Institute for the Control of Biological Products and Veterinary Medicines Icbmv*

The procedure applies to the control of reagents/diagnostic kits in the procedures of authorization, re-authorization, modification, and batch control.

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)

Any operation regarding intra-community trade and the import/export of reagents and veterinary diagnostic kits must be notified in writing to the Institute for the Control of Biological Products and Veterinary Medicines. Notification in the case of import/export and intra-community trade of reagents and veterinary diagnostic kits is made by the importer, exporter, and, as appropriate, by the economic operator within 24 hours from the receipt of the products in a veterinary pharmaceutical warehouse authorized for the distribution of veterinary medicinal products, reagents, and veterinary diagnostic kits. The Institute for the Control of Biological Products and Veterinary Medicines is obliged to enter in the REGISTER OF NOTIFICATIONS of import/intra-community trade operations with reagents and veterinary diagnostic kits all notified operations of import/export and intra-community trade with reagents and veterinary diagnostic kits.

Indigenous manufacturers of reagents/diagnostic kits for veterinary use may manufacture these products only after obtaining the manufacturing authorization issued by the Institute for the Control of Biological Products and Veterinary Medicines. The manufacturing authorization is issued for each reagent and diagnostic kit for veterinary use and is valid for 5 years from the date of issue.

Any modification of the documentation based on which the manufacturing authorization was issued must be notified within 30 calendar days to the Institute for the Control of Biological Products and Veterinary Medicines for the purpose of updating the manufacturing authorization.

The marketing authorization (MA) is the document issued by the Institute for the Control of Biological Products and Veterinary Medicines, which allows the circulation, marketing, and use of veterinary reagents and diagnostic kits on the territory of Romania and is valid for 5 years from the date of issue. The marketing authorization may be granted to a legal entity with a registered office in Romania or in another member state of the European Union. The marketing authorization is issued within a maximum of 90 working days from the date of submission of the complete technical documentation and the product samples to be analyzed. The marketing authorization holder is responsible for the marketing of the products and is obliged to notify in writing the Institute for the Control of Biological Products and Veterinary Medicines of any information and data that arise after the issuance of the marketing authorization.

The marketing authorization is not granted if, after checking the technical documentation, laboratory testing, and verification of the diagnostic value, it is found that they do not comply with the provisions of this veterinary sanitary norm.