Request for participation for the supply of
Icatibant30mg solution for injection in pre-filled syringe
RFP No: / 021-14012/17 / CPSU Reference / 05100N17SM
Closing Date: / 24/7/2017 / at 10:00am 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 (A782): / Icatibant 30mg solution for injection in pre-filled syringe
Item Description: / Details for Icatibant 30mg solution for injection in pre-filled syringe:
Each pre-filled syringe of 3ml is to contain icatibant acetate equivalent to 30mg icatibant to be administered by subcutaneous administration.

Item 1: (A782):Icatibant 30mg solution for injection in pre-filled syringe

  1. COMPANY CONTACT DETAILS

Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
  1. PATENCY

Patent No.
Patent Certificate is being attached
  1. 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 2: (A245A): Sodium Valproate 500mg tablets

  1. COMPANY CONTACT DETAILS

Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
  1. PATENCY

Patent No.
Patent Certificate is being attached
  1. 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 3: (C047): Sodium Valproate Oral Solution

  1. COMPANY CONTACT DETAILS

Name of Company
Address
VAT No.
Contact Person
(for this interest)
Telephone / Mobile
E-mail / VAT No.
  1. PATENCY

Patent No.
Patent Certificate is being attached
  1. 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.

Page 1
©2015 CPSU / V1.1