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Personal Data Protection

Personal Data Protection

Select the Privacy Information below that is important to you, to read in more detail about the processing of your personal data by ALKALOID AD Skopje, as well as the manner of exercising your rights as an entity from which personal data are collected.

If you have any questions regarding our privacy notices or our privacy practices,

please contact our Corporate Data Protection Officer, Vesna Sokolovska, at dpo@alkaloid.com.mk

This privacy notice explains how ALKALOID AD Skopje (hereunder ALKALOID) as controller, processes and protects your personal data in the context of professional cooperation or correspondence if you belong to one of the following categories: 

  • Business partners, clients, or scholarship holders of ALKALOID 

  • Students from dual classes whose educational process includes practical teaching in ALKALOID, on a regular basis

  • Visitors to ALKALOID’s premises 

  • Hotel guests at the ALKALOID resort in Star Dojran 

  • ALKALOID Shareholders 

  • Persons who consented to the processing of their personal data for direct marketing or other purposes 

  • Respondents, associates, or other persons whose data is processed as part of clinical trials or during the preparation of a drug registration file 

  • Reporters of adverse drug reactions 

Retired Alkaloid employees

 

When processing personal data, ALKALOID fully complies with the principles of the Law on Personal Data Protection, as follows: 

 

  • Processes personal data lawfully, fairly, and in a transparent manner ("lawfulness, fairness and transparency") 

  • Collects personal data for specified, explicit, and legitimate purposes and not further processed in a manner that is incompatible with those purposes ("purpose limitation") 

  • Personal data is adequate, relevant, and limited to what is necessary in relation to the purposes for which it is processed ("data minimisation") 

  • Personal data is accurate and, where necessary, kept up to date, taking all appropriate measures to erase or correct inaccurate or incomplete data without delay, having regard to the purposes for which it is processed ("accuracy") 

  • Personal data is stored in a form that permits identification of data subjects for no longer than is necessary for the purposes for which the personal data is processed ("storage limitation") 

  • Personal data is processed in a manner that ensures appropriate security of the personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction, or damage, using appropriate technical or organisational measures ("integrity and confidentiality"). 

  • ALKALOID is not only responsible to comply with these principles but able to demonstrate that too ("accountability"). 

 

 

For more details about how ALKALOID processes your personal data, please click on the subheading below that corresponds to your data subject category. 

What is the legal basis for the processing of your personal data?

The legal basis for the processing of your personal data is a contract you are a party to or action taken on your request before signing a contract.

 

What is the purpose of the processing of your personal data?

Depending on the context of the cooperation, we may process your personal data for the purposes of planning, execution, management, and administration of a contractual relation with you, e.g., performance of a contract, your request from us to perform services under a contract we would have with you, making payments, or supporting any other purpose necessary to fulfil our contractual commitments.

 

What categories of personal data do we process?

Name and surname, personal identification number, passport number (for foreign natural persons), postal address, telephone number, email address, bank account number and degree of education.

How long do we keep your personal information? 10 years since the end of the business cooperation with you.


 

What is the legal basis for processing your personal data? 

The legal basis for processing your personal data is the fulfillment of an agreement concluded between your school and ALKALOID, on the basis of which ALKALOID is directly involved in your educational process through the organization and implementation of practical teaching.

 

What is the purpose of the processing of your personal data?

We process your personal data for the purposes of performing the contractual relationship with your school, i.e. for the purposes of conducting practical teaching organized by ALKALOID, as well as to pay you compensation in accordance with the assumed contractual obligations.

 

What categories of personal data do we process?

Name and surname, personal identification number, ID card number, postal address, private phone number, private email address, bank account number, date of birth/age, level of education.

How long do we keep your personal information?

10 years since the end of the practical teaching in ALKALOID.

What is the legal basis for the processing of your personal data?

The legal basis for the processing of your personal data is the legitimate interest of ALKALOID established through a test of legitimate interest.

 

What is the purpose of the processing of your personal data?

We process your personal data to prevent the entry of unauthorised and uninvited persons, to ensure the security throughout ALKALOID’S sites and facilities, the safety of our employees, and the assets and information located and stored on our premises.

 

What categories of personal data do we process?

Name and surname, ID card number, passport data (for foreign natural persons), vehicle registration plate number, general data for the department you visit, times of entry and exit, company you work for and your signature.

 

How long do we keep your personal information? 
3 years since the visit.


 

What is the legal basis for the processing of your personal data?

The legal basis for the processing of your personal data is compliance with a legal obligation under the Company Law.

 

What is the purpose of the processing of your personal data?

We process your personal data so you can exercise your right (for payment of dividends) under the Company Law.

 

What categories of personal data do we process?

Name and surname, residential address, personal identification number, bank account number, city and country, passport number, tax number in country of domicile, tax number in Republic of North Macedonia.

 

How long do we keep your personal information? 

Lasting value


 

What is the legal basis for the processing of your personal data?

The legal basis for the processing of your personal data is compliance with a legal obligation under the Law on Catering Activities and the Law on Foreigners.

 

What is the purpose of the processing of your personal data?

We process your personal data to keep a log of domestic and foreign guests at the accommodation facility of the ALKALOID-owned Star Dojran resort.

 

What categories of personal data do we process?

On domestic guests: Name and surname, ID card number, home address, place and date of birth.

On foreign guests: Name and surname, ID card number, type and number of travel document, place and country of birth, date and place of birth, and nationality.

 

How long do we keep your personal information? 

3 years of stay at the resort.

What is the legal basis for the processing of your personal data?

The legal basis for the processing of your personal data is the statement of consent to the processing for a specified purpose. You may withdraw your consent at any time. The withdrawal of consent will not impact the data processed before the withdrawal.

 

What is the purpose of the processing of your personal data?

We process your personal data for direct marketing, commercial research, planning of operations, to respond to your questions concerning our products and services, or for other purposes you have consented to.

 

What categories of your personal data do we process?

Depending on the context and purpose for collection, we may process the following personal data:

  • Contact details (name and surname, sex, private telephone number, business telephone number, home address (if necessary), email address, place of work)

  • Data related to education and profession (level of education, academic and professional qualifications)

  • Other information you opt to share with us (e.g., date of birth/age, number of children, consumer habits, etc.)
     

How long do we keep your personal information? 
Personal data collected on the basis of your consent is processed for the duration of the purposes for which the consent was given or until the consent is withdrawn. Consent may be withdrawn at any time. Withdrawal of consent will not affect data processed prior to withdrawal of consent.

What is the legal basis for the processing of your personal data?

The legal basis for the processing of your personal data during clinical trials is compliance with legal obligations under the Law on Drugs and Medical Devices, the Guidelines for the Principles of Good Clinical Practice, and the Law on Personal Data Protection related to the processing of special categories of personal data.

 

What is the purpose of the processing of your personal data?

We process your personal data to keep drug registration files, to comply with the Law on Drugs and Medical Devices and the Guidelines for the Principles of Good Clinical Practice.

 

What categories of your personal data do we process?

Depending on the category of the data subject (whether a participant in clinical research or medical professional, expert, etc.), we process the following data: name and surname, knowledge of languages, sex, CV/biography/work experience, home address, business phone number, place of birth, date of birth/age, level of education, place of work, physical appearance (weight and height), racial background, health/medical data.

 

How long do we keep your personal information? 
10 years after the date of delisting of the portfolio registration file.


 

What is the legal basis for the processing of your personal data?

The legal basic for processing your personal data when reporting adverse drug reactions is the compliance with a legal obligation under the Law on Drugs and Medical Devices, the Guidelines on the manner of reporting, the content of the adverse drug reaction reporting form, and the organization of the pharmacovigilance system, as well as in accordance with the provisions of the Law on Personal Data Protection relating to the processing of special categories of personal data.  

 

What is the purpose of processing your personal data?

The personal data we receive in connection with reports of adverse drug reactions is processed exclusively for the purpose of monitoring adverse reactions, ensuring that each reported reaction is properly documented, assessed, and reported in compliance with legal obligations, for the purpose of identifying and preventing adverse reactions or other risks associated with the use of medicinal products.

 

What categories of your personal data do we process?

Name, surname, phone number, email address, residential address, date of birth, sex, age and occupation of the person filling out the form.

Images/photographs (related to adverse drug reactions), as well as information related to the health and medical history of the subject - the user of the medicine - may also be collected, if necessary for the processing of adverse reaction data, in order to fulfil legally prescribed pharmacovigilance obligations.

 

How long do we keep your personal data?

At least 10 years after the withdrawal of the medicinal product or medical device from the market, or at least 10 years after the termination of the pharmacovigilance system.

What is the legal basis for processing your personal data?

The legal basis for processing your personal data is your consent and ALKALOID’s legitimate interest, determined on a legitimate interest test.

 

What is the purpose of processing your personal data?

The purpose is to express ALKALOID’s concern about you, our retired colleagues, recognizing your contribution to the growth of our company by implementing many social responsibility activities.

 

What categories of your personal data do we process?

Name and surname, residential address, contact telephone number, year of birth, and year of retirement.

 

How long do we keep your personal data? 

We process the personal data collected with your consent for the duration of the purpose for the consent or until the consent is withdrawn. You may withdraw the consent at any time. The withdrawal of consent will not affect the data processed before its withdrawal.

If the consent is not withdrawn or the legal basis is a legitimate interest, we will keep it for ten years.

To achieve the purpose for collecting your personal data, depending on your subject category the access is limited to:

  • ALKALOID employees who need to receive the data to achieve the purpose of collection
  • Banks, to be able to make a payment
  • Competent authorities of the Republic of North Macedonia or other competent EU or non-EU agencies (including regulatory agencies) to whom ALKALOID is obliged to send your personal data to, based on legal requirements, or based on a court order or other official legal requirement.
  • Certain companies from the Republic of North Macedonia or the European Union that ALKALOID has engaged to perform auxiliary data processing activities. All these companies are under contractual obligations with ALKALOID to protect the data secrecy, to act according to ALKALOID’s directions, and in compliance with applicable data protection regulations. The company will take care of the confidentiality and the duty to keep a commercial secret. If the company processes your personal data based on your consent, its withdrawal shall apply to the respective companies too.
  • Under certain circumstances, when executing regulatory procedures set by laws outside of the Republic of North Macedonia (registration of a drug), our business partners may have access to your personal data within the limits set by law. We may transfer your personal data to an EU or EEA (European Economic Area) member country and outside of the EU if such transfer is necessary for the public interest or in compliance with local regulatory procedures (registration of a drug) of a specific country.
  • Legal representatives for the execution of legal proceedings.

ALKALOID guarantees that you will be able to exercise your legal rights concerning the processing of your personal data. At any time, you can ask ALKALOID for the following rights:

 

Right to access – right to request access to your personal data, i.e., to be informed about the data processed about you and check if it is accurate and up to date.

 

Right to rectification – if you find out your personal data we process is inaccurate or incomplete, you have the right to request that it is rectified

 

Right to erasure – right to request that we erase your personal data under certain conditions set by law

 

Right to restriction of processing – right to request that we restrict the processing of your personal data under certain conditions set by law

 

Right to data portability – right to receive your personal data in a structured, commonly used, and machine-readable format and to transmit it to another processor without ALKALOID obstructing.

 

Right to object – right to object for a specific situation if the processing of your personal data is based on legitimate interest or for direct marketing or profiling related to direct marketing under certain conditions set by law, and

 

Right to withdraw consent – at any time, you have the right to withdraw your consent to the use of your personal data. The withdrawal of consent will not affect the lawfulness of processing based on consent before its withdrawal

 

If you wish to exercise the above rights derived from the Law on Personal Data Protection, please click on the following link, complete the appropriate form and send it to us by email or post at the address listed below.

If you have any questions you can write to us at any time at the following address:

 

Alkaloid AD Skopje

Blvd. Aleksandar Makedonski no. 12

1000 Skopje

to the attention of the Data Protection Officer

 

or

 

to the email address of the Data Protection Officer at: dpo@alkaloid.com.mk

 

To answer your questions, please provide the following information:

 

Your reference and interaction with us and description of the request/information you need from us.

If you think Alkaloid has processed your personal data contrary to the Law on Personal Data Protection or that some of your data protection rights have been violated, you may file a request to examine the violation with the Personal Data Protection Agency.

PERSONAL DATA PROTECTION IN ALKALOID KONS

Please select the privacy information that is important to you to read in more detail about the processing of your personal data by ALKALOID KONS DOOEL Skopje and how to exercise your rights as a personal data subject. If you have any questions regarding our privacy notices or practices, please contact our Personal Data Protection Officer at dpokons@alkaloid.com.mk.

This Privacy Notice details how ALKALOID KONS DOOEL Skopje (hereinafter referred to as "ALKALOID KONS"), as the Controller, processes and safeguards your personal data in the context of business cooperation or communication if you belong to the following categories of entities:

· Associates of ALKALOID KONS

· Medical professionals who have given their consent to the processing of their personal data for direct marketing or other purposes

· Reporters of adverse drug reactions.

 

When processing personal data, ALKALOID KONS fully adheres to the principles prescribed in the Law on Personal Data Protection, including:

· Processing personal data lawfully, fairly, and transparently (“lawfulness, fairness, and transparency").

· Collecting personal data for specific, explicit, and legitimate purposes and not processing them in a manner incompatible with those purposes ("purpose limitation").

· Ensuring that personal data is adequate, relevant, and limited to what is necessary for the purposes for which it is processed ("data minimization").

· Ensuring that personal data is accurate and, where necessary, updated by taking appropriate measures to promptly correct or erase incorrect or incomplete data, considering the purposes for which it is processed ("accuracy").

· Storing personal data in a form that allows for identifying the data subjects for no longer than necessary for the purposes for which it is processed ("storage limitation").

· Processing personal data to ensure an appropriate level of security, including protection against unauthorized or unlawful processing, as well as accidental loss, destruction, or damage, by applying appropriate technical and organizational measures ("integrity and confidentiality").

· ALKALOID KONS is not only obligated to comply with these principles but also to demonstrate that compliance. ("accountability").

 

To learn more about how ALKALOID KONS processes your personal data, please select the appropriate subheading based on your category as a personal data subject.

What is the legal basis for processing your personal data?

The processing of your personal data is based on fulfilling a contract in which you appear as a contracting party or undertaking activities at your request before entering into a contract.

 

What is the purpose of processing your personal data?

Depending on the context of our cooperation, we may process your personal data for planning, executing, managing, and administering the contractual relationship with you. For instance, we may use your personal data to fulfil a contract, request your service in accordance with the agreement we have with you, make payments, or provide support for any other purpose necessary for the performance of our contractual obligations.

 

What categories of personal data do we process for you?

We process your name, surname, personal identification number, passport number (if you are a foreign national), postal address, telephone number, email address, and current account number.

 

How long do we keep your personal data?

Ten years from the end of our business cooperation with you.


 

What is the legal basis for processing your personal data?

We process your personal data based on your statement of consent for processing for a specific purpose. You have the right to withdraw your consent at any time, and this withdrawal will not affect any data processed prior to the withdrawal.

 

For what purpose do we process your personal data?

We process your personal data for the purposes of direct marketing, commercial research, work planning, answering your questions related to our products and services, or for any other purposes for which you have given your consent.

 

What categories of personal data do we process for you?

Depending on the context and purposes for which personal data is collected, we may process the following personal data:

Contact details such as your name, surname, gender, private and official phone numbers, private and official email addresses, and your place of work.

Data on your education and profession, such as your level of education, academic and professional qualifications.

 

How long do we keep your personal data?

The personal data we collect based on your consent will be processed for the duration of the purposes for which the consent was given or until you withdraw your consent. You have the right to withdraw your consent at any time, and this withdrawal will not affect any personal data processed prior to the withdrawal.

What is the legal basis for processing your personal data?

The processing of your personal data when you report adverse drug reactions, is based on fulfilling a legal obligation according to the Law on Medicines and Medical Devices, the Rulebook on the method of reporting, the content of the form for reporting adverse drug reactions and the way of organization of the system of pharmacovigilance. The processing is also carried out in accordance with the provisions of the Law on Personal Data Protection related to the processing of special categories of personal data.

 

For what purpose do we process your personal data?

We process your personal data that we receive in connection with reports of adverse drug reactions solely to monitor adverse reactions. It allows us to properly document, evaluate, and report each adverse reaction under legal obligations. By doing so, we aim to identify and prevent adverse reactions or other risks associated with using medicines.

 

What categories of personal data do we process for you?

The personal data we process include the name, surname, telephone number, email address, country of residence, date of birth, gender, age, and profession of the reporting subject.

In some cases, we may also collect images/photographs related to adverse drug reactions, as well as information related to the health and medical history of the subject - the drug user - if this is necessary to fulfil legal requirements and obligations for pharmacovigilance.

 

How long do we keep your personal data?

At least 10 years after the withdrawal of the drug or medical device from the market.


 

Access to your personal data is limited to the following entities or categories of users, depending on your category and to achieve the purpose for which the personal data was provided:

 

ALKALOID KONS employees who need to access the data to achieve the intended purpose;

 

Banking institutions to facilitate payment processing;

 

Competent state authorities in the Republic of North Macedonia to which ALKALOID KONS is required to submit your personal data based on a legal obligation arising from applicable regulations or in response to a court or other official request based on the law;

The manufacturers with whom ALKALOID KONS has concluded agreements nd whose products it distributes;

 

ALKALOID AD Skopje, which ALKALOID KONS engages to perform data processing activities, and other companies acting as processors. Each such company is contractually obliged by ALKALOID KONS to protect the confidentiality of the data and act according to the instructions of ALKALOID KONS, and following applicable personal data protection legislation. Processors are bound by confidentiality and the obligation to maintain trade secrets;

 

Legal representatives to conduct legal proceedings.


 

ALKALOID KONS ensures that all your legal rights regarding the processing of your personal data are respected. You have the following rights that you can exercise at any time by contacting ALKALOID CONS:

 

Right of access – the right to request access to your personal data, receive information about the data being processed, and check its accuracy and completeness;

 

Right to rectification – the right to request the correction of any inaccurate or incomplete personal data;

 

Right to erasure – the right to request the erasure of your personal data under certain circumstances prescribed by law;

 

Right to restriction of processing – the right to request the limitation of processing under certain circumstances prescribed by law;

 

Right to data portability – the right to receive your personal data in a structured, commonly used, and machine-readable format and transfer it to another data controller without obstructions by ALKALOID KONS;

 

Right to object – the right to object based on a specific situation if your personal data is being processed for purposes of legitimate interest or direct marketing, including profiling related to direct marketing, under certain conditions prescribed by law; and Right to withdraw consent – the right to withdraw your consent to the processing of your personal data at any time. The withdrawal of consent does not affect the legality of the processing that was based on your consent before its withdrawal.

 

To exercise your rights, under the Law on Personal data Protection please fill out the appropriate form at the following link and send it to ALKALOID KONS via email or the postal address below.

If you have any additional questions, you may contact us at the following address:

 

ALKALOID KONS DOOEL

Blvd. "Aleksandar Makedonski" no. 12

1000 Skopje

Attn: Personal Data Protection Officer

 

Alternatively, you may email the Personal Data Protection Officer at dpokons@alkaloid.com.mk. 

 

To assist us in providing an appropriate response, please include the following information:

 

Your relationship and interaction with us, and Description of the request/information you would like to receive from us.

 

If you believe that the processing of your personal data by ALKALOID KONS does not comply with the provisions of the Law on Personal Data Protection, or if you believe that any of your rights to the protection of personal data have been violated, you have the right to file a complaint for determination of the violation of the regulations for the protection of personal data through the Personal Data Protection Agency.