Pharma­covigilance policy

The purpose of this Pharmacovigilance policy is to describe how AGB-Pharma AB (“AGB”, “we”, “our” or “us”) collect and process personal data in order to fulfil our obligation to monitor the safety of the products we develop and market (“Pharmacovigilance Obligation”).

All personal data collected in order to fulfil this Pharmacovigilance Obligation is processed in accordance with the UK Data Protection Act 2018, and solely to the extent that it is relevant to and necessary for the fulfilment of our Pharmacovigilance Obligation.

For further information on how we process personal data in other contexts, see our Personal Data Policy.

Product safety and personal data

Product safety is important to us. Different forms of side effects or adverse events associated with the use of a pharmaceutical product can differ and it may not, therefore, always be possible to detect them during the clinical development of the products. It is consequently of the utmost importance that we are able to catch all side effects, whether common or uncommon, so that we can monitor the safety of the products, protect public health, and ensure a high standard of quality. The Pharmacovigilance Obligation exists to enable regulatory authorities (MHRA and other authorities) and us to follow up on and address side effects and adverse events, and to work to prevent similar side effects occurring in future.

The Pharmacovigilance Obligation means that AGB-Pharma has a legal obligation to collect certain personal data from people who use our pharmaceutical products. The types of personal data that we collect and process are shown below.

Which personal data do we process?

We may collect and process the following types of personal data when you, your doctor, or another third party submits information to us regarding a side effect experienced in conjunction with the use of AGB-Pharma’s products.

Personal data about the person reporting a side effect:

• name and/or initials;
• date of birth/age group, gender, weight, height;
• contact details (may include your email address or phone number).

The information collected also includes special categories of personal data, such as:

• health, ethnic origin, and sexual orientation;
• medical history and status, which may, for example, include:
  • details of AGB-Pharma’s products that are suspected of having caused an adverse event, including the dose you have taken or were prescribed, the reason why you took the product or were prescribed the product, and other subsequent changes to your normal treatment;
  • details of other pharmaceutical products or other products that you take or had taken at the time when the side effect was experienced, including the dose you took or were prescribed, the length of time you took the pharmaceutical product, the reason why you have taken a medicinal product, and other subsequent changes to your normal treatment;
  • details of the adverse event you experienced, the treatment you have received, and potential long-term effects of the adverse event on your health; and other medical history deemed relevant by the reporter, including documentation such as laboratory results, pharmaceutical history and

Personal data about the person reporting a side effect:

• name;
• contact details (may include your address, email address, phone number, and fax number);
• occupation/profession (this information may determine the questions we ask you when a side effect is reported);
• links to the person whom the report concerns

For what is the personal data used?

We may, as part of our Pharmacovigilance Obligation, need to process personal data in order to:

• investigate the side effect or adverse event;
• contact you to obtain additional information about the side effect/adverse event you have reported;
• collect information on the reported side effect/adverse event and about other side effects/adverse events reported to us in order to analyse and evaluate the safety of the product, a manufacturing batch, or the active ingredient in its entirety;
• be able to submit mandatory reports to relevant regulatory authorities to enable them to analyse the safety of the product, a manufacturing batch, or the active ingredient as a whole.

AGB-Pharma will only process personal data for these purposes and will not process the personal data collected for any other purpose.

The lawful basis for the processing of personal data in accordance with the General Data Protection Regulation is compliance with the statutory obligations in accordance with applicable pharmacovigilance legislation (UK Data Protection Act 2018).

How long do we save your personal data?

We will only retain your personal data for the period of time for which we are, by law, required to save them. The Pharmacovigilance Obligation mandates that we archive information that may contain personal data for the lifecycle of the product and for a further ten years after the product is no longer available on the market. The data will then be deleted.

To whom do we disclose your personal data?

We may, as part of our Pharmacovigilance Obligation, share your data with the The MHRA and other equivalent regulatory authorities within other countries where we market our products.

We may also share the information with other companies within our corporate group, or with our partner/supplier companies in such areas as pharmacovigilance, marketing, or distribution (when such exchange of information is required).

We also share the information in conjunction with the publication of information on adverse events (such as case studies and summaries). The information is always, in these instances, anonymised to ensure that your identity remains unknown.

Third countries

We will not, as a general rule, transfer any personal data to a country outside UK or EU/EEA. The Pharmacovigilance Obligation does, however, require us to review side effect reports from all countries where we market our products. If a transfer of data to a third country is necessary in order to fulfil our Pharmacovigilance Obligation, we will always implement appropriate security measures in order to protect your personal data and ensure that they are processed in accordance with this Pharmacovigilance Policy and applicable data protection legislation.

Your rights

You have the right, at all times, to contact us in our capacity as Personal Data Controller, and request access to the personal data we process.

You have the right to have incorrect personal data concerning you corrected by us and, in certain cases, to have it restricted, deleted, or transferred by us.

You have the right, at any time whatsoever, to object to the processing of your personal data unless we have a legal basis for the processing.

You have the right, at any time whatsoever, to revoke your consent where the only legal basis for our processing was that we had your consent to do so. Please note this will only affect future processing and does not mean that processing carried out before you withdrew your consent is unlawful.

You also have the right to submit complaints to the The UK body (Information Commissioner´s Office, ICO)

Addenda and amendments

AGB-Pharma may make addenda and amendments to this Pharmacovigilance Policy. The updated Policy will be published on this page.

Contact details

AGB-Pharma AB, Medicon Village, Scheeletorget 1, SE-223 81 Lund, Sweden, is responsible for the personal data processing as described in this Pharmacovigilance Policy. This means that if you have any questions or comments, or if you wish to exercise any of the rights you have by reason of our processing of your personal data, you should contact us.

If you have any questions about the content of our Pharmacovigilance Policy, contact us at: privacy@agb-pharma.com.