THE APSM
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, also known as unlicensed medicines, in the UK.
ROLE OF THE APSM
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To promote and strengthen the UK Specials medicines industry and the use of Specials and unlicensed medicines in the UK
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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
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To provide a compliant forum for the exchange of ideas and best practice and agree and maintain appropriate standards of conduct for APSM members
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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
OUR MEMBERS
MEMBER QUALITY COMMITMENT
All members should offer:
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Premises inspected by MHRA for compliance to GMP (Good Manufacturing Practice)
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A pharmaceutical quality assurance system, e.g. pharmacopoeial monograph, stability tests
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Batch testing / Certificates of Analysis provided
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Certificates of Compliance (for single products)
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Best practice labelling
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Customer support line
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Unique codes on all products
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Innovation – e.g. clearer patient labelling
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Yellow card adverse event reporting
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Investment in facilities for medicines manufacture
In the UK, the majority of Specials are manufactured and prepared by Specials manufacturers who are licensed, regulated and inspected by the MHRA and must comply with the principles of Good Manufacturing Practice (GMP) adopted by the EU Commission.
These licensed manufacturers provide additional assurances of quality. A certificate of analysis is provided for batch manufactured Specials as evidence that critical parameters have been met through physical, chemical or microbiological analysis of the final product. Where individual or bespoke Specials are prepared, the manufacturer will provide a certificate of conformity to show that the product meets the specification.
In addition, APSM members voluntarily undertake to apply the Yellow Card reporting scheme for their Specials (unlicensed medicines). This is the same pharmacovigilance process adopted by manufacturers of licensed pharmaceuticals.
Pharmacovigilance involves the continuous monitoring of medicines for any adverse side effects. In the UK, this process is managed under the Yellow Card scheme whereby patients, doctors and health professionals can report any potential side effects.
In this way, any adverse events related to unlicensed medicines produced by APSM members would be brought to the attention of the MHRA and therefore fully monitored and investigated in the same way as any licensed medicine.
OUR CODE OF CONDUCT
Principles of the Code of Conduct - Members agree to apply the following principles:
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APSM Members agree to operate to business standards so as to avoid bringing the Specials manufacturing industry into disrepute.
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Members will hold and maintain a Specials manufacturer’s licence issued by the UK Medicines and Healthcare products Regulatory Authority (MHRA).
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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.
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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.
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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.
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Members will maintain an information service for healthcare professionals.
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Members will maintain product liability and other relevant insurance.
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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.
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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.
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Products supplied will, where possible, carry unique company and/or product codes on all preparations.
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Packaging shall conform to relevant EU and UK rules and requirements and endeavour to comply with best practice.
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Where practical, provision should be made on packaging for space for the application of a dispensing label without obliteration of essential patient information.
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APSM Members agree to inspection of their own premises by relevant authorities.
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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.
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APSM Members will ensure compliance with pharmacopoeial monograph requirements for unlicensed medicines, where appropriate.
JOIN US
We welcome applications for membership to the APSM from organisations involved in the manufacture and supply of specials in the UK. Please refer to contact details below.
