Modelo de permiso de fabricacion producto farmaceutico india

Páginas: 1 (250 palabras) Publicado: 19 de enero de 2011
No. APrrR0lKAAJ2008/J-31 /B Office of the CommissiOner,
f Food & DrugConrrolAdmmistration .
GUjarat.gtat~ Block No.8; 1st Fioor,
Old Sachivalaya,Gandhinagar.
Dated: I /2008.
LpharmaeeUtiealSLtd.. Thol,-Mehsena -382 728 Gujarat, India. Sub: Drugs & Cosmetics Act 1940 and rules thereunder Perniission to manufacturer additional products. Dear Sirs, .. Ref: Your letter No, TPL IAPI003/2008. Dated 30 1011 2008.
I have to state that you are permitted to.manufacture andmarket the following products as per the'
supplementary list subIilitted by you vide you letter under referencec-1.
o L----· .
The above products permission-is-granted subject to the following conditions:
I. The product should be safe and efficacious.
2. Youshould see that you comply with the labelingprovisions"made under the Drugs & Cosmetics Rules 1945 (asamendedj.forthisproductbeforemarketingandfurnishprintedlabels ofthe productin question underRule96ofDrugs & Cosmeties Rules asamendedrequired tliat the propernameofthedrugshall begivenin-amore conspicuousmannerandthetradename, ifany. which shall be shownimmediately after or under the proper name.
.3. " IIi case ofnew drug as givenru.1e·69~RofDhlgS·~Cosmetics Rules permission to import,raw
materials be obtalned under Rules 30(A) from Drugs Controller General (India) NewDelhi.'
4. The permissionis granted only subjeet tothe provisions ofDrugs & Cosmetics Aet and does not ' relieveyouofyourresponsibilities to eleartheitemscovered under the"list from.any enactment orstatueororder-issued"either-bytheStateGovernmentorCentralGovernmentand enforced by anyauthorities.You mustthereforeobtainelearancebeforemarketing im~ product, . Before introducing ~ productin this market you should comply with the provisionsofDrugs (price control) Order, 1995. . . The originalproduct list attested by this office and draft labels specimens copy are returned
. herewith. . .
Kindly acknowledge the receipt ofthis letter.
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