DATA PROTECTION AND OWNERSHIP. In accordance with Article 35, para. 1, h) of the Delegated Regulation, the structure of the MVO Portugal National System shall be such as to guarantee the protection of Personal Data and information of a commercially confidential nature and the ownership and confidentiality of the data generated when the End User interacts with it, in accordance with Article 38 of the Delegated Regulation, as described below. As a principle, the Data contained in the EMVS belongs to the User who generates this Data when interacting with the EMVS (‘whoever creates the Data, owns the Data’). The EMVS shall hold the following data components: Static data (i.e., the information listed under Article 33, para. 2 of the Delegated Regulation); and Dynamic data i.e.,: the status of the unique identifier, i.e., active or de-commissioned. In case of ‘de-commissioned’ unique identifier, dynamic data also includes the detail, e.g. dispensed, recalled, stolen, etc.; and changes to the complete record ("Audit Trail") as referred to in Article 35, para. 1, g) of the Delegated Regulation, which contains a record of all operations concerning a unique identifier, of the Users performing those operations and the nature of the operations. As per the principle outlined above, dynamic data and static data contained in the EMVS belong to the operator who generates the Data when interacting with the system. This information must not be accessible for any other party, with exception of the static data and the information on the status of a unique identifier for the sole purpose of verification (Article 38, para. 1 of the Delegated Regulation) and without prejudice to the right of access by national competent authorities as provided for under Article 39 of the Delegated Regulation. Data generated by an End User’s own IT system (e.g., sales or transactional data, stock movements, pricing information, etc.) by electronic or manual means, or captured with the same, is exclusively owned and may be freely used without any restriction whatsoever by the concerned End User. For the avoidance of doubt, this means that pharmacists own the data generated by their own IT system, that wholesalers own the data generated by their own IT system, and that manufacturing and/or marketing authorisation holders own the data generated by their own IT system. Without any restriction whatsoever to the use of the data generated by an End User's own IT system as mentioned above, access to and/or use of any Data (static or d...
DATA PROTECTION AND OWNERSHIP. 10.1. In accordance with Article 35(1)(h) of the Delegated Regulation, the structure of the UKMVS shall be such as to guarantee the protection of Personal Data and information of a commercially confidential nature and the ownership and confidentiality of the data generated when the End User interacts with it, in accordance with Article 38 of the Delegated Regulation, as described below.
DATA PROTECTION AND OWNERSHIP. 8.1. In accordance with Article 35, para. 1, h) of the Delegated Regulation, the structure of the NCP National System shall be such as to guarantee the protection of Personal Data and information of a commercially confidential nature and the ownership and confidentiality of the data generated when the User and/or the IT Service Provider interacts with it, in accordance with Article 38 of the Delegated Regulation.
DATA PROTECTION AND OWNERSHIP. 9.1. In accordance with Article 35, para. 1, h) of the Delegated Regulation, the structure of the IMVS shall be such as to guarantee the protection of Personal Data and information of a commercially confidential nature and the ownership and confidentiality of the data generated when the End-User interacts with it, in accordance with Article 38 of the Delegated Regulation, as described below.
DATA PROTECTION AND OWNERSHIP. 10.1. In accordance with Article 35(1)(h) of the Delegated Regulation, the structure of the UK MVS shall be such as to guarantee the protection of Personal Data and information of a commercially confidential nature and the ownership and confidentiality of the data generated when the End User interacts with it, in accordance with Article 38 of the Delegated Regulation, as described below.
