Product

We work hard to ensure the quality, safety and efficacy of our products and to maintain reliable supplies, because the trust of our customers depends on this.

We are committed to remaining fully compliant with all applicable regulations. Our quality assurance systems and processes aim to provide confidence that our suppliers, vendors, and contractors are able to supply consistent quality of materials, components, and services in compliance with regulatory requirements and to identify and mitigate any associated risks.

All our contract manufacturers are expected to comply with appropriate external quality standards, such as EU GMP¹, ISO 13485, ISO 22716 and GPvP², and to hold appropriate third-party authorisations, e.g., MIA³ for medicines, issued by a competent authority.

The nature of our business means that we are frequently subject to inspections and audits from a number of government bodies to ensure that we remain compliant with the authorisations we hold to support those aspects of our supply chain which we are directly involved with. We wholeheartedly welcome these and always commit to providing prompt, accurate and complete responses to associated requests for information.

_{1 Good Manufacturing Practice}

_{2 Good Pharmacovigilance Practice}

_{3 Medical Industry Accredited}

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Whilst the environmental impact of the scope 1 & 2 emissions from our own operations is relatively low, and so not material to the longer-term sustainability of our business from a financial perspective, we seek to reduce them for the benefit of society as a whole.

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We strive to ensure that all our products are readily available to consumers and patients, subject to relevant regulatory restrictions, and that the prices we charge for our products are reasonable and reflective of local market conditions. For many of our Prescription Medicines products, we are subject to external pricing controls, such as the voluntary scheme for branded medicines pricing and access in the UK (VPAS).

We work closely with our suppliers and logistics providers to avoid, where at all possible, any disruption to the continuity of supply, particularly for those prescription medicine products deemed to have a high medical need. In addition, we offer access to our products to those in need through our product donations to International Health Partners.

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As a business which outsources all its manufacturing activities, we have an obligation to maintain adequate oversight of our end-to-end supply operations and to be aware of any associated environmental health and safety, business ethics and supply chain security risks which may exist within our supply chain, including risks to our supply chain arising from the effects of climate change, so these can be effectively managed.

Systems and accreditations

To support those aspects of our supply chain which we are directly involved with:

• We hold Wholesale Dealers Authorisations, assessed, and approved by the MHRA to allow wholesale dealing of medicines in the UK
• We hold Exploitant status and a Wholesale Dealers Authorisation, assessed and approved by ANSM, to allow the marketing and wholesale dealing of medicines in France.

Both our UK and Italian companies hold ISO 13485:2016 (similar to ISO 9001) assessed quality systems to support the marketing of medical devices, which are independently assessed by BSI (UK) and TUV (Italy). Both of these entities also have CE marked medical devices, Class II and above, independently assessed by the Italian and UK Ministry of Health assigned Notified Bodies. In the UK, we are audited regularly by Trading Standards to support the placing on the market of products designated as food supplements.

In China, we hold the Production Approval Certificate issued by Shanghai FDA, and our QMS for medicinal product has been duly audited to be GMP-compliant, enabling us to appoint a contract manufacturer, and to operate both as MAH and wholesaler of Triatop Lotion (Nizoral Shampoo) in China. In March 2022, NMPA has approved the transfer of the Marketing Authorisations for Triatop Lotion from Xi’an Janssen to our Alliance affiliate in Shanghai.

Internal training

To support these accreditations, in addition to annual pharmacovigilance training, all employees receive training on Good Distribution Practice, with regular training on Company procedures and policies being provided to relevant employees within the business, as needed. Those employees holding statutory roles, such as QPPV, RP, Clinicians, are expected to perform ongoing professional development as a prerequisite for holding these roles.

Vendor selection

Our established vendor selection processes aim to ensure that all new CMOs are subject to cross-functional assessment by representatives from our Finance and Legal, Sourcing, Technical and Quality teams against a broad set of measures, to ensure compliance with Alliance’s internal policies, in addition to appropriate external quality standards, such as EU GMP, ISO 13485, ISO 22716 and GPvP, and that they have hold appropriate third party authorisations, e.g. MIA for medicines, issued by a competent authority.

Supply chain security

We recognise that, for some of our consumer products, there is a risk of counterfeit product reaching the market, which may not have been subject to the same rigorous production standards and quality testing as genuine product, rendering it potentially less effective.

We have an established Brand Protection team, to assess any potential vulnerabilities in our supply chain and address any identified counterfeiting risks.

We also continue to enhance our customer qualification and approval processes, to ensure we have full visibility over our end-to-end supply chain.

Risk-based monitoring

We carry out ongoing, risk-based monitoring of our suppliers, to ensure they remain able to supply consistent quality of materials, components, and services in compliance with regulatory requirements and to identify and mitigate any associated risks.

To improve and streamline our supplier management and associated business assurance activities, we have partnered with a market-leading data aggregator / analytics provider, enabling us to access wide-ranging supplier data and in-depth analytics capabilities, and giving us improved visibility of any potential ‘red flags’ in our supply chain. Having now integrated this functionality with existing compliance review and escalation processes, we can ensure any identified issues are remediated on a timely basis.

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Alliance is committed to ethical business practices regarding the marketing, advertising, and sales of our brands. We have robust standard operating procedures in place to achieve this, with comprehensive training for all compliance staff, to ensure our activities comply with the appropriate standards and legislation. Ultimately, this provides reassurance for healthcare professionals, patients and consumers regarding the integrity of our brands.

Through our membership of key trade associations such as the Association of the British Pharmaceutical Industry (ABPI), the Proprietary Association of Great Britain (PAGB) and the Association of the British HealthTech Industry (ABHI), we are able to stay at the forefront of continually evolving compliance legislation.

Our processes are regularly audited and refined to ensure continued compliance with relevant internal and external regulatory requirements.

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Alliance is committed to providing transparency and clarity around our collaboration with healthcare professionals, healthcare organisations and patient organisations. In the UK and Republic of Ireland, Alliance publishes transfers of value in accordance with the ABPI and IPHA Codes of Practice.

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We are committed to safeguarding the privacy of data that we may collect on our websites, from third parties, or from other interactions with our business. As part of the day-to-day operation of our business we use personal data in relation to individuals who are not employed in our group for the following: (i) Marketing of our products; (ii) Fulfilling orders placed with us for our products; (iii) Assisting with customer queries or reports of problems relating to our products (including adverse events) and keeping records required by law; and (iv) Dealing with applications for employment. We work hard to ensure compliance with all applicable laws and regulations relating to the collation, processing and retention of personal data. Annual training is provided to all employees on data protection (including the requirements of GDPR) and as a business we periodically audit our operations to ensure that we have the relevant systems and checks around the collation, processing and retention of data.

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