OCABR of human blood products and vaccines

Vaccines and blood products are complex biological medicinal products administered to healthy individuals and sensitive patients. To monitor the quality of these medicinal products and ensure the safety of the Norwegian population, the Norwegian Medical Products Agency (NOMA) participates in a European network for independent authority testing of vaccines and blood products. These biological medicinal products are controlled before they are used.

The collaboration involves Official Control Authority Batch Release (OCABR), which consists of an assessment of the manufacturer’s production and control protocol as well as laboratory testing of samples provided by the manufacturer for the current batch. The control authority then issues an OCABR certificate when it is shown that the batch is in compliance with the specifications for the medicinal product. NOMA performs OCABR for human vaccines.

Release to the Norwegian market

Before a batch of a vaccine or blood product for humans can be released to the Norwegian market, the marketing authorization holder must submit an application for release to NOMA.

The application must include*:

1. Official Control Authority Batch Release (OCABR) certificate.
2. Marketing Information Form (MIF), completed in accordance with the administrative guideline from the administrative guideline from European Directorate for the Quality of Medicines and Healthcare
   • Note that the number of doses for the Norwegian market must be clearly stated.
   • If the MIF indicates the number of doses for multiple countries (e.g., Scandinavia), the applicant must specify in a cover letter/email how many doses are being applied for the Norwegian market.
3. A copy of a satisfactory control report (Certificate of Conformance (CoC) or equivalent documentation referred to in Article 51(1) of Directive 2001/83/EC) that should be accompany the medicinal product when it comes from an EEA country to Norway (ref. the Norwegian wholesaler regulations §9, cf. EU-GDP point 5.4). Alternatively, the application should include a copy of the outer packaging material (all sides of the carton for the current batch) or a sample of the outer packaging material.
   • The CoC or equivalent documentation should preferably be sent together with the application for national release, or provided after approval.

*Contact NOMA for the procedure for parallel import.

Notification of approval

The batch is released for marketing within 7 working days after complete documentation is received. The release of the batch will be notified to the applicant by email.