Source: https://www.basg.gv.at/en/companies/medicinal-products/batch-release
Timestamp: 2020-07-14 20:17:17
Document Index: 10596846

Matched Legal Cases: ['§26', '§26', '§16', '§8', '§16', '§26', '§ 26']

Batch release - BASG
What is batch release? Who must apply for batch release? Which medicinal products are concerned? How is the procedure for receipt of a batch release certificate? Forms Special Services to Shorten and Simplify Batch Release Regulatory framework Fee Regulation
What is batch release?
Who must apply for batch release?
Which medicinal products are concerned?
How is the procedure for receipt of a batch release certificate?
Special Services to Shorten and Simplify Batch Release
For certain proprietary medicinal product, Official Control Authority Batch Release (OCABR) must be obtained from the Austrian Official Medicinal Control Laboratory (OMCL) before they can be placed on the market.
For proprietary medicinal products approved in Austria, batch release certificates from other OMCLs within the EU/EEA countries and Switzerland may also be recognised if the approval in the country of release is in accordance with the Austrian product specification.
The following proprietary medicinal products intended for human use are covered by these provisions:
Medicinal specialities prepared using human blood or blood plasma as a starting material
Immunological medicinal specialities consisting of vaccines, toxins, sera or allergens, in so far as these are
medicinal products used for the primary immunisation of young children or other risk groups
medicinal products used in immunisation programmes in the context of public health; or
medicinal products which are newly authorised or produced by means of novel techniques or which are new to a particular manufacturer. These proprietary medicinal products shall be subject to batch release for a transitional period to be determined. These medicinal specialities must be approved by the Federal Office for Safety in Health Care by official decision.
The batch release requirement also applies to medicinal specialities intended for use on or in animals, provided that they are immunological medicinal specialities consisting of vaccines, toxins, sera or allergens and are intended for the prevention of notifiable animal diseases in accordance with the Animal Diseases Act.
Companies with autorisation from the BASG to produce, control, sale and distribute Medicinal Products
Companies which are approved contract partners with the EWR to produce, control, sale and distribute Medicinal Products
Importeurs of Medicinal Products (especially for clinial trails)
§26 of 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, if they are
life vaccines,
medicinal products used for primary immunisation 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 authorisation 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.
§26 (2) of 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).
If a batch shall be marketed the applicant submits the application form together with the complete protocol and enough sample material for testing at the OMCL.
Subsequently all required parameters are tested accordingly to the product specific OCABR guidelines at the laboratory. The completeness and validity of the submitted batch protocol will be reviewed by an assessor according to the marketing authorization.
After receipt of the complete application, compliant test results and assessment a batch release certificate is granted.
Contact persons Batch Release (L_L320)| 43 KB
Form: Application for Batch Release for an Auxiliary Product / Excipient (F_L366)| 43 KB
Form: Application for Batch Release (F_L379)| 42 KB
Form: Application for Batch Release for Ancillary Medicinal Products derived from Human Blood or Plasma in a Medical Device (F_L380)| 44 KB
Form: Marketing information form (F_L381)| 44 KB
Because of constant improvement, increasing automation of processes and growing customer satisfaction the number of batch release procedures doubled since 2006.
Released Products 2006-2018 (diagram)
The applicant can first hand in samples and later on the batch protocol when testing is completed. Batch release will usually be performed within one working day.
e-Submission of Application
Protocols can be simply submitted by e-mail or fax.
Certificates for Auxiliaries & Excipients
Protocols for excipients can be handed in without samples for testing. Certificate are granted free of charge.
e-Transmission of Release Certificates
Certificates are sent by e-mail or fax before they are sent postal to shorten the time to marketing for the applicants.
Export certificates are granted for products intended for marketing outside the EU.
Meetings with Applicants
Periodical Meetings concerning process improvements are held upon request.
OCABR Guidelines human
OCABR Guidelines veterinary
Clinical trial according to Medicinal Act §8
Notifiable disease according to Austrian Animal Diceases Act §16
Batch release according to Medicinal Act §26
Fee Regulation (VI. Batch testing pursuant to § 26 AMG)
Page last modified: 19/03/2018