GOVERNMENT OF PAKISTAN
MODEL CUSTOMS COLLECTORATE OF APPRAISEMENT (EAST)
CUSTOM HOUSE, KARACHI
C. No. MCC/App (East)/Circular/01/2016 Dated: 07-10-2016
The Collector,
MCC Appraisement (West),
Customs House,
Karachi.
The Collector,
MCC (Port Qasim)
Port Muhammad Bin Qasim,
Karachi.
Sub:- PUBLIC NOTICE ISSUED BY DURG REGULARTORY AUTHORITY OF PAKISTAN.
Kindly refer to the subject cited above and find enclosed this Collectorate’s Circular of even number dated 07.10.2016, which is self-explanatory in nature, for information and further necessary action.
Signed By
(Arshad Jawwad)
Collector
Encl: - As Above
GOVERNMENT OF PAKISTAN
MODEL CUSTOMS COLLECTORATE OF APPRAISEMENT (EAST)
CUSTOM HOUSE, KARACHI
C. No. MCC/App (East)/Circular/01/2016 Dated 07-10-2016
CIRCULAR
Subject:- PUBLIC NOTICE ISSUED BY DRUG REGULATORY AUTHORITY OF PAKISTAN.
During random scrutiny of Goods Declaration, it has been observed that the Public Notice issued under Drug Regulatory Authority of Pakistan Act, 2012 (copy enclosed) is not being adhered to by the importer/clearing agents at time of filing of their Goods Declaration. All the importers/clearing Agents are, therefore, advised to comply with the directives contained in the above-mentioned Public Notice. This is for the information of all concerned that Goods Declaration which do not fulfill legal requirement under said Public Notice, will not be cleared and necessary action as required under law, will be initiated without any further notice.
Encl:- As above (Sanam Qureshi)
Deputy Collector, HQ
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Drug Regulatory Authority of Pakistan
Public Notice
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All manufacturers and importer of Alternative Medicines including products used exclusively in homeopathic, unani, Ayurveda, biochemical, Chinese or any other system of treatment; and Health Products including probiotics, disinfectants, nutritional products, food supplements, baby milks & foods, medicated soaps and medicated shampoos are hereby informed, these medicines and products have been brought under the regulatory control of DRAP, through the Drug Regulatory Authority of Pakistan Act, 2012.
For the purpose of regulation of Alternative Medicine and Health products as mentioned above, as a first step the DRAP has promulgated the Alternative Medicines and Health Products (Enlistment) Rules, 2014 vide SRO No 412(I)/2014, dated 29-05-2014. These rules can be downloaded from the DRAP’s website www.drap.gov.pk and shall apply to the following business:-
(a) Manufacturers, having manufacturing and quality control facilities.
(b) Contract giver, as in rule 6 of Enlistment Rules;
(c) Importers, authorized by the overseas principal manufacturer; and
(d) Manufacturers holding manufacturing license for therapeutic goods under the Act.
Those who are involved in the business of the above said medicines and health products by local manufacture or import, are hereby informed through this advertisement, that the manufacture and market authorization has become mandatory under DRAP Act 2012. Therefore applications for enlistment of manufacturers, contract manufactures, and importers are invited under the said rules on the prescribed forms within 60 days of this advertisement.
I) Application forms can be downloaded from the DRAP,s website or can also be obtained free of cost from the office of the Division of Health & OTC Products, 10 D West, Taimour Chambers Blue Area Islamabad.
II) Application complete in all respect and addressed to Director, Health and OTC Products are to be submitted in the same office through recorded post or in person or through the representative against a receipt.
III) Prescribed application fee can be deposited through (pre numbered and preprinted deposit slips) of DRAP in the Account No “0010008463700018” in designated branches of Allied Bank of Pakistan.
IV) New manufacturer or importer of Alternative Medicines and Health Products may also submit applications under the rules.
V) All applications shall be evaluated as per laid down criteria. Applications fulfilling the criteria of safety, efficacy and quality as per Alternative Medicines and Health Products (Enlistment Rules, 2014 shall be granted provisional manufacture, import and product market authorizations.
VI) It is further informed that manufacture, import, marketing, supply and stocking of unapproved alternative medicine and health products with DRAP is an offence under the DRAP Act, 2012.
Signed by
Abdul Sattar Sohrani
Dy. Drugs Controller (Health & OTC Products)
Drug Regulatory Authority of Pakistan, Islamabad
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