Sideinnhold
The Norwegian Medicines Agency (NoMA) follows the EU administrative procedure for Official Control Authority Batch Release.
Vaccines and blood products are complex biological medicinal products that are given to both healthy people and patients. To monitor the quality of these medicinal products and to ensure the safety of the Norwegian population, the NoMA participates in a European network for independent official testing of vaccines and blood products before the product batches are placed on the market.
Batch release for the Norwegian market
The marketing request of a blood- or vaccine product batch for human use to the Norwegian, marked should include*:
- The Official Control Authority Batch Release (OCABR) Certificate for the batch.
- A completed Marketing Information Form (MIF) in accordance with the administrative guidelines.
- Note that the number of doses for the Norwegian market should be clearly stated.
- If the MIF states the number of doses to be shipped to several countries (e.g. for Scandinavia), the applicant must provide additional information on the total number of doses for the Norwegian market in the cover letter.
- The control report (Certificate of Conformance (CoC) or equivalent referred to in Article 51(1) of Directive 2001/83/EC) issued for the batch of medicinal product coming from a Member State to Norway (in accordance with the Norwegian Regulation on Distribution and Wholesaling of Medicinal Products §9, ref EU-GDP section 5.4) should be provided.
The CoC or another proof of release to the Norwegian market, should preferably be provided together with the application of batch release, or be provided by e-mail after approval. Alternatively, the request should include a copy of the outer packaging (all sides of the actual box) of the batch to be marketed in Norway.
*In case of parallel import of vaccines and blood products, please contact NoMA for procedure.
Notification of approval
The OCABR procedure is followed, and if all documentation is acceptable, the batch will be released for marketing within 7 working days of receiving the complete documentation. The applicant will be notified about the batch release by e-mail.
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