Shaping the future of the UK Specials sector
The Association of Pharmaceutical Specials Manufacturers (APSM) is a not-for-profit trade association established to represent the interests of its members who supply Specials and unlicensed medicines in the UK.
List of members
We welcome applications for membership from the following organisations:
- 1Manufacturers of Specials medicines that operate under an MHRA Specials manufacturing authorisation
- 2Importers of unlicensed medicines that operate as first supplier of these to the UK market
- 3Companies that own the rights to, and supply Specials medicines, as the first supplier to the UK market
APSM Membership will help your company to increase success in Specials
- Input into policy for meetings with Department of Health and key policy makers
- Input into key decisions around new legislation and Specials guidance
- Networking and peer group collaboration
- Shared PR and stakeholder engagement activities
- Commercial insights
- Technical support and consultation
- Issues management and reputation management
- Market statistics and resources
For details of membership please contact the APSM Membership Director
Brian Fisher via email: email@example.com
The APSM code of conduct
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.
The APSM Board
Our quality process
Many of our APSM members are Specials Manufacturers who are licensed, regulated and inspected by the Medicines and Health Regulatory Authority (MHRA) and must also comply with the principles of Good Manufacturing Practice (GMP) adopted by the EU Commission.
The illustration below shows in detail the standards of quality applied to our licensed specials manufacturers and the additional quality assurances from APSM members.
More information of APSM member company quality processes are provided here.
Aims and objectives
- To promote and strengthen the UK Specials medicines industry and the use of Specials and unlicensed medicines in the UK
- To represent the views and interests of Specials manufacturers and suppliers, in particular to the UK government, and the devolved administrations and health departments, regulators and other relevant third parties
- To provide a compliant forum for the exchange of ideas and best practice and agree and maintain appropriate standards of conduct for APSM members
- To promote a regulatory, pricing and market environment that enables the reasonable development and sustainability of Specials and unlicensed medicines markets in the interests of APSM members, patients and UK health services