GREY:ALEAF - Post by User
Comment by
Francoicon Mar 23, 2021 10:12am
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Post# 32857445
RE:RE:RE:Aleafia should post great numbers
RE:RE:RE:Aleafia should post great numbers Report No :MT/001NCR/2019
STATEMENT OF NON-COMPLIANCE WITH GMP
Exchange of information between National Competent Authorities (NCAs) of the EEA following the discovery of serious GMP non-compliance at a manufacturer (1)
Part 1
| Issued following an inspection in accordance with :
Art. 111(7) of Directive 2001/83/EC as amended | The competent authority of Malta confirms the following: The manufacturer :Zenabis Ltd | Site address : | 1668 Fosters Way, Delta, British Columbia, V3M 6S6, Canada | DUNS Number : 20-380-4696
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| From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2018-12-16 , it is considered that it does not comply with the Good Manufacturing Practice requirements referred to in - The principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC
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(1) The statement of non-compliance referred to in paragraph 111(7) of Directive 2001/83/EC and 80(7) of Directive 2001/82/EC, as amended, shall also be required for imports coming from third countries into a Member State.
Part 3
| Nature of non-compliance :Following the inspection, the company provided a CAPA plan to the deficiencies [1 critical (The company did not have a correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management as evidenced by the findings related to the quality system), 9 major and 20 other findings] that was accepted. The company failed to follow-up on this plan and to meet the commitments made. The company changed its plans and no longer actively rectified the deficiencies to come in line with EU-GMP according to the mutually agreed reasonable time-frame. |
| Action taken/proposed by the NCA : Prohibition of supply
Sale, importation or distribution of products for medicinal use manufactured at this site, in part or in full, is prohibited. |
| Additional comments : National legislation requires cannabis products for medicinal use to be manufactured in line with EU-GMP requirements for medicinal products. |
| Teleconference Date : | Teleconference Time (CET) : | Dial in no. : |
sthinei wrote: Great question. Why buy Zanabis. I agree. They have been losing so much money and their European business is negligible. The following article throws cold water on Hexo's move to buy Zenabis. Aleafia would be a much better target once EU GMP Certification received. Great artice by the way and worth the read.
https://mugglehead.com/is-hexo-blowing-smoke-on-euro-entry-via-zenabis-deal/