*Failure of Registering Item Within 150 Days from Date of Award of Contract, the Contracting

Request for participation for the supply of
Lot 1 – Dabrafenib 75mg capsules,
Lot 2 – Dabrafenib 50mg capsules,
Lot 3 – Trametinib 2mg tablets,
Lot 4 – Everolimus 10mg tablets,
Lot 5 – Everolimus 5mg tablets,
Lot 6 – Everolimus 0.75mg tablets and
Lot 7 – Everolimus 0.25mg tablets
RFP No: / 021-14003/17 / CPSU Reference / CPSU 163051N17FSM
Closing Date: / 9th June 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: / Request for Participation for the supply of: Lot 1 – Dabrafenib 75mg capsules, Lot 2 -Dabrafenib 50mg capsules, Lot 3 – Trametinib 2mg tablets, Lot 4 – Everolimus 10mg tablets, Lot 5 – Everolimus 5mg tablets, Lot 6 – Everolimus 0.75mg tablets and
Lot 7 – Everolimus 0.25mg tablets
Item Description: / Lot 1 – Dabrafenib 75mg capsules
Dabrafenib (as mesilate) 75mg capsules
Lot 2: Dabrafenib 50mg capsules
Dabrafenib (as mesilate) 50mg capsules
Lot 3: Trametinib 2mg tablets
Trametinib dimethyl sulfoxide 2mg tablets
Lot 4: Everolimus 10mg tablets
Everolimus tablets containing 10mg of active ingredient.
Lot 5: Everolimus 5mg tablets
Everolimus tablets containing 5mg of active ingredient.
Lot 6: Everolimus 0.75mg tablets
Everolimus 0.75mg tablets for oral administration (Certican® Novartis)
Lot 7: Everolimus 0.25mg tablets
Everolimus 0.25mg tablets for oral administration (Certican® Novartis)

COMPANY CONTACT DETAILS

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

PATENCY

Patent No.
Patent Certificate is being attached

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.