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001209
The Gazette of Pakistan
ISLAMABAD, MONDAY, DECEMBER 11, 2000
Part II
Statutory Notifications (S.R.O.)
Government of Pakistan
Ministry of Health
Notifications
Islamabad, the 9th December, 2000
S.R.O. 877(I)/2000.-- In exercise of
the powers conferred by section 43 of the Drugs Act, 1976 (XXXI of 1976), the Federal
Government is pleased to direct that the following amendments shall be made in the Drugs
(Licensing, Registering and Advertising) Rules, 1976, the same having been previously
published as required by sub-section (3) of the said section, namely:--
(1) in rule 5, in sub-rule (4), for the word "hundred" the word
"thousand" shall be substituted;
(2) in rule 16, after clause (e) the following new clause shall be added, namely:--
"(f) An application for site verification or approval of the layout plan or an
application for extension or revision of layout plan, as the case may be, shall be
accompanied with a fee as prescribed under Schedule F";
(3) in rule 17, after sub-rule (2), the following new sub-rule shall be added, namely:--
"(3) An application for repacking of a drug specified in Schedule D shall be
accompanied with a fee as prescribed under Schedule F and such permission shall be valid
for a period of five years only";
(4) in rule 19, after sub-rule (5), the following new sub-rule shall be inserted,
namely:--
"(5A) A fee of one thousand rupees shall be paid for a duplicate inspection book if
the original is defaced, damaged or lost. Such book shall bear the word
‘duplicate’ and shall be issued after pasting the copies of the last three
inspection reports available on record.";
(5) in rule 26, in sub-rule (5), for the word ‘fifty’ the word
‘thousand’ shall be substituted;
(6) in rule 30, after sub-rule (9), the following new sub-rule shall be added, namely:--
"(10) The application for conducting clinical trials shall be made to the
Registration Board addressed to its Secretary and shall be accompanied with a fee of five
thousand rupees"; and
(7) for the Schedule F the following shall be substituted, namely:--
"SCHEDULE F
1. DRUG MANUFACTURING LICENCE FEE
[See rule 5 (2)]
(A) For the grant of licence:--
Type of licence |
Fee |
| By way of basic | Rs. 10,000 |
| By way of semi-basic | Rs. 10,000 |
| By way of formulation | Rs. 35,000 |
| By way of repacking | Rs. 20,000 |
IV. DRUG REGISTRATION FEE
[See rule 26 (3B)]
(A) For the grant of registration:
Type of drug |
Fee |
| New drug molecule | Rs. 15,000 |
| Any other drug for import | Rs. 15,000 |
| Any other drug for local manufacture including galenicals. | Rs. 8,000 |
(B) For renewal of registration:
(i) If the application for renewal is made before the expiry of the period of validity of
a certificate of registration:
Type of drug |
Fee |
| For import | Rs. 7,500 |
| For local manufacture | Rs. 4,000 |
(ii) If the application for renewal is made after the expiry of the period of validity of certificate of registration but within sixty days after expiry of the period of validity:
Type of drug |
Fee |
| For import | Rs. 15,000 |
| For local manufacture including galenicals. | Rs. 8,000 |
| (C) Variance to registration application i.e. changes in inactive raw materials, method of manufacture, testing methods/quality specifications, product specification, packing materials including change in labelling specifications, etc. | Rs. 1,000 |
(B) For renewal of license:--
(i) If the application for renewal is made before the expiry of the period of validity of
license:
Type of license |
Fee |
| By way of basic | Rs. 5,000 |
| By way of semi-basic | Rs. 5,000 |
| By way of formulation | Rs. 17,500 |
| By way of repacking | Rs. 10,000 |
(ii) If the application for renewal is made after the expiry of the period of validity of license but within sixty days after expiry of the period of validity:
Type of license |
Fee |
| By way of basic | Rs. 10,000 |
| By way of semi-basic | Rs. 10,000 |
| By way of formulation | Rs. 35,000 |
| By way of repacking | Rs. 20,000 |
II. SITE VERIFICATION AND LAYOUT PLAN
[See rule 16(f)]
(Schedule "B" paragraph 1.2 of Section-1)
| (A) Site inspection and verification | Rs. 1,000 |
| (B) Approval of layout plan | Rs. 1,000 per Section |
| (C) Revision or Extension of layout plan | Rs. 500 per Section |
III. REPAKING
[See rule 17(3)]
| Repacking of drugs | Rs. 500 per drug specified in Schedule D. |
(D) Note:
An application for--
(i) transfer of registration from one importer or manufacturer to another,
(ii) transfer from import to local manufacture,
(iii) import in bulk and repacking locally, and
(iv) change of name of registered drug, shall be considered as for grant of a new
registration and shall be made as per rule 26(1).
V. FEE FOR ADVERTISEMENT
[See rule 31 (1B)]
| Application for advertisement | (i) Rs. 2,000 per advertisement for print media. |
| (ii) Rs. 3,000 per advertisement for Radio/Audio. | |
| (iii) Rs. 5,000 per advertisement for T.V/Cinema. |
S.R.O. 878(I)/2000.-- In exercise of the powers
conferred by section 43 of the Drugs Act, 1976 (XXXI of 1976), the Federal Government is
pleased to Direct that the following further amendment shall be made in the Drugs
(Appellate Board) Rules, 1976, the same having been previously published as required by
sub-section (3) of the said section, namely:--
In the aforesaid rules, in rule 4, in sub-rule (2) after the word "appellant"
the following words shall be inserted, namely:--
"and a fee of one thousand rupees for each application"
S.R.O. 879(I)/2000.-- In exercise of the powers conferred by section 43
of the Drugs Act, 1976 (XXXI of 1976), the Federal Government is pleased to direct that
the following further amendments shall be made in the Drugs (Import and Export) Rules,
1976, the same having been previously published as required by sub-section (3) of the said
section, namely:--
In the aforesaid Rules, in rule 6,--
(i) in sub-rule (1), for the word "fifty" the words "two hundred and
fifty" shall be substituted;
(ii) in the proviso to sub-rule (1), for the words "twenty-five" the words
"one hundred and twenty-five" shall be substituted; and
(iii) in sub-rule (2), for the words "twenty-five" the words "one hundred
and twenty-five" shall be substituted.
[No. F. 9-5/2000-Lic.]
DR. FARZANA CHOWDHARY,
Drugs Controller
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