Commentaries: Art. 31

TSPs and PDCSs with more extensive information (Art. 22) or surveillance duties (Art. 52) shall in accordance with Article 33 paragraph 1 SPTA provide proof of their ability to provide information and conduct surveillance.
Proof is provided if:
1. the tests that must be conducted in accordance with PTSS requirements have been successfully completed; and
2. the provider confirms in a questionnaire drawn up by the PTSS it meets the requirements in relation to standardised information and surveillance activities that cannot be proven by testing.
The PTSS shall ensure that it conducts the verification process promptly and does not cause any delay in market introduction. To do so, it shall carry out the following tasks:
1. It shall check the results of the tests in accordance with paragraph 2 letter a.
2. It shall evaluate the questionnaire in accordance with paragraph 2 letter b.
3. It shall keep a record of the test procedures.
4. It shall issue the providers with confirmation in accordance with Article 33 paragraph 6 SPTA.
5. It shall retain the records for as long as the confirmation remains valid and for ten years after its expiry.
The PTSS shall state in the confirmation that the provider has proven its ability to provide certain types of information and conduct certain types of surveillance activities.