Purpose of the procedure: The procedure (PIN) applies to valid national authorization requests for VMPs that have not received a marketing authorization (MA) in the EU and is limited only for marketing VMPs in Romania.

PIN procedure setup:

1. Submission of the letter of intent (at least 14 days before the start of the procedure)
2. Submission of the technical documentation (DT) / Authorization request (see DT = part 1 - administrative information). Submission of the DT and its electronic structure is done in accordance with VET eSubmission, CESP (Common European Submission Portal)
3. The independent national procedure (PIN) for the authorization of VMPs lasts 210 days from the submission of a valid request.
4. For all valid requests for which day 0 has been established, the DT of the VMP is evaluated.
5. Verification of control methods used by the manufacturer and described in the quality specifications of the finished product (samples of the finished product presented in the packaging in which they are to be marketed, in the necessary quantities; the samples are submitted by the applicant at the ICBMV headquarters or sent by courier), to ensure they are appropriate, according to Art 46³ (2) of Order 187/2007, with subsequent additions and amendments.
6. In the case of non-compliant/incomplete applications, as applicable, ICBMV may request additional information to complete the DT, the previously specified term (210 days) is suspended ("stop clock" period) until the requested additional data is provided; the response time to ICBMV requests is 30 days from the date of notification;
7. The maximum suspension period during the DT evaluation procedure is 6 months. If this period is exceeded, the authorization request is rejected, and the applicant is notified regarding the return of the DT. The authorization procedure that benefited from the maximum suspension period of 6 months (182 days) is completed after 210 days + 182 days ("stop clock" period) = 392 days.
8. Issuance of the marketing authorization (MA)