Alcon-iols Cork Ireland-form 10_import License
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:lS"t?-(
n~C~E)q Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-110002 Dated: No. 31-364-MD/2007 -DC To
/
V Sub:
Mis. Alcon Laboratories (India) Private Limited No.3, s" Floor, RMZ Infinity Tower, 'D', Unit No. 502, Old Madras Road, Benniganahalli, Bangalore-560016 Import Licence under the Drugs Act, 1940 and Drugs Rules thereunder.
Dear Sir 1 Sirs, 1. With reference to your applications for import licence forwarded to this office with your letter No. NIL dated 18/06/2009 received by this office vide diary no 25126 dated 25/06/2009. I enclose licence(s) No. MD-364-850 dated ;. A--I-I-r- ~~s 1 these licence(s) has 1 have been granted under the Drugs Act, 1940 and Rules thereunt!er. ,., V i,J
6
,u09
2. I am to point out that the provisions of Drugs Act, 1940 are in addition to and not derogation of any other law for the time being in force and as such the licences issued under Drugs Act will be in addition to and distinct from any licences which may be necessary under the Import Trade Control Regulations made of the Government of India, Ministry of Commerce. 3. The import licence(s) mentioned in para (1) above will not accordingly to itself 1 themselves be sufficient authority for import of Devices covered by that 1 those licences if under the Import Trade control Regulations of the Commerce Ministry separate licenses are required for import of such device(s). 4. I am therefore, to advise you to obtain, where necessary licences for import of devices in question under the Import Trade Control Regulations. 5. Any literature or packing accompanying the device or any matter stated on the label should not contravene the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act. 6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs Control Organisation at the ports will be Officers authorized to inspect the premises of importers establishments for the purpose of Rule 26 of the Drugs Rules. 7.
Please acknowledge receipt of this letter and its enclosures.
Drugs Controller General (India) F.No 31-364-MD/2007-DC Copy together with a copy of Licence No MD-364-850 dated 1. 2. 3. 4.
Asstt. Asstt. Asstt. Asstt.
Drugs Controller Drugs Controller Drugs Controller Drugs Controller
~ 6 A'_': 2009
(India), New Customs House, Fort, Mumbai (India), Customs House, Calcutta (India), Customs House, Chennai (India), Customs House Indira Gandhi International Airport, New Delhi.
Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-11 0002 No. 31-364-MD/2007 -DC Form 10 (See rules 23 and 27) Licence to import devices to the Drugs & Cosmetics Licence Number
Rules, 1945
MD-364-850
Date.
~
6 AUG 2009
MIs. Alcon Laboratories (India) Private Limited, No.3, s" Floor, RMZ Infinity Tower, '0', Unit No. 502, Old Madras Road, Benniganahalli, Bangalore-560016 is hereby licensed to import into India during the period for which this licence is in force, the devices specified below, manufactured by MIs. Alcon Laboratories Ireland Limited, Cork Business and Technology Park, Model Farm Road, Cork, Ireland and any other device manufactured by the said manufacturer as may from time to time be endorsed on this licence. This licence shall be in force from
1.
:-
6 AUG 2009
to
30-11-2010
unless it is sooner suspended or cancelled under the said rules. 2.
Names of device(s) to be imported: Acrysof Single-Piece Intraocular Lenses ITEM (ONE) ONLY
Place: NEW DELHI Date:~G
lOOq.
Conditions of Licence :-;:-;.. -:-,,:,<~';~~ 1. A photocopy of licence shall be displayed in a prominent place in a part,~f tner:premis--es',lfai:fc;l4the original licence shall be produced whenever required.'~:~;~ !¥~i; ('r,,~'!)IL'rl!~~ (:~~:~rc:Her(lli~:'~) --;':'c1 ~
~-;':"-"~,,":,;;'-"I
report'
/
--------------------------------------------------------------~/
n~C~E)q Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-110002 Dated: No. 31-364-MD/2007 -DC To
/
V Sub:
Mis. Alcon Laboratories (India) Private Limited No.3, s" Floor, RMZ Infinity Tower, 'D', Unit No. 502, Old Madras Road, Benniganahalli, Bangalore-560016 Import Licence under the Drugs Act, 1940 and Drugs Rules thereunder.
Dear Sir 1 Sirs, 1. With reference to your applications for import licence forwarded to this office with your letter No. NIL dated 18/06/2009 received by this office vide diary no 25126 dated 25/06/2009. I enclose licence(s) No. MD-364-850 dated ;. A--I-I-r- ~~s 1 these licence(s) has 1 have been granted under the Drugs Act, 1940 and Rules thereunt!er. ,., V i,J
6
,u09
2. I am to point out that the provisions of Drugs Act, 1940 are in addition to and not derogation of any other law for the time being in force and as such the licences issued under Drugs Act will be in addition to and distinct from any licences which may be necessary under the Import Trade Control Regulations made of the Government of India, Ministry of Commerce. 3. The import licence(s) mentioned in para (1) above will not accordingly to itself 1 themselves be sufficient authority for import of Devices covered by that 1 those licences if under the Import Trade control Regulations of the Commerce Ministry separate licenses are required for import of such device(s). 4. I am therefore, to advise you to obtain, where necessary licences for import of devices in question under the Import Trade Control Regulations. 5. Any literature or packing accompanying the device or any matter stated on the label should not contravene the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act. 6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs Control Organisation at the ports will be Officers authorized to inspect the premises of importers establishments for the purpose of Rule 26 of the Drugs Rules. 7.
Please acknowledge receipt of this letter and its enclosures.
Drugs Controller General (India) F.No 31-364-MD/2007-DC Copy together with a copy of Licence No MD-364-850 dated 1. 2. 3. 4.
Asstt. Asstt. Asstt. Asstt.
Drugs Controller Drugs Controller Drugs Controller Drugs Controller
~ 6 A'_': 2009
(India), New Customs House, Fort, Mumbai (India), Customs House, Calcutta (India), Customs House, Chennai (India), Customs House Indira Gandhi International Airport, New Delhi.
Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-11 0002 No. 31-364-MD/2007 -DC Form 10 (See rules 23 and 27) Licence to import devices to the Drugs & Cosmetics Licence Number
Rules, 1945
MD-364-850
Date.
~
6 AUG 2009
MIs. Alcon Laboratories (India) Private Limited, No.3, s" Floor, RMZ Infinity Tower, '0', Unit No. 502, Old Madras Road, Benniganahalli, Bangalore-560016 is hereby licensed to import into India during the period for which this licence is in force, the devices specified below, manufactured by MIs. Alcon Laboratories Ireland Limited, Cork Business and Technology Park, Model Farm Road, Cork, Ireland and any other device manufactured by the said manufacturer as may from time to time be endorsed on this licence. This licence shall be in force from
1.
:-
6 AUG 2009
to
30-11-2010
unless it is sooner suspended or cancelled under the said rules. 2.
Names of device(s) to be imported: Acrysof Single-Piece Intraocular Lenses ITEM (ONE) ONLY
Place: NEW DELHI Date:~G
lOOq.
Conditions of Licence :-;:-;.. -:-,,:,<~';~~ 1. A photocopy of licence shall be displayed in a prominent place in a part,~f tner:premis--es',lfai:fc;l4the original licence shall be produced whenever required.'~:~;~ !¥~i; ('r,,~'!)IL'rl!~~ (:~~:~rc:Her(lli~:'~) --;':'c1 ~
~-;':"-"~,,":,;;'-"I
report'
/
--------------------------------------------------------------~/
