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Impact of the Council of Europe Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients
  1. H P A Scheepers1,2,
  2. V Neerup Handlos3,
  3. S Walser4,
  4. M D B Schutjens5,
  5. C Neef2,6
  1. 1 Health Care Inspectorate, Ministry of Health, Welfare and Sport, Utrecht, The Netherlands
  2. 2 CAPHRI School for Public Health and Primary Care, Maastricht University, Medical Centre, Maastricht, The Netherlands
  3. 3 Capital Region Pharmacy, Herlev, Denmark
  4. 4 European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France
  5. 5 Pharmaceutical Law University of Utrecht, Utrecht, The Netherlands
  6. 6 Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre, Maastricht, The Netherlands
  1. Correspondence to H P A Scheepers, Welfare and Sport, Health Care Inspectorate, Stadsplateau 1, Utrecht 3521 AZ, The Netherlands; hp.scheepers{at}


Introduction and objective The regulation of pharmacy preparations, especially for standards for quality assurance and safety, is not harmonised across Europe and falls under the national competencies of individual states. There are concerns about quality control and safety for the medicinal products made in pharmacies, which is widespread in European countries. There are, however, good reasons to continue this practice, which is able to tailor preparations to the specific needs of a particular patient or patient group and to provide a supplementary source of supply when an industrially manufactured product, which is authorised for marketing is not available or when there are temporary shortages of licensed medicines. In seeking to provide guidelines for legislation and acting on the advice of an expert group dealing in pharmaceutical practices, the Committee of Ministers of the Council of Europe passed a resolution in 2011. The Council of Europe Resolution provides authorities and pharmacists with the means to reinforce safety measures for medicinal products prepared in pharmacies and to harmonise quality assurance and safety standards. It dealt with aspects of pharmacy preparation such as quality standards for preparation and distribution, marketing authorisation, product dossiers, labelling, reporting, and safety. In 2013 and 2014 the Committee of Experts carried out a survey to evaluate the impact of the resolution within a cross section of member states. The objectives of this study were both to monitor the extent to which the recommendations had been enshrined in national legislation and also to understand current differences in legislation and practice between the member states.

Methods In the resolution of 2011 the member states were recommended to adapt their legislation in line with its provisions. The survey that was carried out in 2013 and 2014 followed the recommendations in the resolution. A questionnaire was made and sent to a cross section of member states.

Results Among the member states involved, the results of this survey show a clear commitment to implement the recommendations of the resolution.

Conclusions This report presents the results of the survey with a discussion of outstanding issues.

  • Pharmacy preparations
  • Product dossier
  • Unlicensed products
  • Council of Europe Resolution ResAP(2011)1
  • Quality and safety standards
  • Survey
  • Regulation

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