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. 2017 Jul;24(4):224-229.
doi: 10.1136/ejhpharm-2016-001016. Epub 2016 Sep 5.

Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution

H Pa Scheepers  1 , J Langedijk  2 , V Neerup Handlos  3 , S Walser  4 , M H Schutjens  5 , C Neef  6   7
Affiliations

Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution

H Pa Scheepers et al. Eur J Hosp Pharm. 2017 Jul.

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.

Keywords: Council of Europe Resolution ResAP(2011)1; EU regulation; European Court of Justice; Patient safety; Pharmacy preparations.

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Conflict of interest statement

Competing interests: None declared.

References

    1. Scheepers HPA, Busch G, Hofbauer E, et al. . Abridged survey report on quality and safety assurance standards for the preparation of medicinal products in Pharmacies. Pharmeuropa 2010;22.
    1. “Promoting Standards for the Quality and Safety Assurance of Pharmacy-Prepared Medicinal Products for the Needs of Patients”, (24 September 2009 at the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, in Strasbourg). http://www.edqm.eu/en/quality-and-safety-standards-1244.html (accessed 17 Oct 2014).
    1. Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. Council of Europe. - PMC - PubMed
    1. Scheepers HPA, Neerup Handlos V, Walser S, et al. Impact of the Resolution on quality and safety Assurance standards for the preparation of medicinal products in pharmacies. doi:10.1136/ejhpharm-2016-001017. - PMC - PubMed
    1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.