GERMAN PATIENT ROUNDTABLE – Cenedella.de

"Giving voice to the needs of the German Medical Marijuana/Cannabis Patient Community" / Cenedella, Patient Advocate since 1977.

New document from BfArM related to cultivation re-bid – July 2018

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bfarm outline july 2018 for cultivation bid Leistungsbeschreibung_

Highlights:

There are only three types of cannabis allowed:

Typ 1 mit der Definition: THC zwischen 18 und 22%, CBD < 1%

Typ 2 mit der Definition: THC zwischen 12 und 16%, CBD < 1%

Typ 3 mit der Definition: THC zwischen 5 und 9%, CBD zwischen 5 und 9%.

This is total sum which can be produced within 4 years:

 

Liefertermin Gesamtmenge Aufteilung auf die definierten Typen

  1. Lieferjahr 2600 kg (Typ 1 1600 kg, Typ 2 600 kg, Typ 3 400 kg)
  2. Lieferjahr 2600 kg (Typ 1 1600 kg, Typ 2 600 kg, Typ 3 400 kg)
  3. Lieferjahr 2600 kg (Typ 1 1600 kg, Typ 2 600 kg, Typ 3 400 kg)
  4. Lieferjahr 2600 kg (Typ 1 1600 kg, Typ 2 600 kg, Typ 3 400 kg)

Das 1. Lieferjahr beginnt mit dem Zeitpunkt der ersten Lieferung und endet nach 12 Monaten. Lieferbeginn ist spätestens 18 Monate nach Zuschlagserteilung. Der Lieferzeitraum beträgt 4 Lieferjahre ab Lieferbeginn.

Die Leistungen werden losweise vergeben. Die Liefermenge je Los beträgt 200kg pro Jahr (Jahresplanbedarf pro Lieferjahr). Es werden folgende Lose gebildet:

Los 1 bis Los 8: Cannabisblüten Typ 1

Los 9 bis Los 11: Cannabisblüten Typ 2

Los 12 und Los 13: Cannabisblüten Typ 3

English translation:

Procurement procedure for cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes here: Description of services as of: 18.07.2018 1. Principles According to § 19 section 2a of the Narcotics Act (BtMG) the Federal Institute for Drugs and Medical Devices (“BfArM”) became a state Established in accordance with Articles 23 and 28 (1) of the 1961 Single Convention on Narcotic Drugs, the so-called cannabis agency. The cannabis agency has u.a. the task of granting and supervising the cultivation of cannabis for medical purposes in Germany. To fulfill the tasks, the cannabis agency awards an order for the cultivation of cannabis. The cannabis agency monitors the cultivation, the quality controls to be performed by the contractor and the processing and distribution of the cannabis. The cannabis agency is required to acquire and take ownership of the entire harvest. The cannabis agency then sells the cannabis and sets the selling price. 2. Specifications 2.1 Overview The contractor must provide the following services in the order that follows from his offer: – cultivation of the cannabis plants and harvest; – processing of cannabis flowers; – control of the quality of cannabis flowers; – release of cannabis flowers; – storage of cannabis flowers; – filling and packaging the processed cannabis flowers as bulk goods in containers; – Handover of the packed cannabis flowers at the agreed place of delivery; – Destruction of cannabis plants and possibly cannabis flowers. 2 The contractor is the manufacturer who also releases the cannabis flowers. The client (cannabis agency) brings the cannabis for medical purposes as a pharmaceutical entrepreneur in the market. 2.2 Delivery quantities and lot allocation The delivery shall comprise the following periods and quantities (in the quality according to the monograph “Cannabis flowers”): Delivery date Total quantity Breakdown to the defined types 1. Delivery year 2600 kg (Type 1 1600 kg, Type 2 600 kg, Type 3 400 kg) 2. Delivery year 2600 kg (Type 1 1600 kg, Type 2 600 kg, Type 3 400 kg) 3. Delivery year 2600 kg (Type 1 1600 kg, Type 2 600 kg, Type 3 400 kg) 4. Delivery year 2600 kg ( Type 1 1600 kg, Type 2 600 kg, Type 3 400 kg) The first delivery year starts with the time of the first delivery and ends after 12 months. The start of delivery is at the latest 18 months after the award of the contract. The delivery period is 4 delivery years from the start of delivery. The services are awarded by lot. The delivery quantity per lot is 200kg per year (annual plan requirement per delivery year). The following lots are formed: lot 1 to lot 8: cannabis flowers type 1 lot 9 to lot 11: cannabis flowers type 2 lot 12 and lot 13: cannabis flowers type 3 2.3 cultivation of cannabis and harvest The contractor has to grow and harvest cannabis in Germany. 2.3.1 The cannabis flowers must meet the following specifications at the time of acceptance in accordance with § 4 (2) of the contract: they must be suitable for use for medical purposes. They must fulfill the legal requirements (valid at the time of acceptance) and the requirements of the respective monograph “Cannabis Flowers” of the German Pharmacopoeia (DAB) and the European Pharmacopoeia (Ph. Eur.) Applicable at the time of acceptance as well as all (at the time of acceptance) Approval) guidelines on the quality of herbal medicinal products. In particular, they must meet the following requirements: 3 The cannabis flowers must comply with the requirements of the general method “Pesticide residues (2.8.13)” of the European Pharmacopoeia. The cannabis flowers must be tested according to the general method “Heavy Metals in Herbal Drugs and Preparations of Herbal Drugs (2.4.27)” of the European Pharmacopoeia. The following limit values ​​must be observed: -Cadmium: not more than 1.0 ppm -Blue: not more than 5,0 ppm -Cornings: not more than 0,1 ppm Cannabis flowers must meet the requirements of the general method “Determination of Aflatoxin B1 in herbal drugs (2.8 .18) of the European Pharmacopoeia. The cannabis flowers must not contain more than 2 μg aflatoxin B1 per kilogram. The total content of Aflatoxin B1, B2, G1 and G2 must not exceed a limit of 4 μg per kilogram. The cannabis flowers must not exceed the following limit values ​​when testing for microbial contamination: TAMC (2.6.12) Acceptance criterion: 104 CFU · g-1 or KBE · ml-1 Maximum acceptable number: 50 000 CFU · g-1 or KBE · ml- 1 TYMC (2.6.12) Acceptance criterion: 102 CFU · g-1 or KBE · ml-1 Maximum acceptable number: 500 CFU · g-1 or KBE · ml-1 bile salt tolerant, gram-negative bacteria (2.6.31) Acceptance criterion: 102 KBE · g-1 or KBE · ml-1 Escherichia coli (2.6.31) Absence (1 g or 1 ml) Salmonella (2.6.31) Absence (25 g or 25 ml) Regarding the test

Author: Cenedella.de

Philip J. Cenedella IV Over the last 4 decades I have been involved in the fight for patient rights in America, and now here in Germany. I have served as a Board of Director for the World Trade Center San Diego, as a Lead Consultant for Deutsche Telekom's Executive Board, Founded the Dayton Human Trafficking Accords and have been a C-Level Business Development Executive in the technology sector. Since 2016 I have been fulltime in the legal medical marijuana industry, helping companies navigate the biggest potential market in the world. This website is light on details due to confidentiality issues, but be rest assured I am knowledgeable and can assist your growth in some way. Consulting Services: Sales and Business Development Assist with Strategic Direction Professionally represent your firm Licensing and compliance Sales and Distribution networks Qualify potential partners I am your resource, on the ground in Europe! Philip J. Cenedella IV Call +1.888.206.3264 USA +49.0.151.720.17652 GERMANY Skype: philip.j.cenedella eMail: phil@cenedella.de LinkedIN: https://www.linkedin.com/in/cenedellade/

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