{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:01:45Z","timestamp":1787029305511,"version":"build-2736575974"},"reference-count":58,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2025,8,8]],"date-time":"2025-08-08T00:00:00Z","timestamp":1754611200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Ministry of Education and Science (MES) to the Science Fund at the Medical University\u2014Varna","award":["22018"],"award-info":[{"award-number":["22018"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacy"],"abstract":"<jats:p>The common border between Bulgaria and North Macedonia, alongside the regulatory requirements stemming from Bulgaria\u2019s membership in the European Union, provide grounds for comparing the legislative environment in both countries. This article presents a comparative case study of the regulatory frameworks governing community pharmacies in Bulgaria and North Macedonia. The aim of this study is to examine the specific features of current legislation related to the operation of community pharmacies, and to identify similarities, differences, and gaps in the organizational structure of pharmacy services, the population\u2019s access to pharmaceutical care, and the qualification requirements for personnel working in community pharmacies. Bulgaria has been a member of the European Union since 2007, while the Republic of North Macedonia has had official EU candidate status since 2005. This provides a basis for comparing the regulatory frameworks of an EU and a non-EU system within the same regional context. In both countries, the overall pharmacy-to-population ratio exceeds the European average (3.3 pharmacies per 10,000 inhabitants), indicating sufficient availability. However, pharmacies are predominantly concentrated in major urban areas. In Bulgaria, challenges remain in ensuring access to pharmaceutical services in smaller and rural settlements, while in North Macedonia, the provision of such services is better ensured. The findings of this case study may be particularly relevant for countries undergoing health system reforms or EU harmonization processes.<\/jats:p>","DOI":"10.3390\/pharmacy13040108","type":"journal-article","created":{"date-parts":[[2025,8,8]],"date-time":"2025-08-08T13:20:09Z","timestamp":1754659209000},"page":"108","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Analysis of Legislative and Regulatory Frameworks Governing Community Pharmacy in Bulgaria and North Macedonia"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9273-3487","authenticated-orcid":false,"given":"Anna","family":"Todorova","sequence":"first","affiliation":[{"name":"Faculty of Pharmacy, Medical University of Varna, 9000 Varna, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6766-056X","authenticated-orcid":false,"given":"Mariya","family":"Ivanova","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy, Medical University of Varna, 9000 Varna, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2478-1177","authenticated-orcid":false,"given":"Magdalena","family":"Pesheva","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy, Medical University of Varna, 9000 Varna, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5474-7461","authenticated-orcid":false,"given":"Dijana","family":"Miceva","sequence":"additional","affiliation":[{"name":"Faculty of Medical Sciences, Goce Delcev University, Krste Misirkov Str., No. 10-A, P.O. Box 201, 2000 Stip, North Macedonia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bistra","family":"Angelovska","sequence":"additional","affiliation":[{"name":"Faculty of Medical Sciences, Goce Delcev University, Krste Misirkov Str., No. 10-A, P.O. Box 201, 2000 Stip, North Macedonia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,8]]},"reference":[{"key":"ref_1","unstructured":"Access2Markets (2024, October 13). Pharmaceutical and Cosmetic Products. Available online: https:\/\/trade.ec.europa.eu\/access-to-markets\/\u55c4en\/content\/pharmaceutical-and-cosmetic-products."},{"key":"ref_2","unstructured":"European Parliament and of the Council (2025, June 16). Directive\u20142001\/83\u2013EN\u2013EUR-Lex, Available online: https:\/\/eur-lex.europa.eu\/eli\/dir\/2001\/83\/oj\/eng."},{"key":"ref_3","unstructured":"Petrova, G., Petkova, V., and Getov, I. (2024). Social Pharmacy and Pharmaceutical Legislation, Central Medical Library."},{"key":"ref_4","unstructured":"European Directorate for the Quality of Medicines & HealthCare\u2014EDQM (2025, July 11). Structure. Available online: https:\/\/www.edqm.eu\/en\/edqm\/about\/structure."},{"key":"ref_5","unstructured":"(2007, April 13). Medicinal Products in Human Medicine Act. Available online: https:\/\/www.bda.bg\/images\/stories\/documents\/legal_acts\/20210208_ZLPHM_English.pdf."},{"key":"ref_6","unstructured":"Government of the Republic of Macedonia (2004). National Strategy for European Integration of the Republic of Macedonia."},{"key":"ref_7","unstructured":"European Council (2025, July 11). North Macedonia. Available online: https:\/\/www.consilium.europa.eu\/en\/policies\/republic-north-macedonia\/."},{"key":"ref_8","unstructured":"(2025, July 11). Law on Medicinal Products and Medical Device. Off. Gazette 17\/97, 106\/2007 to 275\/2019, Available online: https:\/\/lekovi.zdravstvo.gov.mk\/documents\/2."},{"key":"ref_9","unstructured":"(1995). Law on Medical Supplements and Pharmacy in Human Medicine. Off. Gazette, 36."},{"key":"ref_10","unstructured":"Bulgarian Drug Agency (2005). Report on the Results of an Audit of the Performance of the Activities of Bulgarian Drug Agency for Period 1 January 2004\u201331 December 2005."},{"key":"ref_11","unstructured":"(2024, October 13). Ordinance \u2116 28 of 09.12.2008 on the Device, Order and Organization of the Work of Pharmacies and the Nomenclature of Medicinal Products Prom. SG 109\/23th December 2008, amen. In SG64\/09.08.2022. Available online: https:\/\/lex.bg\/laws\/ldoc\/2135610889."},{"key":"ref_12","unstructured":"(2024, October 13). Ordinance No. 29 of 9 December 2008, on the Conditions and Procedures for Organizing Work in the Drugstore, Amended, State Gazette No. 2 of 6 January 2012. Available online: https:\/\/lex.bg\/laws\/ldoc\/2135610890."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"88","DOI":"10.5655\/smr.v4i2.1006","article-title":"Pharmacy practice in the Republic of Macedonia","volume":"4","author":"Ivanovska","year":"2011","journal-title":"South Med. Rev."},{"key":"ref_14","unstructured":"(2025, February 19). Rulebook Regarding Premises, Equipment and Professional Staff for Establishing, Starting Work and Performing Health Activity in Health-Care Institutions. Official Gazette of the Republic of North Macedonia. Available online: https:\/\/www.slvesnik.com.mk\/Issues\/8491321DA9E0411FA06DBF68285377C7.pdf."},{"key":"ref_15","unstructured":"Ministry of Health of The Republic of Macedonia (2024, October 13). Guidelines for the Principles for Good Pharmacy Practice, Available online: https:\/\/www.slvesnik.com.mk\/Issues\/9AD54B3675BDBB47B90DDDAC2B29C6F0.pdf."},{"key":"ref_16","unstructured":"Official Gazette of the Republic of Macedonia 38\/91, 46\/93, 55\/95, 5\/2007 (2024, October 13). Law on Health Care, Available online: http:\/\/moh.gov.mk\/index.php?category=27."},{"key":"ref_17","unstructured":"(2025, June 16). Community Pharmacy Regulatory and Practice Models in Eastern Europe and Central Asia. Available online: https:\/\/iris.who.int\/handle\/10665\/376552."},{"key":"ref_18","unstructured":"Ministry of Health, National Medicines Agency (2024, October 13). List of Licensed Pharmacies in the Republic of Macedonia, Available online: https:\/\/lekovi.zdravstvo.gov.mk\/pharmacies."},{"key":"ref_19","unstructured":"(2024, October 13). Central Drug Registry, Virtual Warehouse and Aggregator for Collecting the Lowest Drug Prices, Available online: https:\/\/lekovi.zdravstvo.gov.mk\/pharmacies."},{"key":"ref_20","unstructured":"(2024, October 13). Register of Pharmacies. Available online: https:\/\/opendata.his.bg\/pharmacies\/."},{"key":"ref_21","unstructured":"Countrymeters (2025, June 16). North Macedonia Population (2025) Live. Available online: https:\/\/countrymeters.info\/en\/North_Macedonia."},{"key":"ref_22","unstructured":"Countrymeters (2025, June 16). Bulgaria Population (2025) Live. Available online: https:\/\/countrymeters.info\/en\/Bulgaria."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"197","DOI":"10.33320\/maced.pharm.bull.2020.66.03.098","article-title":"Community pharmacies in North Macedonia\u2013legal statu","volume":"66","author":"Angelovska","year":"2020","journal-title":"Maced. Pharm. Bull."},{"key":"ref_24","first-page":"10","article-title":"Study and analysis of the state of the workforce from master pharmacists in the community pharmacies network in Bulgaria at the beginning of year 2019","volume":"11","author":"Krumov","year":"2019","journal-title":"Bulg. J. Public Health"},{"key":"ref_25","unstructured":"(2024, October 13). Pharmacies on Duty by Year. Available online: https:\/\/fzo.org.mk\/dezurni-apteki."},{"key":"ref_26","unstructured":"(2024, October 13). FIP Statement of Professional Standards on Continuing Professional Development; International Pharmaceutical Federation: The Hague, The Netherlands. Available online: https:\/\/www.fip.org\/file\/1544."},{"key":"ref_27","unstructured":"(2025, January 12). Healthcare Personnel Statistics\u2014Dentists, Pharmacists and Physiotherapists. Available online: https:\/\/ec.europa.eu\/eurostat\/statistics-explained\/index.php?title=Healthcare_personnel_statistics_-_dentists,_pharmacists_and_physiotherapists."},{"key":"ref_28","unstructured":"Council of Ministers (2025, July 11). Decision No. 918 of 20 December 2023, National Pharmacy Map, Available online: https:\/\/pris.government.bg\/document\/ee5d468ab538108d234ed472485ae563."},{"key":"ref_29","unstructured":"(2025, July 11). State Gazette. Issue No. 106 of 22 December 2023. Available online: https:\/\/dv.parliament.bg\/DVWeb\/showMaterialDV.jsp?idMat=202103."},{"key":"ref_30","unstructured":"(2025, February 10). The Bologna Declaration. 9 June 1999. Available online: https:\/\/web.archive.org\/web\/20220331214436\/http:\/\/www.magna-charta.org\/resources\/files\/BOLOGNA_DECLARATION.pdf."},{"key":"ref_31","unstructured":"(2024, October 13). Directive 2005\/36\/EC of the European Parliament and of the Council of 7 September 2005 on the Recognition of Professional Qualifications (OJ L 255, 30.9.2005). pp. 22\u2013142. Available online: https:\/\/eur-lex.europa.eu\/eli\/dir\/2005\/36\/oj\/eng."},{"key":"ref_32","unstructured":"(2025, June 16). Directive 2013\/55\/EU of the European Parliament and of the Council of 20 November 2013 Amending Directive 2005\/36\/EC on the Recognition of Professional Qualifications and Regulation (EU) No 1024\/2012 on Administrative Cooperation through the Internal Market Information System. Available online: https:\/\/eur-lex.europa.eu\/eli\/dir\/2013\/55\/oj\/eng."},{"key":"ref_33","unstructured":"(2025, February 02). Law on Vocational Education and Training, in Force from 30.07.1999, Amend. SG. 102\/23.12.2022. Available online: https:\/\/natlex.ilo.org\/dyn\/natlex2\/natlex2\/files\/download\/53686\/BGR53686.pdf."},{"key":"ref_34","unstructured":"(2024, October 13). The Recognition of Professional Qualifications Act. Promulgates, State Gazette Issue 13 of 8th February 2008. Available online: https:\/\/psc.egov.bg\/documents\/20124\/0\/RECOGNITION+OF+PROFESSIONAL+QUALIFICATIONS+ACT_14.pdf."},{"key":"ref_35","unstructured":"Ministry of Education and Science of the Republic of Bulgaria (2005). Ordinance on the Unified State Requirements for Acquiring Higher Education in the Specialty of \u2018Pharmacy\u2019 for the Educational and Qualification Degree of \u2018Master\u2019."},{"key":"ref_36","unstructured":"(2024, October 13). Ordinance on the Uniform State Requirements for Obtaining Higher Education in the Specialty of Pharmacy for the Educational and Qualification Degree\u2014Master Effective from the Academic Year 2005\u20132006; Adopted by Council of Ministers Decree No. 61 of 05.04.2005. Promulgated in the State Gazette No. 32 of April 12, 2005, Amended and Supplemented, State Gazette No. 1 of January 2, 2024. Available online: https:\/\/dv.parliament.bg\/DVWeb\/broeveList.faces."},{"key":"ref_37","unstructured":"(2024, October 13). Law on Health Protection (Off. Gazette 43\/2012-275\/2019), Available online: https:\/\/zdravstvo.gov.mk\/wp-content\/uploads\/2018\/01\/ZAKON-ZA-ZDRAVSTVENATA-ZASHTITA-zakluchno-so-br.-37-od-2016.pdf."},{"key":"ref_38","unstructured":"(2024, October 13). Law on the Professional Organization of Master Pharmacists Promulgated in the State Gazette No. 75 of September 12, 2006, Amended and Supplemented, State Gazette No. 64 of August 13, 2019, Available online: https:\/\/www.mh.government.bg\/bg\/normativni-aktove\/zakoni."},{"key":"ref_39","unstructured":"(2024, October 13). Health Act; Effective from 01.01.2005, Amended and Supplemented, SG (State Gazette) No. 8 of January 25 2023, Available online: https:\/\/www.mh.government.bg\/bg\/normativni-aktove\/zakoni."},{"key":"ref_40","unstructured":"(2025, January 10). Rules for Conducting Continuing Education of Master Pharmacists in Bulgaria. Effective from: 01.01.2015. Amended and Supplemented by Protocol No. 103\/11.02.2018 from the Regular Extended Meeting of the Management Board of the Bulgarian Pharmaceutical Union (BpHU). The Amendments Enter into Force on: 12.02.2018. Available online: https:\/\/bphu.bg\/upload\/files\/Pravila%20za%20prodyljavashto%20obuchenie_2018.pdf."},{"key":"ref_41","unstructured":"Health Insurance Fund (2024, October 13). Rulebook of the Agreement Criteria and Payment Regarding Medicines Covered by the Health Insurance System in Primary Health Care, Available online: https:\/\/lekovi.zdravstvo.gov.mk\/."},{"key":"ref_42","unstructured":"The European Observatory on Health Systems and Policies, and World Health Organization (2006). The Former Yugoslav Republic of Macedonia Health System Review on Health Systems and Policies. Health Syst. Transit., 8, 1\u201398."},{"key":"ref_43","unstructured":"(2025, January 10). Law on Medical Devices. In Force from 12.06.2007, Amend. SG. 41\/10 May 2024. Available online: https:\/\/www.bda.bg\/images\/stories\/documents\/legal_acts\/ZMI_en_20160308.pdf."},{"key":"ref_44","unstructured":"(2024, October 13). National Health Strategy 2030 (Bulgaria). Available online: https:\/\/www.strategy.bg\/StrategicDocuments\/View.aspx?lang=bg-BG&Id=1604."},{"key":"ref_45","unstructured":"(2025, June 16). Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices. OJ L 117. Available online: https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng."},{"key":"ref_46","unstructured":"(2025, June 16). Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on In Vitro Diagnostic Medical Devices. Available online: https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\/eng."},{"key":"ref_47","unstructured":"WHO (2019). The Legal and Regulatory Framework for Community Pharmacies in the WHO European Region, WHO Regional Office for Europe."},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"227","DOI":"10.2147\/JMDH.S236488","article-title":"The Rural Pharmacy Practice Landscape: Challenges and Motivators","volume":"13","author":"Hays","year":"2020","journal-title":"JMDH"},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"1816","DOI":"10.1016\/j.japh.2022.07.003","article-title":"Access to community pharmacies: A nationwide geographic information systems cross-sectional analysis","volume":"62","author":"Berenbrok","year":"2022","journal-title":"J. Am. Pharm. Assoc."},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1177\/1715163512473062","article-title":"The geographic accessibility of pharmacies in Nova Scotia","volume":"146","author":"Law","year":"2013","journal-title":"Can. Pharm. J."},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"2833","DOI":"10.2147\/RMHP.S443325","article-title":"Trends, Capacity Growth, and Current State of Community Pharmacies in Saudi Arabia: Findings and Implications of a 16-Year Retrospective Study","volume":"16","author":"Alrasheedy","year":"2023","journal-title":"Risk Manag. Health Policy"},{"key":"ref_52","first-page":"67","article-title":"Analysis of the access to pharmaceutical activities in community pharmacies in Bulgaria","volume":"19","author":"Pesheva","year":"2023","journal-title":"Acad. J. Manag. Educ."},{"key":"ref_53","unstructured":"(2007). Appendix No. 6 to Article 32, Paragraph 3 of the Terms and Conditions for Concluding Individual Contracts for the Payment of Medicinal Products under Article 262, Paragraph 6, Item 1. Law on Medicinal Products in Human Medicine, Medical Devices, and Dietary Foods for Special Medical Purposes, Fully or Partially Paid by the National Health Insurance Fund, Parliament of the Republic of Macedonia."},{"key":"ref_54","unstructured":"Pharmaceutical Chamber of the Republic of North Macedonia (2025, June 10). Probationary Work and Professional Exam. Available online: https:\/\/www.fk.mk\/\u0437\u0430-\u0447\u043b\u0435\u043do\u0432\u0438\u0442\u0435\/\u043f\u0440o\u0431\u043d\u0430-\u0440\u0430\u0431o\u0442\u0430\/."},{"key":"ref_55","unstructured":"International Pharmaceutical Federation (2023). Early Career Pharmaceutical Group (FIP ECPG) Strategic Plan 2023\u20132030, International Pharmaceutical Federation. Available online: https:\/\/www.fip.org\/files\/content\/young-pharmacists-group\/about-young-pharmacists-group\/2023\/FIP_ECPG_Strategic_Plan_2023-2030.pdf."},{"key":"ref_56","unstructured":"World Health Organization (2024, October 13). Pharmacists (per 10,000 Population). Available online: https:\/\/www.who.int\/data\/gho\/data\/indicators\/indicator-details\/gho\/pharmacists-(per-10-000-population)."},{"key":"ref_57","unstructured":"World Health Organization (2024, October 13). Health Data Overview for the Republic of North Macedonia, Density of Pharmaceutical Personnel (per 10,000 Population). Available online: http:\/\/data.who.int\/indicators\/i\/C668579\/45CA7C8."},{"key":"ref_58","unstructured":"World Health Organization (2024, October 13). Health Data Overview for the Republic of Bulgaria, Density of Pharmaceutical Personnel (per 10,000 Population). Available online: http:\/\/data.who.int\/indicators\/i\/C668579\/45CA7C8."}],"container-title":["Pharmacy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2226-4787\/13\/4\/108\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:26:36Z","timestamp":1760034396000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2226-4787\/13\/4\/108"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,8]]},"references-count":58,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2025,8]]}},"alternative-id":["pharmacy13040108"],"URL":"https:\/\/doi.org\/10.3390\/pharmacy13040108","relation":{},"ISSN":["2226-4787"],"issn-type":[{"value":"2226-4787","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,8]]}}}