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000927

THE GAZETTE OF PAKISTAN
Islamabad, Wednesday, October 4, 2000
PART II
Statutory Notification (S.R.O.)
GOVERNMENT OF PAKISTAN
MINISTRY OF HEALTH

NOTIFICATIONS
Islamabad, the 27th September, 2000

S.R.O. 719(I)/2000.-- The following draft of certain further amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976 which are proposed to be made, in exercise of the powers conferred by section 43 of the Drugs Act, 1976 (XXXI of 1976), are hereby published, as required by sub-section (3) of the said section, for the information of all persons likely to be affected thereby and notice is hereby given that the draft will be taken into consideration after fifteen days of its publication in the official Gazette.

2. Any objection or suggestion which may be received from any person in respect of the said draft before the expiry of the said period will be considered by the Federal Government.

DRAFT AMENDMENTS

In the aforesaid Rules,--

(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) of 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 plant, 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 deface, damaged or lost. Such book shall bear the word 'duplicate' and shall be issued after passing the copies of the last three inspection reports available on record.";

(5) in rule 26, in sub-rule (5), for the word 'fifty' and 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 license:-

Type of license Fee
By way of basic Rs 10,000
By way of semi-basic Rs 10,000
By way of formulation Rs 25,000
By way of repacking Rs 20,000

(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 licence 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-I)

(A) Site inspection and verification Rs 1,000
(B) Approval of layout plan Rs 1000 per Section
(C) Revision or Extension of layout plan Rs 500 per Section


III. REPACKING
[See rule 17(3)]

Repacking of drugs Rs. 500 per drug specified in Schedule D.


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 of labelling specifications, etc Rs 1,000


(D) Note:
An application for -1--
(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) 91).

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.

[No. F. 8-1/98-AU (Pt).]

S.R.O. 720 (I)/2000.-- The following draft of certain further amendments in the Drugs (Import and Export) Rules, 1976, which are proposed to made, in exercise of the powers conferred by section 43 of the Drugs Act, 1976 (XXXI of 1976), are hereby published, as required by sub-section (3) of the said section, for the information of all persons likely to be affected thereby and notice is hereby given that the draft will be taken into consideration after fifteen days of its publication in the official Gazette.

2. Any objection or suggestions which may be received from any person in respect of the said draft before the expiry of the said period will be considered by the Federal Government.

DRAFT AMENDMENTS

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.8-1/98-AU (Pt).]

S.R.O. 721 (I)/2000.-- The following draft of certain further amendment in the Drugs (Appellate Board) Rules, 1976, which are proposed to be made, in exercise of the powers conferred by section 43 of the Drugs Act, 1976 (XXXI of 1976), are hereby published, as required by sub-section (3) of the said section, for the information of all persons likely to be affected thereby and notice is hereby given that the drat will be taken into consideration after fifteen days of its publication in the official Gazette.

2. Any objection or suggestion which may be received from any person in respect of the said draft before the expiry of the said period will be considered by the Federal Government.

DRAFT AMENDMENT

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."?

[No. F.8-1/98-AU (Pt).]

Sd/-
DR. FARZANA CHOWDHARY
Drugs Controller


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