Privacy Policy for Pharmacovigilance

 

1. Introduction

The objective of Pharmacovigilance is to improve the quality and safety of medicines and healthcare products, as well as safeguard users and Public Health, by detecting, assessing and preventing adverse reactions.

ALLOGA LOGIFARMA, S.A (hereinafter referred to as Alloga Logifarma) is a company whose business activities involve the requirement to access the personal data of individuals reporting potential adverse events or reactions.

 

2. Objective

This Policy explains how we collect and process personal data as part of the following activities:

• Recording and reporting information concerning adverse reactions;
• Recording and reporting medical information requests; and
• Recording and reporting complaints with an impact on product safety.

 

3. Scope and Application

This Policy applies to all personal data accessed by Alloga Logifarma within the pursuit of its purposes and exercise of its powers.

 

4. Responsibilities

All employees receiving ADR reports are responsible for recording all relevant information and providing all available data concerning the report to the Client.

The Client is responsible for ensuring that complaints are processed as established in their Pharmacovigilance system.

 

5. Definitions and Abbreviations

ADR: Adverse Drug Reaction: according to the WHO, an adverse drug reaction is defined as “any response to a drug which is noxious and unintended, and which occurs at doses used in man for prophylaxis, diagnosis, treatment or modification of physiological functions”. In this sense, an ADR is understood as any undesirable effect of a drug, distinct from its primary intended effect, that may be life-threatening, cause or prolong hospitalisation, result in significant or persistent disability, lead to congenital anomalies or malformations, cause death or be deemed “clinically significant” by healthcare professionals;

Pharmacovigilance: according to the WHO, Pharmacovigilance is defined as a series of activities related to the detection, recording and assessment of adverse reactions, aimed at determining their incidence, severity and causal relationship with medicines, based on the systematic, multidisciplinary study of drug effects;

WHO: World Health Organisation.

 

6. References and Legislation

Applicable legislation	Annex I to PRO-AL001 Documentation Management
NP EN ISO 9001	Portuguese Standard – ISO 9001 Quality Management System
General Data Protection Regulation (GDPR)	European legislation that establishes a series of rules on personal data processing and free transfer, aimed at protecting data subjects.
Data Protection Act	National legislation that ensures the implementation of the GDPR.

 

7. Why does Alloga Logifarma collect your data?

• ALLOGA LOGIFARMA, S.A., a company with TIN 503.934.640 and registered office at Estrada Nacional 9, Km 17, 2709-504 Terrugem (Portugal) (hereinafter referred to as Alloga Logifarma) collects your personal data within the scope of its business as a pharmaceutical product distributor, for the following reasons:

• • the company seeks to ensure a high level of quality and safety concerning the medicinal products, medical devices and other distributed products, such as to comply with public health requirements; or
  • the company is contracted by the Marketing Authorisation (MA) Holders of medicinal products, medical devices or other products to provide Pharmacovigilance services.

 

8. Who is the data controller?

• The data controller may be either of the following entities:

• • Alloga Logifarma, when collecting personal data for purposes related to public health requirements and no pharmacovigilance services are provided to the MA Holder of the medicinal product, medical device or product to which the report pertains; or
  • The MA Holder, when Alloga Logifarma is contracted by the former to provide Pharmacovigilance services, involving the collection of personal data.

• You can request detailed information on the personal data controller through the contact information provided in Section 11.

 

9. Which personal data are collected?

• Alloga Logifarma may collect personal data from the Patient – the individual who has experienced or been affected by the adverse reaction – or the Reporter – the individual who reports the adverse reaction or complaint and submits the request for information.
• The personal data collected by Alloga Logifarma are those deemed necessary and appropriate for the purposes listed in the following table.

PURPOSE	DATA SUBJECT	DATA
Recording and reporting information concerning adverse reactions; and Recording and reporting complaints with an impact on product safety	Patient	·       Identification and contact details: name, telephone/mobile phone number, email; ·       Demographic data: gender, age; ·       Health data: relevant medical history, namely detailed information concerning the product that caused the adverse reaction, including the respective indication and dose, other medicines taken by the patient and other relevant details;
	Reporter	·       Identification and contact details: name, telephone/mobile phone number, email;
Recording and reporting medical information requests	Reporter	·       Identification and contact details: name, telephone/mobile phone number, email; ·       Professional data: profession.

 

• Alloga Logifarma may occasionally collect other personal data, in addition to those listed above, in order to ensure the provision of Pharmacovigilance services to the MA Holder of the medicinal product, medical device or product to which the report pertains.

 

10. How long are personal data retained?

• The retention period for personal data is determined based on the legitimate grounds on which they were collected:

• • Data collected by Alloga Logifarma to ensure compliance with public health requirements will be retained for as long as necessary to fulfil the intended purposes, as indicated in the following table:

PURPOSE	MAXIMUM RETENTION PERIOD
Recording and reporting information concerning adverse reactions	6 years (according to the Alloga Logifarma quality management system)
Recording and reporting medical information requests
Recording and reporting complaints with an impact on product safety

 

• • Data collected within the scope of provision of Pharmacovigilance services to any MA Holder will be retained throughout the service provision period and/or in accordance with the instructions of the latter.

 

11. How do we protect your personal data?

• Alloga Logifarma has implemented a series of technical and organisational security measures aimed at ensuring the confidentiality, integrity and availability of personal data.
• Your personal data will only be accessed by duly authorised employees of Alloga Logifarma.
• All employees of Alloga Logifarma have undertaken a commitment to confidentiality, in order to ensure that personal data are treated with the utmost secrecy.
• In order to protect your personal data, Alloga Logifarma uses data centre providers that implement adequate, documented security measures, namely by guaranteeing that personal data are stored on servers maintained in controlled environments, with restricted access.

 

12. When do we disclose data to third parties?

• Alloga Logifarma may disclose your data:

• • To the MA Holder of the medicinal product, medical device or product to which the report pertains, in order to enable them to undertake the necessary diligences to fulfil their Pharmacovigilance obligations;
  • To the Competent Authorities in the field of Pharmacovigilance, as instructed by the MA Holder.

 

13. How can you exercise your rights?

• According to the applicable legislation, you are entitled to exercise the following rights regarding your personal data, in accordance with and within the limits defined in the law:

ACCESS	Confirmation as to whether or not your personal data are being processed and, if applicable, access to your personal data.
RECTIFICATION	Rectification of inaccurate personal data and the right to have incomplete personal data completed.
ERASURE	Erasure of personal data in any of the situations specified in the legislation.
RESTRICTION OF PROCESSING	Restriction of processing in any of the situations specified in the legislation.
OBJECTION	Objection, at any time, to the processing of your personal data, or to being subject to decisions based solely on automated processing, including profiling.
PORTABILITY	Receiving your personal data, as provided to a controller, in a structured, commonly used and machine-readable format.

 

• In order to exercise the aforementioned rights, contact Alloga Logifarma at farmacovigilancia@alloga-logifarma.pt
• It should be noted that the aforementioned rights may be limited, since the MA Holder is required to comply with their pharmacovigilance obligations and Alloga Logifarma is required to fulfil its contractual obligations.
• You also have the right to submit a complaint to the competent supervisory authority (in Portugal, the National Data Protection Commission, at cnpd.pt)

 

14. Data transfers to non-EU countries

• If data are transferred to non-EU countries, namely to the MA Holder, Alloga Logifarma will ensure compliance with all legal regulations, in order to ensure the adequate protection of your personal data, namely by (i) transferring personal data to a country with data protection legislation similar to European legislation (with an adequacy decision in force); or (ii) ensuring the existence of appropriate guarantees, namely contractual clauses approved by the European Commission and, if necessary, additional data protection measures.

 

15. Changes to the Privacy Policy

• Alloga Logifarma reserves the right to make adjustments or changes to this Privacy Policy for Pharmacovigilance, at any time. All changes will be publicised.

16. Our contact details

• If you have any questions or doubts regarding Pharmacovigilance, contact us at farmacovigilancia@alloga-logifarma.pt
• If you have any questions or doubts regarding this Privacy Policy for Pharmacovigilance, contact our Data Protection Officer at privacidade@alloga-logifarma.pt.

 

17. Work Instructions

N/A

 

18. Templates and Archives

Code	Description	Person Responsible for Archiving	Duration of Archiving
N/A	N/A	N/A	N/A

 

19. Version History

Version	Change	Date
1	New Policy.	16 APR 2024