Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the... (32021R0016)
Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database)
- COMMISSION IMPLEMENTING REGULATION (EU) 2021/16
- of 8 January 2021
- laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database)
- SECTION 1
- GENERAL PROVISIONS
- Article 1
- Definitions
- Article 2
- Development, maintaining and upgrading of the Union product database
- Article 3
- Submission of information on veterinary medicinal products by the competent authorities for the initial input to the Union product database
- Article 4
- Timelines for the submission for the initial input of data on various types of veterinary medicinal products
- Article 5
- Order of precedence
- SECTION 2
- TECHNICAL SPECIFICATIONS OF THE UNION PRODUCT DATABASE
- Article 6
- User interface
- Article 7
- Components
- Article 8
- Functionalities of the Union product database
- Article 9
- Electronic data and document exchange mechanism for exchanging with other systems
- Article 10
- Format for electronic submission to the Union product database
- SECTION 3
- PRACTICAL ARRANGEMENTS FOR THE FUNCTIONING OF THE UNION PRODUCT DATABASE
- Article 11
- Protection of commercially confidential information
- Article 12
- Security of exchange of information
- Article 13
- Access policy for super users and controlled users
- Article 14
- Access for the general public
- SECTION 4
- DETAILED SPECIFICATIONS OF THE INFORMATION AND DATA TO BE INCLUDED, UPDATED AND SHARED IN THE UNION PRODUCT DATABASE
- Article 15
- Detailed specifications of the information to be included, updated and shared
- Article 16
- Information referred to in Article 55(2) of Regulation (EU) 2019/6
- Article 17
- Data to be included in the Union product database in addition to the information referred to in Article 55(2) of Regulation (EU) 2019/6
- Article 18
- Responsibilities for including, updating and sharing information
- Article 19
- Union Product Database Functionalities Enabling Post-Authorisation Changes to Product Data
- SECTION 5
- CONTINGENCY ARRANGEMENTS TO BE APPLIED IN CASE OF UNAVAILABILITY OF ANY OF THE FUNCTIONALITIES OF THE UNION PRODUCT DATABASE
- Article 20
- Contingency arrangements in case of failure or unavailability of the Union product database
- Article 21
- ANNEX I
- Functionalities of the Union product database
- ANNEX II
- Data fields to record the information referred to in Article 55(2) of Regulation (EU) 2019/6
- ANNEX III
- Data fields to be included in the Union product database in addition to the information referred to in Article 55(2) of Regulation (EU) 2019/6
Feedback