03/08/2015
NOTICE FOR MEETING OF THE APPELLATE BOARD
It is hereby notified that the 143rd meeting of the Appellate Board is scheduled to be held on 29th July, 2015 at 10.30 a.m in the committee room, first floor, Ministry of National Health Services, Regulations and Coordination, G-5/2, Islamabad. Below mentioned appeals will be considered by the Appellate Board. Although letters have already been issued to the individual Appellants through UMS, for attending the subject meeting, however, through this notice, below mentioned Appellants are once again informed :-
i. To appear before the Appellate Board in person or through a duly authorized representative who is well versant with the matter to make further submission, if any, in support of your Appeals as you may deem fit.
ii. Please note that if you or your representative fails to appear before the Board on the date fixed, the case will proceed and ex-parte decision may be taken.
iii. No TA/DA will be admissible.
iv. Kindly acknowledge the receipt of this letter and confirm your attendance along with a letter of authorization / nomination for the person(s) appearing on your behalf.
a) Fresh Appeals:-
Sr. No. Appeal No. Name of the Appellant Brief of Appeal
1. 19/2013 M/s Festel Laboratories, Lahore. Appeal against the cancellation of registration of Dudofen Tablet 40 mg (Famotidine) Reg. No. 034611 by the Registration Board in its 237th Meeting held on 26-02-2013.
2. 03/2014 M/s Sanofi-Aventis Pakistan Limited, Karachi Appeal against decision of Registration Board taken in its 242nd meeting wherein the Board did not accede to the request of the appellant for transfer of registration of Thymoglobulin (Reg. No. 069513) from M/s Scitech Health (Pvt) Ltd., Karachi to M/s Sanofi-Aventis.
3. 04/2014 M/s Ghazi Brothers, Karachi Appeal against the order dated 12th June, 2014 passed in the 243rd meeting of the Registration Board regarding rejection of registration application of Analgin Solution for Injection.
4. 05/2014 M/s Servier Research and Pharmaceuticals [Pakistan](Pvt) Ltd., Lahore Appeal against decision of Registration Board taken in its 245th meeting wherein the Board rejected the registration application due to reason that Daflon 1gm is not approved by any reference regulatory authority i.e., US FDA, EMA, TGA, MHRA and in country of origin i.e., France and that safety and efficacy data has not been provided.
5. 01/2015 M/s ICI Pakistan Limited, Karachi Appeal against decision of Registration Board communicated vide letter No. F. 3-4/2014 Reg-I (M-245) dated 6th November, 2014.
6. 02/2015 M/s Biocare Pharmaceutica, Lahore. Appeal against decision of Registration Board communicated vide letter No. F. 3-4/2014 Reg-I (M-245) dated 10th November, 2014 rejecting registration application of Ceflet 0.75g for injection.
7. 03/2015 M/s Biocare Pharmaceutica, Lahore. Appeal against decision of Registration Board communicated vide letter No. F. 3-4/2014 Reg-I (M-245) dated 10th November, 2014 rejecting registration application of Ceflet 1.5g for injection.
8. 04/2015 M/s Biocare Pharmaceutica, Lahore. Appeal against decision of Registration Board communicated vide letter No. F. 3-4/2014 Reg-I (M-245) dated 10th November, 2014 rejecting registration application of Ceflet 3.0g for injection.
9. 05/2015 M/s Biocare Pharmaceutica, Lahore. Appeal against decision of Registration Board communicated vide letter No. F. 3-4/2014 Reg-I (M-245) dated 10th November, 2014 rejecting registration application of Xtra 1.5g for injection.
10. 06/2015 M/s Biocare Pharmaceutica, Lahore. Appeal against decision of Registration Board communicated vide letter No. F. 3-4/2014 Reg-I (M-245) dated 10th November, 2014 rejecting registration application of Xtra 3.0g for injection.
11. 07/2015 M/s Weather Folds Pharmaceuticals, Hattar. Appeal against decision of Central Licensing Board taken in its 238th meeting communicated vide letter No. F. 3-6/2007-Lic (Vol-I) dated 5th December, 2014.
b) Appeals deferred in the previous meetings of the Board: -
Sr. No. Appeal No. Name of the Appellant Brief of Appeal
1. 1987 M/s. Novo Nordisk Pharma, Khi Appeal against the decision of Drug Pricing Committee for fixation of low MRP of Mixtard 30 ® FlexPen 100IU Reg. No. 069522.
2. 1988 M/s. Novo Nordisk Pharma, Khi Appeal against the decision of Drug Pricing Committee for fixation of low MRP of Insulatard ® FlexPen 100IU Reg. No. 069524.
3. 1989 M/s. Novo Nordisk Pharma, Khi Appeal against the decision of Drug Pricing Committee for fixation of low MRP of Actrapid ® FlexPen 100IU Reg. No. 069523.
4. 1997 M/s. ISIS Pharmaceuticals and Chemical Works, Karachi Appeal against the decision of Registration Board regarding cancellation of registration of Stop-P 50mg (Diclofenac Potassium) Tablets, Registration No. 028140.
5. 20/2013 M/s Wyeth Pakistan Limited, Karachi. Appeal against the cancellation of registration of Myambutol INH Forte (Reg. No. 031293) by the Registration Board in its 237th Meeting held on 26-02-2013.
c) Miscellaneous Case(s): -
Sr. No. Appeal No. Name of the Appellant Brief of Appeal
1. 01/2013 M/s Efroze Chemical Industries (pvt.) Ltd., Karachi Appeal against orders passed by Central Licensing Board on 30-01-2013.
