Lot 1: Pomalidomide 3Mg Capsules;

Request for participation for the supply of

Lot 1: Pomalidomide 3mg capsules;

Lot 2: Pomalidomide 4mg capsules;

Lot 3: Ibrutinib 140mg capsules;

Lot 4: Idelalisib 150mg tablets;

Lot 5: Dasatinib 20mg tablets;

Lot 6: Dasatinib 100mg tabletsLot 7: Idelalisib 100mg tablets - (new item added)

RFP No: / 021-14016/17 / CPSU Reference / 0164053N17DAD
Closing Date: / 05.09.2017 / at 10:00am CET/CEST
Requests for participation are to be submitted in English on , by closing date and time as specified above. Late submissions or interests submitted by any other means will not be considered.
Item Name : /

Lot 1: Pomalidomide 3mg capsules

Item Description: / Pomalidomide 3mg capsules for oral administration.
A.  COMPANY CONTACT DETAILS
Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
B.  PATENCY
Patent No.
Patent Certificate is being attached
C.  PRODUCT REGISTRATION
IN CASE OF REGISTERED PRODUCT/S
Marketing Authorisation Holder in country of licensing:
MA/QL/PI/EU No.
A certified true copy of the MA/QL/PI issued by the Licensing Authority of Malta, is being attached / Please select as applicable
IN CASE OF NON REGISTERED PRODUCT/S
An application for registering product with Licensing Authority of Malta has been submitted. A copy of the Registration Application receipt, is being attached / Please select as applicable
Process for registering product/s has not yet been initiated. Product/s will be registered within 150 days from award of Contract* / Please select as applicable

*Failure of registering item within 150 days from date of Award of Contract, the Contracting Authority reserves the right, at its own discretion, either to purchase registered products on the account of the defaulting contractor until such time the product is registered OR the product shall be registered by the Contracting Authority on behalf of the Contractor at a onetime registration fee of €1,000 and an annual fee as applicable by the Medicines Authority. In the later case, the Contracting Authority shall also be charging an annual administration fee of €500 per year. Such registration shall abide to the procedures and policies applicable by the Medicines Authority.

Item Name : /

Lot 2: Pomalidomide 4mg capsules

Item Description: / Pomalidomide 4mg capsules for oral administration.
A.  COMPANY CONTACT DETAILS
Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
B.  PATENCY
Patent No.
Patent Certificate is being attached
C.  PRODUCT REGISTRATION
IN CASE OF REGISTERED PRODUCT/S
Marketing Authorisation Holder in country of licensing:
MA/QL/PI/EU No.
A certified true copy of the MA/QL/PI issued by the Licensing Authority of Malta, is being attached / Please select as applicable
IN CASE OF NON REGISTERED PRODUCT/S
An application for registering product with Licensing Authority of Malta has been submitted. A copy of the Registration Application receipt, is being attached / Please select as applicable
Process for registering product/s has not yet been initiated. Product/s will be registered within 150 days from award of Contract* / Please select as applicable

*Failure of registering item within 150 days from date of Award of Contract, the Contracting Authority reserves the right, at its own discretion, either to purchase registered products on the account of the defaulting contractor until such time the product is registered OR the product shall be registered by the Contracting Authority on behalf of the Contractor at a onetime registration fee of €1,000 and an annual fee as applicable by the Medicines Authority. In the later case, the Contracting Authority shall also be charging an annual administration fee of €500 per year. Such registration shall abide to the procedures and policies applicable by the Medicines Authority.

Item Name : /

Lot 3: Ibrutinib 140mg capsules

Item Description: / Ibrutinib 140mg capsules for oral administration
A.  COMPANY CONTACT DETAILS
Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
B.  PATENCY
Patent No.
Patent Certificate is being attached
C.  PRODUCT REGISTRATION
IN CASE OF REGISTERED PRODUCT/S
Marketing Authorisation Holder in country of licensing:
MA/QL/PI/EU No.
A certified true copy of the MA/QL/PI issued by the Licensing Authority of Malta, is being attached / Please select as applicable
IN CASE OF NON REGISTERED PRODUCT/S
An application for registering product with Licensing Authority of Malta has been submitted. A copy of the Registration Application receipt, is being attached / Please select as applicable
Process for registering product/s has not yet been initiated. Product/s will be registered within 150 days from award of Contract* / Please select as applicable

*Failure of registering item within 150 days from date of Award of Contract, the Contracting Authority reserves the right, at its own discretion, either to purchase registered products on the account of the defaulting contractor until such time the product is registered OR the product shall be registered by the Contracting Authority on behalf of the Contractor at a onetime registration fee of €1,000 and an annual fee as applicable by the Medicines Authority. In the later case, the Contracting Authority shall also be charging an annual administration fee of €500 per year. Such registration shall abide to the procedures and policies applicable by the Medicines Authority.

Item Name : /

Lot 4: Idelalisib 150mg tablets

Item Description: / Idelalisib 150mg tablets
Idelalisib 150mg tablets for oral administration.
A.  COMPANY CONTACT DETAILS
Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
B.  PATENCY
Patent No.
Patent Certificate is being attached
C.  PRODUCT REGISTRATION
IN CASE OF REGISTERED PRODUCT/S
Marketing Authorisation Holder in country of licensing:
MA/QL/PI/EU No.
A certified true copy of the MA/QL/PI issued by the Licensing Authority of Malta, is being attached / Please select as applicable
IN CASE OF NON REGISTERED PRODUCT/S
An application for registering product with Licensing Authority of Malta has been submitted. A copy of the Registration Application receipt, is being attached / Please select as applicable
Process for registering product/s has not yet been initiated. Product/s will be registered within 150 days from award of Contract* / Please select as applicable

*Failure of registering item within 150 days from date of Award of Contract, the Contracting Authority reserves the right, at its own discretion, either to purchase registered products on the account of the defaulting contractor until such time the product is registered OR the product shall be registered by the Contracting Authority on behalf of the Contractor at a onetime registration fee of €1,000 and an annual fee as applicable by the Medicines Authority. In the later case, the Contracting Authority shall also be charging an annual administration fee of €500 per year. Such registration shall abide to the procedures and policies applicable by the Medicines Authority.

Item Name : /

Lot 5: Dasatinib 20mg tablets

Item Description: / Dasatinib 20mg tablets
A.  COMPANY CONTACT DETAILS
Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
B.  PATENCY
Patent No.
Patent Certificate is being attached
C.  PRODUCT REGISTRATION
IN CASE OF REGISTERED PRODUCT/S
Marketing Authorisation Holder in country of licensing:
MA/QL/PI/EU No.
A certified true copy of the MA/QL/PI issued by the Licensing Authority of Malta, is being attached / Please select as applicable
IN CASE OF NON REGISTERED PRODUCT/S
An application for registering product with Licensing Authority of Malta has been submitted. A copy of the Registration Application receipt, is being attached / Please select as applicable
Process for registering product/s has not yet been initiated. Product/s will be registered within 150 days from award of Contract* / Please select as applicable

*Failure of registering item within 150 days from date of Award of Contract, the Contracting Authority reserves the right, at its own discretion, either to purchase registered products on the account of the defaulting contractor until such time the product is registered OR the product shall be registered by the Contracting Authority on behalf of the Contractor at a onetime registration fee of €1,000 and an annual fee as applicable by the Medicines Authority. In the later case, the Contracting Authority shall also be charging an annual administration fee of €500 per year. Such registration shall abide to the procedures and policies applicable by the Medicines Authority.

Item Name : /

Lot 6: Dasatinib 100mg tablets

Item Description: / Dasatinib 100mg tablets
Dasatinib 100mg tablets
A.  COMPANY CONTACT DETAILS
Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
B.  PATENCY
Patent No.
Patent Certificate is being attached
C.  PRODUCT REGISTRATION
IN CASE OF REGISTERED PRODUCT/S
Marketing Authorisation Holder in country of licensing:
MA/QL/PI/EU No.
A certified true copy of the MA/QL/PI issued by the Licensing Authority of Malta, is being attached / Please select as applicable
IN CASE OF NON REGISTERED PRODUCT/S
An application for registering product with Licensing Authority of Malta has been submitted. A copy of the Registration Application receipt, is being attached / Please select as applicable
Process for registering product/s has not yet been initiated. Product/s will be registered within 150 days from award of Contract* / Please select as applicable

*Failure of registering item within 150 days from date of Award of Contract, the Contracting Authority reserves the right, at its own discretion, either to purchase registered products on the account of the defaulting contractor until such time the product is registered OR the product shall be registered by the Contracting Authority on behalf of the Contractor at a onetime registration fee of €1,000 and an annual fee as applicable by the Medicines Authority. In the later case, the Contracting Authority shall also be charging an annual administration fee of €500 per year. Such registration shall abide to the procedures and policies applicable by the Medicines Authority.

Item Name : /

Lot 7: Idelalisib 100mg tablets

Item Description: / Idelalisib 100mg tablets for oral administration
A.  COMPANY CONTACT DETAILS
Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
B.  PATENCY
Patent No.
Patent Certificate is being attached
C.  PRODUCT REGISTRATION
IN CASE OF REGISTERED PRODUCT/S
Marketing Authorisation Holder in country of licensing:
MA/QL/PI/EU No.
A certified true copy of the MA/QL/PI issued by the Licensing Authority of Malta, is being attached / Please select as applicable
IN CASE OF NON REGISTERED PRODUCT/S
An application for registering product with Licensing Authority of Malta has been submitted. A copy of the Registration Application receipt, is being attached / Please select as applicable
Process for registering product/s has not yet been initiated. Product/s will be registered within 150 days from award of Contract* / Please select as applicable

*Failure of registering item within 150 days from date of Award of Contract, the Contracting Authority reserves the right, at its own discretion, either to purchase registered products on the account of the defaulting contractor until such time the product is registered OR the product shall be registered by the Contracting Authority on behalf of the Contractor at a onetime registration fee of €1,000 and an annual fee as applicable by the Medicines Authority. In the later case, the Contracting Authority shall also be charging an annual administration fee of €500 per year. Such registration shall abide to the procedures and policies applicable by the Medicines Authority.

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