mcaz.co.zw/index.php/downloads/file/74-mcaz-ctd-guidelines. Accessed 8th April, 2020.

46.

Medicine Control Authority of Zimbabwe. Guidelines on the import and export of registered medicines - Zimbabwe. 2017; available at: www.mcaz.co.zw. Accessed April, 2020.

47.

Zimbabwe Ministry of Health. Medicines and, Act ASC. 2015. 2015; Available at: http://extwprlegs1.fao.org/docs/pdf/zim24977.pdf. Accessed Oct, 2020.

48.

Zimbabwe Ministry of Health. Medicines and Allied Substances Control General Regulations. 1991; Available at: https://www.mcaz.co.zw/index.php/downloads/category/7-regulations?download=99:medicines-and-allied-substances-control-general-regulations-1991-si-150-of-1991&start=10. Accessed 5 Dec, 2022.

49.

Mauritius Pharmacy Board. Mauritius application for registration of a drug. 2012; Available at: http://www.rrfa.co.za/mauritius/guidelines/. Accessed June, 2022.

50.

Mauritius Ministry of Health and Quality of Life. Procedures for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products. 2016; Available at: http://health.govmu.org/English/Legislations/Documents/Pharmaceutical%20products%20(fees)/Procedures%20Guidelines%20%20for%20the%20registration%20of%20pharmaceutical%20%20products.pdf.

51.

Mauritius Ministry of Health and Wellness. The Pharmacy Council Act, Act No. 13 of 2015. 2015; Available at: http://health.govmu.org/English/Legislations/Pages/Pharmacy%20Act%202015.pdf. Accessed Oct, 2022.

52.

Cullinan K. African Union is Making ‘Good Progress’ in Setting up its Medicines Agency. 2023; Available at: https://healthpolicy-watch.news/african-union-is-making-good-progress-in-setting-up-its-medicines-agency/. Accessed 13 March, 2023.

Title: Outer packaging labelling of medicines in Southern African Development Community (SADC) countries: comparative analysis of requirements and transition terms for harmonisation
Authors: K. Narsai
F. B. Masekela
H. G.M Leufkens
A. K. Mantel-Teeuwisse
Publication date: 01-12-2024
Publisher: BioMed Central
Published in: BMC Health Services Research / Issue 1/2024
Electronic ISSN: 1472-6963
DOI: https://doi.org/10.1186/s12913-024-10585-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Outer packaging labelling of medicines in Southern African Development Community (SADC) countries: comparative analysis of requirements and transition terms for harmonisation

Abstract

Introduction

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

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