The EC administrative procedure for Official control authority batch release is a guideline for the administrative procedure to be followed by the competent OMCL authorities for the implementation of Directive 2001/83/EC Article 114 as amended by Directive 2004/27/EC and published by the European Directorate for the Quality of Medicines & HealthCare (EDQM). The procedure for release to the Norwegian market is also in accordance with the Norwegian Regulation relating to medicines, see regulation §8-9.
The request for marketing of a batch of a blood product or a vaccine for human use to the Norwegian marked should include:
- A copy of the Official Control Authority Batch Release (OCABR) Certificate for the batch.
- The Marketing Information Form (MIF) filled in (in accordance with the administrative guideline). Note that the number of doses for the Norwegian market should be clearly given. 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 total doses for the Norwegian market in the cover letter.
- A copy of the control report (Certificate of Conformance (CoC) or equivalent referred to in Article 51(1) of Directive 2001/83/EC) that is 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 copy of 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. This e-mail has to be marked with our case number for the application. Alternatively the request should include a copy of the outer packaging (all sides of the actual box) or a sample of the packaging of the batch which is to be marketed in Norway.
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. Applicant will be notified about release of the batch by e-mail.