Lieferungen - 189012-2017

Unrevised Machine Translation

19/05/2017    S96

Germany-Bonn: Medical equipments, pharmaceuticals and personal care products

2017/S 096-189012

Corrigendum

Notice for changes or additional information

Supplies

(Supplement to the Official Journal of the European Union, 2017/S 070-131987)

Section I: Contracting authority/entity

I.1)Name and addresses
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Kurt-Georg-Kiesinger-Allee 3
Bonn
53175
Germany
Contact person: Bundesinstitut für Arzneimittel und Medizinprodukte, Frau Stefanie Vogt
Telephone: +49 228-2074124
E-mail: Z122@bfarm.de
Fax: +49 228-2074352
NUTS code: DEA22

Internet address(es):

Main address: http://www.bfarm.de

Section II: Object

II.1)Scope of the procurement
II.1.1)Title:

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

Reference number: 2281-1713
II.1.2)Main CPV code
33000000
II.1.3)Type of contract
Supplies
II.1.4)Short description:

Cultivation, processing, storage, packaging and distribution of cannabis for medical purposes in a secure Inhouse-Plantage in Germany.

Section VI: Complementary information

VI.5)Date of dispatch of this notice:
15/05/2017
VI.6)Original notice reference
Notice number in the OJ S: 2017/S 070-131987

Section VII: Changes

VII.1)Information to be changed or added
VII.1.2)Text to be corrected in the original notice
Section number: II.2.9)
Lot No: 1
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference in the last three years (whether under a Auftragsoder more...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.10)
Lot No: 1
Place of text to be modified: Varianten/Alternativangebote sind zulässig
Instead of:

None.

Read:

Yes.

Section number: II.2.9)
Lot No: 2
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference in the last three years (whether under a contract or several A...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.9)
Lot No: 3
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference number in the past three years under a contract (whether one or more...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in the country under Art 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.9)
Lot No: 4
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference number in the past three years under a contract (whether one or more...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority under Art. 23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.9)
Lot No: 5
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference number in the past three years under a contract (whether one or more...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.9)
Lot No: 6
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference number in the past three years under a contract (whether one or more...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.9)
Lot No: 7
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference number in the past three years under a contract (whether one or more...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.9)
Lot No: 8
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference number in the past three years under a contract (whether one or more...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.9)
Lot No: 9
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per letztendrei in the reference years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference in the last three years (whether under a Auftragsoder several A...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: II.2.9)
Lot No: 10
Place of text to be modified: Objektive Kriterien für die Auswahl der begrenzten Zahl von Bewerbern
Instead of:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with a flow of at least 50 kg per reference in the last three years. A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art.23 of the 1961 Single Convention on Narcotic Drugs” for this position directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg; The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding cannabis) with a flow of at least 50 kg per reference number in the past three years under a contract (whether one or more...

Read:

A) references to earlier work of cultivation, processing and supply of cannabis for medical purposes with the competent body in each country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs with a flow of at least 50 kg per reference in the last 3 years.

A mandate as a reference to the cultivation, processing and supply of medical cannabis is also the country with the consent of the competent authority in the meaning of Art. 23 of the Single Convention on Narcotic Drugs of 1961 for this post directly to a wide range of beneficiaries and the quantities delivered a total of at least 50 kg;

The candidate will be given in 50 kg quantity delivered (whether under a contract or several contracts): 10 points (out of a maximum of 40 points).

b) references in relation to the cultivation, processing and supply of medicinal plants (excluding Cannab...

Section number: III.1.2)
Place of text to be modified: Auflistung und kurze Beschreibung der Eignungskriterien
Instead of:

— an indication of the overall turnover of the tenderer over the past three financial years, if available.

— Information on the applicant’s turnover in the field of cultivation, processing and supply of cannabis for medical purposes, if any.

— indication of the applicant’s turnover in the field of cultivation, processing and supply of medicinal plants for the past three financial years, if available.

— an indication of the existence of a professional or commercial liability insurance amounting to EUR 5 million (2 times per year), or to maximise the tenderer’s insurance, such insurance in the case of the award of the contract.

Financial statements of the applicant, if the candidates whose publication is required by law.

They indicated that, as in the case of the award and the funding of the contract will be ensured (loan, equity financing, loans, etc.) or a credit institution or insurance de...

Read:

— an indication of the overall turnover of the tenderer over the past 3 financial years, if available,

— Information on the applicant’s turnover in the field of cultivation, processing and supply of cannabis for medical purposes for the past 3 financial years, if available,

— indication of the applicant’s turnover in the field of cultivation, processing and supply of medicinal plants in the last 3 financial years, where available,

— an indication of the existence of a professional or commercial liability insurance for an amount of EUR 5 000 000 (2 times per year), or to maximise the insurance, such insurance on behalf of the tenderer in the event of award,

The applicants, submission of the annual accounts for the last 3 years for which accounts have been closed if their publication is prescribed by law for the applicant,

They indicated that, as in the case of the award and the funding of the contract will be ensured (equity, shareholder loan, D...)

Section number: III.1.3)
Place of text to be modified: Auflistung und kurze Beschreibung der Eignungskriterien
Instead of:

— details of tenderer’s references to previous orders executed the cultivation, processing and supply of medical cannabis in the last three years (a list indicating the value, volume delivered, the delivery period and of the customer and, as far as they are available in a given country’s designated body under Art 23 of the 1961 Single Convention on Narcotic Drugs, concluded in New York on 30.03.1961).

Tenderer’s references, details of previous orders executed to cultivation, processing and supply of Arzneimittelpflanzen over the last three years (a list indicating the value, quantity and delivery period, the recipient of the services).

— an indication of the technicians of the tenderer related to the performance of the programme period.

— details of the tool, equipment and technical equipment available to the tenderer for the purpose of executing the order No...

Read:

— details of tenderer’s references to previous orders executed the cultivation, processing and supply of medical cannabis in the past 3 calendar years (if fitted) (list with the value, volume delivered, the delivery period and of the customer and the competent body in the respective country within the meaning of Article of 23 of the 1961 Single Convention on Narcotic Drugs, concluded in New York on 30.3.1961),

Tenderer’s references, details of previous orders executed to cultivation, processing and supply of Arzneimittelpflanzen over the last 3 years (if fitted) (list with the value, quantity and delivery period, the recipient of the services). The contract must be completed in compliance with the provisions of the "Eudralex: Volume 4 Medical Products for Human and Veterinary Use: “Good Manufacturing Practices” and Annex 7: Manufacture of Herbal Medical Product” and “Guideline on Good Agricultural and Co....

VII.2)Other additional information: