‫ המכון לביקורת ותקנים של חומרי רפואה‬Official release of a batch form
2 ‫ מתוך‬1 ‫עמוד‬
EX-006B/01
Official release of a batch
I ____________, the Qualified Person of _________________
Request,in accordance with the legislation The Pharmacists Regulations
(Medicinal Products) 1986, and The Pharmacists Regulations (Good
Manufacturing practice for Medicinal Products) 2008, to test the quality of
the batch detailed below and receive an official release certificate .
Name of the product
Batch number.
Marketing authorization number
Manufacture Date
Name of the manufacture
Expiry date
Address of the manufacture
Lot size
Pharmaceutical form
Number of containers
Package size
Date of delivery
Official control authority batch release certificate
This batch has been examined according to article 17 of the Israeli
Pharmacists Regulations (Medicinal Products) 1986,
This batch is in compliance with the approved specification laid down in
the approved marketing authorization in Israel.
This examination is based either on:
o The review of the manufacturer protocol and control laboratory
tests and /or,
o Laboratory tests according to the EU OCABR guidelines unless
specified
Name and Title :
‫ המכון לביקורת ותקנים של חומרי רפואה‬Official release of a batch form
2 ‫ מתוך‬2 ‫עמוד‬
EX-006B/01
Signature :
Date of issue