1. Which medicinal products require official batch release by the Official Medicines Control Laboratory (OMCL)?
Art 26 para 1 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) stipulates that, before bringing certain medicinal products, such as products made from human blood or blood constituents and vaccines, to the Austrian market, the respective batches must be released by an Official Medicines Control Laboratory (OMCL). In accordance with Ordinance 862 (Federal Gazette 271 dated 1994-11-09), the labelling of such products must include the phrase ‘Charge staatlich freigegeben’ (‘Batch released by OMCL’).
2. Are there any exemptions to the requirement of official batch release?
According to Art 26 para 4 AMG, an exemption to the batch release requirement is possible but has to be specifically applied for. The application for an exemption can be submitted at the time of submission of the application for marketing authorisation or afterwards within the lifecycle.
Please send the application for exemption from the requirement of batch release to hotline.euregulatoryagesat.
The application is assessed by the Department Regulatory Affairs of the Austrian Medicines and Medical Devices Agency (AGES). If needed, the applicant may be asked to submit additional documents and statements.
Requirements for a request for exemption from the requirement of batch release using the example of Human albumin:
- The Human Albumin has to be authorised in the EU / EEA.
- The batches of Human Albumin used have to be tested and approved by an OMCL (EU / (EEA ) . The approval by an OMCL will be verified by the Institute BGA (Assessment and Analytics).
- The traceability from plasma donor to the end product has to be granted over the whole shelf-life of the end product.
- If the manufacturer of Human Albumin is different from the manufacturer of the end product:
- an appropriate contract for traceability must be provided.
- In the case of recalls of Human Albumin batches, the manufacturer of
Human Albumin is obliged to inform the manufacturer of the end
product immediately about the recall and the reasons for it.
- The shelf life of Human Albumin and the final product should be synchronized (see Guideline on plasma-derived medicinal products EMA/CHMP/BWP/706271/2010). At least, Human Albumin shell not exceed a shelf life more than 5 years. In any case, no Human Albumin must be used if it is already expired at the time of addition.
Importation from a third Country:
- An application for marketability (Verkehrsfähigkeitsbescheinigung, § 12 AWEG) has to be applied for separately before import of each batch to Austria, please see http://www.basg.gv.at/arzneimittel/faq/arzneiwareneinfuhr/.
- All changes of the above mentioned conditions are subject to approval by the BASG. Otherwise, the licence for exception from the requirement of batch release will be deemed as cancelled.
If such an exemption to the batch release requirement is granted, Ordinance 862 (Federal Gazette 271 dated 9 November 1994) requires the labelling of the medicinal product to include the phrase ‘Charge verkehrsfähig’ (‘Batch marketable’). see also ""Bluebox requirements".
Created: 13.08.2012 | Page last modified: 18.11.2016