Aleafia Health Inc ALEAF

RE:RE:RE:RE:RE:RE:Whats taking so long for this EU-GMP licence

[ShakngMyHead00]

wrangler327 wrote: They'll get it eventually. Third party approval allows ah to ship it, sell it while they wait. 

Francoic wrote:

AbCann medicinals had been inspected on Sep 12, 2019. However, there was a problem which took approximately 18 months before they received their certificate

The competent authority of Germany confirms the following:

The manufacturer :ABcann Medicinals Inc.

Site address :

126 Vanluven Road, Napanee, ON, K7R 3L2, Canada

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with   Art. 8(2) of Regulation (EC) 726/2004 .

 

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2019-09-12 , it is considered that it complies with :

• The principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC (3)

Human Medicinal Products

 

1  MANUFACTURING OPERATIONS

1.4  Other products or manufacturing activity 

   1.4.1  Manufacture of 
           1.4.1.3  Other: radiated Cannabis Flowers (Cannabis Flos)(en) 

1.5  Packaging

   1.5.1  Primary Packaging 
           1.5.1.17  Other non-sterile medicinal products: radiated Cannabis Flowers (Cannabis Flos)(en) 

 

Clarifying remarks (for public users) :

Primary packaging is not equivalent to the final medicinal product packaging

 

 

2021-03-09	Name and signature of the authorised person of the Competent Authority of Germany
	Confidential Landesamt fur Arbeitsschutz, Verbraucherschutz und Gesundheit - Abteilung Gesundheit Dezernat G3

 

subaru1 wrote: well, why Vivo got is license on march 11 and Alefia can't get it......