Cenedella.de

Philman's Pharm: "German Quality, California Ingenuity." Est. 1977


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

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


German Cannabis Cultivation RFP revised – in English

https://www.evergabe-online.de/tenderdetails.html;jsessionid=8F64F6EA6499791221E9BDCF72EA5AA8?0&id=206953

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes

Release date:

07/19/2018

Activate participation until:

22.10.2018 12:00

Deadline offer:

22.10.2018 12:00

Business sign:

2281-1788

Awarding Body:

Federal Institute for Pharmaceuticals and Medical Products

Last change:

30.07.18 15:03

My e-assignment

Your current status in the procedure:Member

Current processor of the procedure:Philip Cenedella


contract notice

Directive 2014/24 / EU

Section I: Contracting authority (contracting authority)

I.1)
Name, addresses and contact point (s)
Official name: Federal Republic of Germany, Federal Institute for Drugs and Medical Devices (BfArM)
Postal address: Kurt-Georg-Kiesinger-Allee 3
Postcode: 53175
Location: Bonn
NUTS: Bonn, district-free city (DEA22)
Country: Germany (DE)
Contact point (s): Federal Institute for Drugs and Medical Devices, Ms Stefanie Vogt and Ms Melanie Krüger
Phone: +49 228-2074124
Fax: +49 228-2074352
E-Mail: Z122@bfarm.de
Main address: http://www.bfarm.de

I.3)
communication
The order documents are available for full and full direct access free of charge at:
For further information:
the above contact points.
Tenders or requests to participate must be submitted:

to the above contact points.


I.4)
Type of contracting authority

Ministry or other central or federal authority, including regional or local subdivisions


I.5)
Main activity (s)

health

Section II: Subject

II.1)
Scope of Procurement
II.1.1)
designation

Title of contract:Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes

Reference number of the notice:2281-1788

II.1.2)
CPV code

Bulk:Medical Equipment, Pharmaceuticals and Personal Care Products (33000000)

II.1.3)
Type of order

Supplies

II.1.4)
Short description

The subject of the contract is the cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany for four delivery years. The contract will be awarded in 13 lots.

II.1.6)
Information about the lots

Division of the contract into lots:Yes

Offers are possible for:all lots

Maximum number of lots that can be awarded to a tenderer:
5


II.2)
description
Lot 1
II.2.1)
Designation of lot 1

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 1

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 1): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 2
II.2.1)
Designation of lot 2

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 2

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 1): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 3
II.2.1)
Designation of lot 3

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 3

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 1): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 4
II.2.1)
Designation of lot 4

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secure in-house plantation in Germany Lot No .: 4

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 1): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 5
II.2.1)
Designation of lot 5

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 5

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 1): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 6
II.2.1)
Designation of lot 6

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 6

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 1): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 7
II.2.1)
Designation of lot 7

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 7

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 1): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 8
II.2.1)
Designation of lot 8

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 8

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 1): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 9
II.2.1)
Designation of lot 9

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 9

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 2): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 10
II.2.1)
Designation of lot 10

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 10

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 2): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 11
II.2.1)
Designation of lot 11

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No: 11

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 2): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 12
II.2.1)
Designation of lot 12

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 12

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 3): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No


Lot 13
II.2.1)
Designation of lot 13

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secured in-house plantation in Germany Lot No .: 13

II.2.2)
Additional CPV code (s)

Bulk:Plants for the production of medicines (03117120)

II.2.3)
Place of fulfillment

NUTS code:Bonn, Kreisfreie Stadt (DEA22)

II.2.4)
Description of the procurement

Cultivation, processing, storage, packaging and delivery of cannabis (with the specifications for cannabis type 3): Delivery period 4 years, delivery approx. 200 kg per year.

II.2.5)
Award criteria
The price is not the only award criterion; all criteria are only listed in the procurement documents.
II.2.7)
Duration of the contract or framework agreement

Duration in months:
66

II.2.10)
Information about variants / alternative offers
Variants / alternative offers are not permitted.
II.2.11)
Information about options

options:Yes

Description of options:Right to increase annual plan requirements per delivery year by up to 30%.

II.2.13)
Information on European Union funds

The contract is related to a project and / or program financed by EU funds:No

Section III: Legal, economic, financial and technical information

III.1)
conditions of participation
III.1.1)
Employment ability, including requirements for entry in a professional or commercial register

List and brief description of the conditionsTo be submitted with the offer: Statement by the tenderer concerning entry in a trade or professional register or other proof of the lawful practice in the State in which the candidate is established.

To be submitted on separate request: Commercial Central Register Information; Attestation by the competent social security authorities that the social security contributions are properly paid; Certification of the competent professional association that the bidder is a member there and is performing according to the order; Clearance certificate of the tax office; Explanation of the exclusion reasons according to §§ 123, 124 GWB.

III.1.2)
Economic and financial capacity

List and brief description of the conditionsTo submit with the offer:

– information on the total turnover of the tenderer in the last three financial years, if any.

– information on the bidder’s turnover in the cultivation, processing and supply of medical cannabis (THC content> 1%) for the last three financial years, if any.

– information on the turnover of the tenderer in the field of growing and supplying medicinal plants marketed (after processing and, where applicable, by third parties) as a medicinal product or as an active substance in a medicinal product, in the last three financial years, if any.

– information on the turnover of the tenderer in the field of processing and supply of medicinal plants put on the market after processing as a medicinal product or as an active substance in a medicinal product in the last three financial years, if any.

– information on the existence of a professional or public liability insurance in the amount of Euro 5 million (2 times maximized per year) or the assurance of the tenderer to conclude such insurance in the event of award of the contract (hereinafter referred to as “liability insurance statement”).

– presentation of the Bidder’s annual accounts for the last three financial years, if their publication is legally required by the Bidder.

– Indication that, as in the case of award of contract, the financing of the contract is secured (financing by equity, shareholder loans, loans from a credit institution or similar) and the tenderer’s assurance that the secured financing will be provided to the contracting entity prior to the award of the contract.

To be submitted on separate request: proof of secured financing

Possibly required minimum standards- Submission of a statement on the existence or the conclusion of a liability insurance in the amount of Euro 5 million (2 times maximized per year).

– Proof of secured financing (before award of the contract)

III.1.3)
Technical and professional capacity

List and brief description of the conditionsTo submit with the offer:

– details of the technical staff that the tenderer will use in connection with the provision of services, as well as information on the qualifications of the persons to be employed. A name by name is not required.

– details of the equipment and the technical equipment that the tenderer will use to carry out the contract.

– Details of orders for cultivation, processing and delivery of medicinal cannabis with a THC content of dried cannabis flowers> 1% (“cannabis reference”) between the 01.01.2015 and the expiry of the submission deadline. The total quantity delivered (whether in one order or more) must have been at least 50 kg (weight of cannabis flowers when dried). The delivery must have been made to the competent authority in the country under Art. 23 of the Single Convention on Narcotic Drugs 1961, completed on 30 March 1961 in New York or, with the agreement of the competent authority, directly to the patients. The tenderer must provide the following information: competent authority, quantity of cannabis flowers harvested, quantity of cannabis flowers processed,

– information on contracts for cultivation of medicinal plants which have been placed on the market (after processing and, where applicable, by third parties) in the period between 01.01.2015 and the expiry of the time limit for the submission of tenders in a medicinal product or as an active substance in a medicinal product Delivery quantity of at least 50 kg (“cultivation reference”). The services must have been carried out in accordance with the GACP standard, ie the Guidelines for Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin “(EMEA / HMPC / 246816/2005) for the supply of medicinal plants in which the contractor of the supply contract has grown the medicinal plants themselves The following information must be provided by the tenderer: the contracting entity or the purchaser (with contact details), description of the services performed, period of delivery,

– Details of orders for the processing and delivery of medicinal plants made in the period between 01.01.2015 and the expiry of the time limit for the submission of tenders (possibly after further processing and possibly by third parties) as a medicinal product or as an active substance in a medicinal product are, with a delivery quantity of at least 50 kg (“processing reference”). The services must be comparable to the contract to be awarded. Benefits are comparable if they have been carried out in compliance with the GMP standard, ie in accordance with EUDRALEX: Volume 4 Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice and Annex 7: Manufacture of Herbal Medicinal Products, and a manufacturing authorization of medicinal products from the competent authority. A processing reference also includes an order for the supply of medicinal plants in which the contractor of the delivery order has processed the medicinal plants themselves. Specify: Client or customer (plus contact details), description of the services performed, delivery period, delivery quantity (calculated as dried drug) and delivery value.

To be submitted on separate request:

Proof that the site designated as the site on which the site is to be constructed is available to the bidder.

Possibly required minimum standards- Minimum conditions for affirmation of fitness: At least one cannabis reference as defined above or instead of one cannabis reference: at least one cultivation reference and at least one processing reference as defined above.

– proof that the site designated as the site on which the plant is to be constructed is available to the tenderer (prior to award of the contract).


III.2)
Conditions for the order
III.2.2)
Conditions for the execution of the contract

Permission according to § 3 Narcotics Act

Permission according to § 13 Arzneimittelgesetz

Section IV: Procedure

IV.1)
description
IV.1.1)
of procedure

Open procedure

IV.1.8)
Information on the Government Procurement Agreement (GPA)

The contract is covered by the Government Procurement Agreement:No


IV.2)
administrative information
IV.2.2)
Final date for receipt of tenders or requests to participate

Day:22/10/2018

local time:12:00

IV.2.4)
Language (s) in which tenders or requests to participate can be submitted
  • German (DE)
IV.2.6)
Binding period of the offer

Duration in months:3 (from the closing date for receipt of tenders)

IV.2.7)
Conditions for opening tenders

Day:22/10/2018

local time:13:00

Place:Bonn

Information about authorized persons and the opening procedure:The opening of the offers takes place according to § 55 VgV. Tenderers are not allowed.

Section VI: Further Information

VI.1)
Information about the return of the order

This is a recurring order.

VI.3)
Additional information

1. In this Notice and in the tender documents, the terms bidder and candidate are used interchangeably.

2. The award procedure is partly carried out electronically on the website of the eVergabe platform (www.evergabe-online.de). This means that incoming bidder questions are only communicated on the aforementioned platform. The offer has to be made in writing. Details are given in the application conditions.

3. The possibility of employing subcontractors, the possibility of invoking the suitability of third parties in accordance with § 47VgV, and the possibility of forming a consortium. Details of which declarations have to be submitted are given in the application conditions.


VI.4)
Appeal / review procedures
VI.4.1)
Responsible body for appeal / review procedure
Official name: Federal Procurement Chamber
Postal address: Villemombler Str. 76
Postcode: 53123
Location: Bonn
Country: Germany (DE)
VI.4.3)
Filing of legal remedies

Details of the time limits for the lodging of appeals§ 160 GWB

(1) The public procurement tribunal shall initiate a review procedure only on request.

(2) Any enterprise which has an interest in the public contract or the concession and claims an infringement in its rights under Section 97 (6) by non-observance of public procurement rules shall be entitled to apply. It must be stated that the alleged breach of the public procurement rules has caused or threatened to harm the company.

(3) The application is inadmissible insofar

1.

the applicant has recognized the alleged infringement of public procurement rules prior to the submission of the petition for review and has not complained to the contracting authority within a period of ten calendar days; the expiration of the period under § 134 (2) remains unaffected

Second

Infringements of public procurement rules which are discernible on the basis of the notice shall not be claimed against the customer by the expiry of the time limit specified in the contract notice for the application or the submission of tenders,

Third

Infringements of procurement rules, which can only be identified in the tender documents, can not be notified to the client at the latest by the deadline for the application or for the submission of tenders,

4th

more than 15 calendar days after receipt of the notification from the client that he did not wish to remedy a complaint.

VI.4.4)
A body providing information on the lodging of appeals
Official name: Federal Procurement Chamber
Postal address: Villemombler Str. 76
Postcode: 53123
Location: Bonn
Country: Germany (DE)

VI.5)
Date of dispatch of this notice

07/18/2018

 

 

======================================

 

 

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.

During my career I have served as a Board of Director for the World Trade Center San Diego and as a Lead Consultant for Deutsche Telekom’s Executive Board, Co-Founded the San Diego Software Council and the Dayton Human Trafficking Accords and was Director of LawInfo’s Lead Council Program.

Previously I was a C-Level Business Development Executive in the technology sector, but also involved with the cannabis industry since 1977.    More recently I have been fulltime in the legal medical marijuana industry here in Europe, helping international companies navigate the biggest potential market in the world.

This website is light on details due to confidentiality issues with clients but be rest assured I am knowledgeable, professional and with street cred in the industry that can immediately assist your growth in some way.

 

Consulting Services:

Sales and Business Development

Assist with Strategic Direction

Professionally represent your firm
Special Projects management

Licensing and compliance

Sales and Distribution networks

Qualify potential partners

I am your resource on the ground in Europe, contact me directly to schedule an initial discussion on the German Cannabis-as-Medicine market.

Thank you,

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:  www.linkedin.com/in/cenedellade

https://www.linkedin.com/in/cenedellade/


Theresa May’s husband’s company owns 22% of medical cannabis company GW Pharmaceuticals. The husband of UK drug Minister Victoria Atkins has a government license for 18 hectares of cannabis cultivation for GW. During her two men are at work, both women Cannabis Illegal work hard to keep.

 

https://www.facebook.com/permalink.php?story_fbid=2178398779108224&id=1643480862600021
VIDEO: Theresa May’s husband’s company owns 22% of medical cannabis company GW Pharmaceuticals. The husband of UK drug Minister Victoria Atkins has a government license for 18 hectares of cannabis cultivation for GW. During her two men are at work, both women Cannabis Illegal work hard to keep. Corruption at the top of the UK government?
https://www.facebook.com/permalink.php?story_fbid=2178398779108224&id=1643480862600021
https://netzfrauen.org/2018/01/22/marihuana-2/

https://www.facebook.com/1643480862600021/photos/a.1656256014655839.1073741828.1643480862600021/2014694718811965/?type=3&theater What does / did the pharmaceutical industry? The politic? Since when? We were lied to and cheated? “Questions, questions” to which we received no satisfactory answers. Please make their own judgment. www.diehanfinitiative.de

[… Mykayla Comstock was at that time the youngest cancer patient in Oregon, USA, which was allowed to treat their leukemia with hemp medicine healing. In Oregon, one of more than 20 federal states, the US, is allowed in the hemp medicine, there were in 2012, more than 5,500 cancer patients who were allowed to treat your cancer with hemp healing medicine. Why is this [Note .: Stand 2016] forbidden with us? …]

https://diehanfinitiative.de/index.php/medizin

Many thanks to Emin M. Arpaci that just as my family doctor Dr. Schölzel who has supported me even in my “attachment request” to the BfArM, was a harsh critic of Hemp Prohibition. Both of whom died this year.

https://diehanfinitiative.de/index.php/aktionen/38-medical-cannabis-declaration

[… millions of people around the world share similar fates, be sentenced – sitting in prisons, die.

For decades, the knowledge and research is suppressed (except for, among other things Monsanto, Bayer and their “straw man company” Hortapharm GW Pharm – the now 39 patents hold).

And we watch.

Absurd. Simply absurd.

Again, since the 60s of the last century, only one company had the right to do research. All others were forbidden.

This company is a “licensor-Contractors” from Monsanto, Bayer? For, Lizensvergaben “and” Get patent “? How they have managed to cheat us so?

What do you think about this?

Protect cannabis constituents (cannabinoids) and regenerate human nerve cells – “cannabidiol and (-) Δ9-tetrahydrocannabinol are neuroprotective antioxidants”. Hemp protects nerves and strengthens the immune system. The US government has even patented these properties of hemp (cannabis)! Why is this knowledge suppressed in Germany or simply not taken seriously? So long! Please refer:
https://www.google.com/patents/US6630507
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC20965/

…]

The most important research of Emin:

[… “Your immune system, cardiovascular system, digestive system, reproductive system, skin system, skeletal system … is controlled and kept in balance of your endocannabinoid system (ECS).

If you have stress, or of old age are when your body can not make enough body’s own cannabinoids, so you’ll get sick.

Since God (Nature) has created a wonderful plant that produces cannabinoids and man and all animals (also an ECS), can (except insects), take this not to be sick or healthy.

Even without “high” to become. This plant is hemp (cannabis). Who is against hemp, cuts in the foot and is unconsciously a criminal, against all humans and animals.

GW Pharm ( http://gwpharm.com/ ) has made 39 patents:

http://www.patentsencyclopedia.com/assignee/gw-pharma-limited/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC20965/

Cancer, diabetes, Alzheimer’s … (virtually all diseases!).

Consisting of extracts from hemp. Depending on the disease various percentages of THC and CBD and other cannabinoids.

Sativex example is the ratio of THC to CBD from 1 to 1

This drug against MS is already on the market. What would cost a few euros, costs through the sale of Almirall 300-400 hundred euros because cannabis is prohibited.

http://www.gwpharm.com/gw-partners.aspx

Otsuka Pharmaceutical Co. (USA + Japan), LtdNovartis Pharma AG (Australia, Asia (excluding Japan, Hong Kong) Africa), Almirall SA (Europe, Turkey), Bayer HealthCare AG (England + Canada), Ipsen Pharma SAS (South America) Neopharm Group (Israel / Palestene).

Have paid for rights to sell the products made from hemp together about 500 million euros.

They strongly believe that hemp against cancer and Alzheimer’s helps, otherwise you would not have paid so much for resale rights.

The cancer patients and Alzheimer’s patients do not have time to wait until you can buy the drugs expensive.

It is unethical, immoral and inhuman avarice withhold knowledge of the people and work against legalization.

100 billion euros and more (annually) would be saved in Germany, where every citizen would his medicine on the balcony, in the garden, would raise with love and the juice of the leaves and flowers drink, eat or smoke.

2 billion euros is the pharmaceutical industry annually as a party donation (CDU / CSU + later lucrative positions in the economy) bribery and advertising. ”

Emin M. Arpaci …]

Sources:
http://www.spiegel.de/gesundheit/diagnose/cannabis-krebs-der-7-jaehrigen-mykayla-soll-mit-drogen-therapiert-werden-a-871095.html
http://www.focus.de/gesundheit/ratgeber/krebs/us-gesundheitsministerium-bestaetigt-studien-zeigen-cannabis-toetet-krebszellen_id_4898162.html
https://diehanfinitiative.de/index.php/medizin/12-sein-oder-nichtsein-bfarm
https://diehanfinitiative.de/index.php/prohibition/11-das-kartenhaus-bricht-zusammen
https://www.facebook.com/permalink.php?story_fbid=1584343035013101&id=109440222503397
https://www.facebook.com/Dampfparade.koeln/posts/1817535844928558
https://diehanfinitiative.de/index.php/medizin
http://julius-hensel.com/2012/10/jesus-heilte-mit-cannabis/
https://www.facebook.com/permalink.php?story_fbid=1948214232126681&id=1643480862600021
https://diehanfinitiative.de/index.php/medizin/24-endocannabinoide
https://diehanfinitiative.de/index.php/medizin/30-nobelpreis-please

“Questions, questions!”

Phytocannabinoids for use in the treatment of breast cancer http://www.google.com/patents/EP2768493A1?cl=en

PHYTOCANNABINOIDS FOR USE IN THE TREATMENT OF CANCER
http://www.faqs.org/patents/app/20140221469

Patent application title: Inhibition of Tumor Cell Migration
http://www.faqs.org/patents/app/20080262099

https://www.youtube.com/watch?v=m9PeRuyorGA

https://youtu.be/UzbGb9S4M8w

https://www.facebook.com/Bongtesterverband/posts/1243087002480239

Finished medicinal products are not the best! Cbd of THC Pharm GmbH vs. Cbd of plants
compared to University of Jerusalem in Clinical Study.
http://file.scirp.org/pdf/PP_2015021016351567.pdf

Germany prevented early treatment of children suffering from cancer with cannabis, a crime:
https://www.facebook.com/476468035745801/videos/1594470490612211/

VIDEO. Theresa May’s husband’s company owns 22% of the medical cannabis company GW Pharmaceuticals. …


1 Comment

Medical Cannabis & Cannabinoids EU: Where Do We Go From Here? –15th to 16th November 2018 – Frankfurt, Germany

0001181_medical-cannabis-cannabinoids-eu-where-do-we-go-from-here_200

Join us this November 15th & 16th and be part of medical cannabis

& cannabinoids EU where do we go from here?
15% Discount Code LM15SPK

The only medical cannabis conference created to answer the serious questions behind all things cannabis and cannabinoid in the EU.

Forums and Events cordially invite you to participate in the most exciting topic to hit the medical and business industry in the past 20+ years!

Since the onset of legalization of medical cannabis in Germany, there are still many unknowns concerning the impact it will have on the scientific & medical implications for patients. Secondary to this are the issues surrounding the clarity of laws and legislation concerning everything from licensing, to regulations for both producers and end users. There is intense global interest in business opportunities from both an investment and development side as well. These are just a few of the bigger topics being explored. More importantly and possibly the biggest question of them all is:

 

Where do we go from here?  
Join us this November 15th & 16th in Frankfurt Am Main for a thought provoking and proactive oriented conference.  This is an invaluable opportunity for the diversified members of the cannabis industry to come together and network, learn about the trade and get answers!

We will explore the medical implications of cannabis products for patient treatment in areas such as cancer, epilepsy, glaucoma, HIV/AIDS, post-traumatic stress disorder (PTSD), amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, as well as multiple sclerosis. The list just keeps getting longer.

Lecturers from the scientific community will discuss and present their latest cannabinoid research and development findings.

The conference will also concentrate on business development, investment opportunities, and collaborative projects to shed light on how it will all impact the European market as a whole.

 

We thank you in advance for your patronage. Please share this information with anyone you think would benefit.

 

Sincerely,

The Forums and Events Team

 


Germany Is Looking For Legal Medical Marijuana Growers

https://greenrushdaily.com/news/world/germany-legal-medical-marijuana-growers/

Germany has so far been on the receiving end of the world’s cannabis exports. Now, the country is looking to grow its own.

 

Germany is looking for legal medical marijuana growers; at least three, to be precise. Germany’s medical cannabis program, which is usually on the receiving end of cannabis exports from around the world, is hoping to start cultivating its own crops. But after the first attempt at licensing growers broke down over various lawsuits, the country is taking a more studied approach this time around. Companies are, too. And that should make for a very competitive application process.

Expect Heavy Competition for German Grow Licenses

On Friday, Germany’s Federal Institute for Drugs and Medical Devices (BFARM) announced that it was reviving its call for cultivator applications. The announcement came just a week after BFARM officially canceled its previous call for applications.

The new call for applications is different in a couple key ways. First, Germany is aiming for 10,400 kg over four years (23,000 lbs.) this time. Their first call went out for just 6,600 kg (14,550 lbs.).

Secondly, BFARM is putting a cap on the amount of cannabis a single company can produce in a single year. That cap is 1,000 kg.

The introduction of the cap was potentially an effort to dissuade the largest cannabis producers from muscling out smaller competition. By the standards of the world’s largest cannabis producers, 1,000 kg is a small amount.

But the opportunity to gain a foothold in a country that just legalized medical cannabis, in the center of an expanding market, is too good for established growers to pass up.

So BFARM is expecting fierce competition for the licenses. It’s not just large cultivators that will be vying for a license, but the dozens of other companies who didn’t make the cut last time around. And now, they know the process and are in a better position to compete.

Germany Promises Transparent Application Process

Germany’s first attempt at awarding cultivation licenses was marred by delays and lawsuits. Many companies that didn’t make the shortlist after initial review sued the German government. They claimed BFARM didn’t handle the applications fairly.

After a court in Dusseldorf, Germany ruled in favor of one of the plaintiff companies, BFARM officially canceled the entire application process two weeks ago.

Now, having relaunched the cultivator licensing process with a few new tweaks, BFARM is promising a much more transparent process.

Still, the playing field isn’t exactly even. It already favors the major legal cannabis producers that already have a footprint in Germany. Canadian cannabis producers like Canopy Growth Corp. and MedReleaf Corp. especially have an advantage, as they already export to their medical cannabis subsidiaries in Germany.

But Canadian companies won’t be the only ones applying to grow in Germany. Companies from Israel, the Netherlands and even Latin America, where export markets are just taking off, will all make a bid.

BFARM is looking to award licenses to at least three cultivators. Each would have a 1,000 kg per year production cap. Over four years, that should easily meet the 10,400 kg amount Germany’s medical marijuana program is demanding. Germany has not placed on limit on the number of licenses it can award, however.


The tender of the “Cannabis Agency” in Bonn comprises a total volume of 10,400 kg of cannabis spread over four years, each weighing 2,600 kg. This was announced by the Federal Institute for Drugs and Medical Devices (BfArM) on Friday.

The tender of the “Cannabis Agency” in Bonncomprises a total volume of 10,400 kg of cannabis spread over four years, each weighing 2,600 kg. This was announced by the Federal Institute for Drugs and Medical Devices (BfArM) on Friday. It is not the first attempt to realize cultivation in Germany.

Following the liberalization of the substance in the spring of 2017 , the BfArM had announced a first call for tender, to which 118 companies had applied. In March, however, the Düsseldorf Higher Regional Court stopped the proceedings: The judges agreed with the view of a company that the deadline for submitting documents after a procedural change was too short.

The contract will be awarded to producers in the first half of 2019. In the end, a contract will be signed with at least three companies for the cultivation, harvest, processing and delivery of cannabis in standardized pharmaceutical quality.

So far, medical cannabis is imported from abroad, mainly from the Netherlands and Canada. Medical hemp was a niche in Germany until liberalization, with only about 1,000 sick people having a special permit. Since liberalization, doctors and pharmacists report a sharp rise in demand for prescription cannabis.

The cannabis drug THC can relieve not only pain but also spasticity, such as multiple sclerosis, and nausea after chemotherapy. It should also help against epilepsy. The medical effectiveness is partly controversial.

With material from dpa


Grossrazzia ends legal sale of cannabis – Police stormed “Hanfbar” in Braunschweig during the opening ceremony and captured 200 units of Hanftee

Großrazzia beendet legalen Verkauf von Cannabis

A daily updated by Sadhu van Hemp

Around one million worried citizens in the greater Braunschweig area can breathe easy and let their children play on the street again. On Saturday, several dozen policemen in the anti-cannabis war were allowed to swing the repressive club in order to give the organized hemp crime a proper low blow to the benefit of the German people.

The generalstabsmäßig planned general attack took place at 6.30 pm in the city center of Brunswick, densely filled by passers-by. A large contingent of police locked the fighting area around the Friedrich-Wilhelm-Platz far and wide. In order to avoid unnecessary collateral damage in the combat operation in the anti-cannabis war, as a precaution, the public transport has been set. In the then lightning attack on the shop “Hemp Bar” the armed to the teeth people’s policemen could smoke out the resistance nest of Nutzhanfrebellen, without having to make use of the firearm.

 

police spokesman confirmed that alleged narcotics were seized and handed over to the State Office of Criminal Investigation (LKA) for analysis. Overall, it should be more than 200 so-called sales units with hemp flowers (tea). The Großrazzia had been ordered at the request of the prosecutor by a judge of the district court Braunschweig, after it had previously indicated that in the same day opened shop illicit drugs were traded.

 

The anti-drug combat mission of the police successfully carried out on Saturday is the second major battle against the operators of the “Hanfbar” in Braunschweig within a few weeks. On 3 July, the first “Hanfbar” branch in Mühlenpfordtstraße, opened in 2017, was stormed by the executive and robbed of its inventory. The apartments and the store, which is still under construction, were also turned upside down in Friedrich-Wilhelm-Strasse 47. According to the prosecutor, the search warrant was based on the suspicion that cannabis was being sold for “consumption of intoxication” in the “cannabis bar”. In the first raid three kilograms of hemp tea were confiscated. However, the LKA has not yet been able to present the test result desired by the Braunschweig prosecutor concerning the toxicity of the useful hemp flowers.

 

The owner of the “cannabis bar”, Bardia Hatefi, against whom is now being investigated on suspicion of violation of the Narcotics Act, criticized the Grossrazzia as a “farce”. The “hemp bar” would only offer food from Nutzhanf. The range includes hemp tea, hemp seeds, hemp pesto and hemp cosmetics, as well as smoothies and snacks. The THC content of the hemp flowers used would be less than 0.2 percent, is on the homepage of the “cannabis”insured. Hatefi denies having done anything illegal, since “Nutzhanf” may legally be grown and used in Germany. He accuses the public prosecutor’s office of wanting to “dry us up and fumigate us”. The seized during the raids amounts of tea would have a sales value of 50,000 euros. In addition, missing a stolen by the police from the box office five-digit sum. “You’re starting to have a sense of existential fear,” said Hatefi, who sees the actionism of the Braunschweig law enforcement agencies as “a challenge to fight” directed “against the healing plant and against all those” whom it helps “.