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Germany: Cultivation License, tender information

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Germany-Bonn: medical equipment, pharmaceuticals and personal care products

http://ted.europa.eu/udl?uri=TED:NOTICE:131987-2017:TEXT:DE:HTML&src=0#id1042115-III.

2017 / S 070-131987

contract notice

Supplies

Directive 2014/24 / EU

Section I: Contracting authorities

I.1)Name and addresses

Federal Institute for Drugs and Medical Devices (BfArM)
Kurt-Georg-Kiesinger-Allee 3
Bonn
53175
Germany
Contact: Bundesinstitut für Arzneimittel und Medizinprodukte, Frau Stefanie Vogt
Phone: +49 228-2074124
E-Mail: Z122@bfarm.de
Fax : +49 228-2074352
NUTS Code: DEA22Internet address (es):Main address: http://www.bfarm.de

I.2)Common procurement strategy

I.3) Address from whichfurther information can be obtained:

The order documents are available free of charge for full and complete direct access at: https://www.evergabe-online.de/tenderdetails.html?id=156533
Further information can be obtained from the above-mentioned contact point (s)
Tenders or requests to participate must be submitted to the above mentioned contact point (s)

I.4)Type of the 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) Titleattributed to the contract:

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

Reference number of the contract notice: 2281-1713

II.1.2) Mainterms of the sale or purchase:

33000000

II.1.3)Type of contract

Supplies

II.1.4)Short description:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

II.1.5)Estimated total value

II.1.6)Information about lots

Division of the contract into lots: yes
Offers are possible for all lots
Maximum number of lots to be awarded to a contracting authority: 7
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany

Lot No: 1

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 1): delivery period 2019 to 2022, delivery volume approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum 40 points) per 50 kg of delivery (whether in the context of one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a delivery quantity of at least 50 kg per reference over the last three years (whether in the case of a single order or several contracts) Points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 2

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 1): delivery period 2019 to 2022, delivery volume approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum 40 points) per 50 kg of delivery (whether in the context of one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a minimum quantity of 50 kg per reference for the last three years (whether in the case of a single order or several contracts): the applicant receives 5 points per 50 kg delivery (A maximum of 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total quantity delivered in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 3

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 1): delivery period 2019 to 2022, delivery volume approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum 40 points) per 50 kg of delivery (whether in the context of one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a minimum quantity of 50 kg per reference over the last three years (whether in the context of one or more contracts): The applicant shall be supplied per 50 kg of delivery 5 points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 4

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 1): delivery period 2020 to 2022, delivery volume approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum of 40 points) for each 50 kg of delivery (whether for one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a delivery quantity of at least 50 kg per reference over the last three years (whether in the case of a single order or several contracts) Points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 5

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 1): delivery period 2020 to 2022, delivery volume approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum of 40 points) for each 50 kg of delivery (whether for one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a delivery quantity of at least 50 kg per reference over the last three years (whether in the case of a single order or several contracts) Points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 6

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 1): delivery period 2021 to 2022, delivery quantity approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum 40 points) per 50 kg of delivery (whether in the context of one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a delivery quantity of at least 50 kg per reference over the last three years (whether in the case of a single order or several contracts) Points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 7

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 2): delivery period 2019 to 2022, delivery volume approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum of 40 points) for each 50 kg of delivery (whether for one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a delivery quantity of at least 50 kg per reference over the last three years (whether in the case of a single order or several contracts) Points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 8

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 2): delivery period 2020 to 2022, delivery volume approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum of 40 points) for each 50 kg of delivery (whether for one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a delivery quantity of at least 50 kg per reference over the last three years (whether in the case of a single order or several contracts) Points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 9

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 3): delivery period 2019 to 2022, delivery volume approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum 40 points) per 50 kg of delivery (whether in the context of one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a delivery quantity of at least 50 kg per reference over the last three years (whether in the case of a single order or several contracts) Points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information
II.2)Description

II.2.1)Title attributed to the contract:

Cultivation, further processing, storage, packaging and delivery of cannabis for medical purposes in a secure inhouse plantation in Germany.

Lot No: 10

II.2.2)Additional CPV code (s)

03117120

II.2.3)Place of performance

NUTS code: DEA22

II.2.4)Description of the sourcing:

Cultivation, processing, storage, packaging and delivery of cannabis (type 3): delivery period 2021 to 2022, delivery quantity approx. 200 kg per year.

II.2.5)Award criteria

The price is not the only supplementary criterion; All criteria are listed in the procurement documents only
II.2.6)Estimated value

II.2.7)Duration of the contract or framework agreement or of the dynamic purchasing system

Duration in months:
This contract can be extended: no

II.2.9)Indication about the number of operators who will be invited to tender or to participate

Planned number of candidates: 10
Objective criteria for selecting the limited number of applicants:

(A) references to earlier contracts awarded by the applicant for the cultivation, processing and delivery of cannabis for medical purposes with a delivery quantity of at least 50 kg per reference for the last 3 years. A reference to an order for the cultivation, processing and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to this body in accordance with Article 23 of the 1961 Unified Agreement on Narcotic Drugs A variety of different performance receivers have been delivered and the total delivery quantity has amounted to at least 50 kg. The applicant will receive 10 points (maximum 40 points) per 50 kg of delivery (whether in the context of one or more orders).

(B) references to the cultivation, processing and supply of medicinal plants (without cannabis) with a minimum quantity of 50 kg per reference over the last three years (whether in the context of one or more contracts): The applicant shall be supplied per 50 kg of delivery 5 points (maximum score 20 points).

C) If more than 10 applicants receive a score of more than 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

D) If fewer than 10 applicants receive a score of 60, the selection is based on the highest total delivery quantity in the last three years according to lit. A), according to lit. b).

II.2.10)Information about variants / alternative offers

Variants / alternative offers are permitted: no

II.2.11) Informationon options

Options: no
II.2.12)Information about electronic catalogs

II.2.1)Information about European Union funds

The contract is linked to a project and / or program financed by the EU: no
II.2.1)Additional information

Section III: Legal, economic, financial and technical information

III.1)Conditions for participation

III.1.1)Empowerment in professional or professional capacity, including requirements relating to the professional or trade registers

Listing and brief description of the conditions:

The tenderer’s declaration of entry in a professional or trade register or other proof of the professional qualification required in the State in which the applicant is established.

The client reserves the right to submit the following documents within the framework of the appraisal of the participation requests to a separate request:

– Local business register,

– a certificate from the competent social security authorities that social security contributions are paid in accordance with the regulations,

– the certificate of the competent professional association that the tenderer is a member there and who is contributing,

– Tax exemption certificate issued by the tax office,

– Declaration on the grounds of exclusion pursuant to §§ 123, 124 GWB.

III.1.2)Economic and financial capacity

List and brief description of the suitability criteria:

– the total turnover of the applicant in the last three financial years, if any.

– information on the applicant’s turnover in the area of ​​the cultivation, processing and delivery of cannabis for medical purposes, where available.

– an indication of the applicant’s turnover in the area of ​​the cultivation, processing and supply of medicinal plants during the last three financial years, where available.

– an indication of the existence of a professional or occupational liability insurance amounting to EUR 5 million (twice a year maximized) or the tenderer’s assurance to conclude such insurance in the case of the subdivision.

– submit the candidates’ annual accounts, if their publication is legally required by the applicant.

– indication that the financing of the contract is to be secured (financing by equity, shareholder loans, loans from a credit institution or similar), as well as the insurer’s insurance A corresponding commitment from the financing credit institution.

III.1.3)Technical capacity and professional capacity

List and brief description of the suitability criteria:

Information on the tenderer ‘s previous contracts for the cultivation, processing and delivery of medical cannabis in the last three years, if any (list showing the contract value, the delivery quantity, the delivery period and the recipient of the service and, where available, Country competent authority in accordance with Article 23 of the “Unity Convention 1961 on Narcotics” concluded in New York on 30 March 1961).

– information on the tenderer’s references to contracts for the cultivation, processing and delivery of medicinal plants carried out in the past three years, where available (list showing the contract value, the delivery volume, the delivery period and the beneficiary).

– indication of the technical personnel to be used by the tenderer in connection with the service.

– information on the equipment, equipment and technical equipment of the contractors to carry out the contract.

Minimum standards required:

At least one reference for the purpose of cultivation, processing and delivery of medicinal cannabis (minimum quantity of 50 kg) or a contract for the cultivation, processing and supply of medicinal plants (minimum 50 kg) for the last three years. A reference to a contract for the planting and delivery of medical cannabis shall also apply if, with the consent of the competent authority in the country concerned, the tenderer submits directly to a variety of different beneficiaries, in accordance with Article 23 of the “Unified Convention on Narcotic Drugs” And the total quantity delivered is at least 50 kg. As a reference about an order to cultivate,

III.1.5)Information about reserved contracts
III.2)Conditions relating to the contract

III.2.2)Conditions relating to the performance of the contract:

Permission according to § 3 Drugs Act.

Permission according to § 13 Arzneimittelgesetz.

III.2.3)Personnel responsible for execution of the contract

Obligation to indicate the names and professional qualifications of the persons responsible for the execution of the contract

Section IV: Procedure

IV.1)Description

IV.1.1) Type ofprocedure

negotiated procedure
IV.1.3)Information about a framework agreement or a dynamic purchasing system (DPS)

IV.1.4) Informationabout reduction of the number of operators or solutions to be taken during the negotiation or dialogue

The succession of the procedure in successive stages in order to gradually reduce the number of solutions to be discussed and / or the tenders to be negotiated
IV.1.5)Information about a negotiated procedure
IV.1.6)Information about electronic auction

IV.1.8) Informationabout the Procurement Agreement (GPA)

The contract is covered by the Procurement Agreement: no
IV.2)Administrative informationIV.3)
IV.2.1)Previous publication concerning this procedure

IV.2.2)Time-limit for receipt of tenders or requests to participate

Day: 05/06/2017
Local Time: 12:00

IV.2.3)Time-limit for receipt of tenders or requests to participate:

Day: 28/06/2017

IV.2.4)Language (s) in which tenders or requests to participate may be drawn up:

German

IV.2.6)Minimum time frame during which the tenderer must maintain the tender

Duration in months: 6 (from the date of receipt of tenders)
IV.2.7)Conditions for opening tenders

Section VI: Additional information

VI.1)Information about a return of the contract

This is a recurring job: yes
Estimated timing for further notices:

02/01/2021.

VI.2)Information about electronic work processes

No. VI.3)Additional information:

Details of the invitation to tender and of the documents to be submitted can be found in the tender form “Procurement procedure for the cultivation, processing, storage, packaging and delivery of cannabis for medical purposes, here: Invitation to submit applications for participation”, which forms part of the tender documents.

This procurement procedure will be carried out electronically on the website of the eVergabe platform ( www.evergabe-online.de ).

Please note that the free download of the tender documents is only for a first view. In order to participate in the tender, you must apply for participation. Only if you apply for the tender, you will be actively informed about any changes to the tender documents and will be able to ask questions about the tender or receive the answers.

Any legal or professional questions concerning the award procedure or the tender documents must be addressed to the eVergabe platform.

VI.4)Procedures for appeal / review

VI.4.1) Bodyresponsible for appeal procedures

Awarding Office of the
Confederation Villemombler Straße 76
Bonn
53123
Germany
VI.4.2)Body responsible for appeal procedures

VI.4.3)Lodging of appeals

Precise information on the time limits for lodging appeals:

Section 160 GWB

(1) The awarding authority shall initiate a review procedure only upon request.

2. Any undertaking which is interested in the public contract or the concession and who asserts an infringement in its rights pursuant to Article 97 (6) by not observing public procurement rules shall have the right to submit applications. It must be shown that the alleged infringement of the public procurement rules has caused or is likely to result in damage to the company.

(3) The application is inadmissible in so far as:

1. the applicant has recognized the alleged infringement of public procurement rules before submitting the request for review and has not complained to the contracting authority within a period of ten calendar days; The expiry of the time limit pursuant to Section 134 (2) shall remain unaffected,

2. Infringements of public procurement rules which are discernible on the basis of the notice shall not be complained to the contracting authority not later than the expiry of the period set out in the notice of invitation to tender,

3. Infringements of the public procurement rules, which are only recognizable in the tender documents, are not complained against the contracting authority at the latest until the expiry of the deadline for the application or tender,

4. have passed more than 15 calendar days after receipt of the notice of the contracting authority not to remedy a complaint.

VI.4.4)Service from which information about the lodging of appeals may be obtained

Awarding Office of the
Confederation Villemombler Straße 76
Bonn
53123
Germany

VI.5)Date of dispatch of this notice:

04/04/2017
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Author: Cenedella.de

Philip J. Cenedella IV - The 2-continent Cannabis Consultant. First and foremost, I am a Patient Advocate since 1977. I have also 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 for over 3 decades. From California, now residing in Germany and providing professional business development services to firms from North America, Europe and worldwide. I support the work of United States Congressman Dana Rohrabacher (pictured below at ICBC Berlin) and the BERLIN PEACE ACCORDS which call for an end to the world war on Cannabis. https://cenedella.de/berlin-peace-accords Consulting Services: Sales and Business Development - all facets, C-level, ethical and professional Assist with Strategic Direction - but focused on its implementation Professionally represent your firm - at conventions, sales meetings, and events Research - licensing, compliance, distribution networks and qualify potential partners I am your resource, on the ground in Europe! Philip J. Cenedella IV Call +1.888.206.3264 USA / +49.0.151.720.16752 GERMANY Skype: philip.j.cenedella / eMail: phil@cenedella.de

2 thoughts on “Germany: Cultivation License, tender information

  1. The Act on the Amendment of Drugs and Other Provisions, which entered into force on 10 March 2017, has expanded the scope for the prescription of cannabis medicines. The Act provides for the establishment of a government agency, the so-called cannabis agency, in accordance with the provisions of the United Nations Unity Treaty of 1961 on United Nations drugs. This will control and control the cultivation of cannabis for medical purposes in Germany.

    Until cannabis is available for medical purposes from German cultivation, the demand is still covered by imports, for which the cannabis agency is not responsible (further information – see Bundesopiumtelle ).

    The Cannabis Agency is a specialist area in the Department of Admission 4 (Special Therapies and Traditional Medicines) in the BfArM . It controls cultivation, harvesting, processing, quality testing, storage, packaging as well as delivery to wholesalers and pharmacists or manufacturers. The cannabis agency will take possession of the cannabis for medical purposes after the harvest.

    The harvest is not transported to the BfArM , it is not stored there, nor is it redistributed from there. These steps will be located spatially at the respective construction companies or other commissioned companies.

    The cultivation is therefore not carried out in the BfArM or by the BfArM itself, but by companies selected in a Europe-wide tender procedure and commissioned by the cannabis agency. The procedure takes into account all drug and narcotic drug requirements.

    The tender procedure has now been published in the Official Journal of the European Union.
    The following link leads to the tender documents: Supplement to the Official Journal of the European Union

    Communication in connection with the tendering procedure takes place exclusively through the electronic award platform.

    Cannabis will be grown exclusively for medical purposes. It is therefore a medicine. Only cannabis grown according to the guidelines of the Good Agricultural and Collection Practice (GACP ) will be used, which corresponds to the specifications of the Monograph “Cannabis Blossoms” ( DAB ) and the Requirements of the other relevant monographs and guidelines. This ensures the availability of cannabis for medical purposes in reproducible quality in accordance with drug laws. The cannabis for medical purposes is also subject to the provisions of the law on narcotic drugs.

    The cannabis agency will set a manufacturer’s fee and sell the cannabis to cannabis drug manufacturers, wholesalers or pharmacies. The cannabis agency is not allowed to make any profits or surpluses. In the case of pricing, however, the personnel and material costs incurred by the BfArM are taken into account. However, the cannabis agency has no influence on the actual sales price in the pharmacy. The distribution channels of manufacturers and dealers will comply with the legal regulations and are thus identical with the regulations for the distribution of other drugs containing narcotic drugs.

    Here you can find information about the cannabis agency and the cannabis cultivation of cannabis controlled by the cannabis agency for medical purposes:

    Why must a so-called cannabis agency be established?
    According to the United Nations Unified Substitute Convention of 1961, a Member State must establish or appoint a government agency as soon as cannabis is to be cultivated for purposes other than industrial purposes (useful hemp) within that State. In general, the name “cannabis agency” has prevailed for this site.

    Where is the cannabis agency located?
    The law provides for the establishment of the cannabis agency at the BfArM . The cannabis agency was established as specialty 44 in the “Special Therapies and Traditional Drugs” section. The head of the department, Prof. Dr. W. Knöss, took over the management.

    What are the tasks of the cannabis agency?
    The tasks of the cannabis agency are based on the provisions of the Unified Convention. The Cannabis Agency is awarding contracts for the cultivation of cannabis in Germany. The cannabis agency must take possession of the crop and ensure that exclusively pharmaceutical-grade cannabis is delivered to pharmacies for the care of patients. The contractors for this are determined in a Europe-wide tender procedure.

    The cannabis agency is not responsible for the import of cannabis and will therefore neither buy nor distribute imported cannabis.

    What are the foundations of the tendering procedure?
    Such an invitation to tender must, in principle, be implemented in accordance with the provisions of the Convention on the Law of Obligations and must also take account of all the criteria laid down in the 1961 Unified Conventions, the Medicines Act and the Narcotics Act for the cultivation and marketing of cannabis as a medicinal product.

    How do I participate in the tender procedure?
    Interested parties may participate in the tender procedure only through the electronic tender platform. Corresponding technical notes are made available via the award platform.

    Can you ask questions about the tender procedure?
    Questions about the tender procedure can be submitted exclusively through the electronic tender platform. Requests addressed
    directly to the BfArM for the tender procedure can not be answered; likewise, for legal reasons, it is not possible to consult interested parties.

    How is the quality of the cannabis cultured in Germany to be used in the future?
    Cannabis is delivered exclusively to patients in pharmaceutical quality. To ensure this, the tendering procedure for the cultivation of cannabis involves appropriate legal requirements and relevant guidelines. A draft for a monograph Cannabisblüten of the German medicine book was published in the Bundesanzeiger on 06.06.2016. The monograph is expected to enter into force later this year. It is thus a first standard available, which is of great importance for the care of patients with cannabis in pharmaceutical quality. The BfArM has played a decisive role in the development of the monograph. In addition, the preparation of a monograph for the European Pharmacy was also commissioned.

  2. Pingback: Germany: Cultivation License, tender information | Cenedella.de

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