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Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution
  1. H PA Scheepers1,
  2. J Langedijk2,
  3. V Neerup Handlos3,
  4. S Walser4,
  5. M H Schutjens5,
  6. C Neef6,7
  1. 1Ministry of Health, Welfare and Sport, Health Care Inspectorate, Utrecht, The Netherlands
  2. 2Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands
  3. 3Capital Region Pharmacy, Herlev, Denmark
  4. 4European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France
  5. 5Pharmaceutical law University of Utrecht, Utrecht, The Netherlands
  6. 6Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre, Maastricht, The Netherlands
  7. 7CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands
  1. Correspondence to H P A Scheepers, Ministry of Health, Welfare and Sport, Health Care Inspectorate, Stadsplateau 1, Utrecht 3521 AZ, The Netherlands; hp.scheepers{at}igz.nl

Abstract

Introduction The rights of patients should be sufficiently protected even when an appropriate authorised medicine does not exist or is unavailable on the market. The Resolution, which was adopted by the Committee of Ministers of the Council of Europe in 2011, aims at harmonising quality and safety standards for pharmacy preparation of medicinal products in Europe.

Two pillars of EU regulation and the exceptions to them The system of regulation of medicinal products is built upon two pillars: the marketing authorisation of the medicinal product and the licence for manufacturing and wholesale. This article provides insight into the recent interpretation of the European Court of Justice concerning the scope of European Union (EU) regulation of medicinal products and the circumstances in which the EU regulation does not apply: pharmacy preparations, specialties and the compassionate use of medicines, including manufacturing licence.

EU regulation and the Resolution concerning pharmacy preparation Pharmacy preparations are allowed under certain strict conditions according to EU regulations. However, pharmacies specialised in preparation and distributing medicinal products to local pharmacies do not fulfil these strict conditions in EU regulation. Apart from the legal context, relevant standards for safety and quality assurance are needed in Europe in order to protect patients' rights and to avoid risks from pharmacy preparations.

Discussion and conclusions The Council of Europe Resolution provides a means of establishing standards for safety and quality assurance for pharmacy preparations through Good Manufacturing Practice Guidelines. The Resolution is available to authorities and pharmacists in order to prevent incidents with medicines prepared in pharmacies which may threaten patients' safety. The authors conclude that pharmacy practices have changed over time in Europe and this may imply a reason for a reform of EU regulation on medicinal products.

  • Pharmacy preparations
  • EU regulation
  • Council of Europe Resolution ResAP(2011)1
  • European Court of Justice
  • Patient safety

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