Konfidentsiaalsusleping

Confidentiality agreement

nr PER-20/255

21.04.2025

1. Parties to the Contract

The Estonian State Agency of Medicines (Agency), registration code 70003477, represented by

the Director General Katrin Kiisk, on the basis of the Statutes of the Medicines Agency, and

Lekha Pezhumkattil, GMDP Inspector for Austrian Medicines and Medical Devices Agency

performing work duties for the Estonian State Agency of Medicines on a temporary basis for a

joint inspection of a medicinal product manufacturer GMP licence as an observer (hereinafter

jointly referred to as the Parties), have concluded this Agreement as follows.

2. Subject of the Agreement

Pursuant to the Agreement, Lekha Pezhumkattil undertakes to ensure the confidentiality,

without time limitation, of the information and personal data intended for internal use which

are processed by the Agency or which come to his/her knowledge by chance within the Agency.

3. Obligations of the Parties

3.1. Lekha Pezhumkattil undertakes to keep confidential and not to disclose to third parties any

information that has come to its knowledge while performing work duties for the Estonian State

Agency of Medicines on a temporary basis for a joint inspection of a medicinal product

manufacturer GMP licence as an observer, or accidentally.

3.2. Lekha Pezhumkattil undertakes to comply with the organisational, physical and IT security

measures implemented by the Agency to protect the personal data processed against accidental

or intentional unauthorised alteration, accidental destruction, intentional destruction,

unauthorised access by unauthorised persons and unauthorised processing.

3.3 The obligation of confidentiality applies without time limitation.

4. Resposibility

4.1 A party who violates the requirements for the anonymisation of information intended for

internal use, the processing of personal data and confidentiality requirements arising from the

law or the contract shall be liable for such violation in accordance with the procedure laid down

by law.

4.2. The Party shall be liable for any breach of the law relating to data protection under the

Contract.

5. Confirmation by the Parties

The Parties confirm that they have read the terms and conditions of the Contract and understand

the nature of the obligations they undertake by entering into the Contract.

.......................................... ..........................................

Katrin Kiisk Lekha Pezhumkattil