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

PIN procedure setup:

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