The Council of Europe has adopted a resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients.

The resolution aims to protect patient safety by ensuring that there are no quality and safety gaps between medicinal products prepared in pharmacies and those prepared on an industrial scale. This has been done by outlining assurance principles for structures and processes, developing an innovative model for risk assessment, and making recommendations for the adaptation of existing regulations. These recommendations seek to align the principles of the resolution with the:

- added value of pharmacy-preparations and responsibilities of health-care professionals;
- preparation process;
- product dossier;
- labelling;
- reconstitution of medicinal products in health-care establishments;
- authorisation for pharmacies or licences for companies making preparations for pharmacies.

More information is available on the Council of Europe’s website.