2. Privacy notice for pharmacovigilance, medical information and product complaints
1. Privacy notice
Luye Pharma Ltd (‘Luye’) respects your privacy and is committed to protecting your personal data. This privacy policy will inform you as to how we look after your personal data when you visit our website (regardless of where you visit it from) and tell you about your privacy rights and how the law protects you.
Purpose of this privacy notice
This privacy notice aims to give you information on how Luye collects and processes your personal data through your use of this website, including any data you may provide through this website when you visit. This website is not intended for children and we do not knowingly collect data relating to children. This privacy notice supplements other notices and privacy policies and is not intended to override them.
Controller
Luye is the controller and responsible for your personal data (collectively referred to as “Luye”, “we”, “us” or “our” in this privacy notice).
We have appointed a data protection officer (DPO) who is responsible for overseeing questions in relation to this privacy notice. If you have any questions about this privacy notice, including any requests to exercise your privacy rights, please contact the DPO using the details set out below.
Contact details
Luye Pharma Ltd (company number 11567378) of Unit 11a, Surrey Technology Centre 40 Occam Road, Surrey Research Park, Guildford, Surrey, United Kingdom, GU2 7YG.
Email: dpo@luyepharma.co.uk or write to the DPO at the address above.
You have the right to make a complaint at any time to the Information Commissioner’s Office (ICO), the UK regulator for data protection issues (www.ico.org.uk). We would, however, appreciate the chance to deal with your concerns before you approach the ICO so please contact us in the first instance.
Changes to the privacy notice and your duty to inform us of changes
We keep our privacy notice under regular review. This version was effective on December 01, 2022 and may be updated periodically.
It is important that the personal data we hold about you is accurate and current. Please keep us informed if your personal data changes during your relationship with us.
Third-party links
This website may include links to third-party websites, plug-ins and applications. Clicking on those links, or enabling those connections may allow third parties to collect or share data about you. We do not control these third-party websites and are not responsible for their privacy statements. When you leave our website, we encourage you to read the privacy policy or notice of every website you visit.
The data we collect about you
Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data). We may collect, use, store and transfer different kinds of personal data about you which we have grouped together as follows:
- Identity Data includes first name, last name, username or similar identifier, marital status, title, date of birth and gender.
- Contact Data includes billing address, delivery address, email address and telephone numbers.
- Technical Data includes internet protocol (IP) address, your login data, browser type and version, time zone setting and location, browser plug-in types and versions, operating system and platform, and other technology on the devices you use to access this website.
- Profile Data includes your username and password, purchases or orders made by you, your interests, preferences, feedback and survey responses.
- Usage Data includes information about how you use our website, products and services.
- Marketing and Communications Data includes your preferences in receiving marketing from us and our third parties and your communication preferences.
How we collect your personal data
We use different methods to collect data from and about you including through:
- Direct interactions. You may give us your identity or contact information by filling in forms or by corresponding with us by post, phone, email or otherwise.
- Automated technologies or interactions. As you interact with our website, we may automatically collect Technical Data about your equipment, browsing actions and patterns. We collect this personal data by using cookies and other similar technologies. We may also receive Technical Data about you if you visit other websites employing our cookies. Please see our cookie policy for further details.
- Third parties or publicly available sources. We will receive personal data about you from various third parties and public sources as set out below:
Technical Data from the following parties:
(a) analytics providers such as Google Analytics based outside the UK;
(b) advertising networks such as Google Display Network based outside the UK; and
(c) search information providers such as Google based outside the UK.
Cookies
Please see our cookie policy for more information on how we use cookies.
How and why we use your personal data
Our legal basis for collecting and using the personal information described above will depend on the personal information concerned and the specific context in which we collect it. However, we will normally collect personal information from you only where we have your consent to do so, where the processing is in our legitimate interests and not overridden by your data protection interests or fundamental rights and freedoms (for example network and information systems security). In some cases, we may also have a legal obligation to collect personal information from you or may otherwise need personal information to protect your vital interests or those of another person.
If we ask you to provide personal information to comply with a legal requirement, we will make this clear at the relevant time and advise you whether the provision of your personal information is mandatory or not) as well as the possible consequences if you do not provide your personal information).
The following is a list of purposes or activities that we may use your personal information for and the reason we rely on for doing so:
| Purpose/activity | Our reasons (legal basis) |
| To contact you when you complete our contact form | Consent / legitimate interests |
| To administer and protect our business and this website (including troubleshooting, data analysis, testing, system maintenance, support, reporting and hosting of data) | Legitimate interest |
| To use data analytics to improve our website, products/services, marketing, customer relationships and experiences, tracking | Consent / legitimate interest |
| Undertake website administration and personalisation | Legitimate interest |
| Managing network and data security | Legitimate interest |
| Contacting you by telephone, email or post for marketing | Consent / legitimate interest |
| To ensure that content from our website is presented in the most effective manner for you and for your computer | Legitimate interest |
| To notify you about changes to our service | Legitimate interest |
| To administer our website and for internal operations, including troubleshooting, data analysis, testing, research, statistical and survey purposes | Legitimate interest |
If you have questions about, or need further information, concerning the legal basis on which we collect and use your personal information, please contact us using the contact details provided above.
How do we protect your personal data?
To ensure the security and confidentiality of Personal Data that we collect online, we use data networks protected, inter alia, by industry standard firewall and password protection. In the course of handling your Personal Data, we take measures reasonably designed to protect that information from loss, misuse, unauthorised access, disclosure, alteration or destruction and against other unlawful forms of processing.
Retention Periods
We will only retain your personal data for as long as reasonably necessary to fulfil the purposes we collected it for, including for the purposes of satisfying any legal, regulatory, tax, accounting or reporting requirements. We may retain your personal data for a longer period in the event of a complaint or if we reasonably believe there is a prospect of litigation in respect to our relationship with you.
To determine the appropriate retention period for personal data, we consider the amount, nature and sensitivity of the personal data, the potential risk of harm from unauthorised use or disclosure of your personal data, the purposes for which we process your personal data and whether we can achieve those purposes through other means, and the applicable legal, regulatory, tax, accounting or other requirements.
Security
We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. In addition, we limit access to your personal data to those employees, agents, contractors and other third parties who have a business need to know. They will only process your personal data on our instructions and they are subject to a duty of confidentiality.
We have put in place procedures to deal with any suspected personal data breach and will notify you and any applicable regulator of a breach where we are legally required to do so.
Use of data
Luye, including the subsidiaries, divisions and groups worldwide and/or the companies we hire to perform services on our behalf will use any personally identifiable information you choose to give us to comply with your requests. We will retain control of and responsibility for the use of this information. Some of this data may be stored or processed at computers located in other jurisdictions, such as in Europe, whose data protection laws may differ from the jurisdiction in which you live. In such cases, we will ensure that appropriate protections are in place to require the data processor in that country to maintain protections on the data that are equivalent to those that apply in the country in which you live.
The information that you provide to us, will be helpful for us to better understand your needs and how we can improve our products and services. It helps us also to personalise certain communications with you about products and/or services that you might find interesting. We may use this data in order to provide information to an individual who has agreed to receive information from us. We may also use the data in aggregate form with no personally identifiable information in order to provide analysis internally and to share with others when appropriate.
Profiling
By using Luye’s sites and platforms that link to this privacy notice and upon your consent, we may collect certain information about you, your preferences, and how you have interacted with us in order to understand your interest in our products and services so that we can best serve you and provide relevant information to you. This may include information about your contact, anonymous IP, inferred country, product preferences, browser information, email deliverability and engagement and marketing preferences. No automated decisions are made that would result in legal effects or similarly significantly affect an individual.
Data sharing and transfer
Luye shares personally identifiable data about you with various outside companies or agents working on our behalf to help fulfil business transactions (such as providing customer services) and to help fulfil business operations such as sending marketing and/or customer communications about our products, services and offers including market research and telemarketing; maintaining our customer database and website; conducting analytics, marketing and website optimisation including search engines and online marketing and for the performance of any contract we enter into with you.
In addition, we may share personally identifiable data that we collect from you with our company’s subsidiaries and affiliates globally or store that data with them. All these companies and agents are required to comply with applicable data protection laws. For intra-group transfers of personal data, Luye has adopted Intra-Group Agreements within the Luye Group, provided by law that ensures effective levels of data protection relating to transfers of personal data outside the United Kingdom.
We may also disclose personally identifiable information for these purposes:
(a) in connection with the sale, assignment or other transfer of the business of the website to which the data relates;
(b) to respond to appropriate requests of legitimate government agencies or where required by applicable laws, court orders, or government regulations; or
(c) where needed for corporate audits or to investigate or respond to a complaint or security threat.
No Third-Party Direct Marketing Use: We will not sell or otherwise transfer the personally identifiable information you provide to us at our website to any third parties for their own direct marketing use unless we provide clear notice to you and obtain your explicit consent for your data to be shared in this manner.
Your legal rights
Under certain circumstances, you have rights under data protection laws in relation to your personal data. You may have the right to:
- Request access to your personal data.
- Request correction of your personal data.
- Request erasure of your personal data.
- Object to processing of your personal data.
- Request restriction of processing your personal data.
- Request transfer of your personal data.
- Right to withdraw consent.
If you wish to exercise any of the rights set out above, please contact us using the contact details above.
Updates to this privacy notice
We keep this Privacy Notice under regular review and we will place any updates on this website in response to changing legal, technical or business developments. When we change any processing that is based on consent, we will ask you for a new consent. We encourage you to periodically review this page for the latest information on our privacy practices.
2. Privacy notice for pharmacovigilance, medical information and product complaints
This notice provides you with information on how Luye Pharma Ltd collects, stores, processes, uses and discloses your personal data for Adverse Event reporting.
This notice provides you with information on how Luye Pharma Ltd (hereinafter “Luye”, “we”, “our”, or “us”) registered as the Marketing Authorisation Holder or its local representative for the concerned medicinal product and/or manufacturer, authorized representative in the United Kingdom (UK), importer or distributor for the concerned medical product, together with its affiliates, successors, assignors and subcontractors as described in this Privacy Notice collects, stores, processes, uses and discloses your personal data.
Why we are collecting your personal data
Luye will process your personal data for the purposes of monitoring of the safety and quality of the medicinal products and/or medical devices by collecting, detecting, assessing adverse events and medical incidents as well as quality complaints about those products.
Luye will process your personal data on the following basis:
Pharmacovigilance purposes:
If you are reporter of the adverse event and/or medical incident or other type of complaint referring to the medical product and concerning other person – on the basis that this is necessary to comply with our legal obligations regarding the safety of medicinal products as well as because processing is necessary for reasons of public interest in the area of public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of the law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy;
If you are a patient reporting the adverse event and/or medical incident or other type of complaint referring to the medical product – on the basis that it is necessary for reasons of public interest in the area of public health such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.
The provision of your personal data is voluntary (unless you are a healthcare professional who is obliged to report adverse events or medical incidents), however if you do not provide your personal data we will not be able to address your query.
We will not use this information for any other purpose, and your personal data will not be shared with any other party unless we are legally obliged to do so (e.g. by regulatory authorities) or unless such third party acts on behalf of Luye as data processor.
We may collect the following personal information depending on the individual contacting us (patient or reporter of an adverse event): name, surname, age, date/year of birth, gender, initials, contact details and profession. We may collect additional personal data in relation to health data or medical history of an individual experiencing an adverse event. We may be required by law to use your information to assess the safety of our products and report the data to the regulatory authorities. For reporting data to the regulatory authorities your personal information will be shared in an anonymous manner. Your data will not be used for other purposes other than activities related to pharmacovigilance.
We may receive personal information about you from third party sources (such as the physician who treats you), but only where we have checked that these third parties either have your consent or are otherwise legally permitted or required to disclose your personal information to us. The types of information we may collect from third parties will include the above types of personal information and we use the information we receive from these third parties only to assess the safety of our products, report any adverse events to regulatory authorities and contact you for any follow up information or for confirmation purposes.
Medical Information enquiries purposes:
We may collect name, surname, initials, date/year of birth, gender, contact details and profession of the individual contacting us with a medical enquiry. We may collect health data or data relating to the medical history of an individual submitting an enquiry to us. We collect this information to respond to your enquiry and follow up with you if necessary in order to comply with our legal obligations. We may be required by law to report your data to the regulatory authorities, to the extent, your enquiry is associated with an adverse event.
If we ask you to provide any other personal information not described above, then the personal information we will ask you to provide, and the reasons why we ask you to provide it, will be made clear to you at the point we collect your personal information.
Product complaints purposes:
We may collect name, surname, initials, contact details and profession of individuals reporting a product complaint to us. If relevant for the evaluation of the product complaint, we may collect health data of the individual who suffered the complaint. We collect this information to assess and evaluate the product complaint in order to comply with our legal obligations. We may be required by law to report your data to the regulatory authorities or contact you for any follow up information.
In general, we will use the personal information we collect from you only for the purposes described in this Privacy Notice or for purposes that we explain to you at the time, we collect your personal information. However, we may also use your personal information for other purposes that are not incompatible with the purposes we have disclosed to you (such as archiving purposes in the public interest, scientific or historical research purposes, or statistical purposes) if and where this is permitted by applicable data protection laws.
How long we keep your personal data
Your personal data will only be kept for as long as we reasonably consider necessary for achieving the purposes set out above and as is required and/or permissible under applicable law. In accordance with The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Pharmacovigilance data and documents relating to individual authorised medicinal products shall be retained as long as the product is authorised and for at least 10 years, beginning with the date on which the UK Marketing authorisation ceased to exist. For medical inquiries the general limitation period of 3 years starting at the end of the calendar year in which the inquiry was received.
With whom we may share your personal data and international data transfers
For the purposes outlined above, Luye may transfer your personal data to other Luye group companies and Luye’s service providers acting on behalf of Luye, such as providers of IT system administration and user support services and providers of adverse events and/or quality assurance processing services.
Some of the third parties referred to above may process your personal data outside of your country. The level of data protection in another country may not be equivalent to that in your country. However, we only transfer your personal data either to countries where the Information Commissioners Office /EU Commission has decided that they have an adequate level of data protection, or we take measures to ensure that all recipients provide an adequate level of data protection. We do this, for example, by entering into appropriate data transfer agreements. You can request information about such third parties as well as access copies of the agreements, which Luye entered with them by writing to dpo@luye.co.uk
Your rights
You have the right to:
check whether we hold personal data about you, and if so for what purposes and what kind of personal data we hold about you and to request copies of that data,
request rectification or erasure of your personal data that is inaccurate or processed for purposes not stated above,
request us to restrict the processing of your personal data,
in certain circumstances, object to the processing of your personal data,
request information on the identities or categories of third parties to which your personal data are transferred,
lodge a complaint with the data protection authority in your country.
Data Controller
The controller responsible for processing your personal data is Luye registered as the Marketing Authorisation Holder or its local representative for the concerned medicinal product and/or manufacturer, authorized representative in the UK, importer or distributor for the concerned medical product, indicated in the patient information leaflet and/or on the label.
Please address your requests or questions concerning the processing of your personal data to: dpo@luye.co.uk