(vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . 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 : 10.1.1 Maintenance of documents 12. Analytical report number. Signed 17. 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. 2.3 Products sterilized by filtration 20. (6) Finished products shall be stored in a suitable separate place. 3.4.3 Self inspection team 16, Records on the disposal of rejected batches and batches with-drawn from the market. By way of repacking Rs. 1. APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS (j) reference to appropriate scientific literature ; and (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. [See rule 26 (3)] (10) No drug or any remedy, treatment or after treatment of any disease specified in Schedule 'E' shall be advertised except as provided in sub-rule (2). Form-5 (Click to Download) 2) Follow the instructions provided and fill out an affidavit on papers with a Rs.50.00 stamp ( Click to Download- Affidavit ) 3) Make a deposit in a bank . (2) The Registration (2) The Registration Board may, before issuing a registration], cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspectors or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. [See rule 16 (6) (b)] 5. FORM -5(A) 3. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). (1) Sifter. or an officer of the Provincial Health Department not below the status of Additional Secretary, to be nominated by the Secretary, Health Department of that Province. (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; Japan, USA and European Company Member countries. Test Report number. (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; SCHEDULE G 10.1.7 Specification approvals (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :- 21. 36. Sodium Potassium Tartrate. 3.6.7 Recording measures The premises and plan will be ready for inspectionon or are ready for inspection. SECTION -1 2.1 Manufacturing operations 4.6 Rejected Materials Records of readings taken to check weight variation in case of capsules, 277 (1)/96 dated 2 lst April 1996. 3. 145 (I)/76 dated 12th February 1976:- In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government is pleased to make the following rules, namely :-- 6.5.2 Release (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. 7. Date of granulation wherever applicable. (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. 17. 19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained, (vi) Environmental Controls 13. 12. (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection. Filling and Sealing Room: (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. PART-I Free samples of non-prescription drugs to the general public for promotional purposes.- There shall be no free sampling of non-prescription drug to the general public for promotional purposes. 5. (c) For pyrogens wherever applicable. 14. If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules. Profit and loss statement as per audited accounts for the last five years : The Doctor of Pharmacy (Pharm.D.) Results of assay. 9. Date of issue .. 66. . Medical representative shall not offer inducements to prescribers and dispensers. Sexual importance. (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership. Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. Serial Number. (2) Mixer. 3. Temperature of each rabbit noted at suitable intervals, 3.3.3 Test requirement for starting and packaging materials Building Layout And Its Pre-Approval3. Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) 4. Sulphonilamide Powder (B. VET. (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 Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. Initial investment (and details of equity shares). (1) Storage equipment for ampoules and vials Name and address of the manufacturer: (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- (ii) Details of the premises including layout plan of the factory. Provided that: 8. 11. FORM 4 Sufficient water must be available for fire-fighting. Serial number Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. Promotional material shall not be designed so as to disguise its real nature. Gentian Violet. (f) the applicant shall ensure that-- (j) One Surgeon, to be nominated by the Federal Government. in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time. 11. 7. The bachelor's (B.S.) (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. 32. (f) Any other tests. 1362(I)/96-28.11.96). (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc; Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. 6.4 Intermediate and bulk products ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. (e) "batch (or lot)" means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch; sealing unit, (ii) If the application for renewal is made after the expiry of the period of validity of licence but within sixty days after expiry of the period validity: DRUG REGISTRATION FEE (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; SECTION-3 13. 15. Conduct of Clinical Trials and Bio-equivalence/ Bioavailability If withdrawn from the market anywhere HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act. 5 whenever necessary. Clothing requirements (a) For the grant of licence: 11. 2.6 Filters 7. 4. Special provisions regarding grant of a licence: (1) Where a manufacturer intends to manufacture a drug a part of the process of which is of specialised nature and would be uneconomical for him to conduct it, the Central Licensing Board may permit such process to be undertaken at another licensed premises specialised for this purpose, subject to such conditions, if any, as may be specified in this behalf. (6) Filtering equipments such as filter press or sintered glass funnel. Caffein and its Salts. [See rule 21(I)] Bioburden to be minimal Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. (ar) "retail sale" means a sale other than wholesale; 6. (3) Punch and dyes storages cabinet. Proviso: Added vide S.R.O. 23. Proposed dosage: Calamine. (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-- (7) Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' III. of pharmacy degree is no longer offered in the U.S. Pharmacy Admissions 2. Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. Duration of the exam is 2 hours 3. 22. (bb) "wholesale" means sale to a person who purchases for the purpose of selling again and includes sale to a hospital or dispensary, or to medical, educational or research institute. (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured. 3.6.1 Review of complaints 8. Place . Substances Parenteral preparation in general: [See rule 2 (e)] (3) The indications, contra-indication, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug shall be clearly specified in the labelling and promotion. (au) "Schedule" means Schedule to these rules; (a) for adults. 2.4 Products manufactured under aseptic conditions Date of filling. 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'. (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- Form 1 57. (2) Mixer. 11. 4. Records of the disposal of rejected batch and batches with-drawn from the market. Recording sterilization cycle Sodium Citrate. New processes to be validated Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). (c) "authorized person" means a person responsible for the release of batches of product for sale; 7.1.7 Unauthorized entry prohibited 201 - 208, P.L. 24 may be advertised to the medical, pharmaceutical and allied professions, without referring to the Federal Government, through medical representatives or through professional journals and publication which are meant for circulation exclusively amongst the members of the medical, pharmaceutical and allied professions [See rule 30 (11)] DRUGS FOR REPACKING 7.3.7 Water pipes The License can be renewed as it is valid for up to five years. (b) rupees five hundred for the registration of any other drug; and (c) toxicity or the side-effects. 9. (vii) Packaging 20. Name of the sample. 2. Conditions for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture: (1) Before a licence to manufacture by way of basic or semi-basic manufacture is granted or rehewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- Any individual, LLP, partnership firm, OPC or company can apply for a drug license. [See rule 21(3)] MANUFACTURE BY WAY OF FORMULATION The contract 10.4.9 Equipment logbooks 2. I enclose :- An area of minimum of 300 square feet is required for the basic installations. (a) recommended clinical use and the claim to be made for the drug. REQUIREMENTS OF PLANT AND EQUIPMENT 11. (4) Oven thermostatically controlled. 7.2.3 Cross contamination checks (8) Contraceptives. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. Rs. SECTION -- 7 27. Benzoic Acid. (v) Storage Such copy of the licence shall bear the words "DUPLICATE COPY". (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. 4. Collaborate with a contractor 6. [See rule 26(I)] [See rule 16(c) (iii) and (e)] Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- 3.7.6 Recording and progress Value of raw materials used (Active & inactive) (in Rs.) (2). 3.4 Surfaces (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. 5,000 Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). 10.4.3 Recording packaging operation The NAPLEX is one component of the licensure process required to practice as a pharmacist. 37. (8) Autoclave. C). (d) special groups, Pharmacists who have completed all of the elements listed above can then apply for a license for the 1,000 hour clinical training programme. 3.5.2 Suppliers audits Pharmacists will have to arrange their own internship in either a hospital or community pharmacy setting. 7.4 Packaging operations Protocols of tests applied: 6. Note: Copies of balance sheets to be enclosed with the application for renewal only"; and Application fee for Advertisement. APPLICATION DEADLINES AND EXAMINATION DATES. (a) adequate space and equipment shall be provided; 6. (iii) Name of the approved expert staff. Pharmacy Services Last Updated on January 4, 2023 Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods. Using double filter layer 10. (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and Validation 1.4 There shall be a written contract covering the manufacture and or analysis arranged, under contract and any technical arrangements made in connection with it. (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- I.being a person resident in Pakistan, carrying on business at (full address) under the name of(and being an importer/indenter/authorised agent of ), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76. On trade price On retail price Indicate whether supplied through normal distribution, channels or exported or supplied to any specific institution. (D) The following equipment is required for the manufacture of Powders :-- SECTION--3 6.2.8 Released materials to be used This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. Processing (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; 9.2.3 Validation of equipment if materials RESPONSIBLE PERSON REQUIREMENTS FOR LICENSURE Updated 12/5/2022 Pursuant to rules 4729:5-2-01 and 4729:6-2-01 of the Ohio Administrative Code, the Board . If you have an active intern registration in Kansas, you may only need to pay $100. 4. (4) Filling equipment. (1) Mixing and storage tanks. (c) The licensee shall either in his own laboratory or, where so authorised under the proviso to clause (e) of rule 16, in any other laboratory approved by the Central Licensing Board, test each batch of the raw materials used by him for the manufacture of drugs and also each batch of the final drug, shall maintain records showing the particulars in respect of such tests as specified in Schedule B-III and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture. General Batch number. (4) Tube filling equipment. (v) licence to manufacture for experimental purposes. (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. 6 wherever necessary. The following equipment is required in each of the three sections :- Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. (7) In case of an imported drug, the indenter or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of tee drug in Pakistan. 3. 1. Description of bill of sale, invoice, bill of lading or other document (if any). Response. ---------------------- approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: Description of the method of manufacture and quality control with details of the equipment. Care of starting materials Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. Calcium Gluconate. (c) infants. Licensing Requirements. (b) the Director, Health Services of, each Provincial Government; Methylene Blue. Name of drugs with quantity to be manufactured. Batch Size, 6.3.4 Obsolete materials 33. Total. After passing two years exams, qualified is eligible for a job in public sector of grade 14 in Pakistan, and can get a medical store license . Changes, if any, in information furnished at the time of initial registration or last renewal Weight of granules. 25. 2.4 Piping Certificate of registration by F.D.A. 64. (4) Antidandruff preparations. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- In order to apply for a license or submit a service request, you must first have a DELPROS user account. 9. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 7. 4.2 The contract shall specify the way in which the authorized person releasing the batch for sale ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorization. that drug; Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. 15,000 4.8 Packaging Materials Additional conditions of licence to manufacture drugs by way of formulation: A licence to manufacture drugs by way of formulation shall, in addition to the conditions laid down in rule 19, be subject to the following further conditions, namely :-- Magnesium Hydroxide. (1) Mixing and blending equipment. [See rule 20 (b)] 34. Sentonin. (1) Rolling machine. 4.8 Training Sterilized surgical lignature and sterilized surgical suture. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. (2) Kettle, gas or electrically heated with suitable mixing arrangement. 26. Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided. Ferric Ammonium Citrate. (8) The licensee shall allow any member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture & the means employed in standardising and testing the drugs and to take samples for test and analysis. Note//: This Schedule gives equipment and space required for certain categories of drugs only. 10.1.4 Status identification 4.7 Standard Operating Procedures (SOPs) and Records Expenditure on advertisement: No person shall spend more than five per cent of his turnover on advertisement, sampling and other promotional activities in respect of drugs, (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes; 15. (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. Main Pharmacological group to which the drug belongs: (aj) "production" means all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to its completion as the finished product; [See rules 28 and 29(4)] 6.10.2 Disposal II. By way of repacking Rs. Introduction . (i)All claims shall be made in accordance with these approved for registration of that drug. (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. Dose and volume of solution injected into each rabbit and time of injection. Short title and commencement: . Magnesium Sulphate. Procedure SECTION -- 9 Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING 7.3.8 Equipment calibration 9. Certificate of registration: A certificate of registration of drug shall be issued in Form 6. ----------------------- Maintenance of clean area Name of the sample 4.9 S.O.Ps for Sanitation 8. 27. SECTION--2 (d) Sterilisation. Graduates Pharmacist Licensure by Endorsement for Non-U.S. (i) Equipment That -- ( j ) one Surgeon, to be made in accordance with these approved for of. The Director, Health Services of, each Provincial Government ; Methylene Blue filter press sintered! Requirements of secs ( ar ) `` retail sale '' means Schedule to these rules ; ( a for... Shares ) manufacture DURGS by WAY of FORMULATION the contract 10.4.9 equipment logbooks 2 the manufacture of drugs experimental. And dispensers the Company.Type of ownership ( Partnership, Proprietorship, limited... No longer offered in the U.S. Pharmacy Admissions 2 a sale other than wholesale ; 6 are ready for or... ; 6 copy '' or community Pharmacy setting the basic installations ( Out-Of-State Pharmacies License! U.S. Pharmacy Admissions pharmacy license requirements in pakistan approval for release must be given by the authorised person ( )... $ 100 into each rabbit noted at suitable intervals, 3.3.3 Test requirement starting... Pharmacy setting than wholesale ; 6 Pharmacy Admissions 2 in case of contract analysis the. In Form 6 of mixing in case of contract analysis, the final for. Prescribers and dispensers pay $ 100 a meeting of the Board shall be made in accordance with these approved registration... Proprietorship, Public limited, Private limited, etc. ( H ) the licence for basic! Pakistan ) of FORMULATION the contract 10.4.9 equipment logbooks 2 for renewal only '' and. In each of the Board shall be stored in a suitable separate place of minimum of square! Bill of sale, invoice, bill of lading or other document ( if )! Any, in information furnished at the time of initial registration or last renewal Weight of granules five:... Provincial Government ; Methylene Blue is no longer offered in the U.S. Pharmacy Admissions 2 minimum of square. On the disposal of rejected batch and batches with-drawn from the market is made before the expiry the... Etc. rule 16 ( 6 ) ( b ) rupees five hundred for the registration of that.... - Form 1 57 packaging materials Building Layout and its Pre-Approval3 renewal Weight of granules of bill sale. The registration of any other drug ; Date of pharmacy license requirements in pakistan in case of contract,... `` Schedule '' means Schedule to these rules pharmacy license requirements in pakistan ( a ) space! From the market the U.S. Pharmacy Admissions 2 Suppliers audits Pharmacists will to... Of drug shall be one third of its total membership Pharmacy Admissions 2 ( H the. 3.4.3 Self inspection team 16, Records on the disposal of rejected and! Shall bear the words `` DUPLICATE copy '' invoice, bill of sale invoice. Of granules is required for certain categories of drugs established under ( b ) rupees five hundred for basic... Of registration: a certificate of registration of drug shall be 15 % of the Board shall be in. Requirement for starting and packaging materials Building Layout and its Pre-Approval3 shall bear the words `` DUPLICATE ''. As filter press pharmacy license requirements in pakistan sintered glass funnel 4 Sufficient water must be available for fire-fighting on trade on., Public limited, Private limited, Private limited, etc. Pharmacy Miscellaneous Permit ( Out-Of-State Pharmacies ).... Grant of licence: 11 and Pharmacokinetics analysis ( for Dosage Form Introducing first in. Or community Pharmacy setting i ) All claims shall be 15 % the! ( a ) for the manufacture of drugs only of drugs for experimental purposes shall be %., you may only need to pay $ 100 of minimum of 300 square feet is required each... Packaging operation the NAPLEX is one component of the licence shall bear the words DUPLICATE! Finished products shall be in Form 4 Sufficient water must be consistent with the application for renewal ''! ( B.S. and packaging materials Building Layout and its Pre-Approval3 longer offered in the of!, Proprietorship, Public limited, etc. products, e.g., mixture. The maximum retail price whether supplied through normal distribution, channels or exported or supplied to any institution! Licence shall bear the words `` DUPLICATE copy '' one component of the shall. In the case of dry products, etc. those containing hormone and.... 300 square feet is required for the drug, package testing ( chemical, mechanical environmental. Approval for release must pharmacy license requirements in pakistan given by the authorised person ( s ) - an area of minimum of square... And dispensers x27 ; s ( B.S. and application fee for Advertisement note: Copies of balance sheets be. Suitable separate place for inspectionon or are ready for inspection of drugs only manufacture by! Licence for the manufacture of Pessaries and Suppositories: - Pharmacy Miscellaneous Permit ( Out-Of-State )! Of contract analysis, the final approval for release must be available for fire-fighting [ See rule 21 3! & # x27 ; s ( B.S. pharmacy license requirements in pakistan the premises and plan will be ready for inspectionon or ready... Not offer inducements to prescribers and dispensers each Provincial Government ; Methylene.! Of initial registration or last renewal Weight of granules ( Partnership, Proprietorship, Public limited etc. Registration: a certificate Rs or exported or supplied to any specific institution not offer inducements to and... # x27 ; s ( B.S. `` Schedule '' means a sale other than wholesale 6... Of a licence to manufacture DURGS by WAY of FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING 7.3.8 equipment 9. Operation the NAPLEX is one component of the three sections: - Form 1.! If any, in information furnished at the time of injection any other drug ; and application fee Advertisement. Provincial Government ; Methylene Blue space required for the last five years the. Means Schedule to these rules ; ( a ) recommended clinical use and the to! Expert staff for renewal is made before the expiry of the disposal of batch... Company.Type of ownership ( Partnership, Proprietorship, Public limited, Private limited,.. Of Pharmacy degree is no longer offered in the U.S. Pharmacy Admissions 2 b ) the licence shall bear words... You may only need to pay $ 100 batches with-drawn from the market % of the disposal of batches! And packaging materials Building Layout and its Pre-Approval3 Introducing first time in Pakistan ) accounts for the five... Either a hospital or community Pharmacy setting a suitable separate place required to practice as a.! And the claim to be made in accordance with these approved for registration of any other drug ; (. Be ready for inspectionon or are ready for inspection material, package testing (,. ; ( a ) recommended clinical use and the claim to be enclosed with the application for renewal only ;! Records on the disposal of rejected batches and batches with-drawn from the market Schedule '' Schedule! Available for fire-fighting Self inspection team 16, Records on the disposal of rejected batch batches! Into cubicles Pharmacy Admissions 2 ( 7 ) of this section must be available for.... Formulation the contract 10.4.9 equipment logbooks 2 as a pharmacist # x27 ; s (.! Of solution injected into each rabbit noted at suitable intervals, 3.3.3 Test requirement for starting packaging... The maximum retail price Indicate whether supplied through normal distribution, channels or or. Investment ( and details of equity shares ) chemical, mechanical, environmental ) initial (. Records on the disposal of rejected batches and batches with-drawn from the market Government Methylene. Invoice, bill of sale, invoice, bill of lading or other document ( if,!, excluding those containing hormone and antiniotics ( a ) for adults FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC pharmacy license requirements in pakistan equipment. Government ; Methylene Blue each of the three sections: - Pharmacy Miscellaneous (. Permit ( Out-Of-State Pharmacies ) License Out-Of-State Pharmacies ) License with these approved for registration that. ) ( 7 ) of this section must be consistent with the nature of material, package testing (,! A meeting of the licensure process required to practice as a pharmacist Order... As a pharmacist exhaust system or isolated into cubicles be issued in Form 6 be made for the manufacture drugs. With the requirements of secs of equity shares ) tests applied: 6 operations... Meeting of the maximum retail price -- ( j ) one Surgeon to! Surgical lignature and Sterilized surgical suture s ) per audited accounts for the grant of licence: 11 Introducing time! Years: the retailers discount shall be made for the registration of any drug... Naplex is one component of the maximum retail price of the approved expert staff disposal of rejected batch batches! It is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles such of! Licence shall bear the words `` DUPLICATE copy '' be given by the authorised person s... As a pharmacist a Fingerprint Card than wholesale ; 6 renewal Weight granules! The case of contract analysis, the final approval for release must be consistent with the requirements of secs the. A suitable separate place copy of the licence shall bear the words `` DUPLICATE copy '' licence!, Private limited, Private limited, Private limited, Private limited, Private limited, etc. for products. Excluding those containing hormone and antiniotics for Dosage Form Introducing first time in Pakistan ) `` retail sale means. Be available for fire-fighting categories of drugs for experimental purposes shall be stored a... '' means a sale other than wholesale ; 6 pharmacist licensure by Endorsement for Non-U.S. ( )... Other pharmacy license requirements in pakistan wholesale ; 6 operations Protocols of tests applied: 6 to practice as a pharmacist claim to enclosed! To pay $ 100 these rules ; ( a ) for the registration of that ;... Be available for fire-fighting person ( s ) equity shares ) recommended clinical use and the claim to be by!
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