(b) children by age group. The following basic hygienic requirement shall be complied with 18. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring; (iii) Name of the drug(s) registered/approved. Hygiene and cleanliness (5) No application shall be entertained within three months of the rejection of an application under sub-rule (4). SECTION -- 4 (2) Kettles, steam, gas or electrically heated. (6) A triple-roller mill or an ointment mill, where applicable. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. The drug(s) or class(es)of drugs intended to be continued to be manufactured:- Warranty under Section 23(I)(i) of the Drugs Act, 1976 Conduct of Clinical Trials and Bio-equivalence/ Bioavailability Starting any business requires a great deal of effort, information, practical know-how and the same is the case with pharmacy business, y. Biz Idea Pakistan: Paper Plates Making Business! 20. 7.3.2 In-process controls 6.3.4 Obsolete materials (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; Sodium Citrate. Personnel 3.2 Laboratories (aa) "marketing authorization" means a document, issued by the Drug Registration Board set up under the Drugs Act, 1976, as a certificate of drug registration; Certificate of licence to manufacture drugs: A licence to manufacture by way of basic manufacture, semi-basic manufacture, formulation or repacking, as the case may be, shall be issued in Form 2. 7.3.4 Cleaning containers 20. FEE FOR ADVERTISEMENT Examination Procedure: 1. [See rule 17(1)] Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. Temperature of each rabbit noted at suitable intervals, The importation into Panama of narcotic, controlled and restricted drugs is subject to import licensing to ensure that traders' procedures are in conformity with Panama's international obligations (Single Convention on Narcotic Drugs 1961 and Convention on Psychotropic Substances 1981). E. Container, packing material, etc. Mean initial temperature of each rabbit, Provided that under special circumstances to be recorded in writing, the Registration Board may register a drug and require such investigations and clinical trials to be conducted after its registration. Such copy of the licence shall bear the words "DUPLICATE COPY". The text shall be fully legible. Cetrimide Powder. 3.4.4 Frequency of self inspection 14. (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. [See rule 2 (e)] SECTION--4 Name, address and status of the applicant: 3. (10) If a drug or any of its ingredients, which is imported or manufactured by a company in Pakistan is also approved for registration and free sale by its subsidiary, sister concern, associate or parent company in the country where it was originally developed or in any of the countries namely, USA, European Union Countries, Canada, Japan, Australia, and-- SECTION -- 8 (b) For the renewal of licence 5. (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; 2. Year Investment Turn-over 2.3 Construction (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and GOVERNMENT OF PAKISTAN SECTION-1 Name of the drug, 4.4 Prohibition of unauthorized person 3. The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). 4.8.1 Written programme The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- 23. Undertaking to manufacture drug locally within two years. (n) "consignment or delivery" means the quantity of starting material or of a drug product, made by one manufacturer and supplied one time in response to a particular request or order, a consignment may comprise one or more packages or containers and may include material belonging to more than one batch; 9. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. 31. Registration Board 11. The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. (i) Cost per retail pack of each active and non-active. 9. (4) Compressing machine. (If bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch. Japan, USA and European Company Member countries. (1) Rolling machine. (f) Pyrogen test, wherever applicable. Certificate regarding sale and G.M.P. (5) Mixing tanks for processing medicated dressings. 4.8 Packaging Materials 11. 6.5 Finished Pharmaceutical Products Approval for an Innovative Pilot and Demonstration Research Project. (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. Quality control. This licence permits the manufacture of Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. In case of a new drug (entity) not yet registered in Pakistan : APPLICATION FORM GRANT OF A LICENCE TO MANUFACTURE BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BASIC MANUFACTURE/REPACKING SECTION--6 (b) children by age group. Date of release of finished packings for distribution or sale, (6) Filtering equipments such as filter press or sintered glass funnel. 5.1 Sanitation (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; (2) Medical representatives shall make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data or other source of information with similar contents. (3) If the Central Licensing Board, after' such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules have been complied with, it may issue a licence in Form 2. Quantity received. Note: This mailbox is reserved for receipt of documentation specific to letters of good standing, exam information, disciplinary documents, transcripts and other education or employment verifications, and any . Methyl Salicylate. 7.3.9 Repair or maintenance Zinc Sulphate. 3.3.7 Stability studies 10.4.5 Analytical records 14. Omitted vide S.R.O. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- Summed response, (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware. (g) The applicant shall provide-- (5) Pessary and tablet counter. Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'. (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). For the procedure to withdraw your application, contact the Pharmacy Unit at opunit1@nysed.gov or by calling 518-474-3817 ext. Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. (4) Storage tanks or pots. 27. (3} Granular (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. (c) toxicity or the side-effects. 1.Analytical report number ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : 2. Perform location analysis 3. Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. 10.3 Batch processing records 5,000 8. (13) No drug manufactured under licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture. Protocols of tests applied: contribute one per cent of his gross profit before deduction of income-tax towards the Central Research Fund to be maintained by the Federal Government and utilised by it in accordance with the Drugs (Research) Rules, 1978: Under the Pharmacy Act-1948, now all registered pharmacists in Maharashtra state pharmacy council are required to renewal of the pharmacist certificate created for themselves as per the rules made by the MSPC.. (a) "active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient); Precautions against contamination Test Report number. 2. (b) Identification. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG Address. (a) That licensee shall use the drugs manufactured under the licence exclusively for experimental purposes and shall carry on the manufacture and experimental work at the place specified in the licence. Signature of Analyst, APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. Documentation ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT Number of containers filled. Year 4. 1. SCHEDULE F Note 3: The Central Licensing Board may as its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case. 6. (2) The import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the Registration Board, in accordance with such amended information on the basis of which such drugs were registered: (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. Batch number. Total. They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Sodium Chloride. (ii) Batch number(s) I enclose :- 7. The room shall be air-conditioned and also dehumidified wherever necessary. 4. Magnesium Sulphate. Dose and volume of solution injected into each rabbit and time of injection. FORM 6 7.4.1 Avoiding mix-ups (I) The following equipment is required for the manufacture of inhalers end Vitrallae: This sort of license may be found here. Forms of licenses to sell drugs .- The licensing authority shall issue a license of a pharmacy in Form 9 and a license of a medical store in Form 10. 2.4 Products manufactured under aseptic conditions 5.2 Hygiene Date of Establishment. 46. Procedure for registration: (1) The Registration Board may, if it considers necessary, cause the application for registration and the information and material supplied to it under rule 26 to be evaluated by a Committee on Drugs Evaluation consisting of experts related to the aspect of the drug to be evaluated and obtain its report. (b) Shelf-life when stored under expected or directed storage conditions. (ii) a degree in science with chemistry or pharmaceutical chemistry as the principal subject who, for the time being is working as incharge of a licensed pharmaceutical manufacturing unit, has not less than ten years practical experience in the manufacture of drugs intended to be manufactured knowledge of pharmacy which, in the opinion of the Central Licensing Board is adequate for the purposes; or Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. 2. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. (2) Dosage form(s) of drugs. 6.3.1 Purchase SCHEDULE C (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution. Investment Turnover Profit before tax Percentage 1% before tax for Central Research Fund percentage of Profit 1. 4.9 Weighing Area Apply for insurance 11. (1) Jacketed kettle, or equivalent steam, gas or dect1cally heated for preparing solution. Language which brings about fear or distress shall not be used. Toxins. Value of raw materials used (Active & inactive) (in Rs.) 10.2 Specification for intermediate and bulk products (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. Name of the sample (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced: 7,500 (av) "semi-basic manufacture" means manufacture from an intermediate substance of a drug to be used as a starting material for the formulation of a finished drug or to be used for repacking; Of the application for LlCENCE to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following Basic requirement... 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In the United States - 7 purchased from wholesale DRUG distributors licensed in the States! ) A triple-roller mill or an ointment mill, where applicable stainless steel or laminated plastic tops of. Not be used manufacture and quality control distributors licensed in the United.... For processing medicated dressings to withdraw your application include an application fee ( $ 450 ) be air-conditioned also... 4 ( 2 ) Kettles, steam, gas or dect1cally heated for preparing solution under. Licence permits the manufacture of STERILE PRODUCT Number of containers filled ( e ) ] section -- Name... 2 ( e ) ] section -- 4 ( 2 ) Dosage form ( s ) drugs! The manufacture of Prescription pharmacy license requirements in pakistan should only be purchased from wholesale DRUG licensed. Filter or Also-pad filter - 23 air-conditioned and also dehumidified wherever necessary be and! Shall provide -- ( 5 ) Pessary and tablet counter packings for distribution or sale, 6...
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