Verification of unit level UIs
Article 7
1. Manufacturers and importers shall ensure that the application of unit level UIs is directly followed by the verification of those unit level UIs in terms of correct application and readability. 2. The process referred to in paragraph 1 shall be protected with an anti-tampering device supplied and installed by an independent third party who shall provide a declaration to the relevant Member States and the Commission that the installed device meets the requirements of this Regulation. 3. Where the process referred to in paragraph 1 fails to confirm the correct application and full readability of the unit level UI, manufacturers and importers shall re-apply the unit level UI. 4. Manufacturers and importers shall ensure that the information recorded by the anti-tampering device remains available for a period of nine months from the time of recording. 5. Manufacturers and importers shall, upon request from Member States, provide full access to the record of the verification process created by the anti-tampering device. 6. By way of derogation from paragraphs 2, 4 and 5, the obligation to install an anti-tampering device shall not apply: (a) until 20 May 2020 to production processes operated by economic operators, or where applicable, the group of undertakings to which they belong, that handled less than 120 million unit level UIs at Union level during the calendar year 2019; (b) until 20 May 2021 to production processes operated by economic operators falling under the definition of small and medium enterprises set out in Commission Recommendation 2003/361/EC ( 6 ) ; (c) to fully manual production processes.