Principles of the Code of Conduct - Members agree to apply the following principles:
1. APSM Members agree to operate to business standards so as to avoid bringing the Specials manufacturing industry into disrepute.
2. Members will hold and maintain a Specials manufacturer’s licence issued by the UK Medicines and Healthcare products Regulatory Authority (MHRA).
3. Members will monitor and apply relevant UK and EU rules regarding the advertising and promotion of products and services and, in particular, with reference to current controls on the advertising of Special medicines.
4. Members will at all times act in the interests of customers and ultimately patients with respect to the timely preparation and supply of Special medicines. It is recognised that members frequently supply on an urgent basis and will apply protocols and standards to supply in accordance with such timelines.
5. Where requested, members will endeavour to prepare and supply specially formulated medicines in accordance with prescriptions from practitioners and for the benefit of patients. Where such requests cannot be met by the member it will try to direct the party making the request to a suitable alternative supplier.
6. Members will maintain an information service for healthcare professionals.
7. Members will maintain product liability and other relevant insurance.
8. Individuals working for APSM members that offer professional representation or education to the pharmacy, nursing and medical professions will be appropriately trained and educated and operate to relevant standards.
9. Members will comply with criteria regarding wholesale practice in line with current wholesaling guidelines (GDP) and hold a wholesale dealers licence and distribution to pharmacies will be either direct or via wholesalers meeting established criteria regarding wholesale practice in line with current wholesaling guidelines (GDP) and be holders of a wholesale dealers licence.
10. Products supplied will, where possible, carry unique company and/or product codes on all preparations.
11. Packaging shall conform to relevant EU and UK rules and requirements and endeavour to comply with best practice.
12. Where practical, provision should be made on packaging for space for the application of a dispensing label without obliteration of essential patient information.
13. APSM Members agree to inspection of their own premises by relevant authorities.
14. APSM Members agree to comply with all regulations contained in the current edition of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors on quality/release of product and full compliance with MHRA and EU rules.
15. APSM Members will ensure compliance with pharmacopoeial monograph requirements for unlicensed medicines, where appropriate.
Download the APSM code of conduct PDF
