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

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

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 to the marketing of VMPs in Romania.

Setting up the PIN procedure:

1. Submission of the letter of intent (at least 14 days before the start of the procedure)
2. Submission of the technical documentation (TD) / Authorization request (see TD = part 1 - administrative information). The submission of the TD and its electronic structure is done in accordance with VET eSubmission, CESP (Common European Submission Portal)
3. The national independent procedure (PIN) for VMP authorization lasts 210 days from the submission of a valid application.
4. For all valid applications for which day 0 has been established, the TD evaluation of the VMP is carried out.
5. Verification of the 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; samples are submitted by the applicant to the ICBMV headquarters or sent by courier), to ensure that 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 requests, as applicable, ICBMV may request additional information to complete the TD; the previously specified period (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 TD 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 TD. The authorization procedure benefiting 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 veterinary reagents and diagnostic kits must be notified in writing to the Institute for the Control of Biological Products and Veterinary Medicines. The notification in the case of import/export and intra-community trade of veterinary reagents and diagnostic kits shall be made by the importer, exporter, or, as the case may be, 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 diagnostic kits. The Institute for the Control of Biological Products and Veterinary Medicines is required to record in the REGISTER OF NOTIFICATIONS of import/intra-community trade operations with veterinary reagents and diagnostic kits all import/export and intra-community trade operations with veterinary reagents and diagnostic kits that are notified.

Indigenous producers of reagents/diagnostic kits for veterinary use can manufacture these products only after obtaining the manufacturing authorization issued by the Institute for 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 issuance.

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

The marketing authorization (MA) is the document issued by the Institute for 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 product samples to be analyzed. The holder of the marketing authorization is responsible for the marketing of the products and is obliged to notify in writing the Institute for 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 verification of the technical documentation, laboratory testing, and checking the diagnostic value, it is found that these do not comply with the provisions of this veterinary sanitary regulation.