GLOBAL 'PIGGY BACK' POLICY |
Re: LOCUM INTERNATIONAL policy of Piggy Back File Dossier and
Stability Data and the procedures to be implemented on a global
basis. |
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Current Policy |
CURRENT POLICY STATEMENT
Our current policy being implemented with all global regulatory
agency and MOH's is as follows"
STATUS of RAW DATA
Stability data is supplied as a SPECIAL PIGGY BACK Stability Agreement
that stands alone separate from the purchase of the KNOW-HOW CMC
Files. |
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EXCLUSIONS |
FULL RAW DATA IS NOT included in any Title 17 , Title 19 , Title
21 CMC 120+ Dossiers |
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IAGIM KNOW-HOW POLICY |
Know-how Files RESTRICTIONS
The time periods allowed for the use of LIG / IAGIM STABILITY
DATA before members
STABILITY DATA @ 40 deg. C (concurrent 25 deg. C + 24 months)
comes into force is given below.
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CURRENT PIGGY BACK USE
PERIODS |
CONTRACT PERIOD TO PIGGY BACK LIG DATABASE (Min & Max.)
3 months - $ quote as per product (~$ cost)
4 months - Plus (~$ cost) + 10% of Contract
5 months - Plus 20% (~$ cost) + 20% of Contract
6 months - Plus 50% (~$ cost) + 50% of Contract (Maximum period
allowed to piggyback)
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VALIDITY SPECIFICATIONS |
Stability Data + Raw data + Spectra + Assay + Full Assay Validation
shall be placed on-line at secure locations to:
1. FDA OGD
2. EU Authorities
3. Local NON EU Authorities.
4. RoW Authorities (Asian, Pacific Rim, South America)
PRINT HARD COPIES
5. MOH + CLIENT ACCESS Relevant Web Access Keys will be provided
to Client and relevant MOH/Agency
6. PRINT COPIES will be forwarded to MOH as per Specific Product
DMF # VALIDITY + AVAILABILITY PERIOD.
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ACCESS PERIOD & EXPIRATION |
After the 3, or 4, or 5 , or 6 month period has expired the
file access will be then SEALED to all viewing and contracted
parties and the in-house stability (40 deg. C data) GENERATED
BY THE COMPANY (i.e. own CLIENT DATA) will become effective AND
supercede LIG and IAGIM data for MOH / Agency review.
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TIME SENSITIVE DATA |
ALL DATA IS TIME SENSITIVE
This is a TEMPORARY (non-permanent) system and procedure that
allows immediate stability raw data access for a limited pre-agreed
(and pre-paid) time period until own CLIENT accelerated stability
data supersedes the existing LIG / IAGIM database on temporary
loan to members. |
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Non-Permanent Systems |
By Members Agreement this "Piggy Back' agreement is a
not a permanent system designed to circumvent the commitments
the IAGIM MEMBER'S real time and accelerated stability data
legal obligations to be performed in the members own laboratories
with own drug finished product produced on own production equipment
with own production staff and current SOPs.
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