§ 26 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) stipulates that, before bringing certain medicinal products to the Austrian market, the respective batches must be released by an Official Medicines Control Laboratory (OMCL).
The Austrian Medicines Act requires batch release for the following medicinal products for human use:
- Medicinal products that were produced using human blood or blood plasma as source material, as well as
- immunological medicinal products consisting of vaccines, toxins, sera or allergens, as far as they are
- life vaccines,
- medicinal products used for primary immunization of infants or other risk groups,
- medicinal products used within the scope of immunization programs of the public health sector,
- or medicinal products with a new marketing authorization or produced by a novel technique or a technique that is novel for a specific manufacturer. These medicinal products are subject to batch release for a specified transition period.
The Austrian Medicines Act requires batch release for immunological medicinal products for veterinary use: vaccines, toxins, sera or allergens used for defence against notifiable epizootic diseases according to §16 Act on epizootic diseases (Tierseuchengesetz RGBl. Nr. 177/1909).
In accordance with Regulation on labelling of medicinal products 2008 § 46(2), the labelling of such products must include the phrase ‘Charge staatlich freigegeben’ (‘Batch released by OMCL’).
Information regarding procedure of 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.
For plasma-derived medicinal products the application for an exemption from the requirement of batch release has to be in line with the “Guideline on plasma-derived medicinal products” EMA/CHMP/BWP/706271/2010.
Requirements for a request for exemption from the requirement of batch release using the example of Human albumin:
- Name and marketing authorisation number of the product have to be stated as well as the country (EU / EEA) where the Human Albumin is authorised.
- The batches of Human Albumin used have to be tested and approved by an OMCL (OCABR list).
- If applicable submission of the PMF certificate
- 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 have to be synchronized.
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.euregulatorybasg.gvat.
If such an exemption to the batch release requirement is granted, Regulation on labelling of medicinal products 2008 § 46(2) requires the labelling of the medicinal product to include the phrase ‘Charge verkehrsfähig’ (‘Batch marketable’).
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.
An application for marketability (Verkehrsfähigkeitsbescheinigung, § 12 AWEG) has to be applied for separately before import of each batch to Austria.