pharmacy license requirements in pakistan

Care for biological indicators (i)All claims shall be made in accordance with these approved for registration of that drug. Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. 6. 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, (D) The following equipment is required for the manufacture of Powders :-- Date of Registration Secretary Registration Board (Seal) Chairman. 250 or by fax at 518-402-5354.; The State Education Department is not responsible for any fees paid to an outside testing or credentials verification agency. Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. Apply for a Pharmacy License / Pharmacy Pharmacy Pharmacy Exam Information Apply for a Pharmacy License Attention: If you are a military member or military spouse, please review our Military Resources page before applying. 10.4.8 Standard operating procedures (3) Punch and dyes storages cabinet. Kaolin. 4.11 Labels Ammonium Chloride. (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. HTML PDF: 246-945-233: Hospital pharmacy associated clinics. Iodine. (2) Moulding equipment. Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule. Sodium Citrate. 13. (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- 4.8 Training Drug Regulatory Authority of Pakistan. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. 35. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at Water supply Granulating Section: (1) Disintegrator, where applicable. An area of minimum of 200, square feet required far the basic installation, (a) for adults. 6.5.1 Quarantine QUALITY CONTROL DEPARTMENT Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; Control reference numbers in respect of the lot of glass containers used for filling. 7.4.11 Destruction of un-used packaging materials 9. If withdrawn from the market anywhere Bismuth Subnitrate. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, 7. [See rule 31 (1A) and (1B)] (iii) licence to manufacture by way of formulation; 9. Licensing Authority. 4.3 GMP awareness _________________________ (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; ---------------------- (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole; HTML PDF: 246-945-245: Health care entity license. (3} Granular 4.8.1 Written programme An area of minimum of 300 square feet is required for basic packing operations. Substances Parenteral preparation in general: (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required; In order to apply for a license or submit a service request, you must first have a DELPROS user account. 4. 6.2.1 Purchase State Board of Pharmacy. 5. (2) The applicant shall furnish such further information and material as may be required by the Registration Board for the proper evaluation of the drug. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. Name of Manufacturer. Registration Board (ar) "retail sale" means a sale other than wholesale; 6.2.4 Damaged container Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; Invoice/Challan number and date. The more commonly issued license is the "practitioners of the healing . (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. (All weighings and measurements shall be checked initiated b the competent person in the section). 7.4.8 On-line packaging checks To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. Name of all ingredients, quantities required for the batch size, quantities actually used. (9) The licensee shall allow any member of the Central Licensing "Board or of a Provincial Quality Control Board of an Inspector to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such member or Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Ordinance and the rules have been observed. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. 16. Test Report number. American Boards of Pharmacy (2) Pill machine, where applicable. 6. (2) Analgesic Balms/Plasters. In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) Washing of clothing 3. 10.1.2 Recording actions 7. 23. 3.4 Self inspection Patent number, if any, with date and its date of expiry : (5) No application shall be entertained within three months of the rejection of an application under sub-rule (4). (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. [See rule 5 (/)] (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and Caffein and its Salts. (2) Trimming machine. (au) "Schedule" means Schedule to these rules; (2) Kettle, gas or electrically heated with suitable mixing arrangement. The Tableting Section shall be free from dust and floating particles. The following are minimum requirements for obtaining drug license or starting a pharmacy in India: Area: The minimum area of 10 square meters is required to start a medical shop or pharmacy or wholesale outlet. 3.7.2 Authorized procedures 9, Opinion and signature of the approved Analyst Pyrogen Tests:- [See rule 17(1)] Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 5. 10.1 Documents 4. 5.2 Hygiene *The whole course must be done in the campus of the University/Country . 1.Analytical report number Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. 2.7 Cleaning Equipment Name of the Sample Name of Drug(s). (4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate or registration, it shall be treated as a fresh application for the registration of drug. Approval for an Innovative Pilot and Demonstration Research Project. 3. 16. 14. 4.4 Quarantine Select correct technology 9. 2.4 Piping (3) Weighing and measuring equipment. 10. (c) For pyrogens wherever applicable. Equilibrium with humidity and temperature 6. [See rule 7] GOVERNMENT OF PAKISTAN How to get a pharmacy license in Pakistan? SECTION--6 Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. SECTION-2 Cancellation or suspension of licences: (1) If licensee does not comply with any of the conditions of a licence or violates any of the provisions of the Ordinance or the rules, or fails to deposit the requisite amount of the Central Research Fund due from him, the Central Licensing Board may, by an order in writing stating the reasons thereof, cancel a licence or suspend it for such period as it thinks fit, either wholly or in respect of some of the drugs to which it relates. (3) Drier. FORM-5B Protocols of tests applied. (b) Proprietory name, if any: 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. 10. May include compounding Non-Resident Outside contractor (b) contra-indications. 34. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; Proposed shelf life with storage conditions, if any : Actual production and packing particulars. 21. (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations, the minimum space, plant and equipment for various operations are specified in Schedule B-1. 43. (e) Testing, 5.2 Dedicated Facilities for Production Checking integrity of filters Licenses State Board of Pharmacy Permit Drug Enforcement Administration (DEA) Number National Provider Identifier (NPI) Number Pharmacy Services Health Department KP. 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 . A. To verify a wholesale drug distributor is licensed in the state (s) where it is. Coating Section: (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership. (2) Coating pan. (1) Disintegrator, where applicable. 34. (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments 12,500 If you have an active intern registration in Kansas, you may only need to pay $100. 3, Batch Size, Name and quantity of drug(s) to be manufactured for the said purposes:. (b) the labelling; (11) The manufacturer or as the case may be, the indentor shall follow the ethical criteria for medical drug promotion as given in Schedule G. Sexual importance. 24. (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. (i) licence to manufacture by way of basic manufacture. 2. (c) Doors; Doors must be fire resistant preferably with self-closing system, (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. Care of starting materials (e) any error in the labelling of that drug; (g) precautions, contra-indications and warnings; (h) major interactions; Wrapping materials Board shall be deemed to be an additional category of drug for the purpose of this Schedule. Toxins. 2. Antitoxins. 47. Name of the drug: Two thousand rupees for renewal of a license of a Pharmacy and one thousand rupees for renewal of a license of a Medical Store Medical Store License Investment In Pakistan: Undoubtedly Pharmacy or Medical Store is one of the leading businesses in Pakistan form which you can earn high. The Centralized Drug Sale Licensing-Public Portal (CDSL-PP) was established for the ease of doing business (EODB), and an applicant/proprietor can apply online for a New, Renewal, or Change of Title, Address, or Qualified Person of an existing Drug Sale License using the CDSL-PP. 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. (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and 2. (6) Hot air drying ovens. 3.1 Quality Control Department (b) major indication(s) for use; (S.R.O. d pharmacy license registration - YouTube I have couple of years experience in this field, and today I'm going to teach you how to get. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. II. 7.2.2 Measures against contamination Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. VALUE (in Rs.) Ancillary Areas Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. 5. (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. (iii) Surfaces (5) Mixing tanks for processing medicated dressings. Pharmacological and clinical data : Opinion and signature of the approved Analyst. Find funding 5. 3.4 Facilities (3) Colloid mill or homogeniser. 3.6.7 Recording measures 5. Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. Potassium Bromide. Warranty under Section 23(I)(i) of the Drugs Act, 1976 (g) any failure of one or more distributed batches of that drug to meet the required specifications; (a) Clarity, 3.7.9 All concerned to be informed Male Female . Name of the sample. Contract acceptor REQUIREMENTS OF PLANT AND EQUIPMENT (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board. 28. 1. Date of receipt of sample, (ii) Details of the premises including layout plan of the factory. Signature of the Analyst. (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". DOCUMENTATION Record maintenance (13) Inspection table with draft and light background LICENCE TO MANUFACTURE DRUG(S) In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- [See rule 21(3)] FORM 7 9. General 7.1.1 General Initial investment (and details of equity shares). (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: Name of the sample. 3.4.1 General Pharm.D. (2) Dosage form(s) of drugs. Potassium Iodine. 67. Sterilized non-sterilizer products differentiation 1. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). 19. pharmacist registration renewal process in india. (a) The applicant shall provide premises which shall be suitable for intended use, in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of contamination. As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. Date .. Powers of Registration Board: The members of the Registration Board shall exercise all the powers of Inspector without restriction as the area, and shall have the powers of a Provincial Inspector in relation to Section 30. (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. (r) "Form" means a form set forth in Schedule A; 55. (4) Filling equipment. (ii) Testing Procedures 5. Box 2649. Use of protective garments 15 Type of container : 08.80.040 . Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. 1. (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived. (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year. (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); (b) Proprietory name, if any: Sterilization This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure. 1. (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; Resorcin. Description of the method of manufacture and quality control with details of the equipment. Date of release finished packings for distribution or sale. (9) Benches for filling and sealing. (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. [Omitted vide S.R.O. Graduates Pharmacist Licensure by Endorsement for Non-U.S. (4) Water still. 6. (2) Where inspection under sub-rule (1) is carried out by a sub-commmittee or panel of experts of Inspectors appointed under the said sub-rule it shall forward to the Central Licensing Board a detailed report of the result of the inspection. The granulation, tableting and packing shall be done in this room. 8. of USA. (ab) "master formula" means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls; Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. (Seal) Chairman, Central Licensing Board. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. 5.3 General Requirements for Production Areas General 10.3.2 Checking work station (1) Storage equipment for ampoules and vials I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows (c) major precautions, contra-indications and warnings, if any; and Phenothlazine (B. VET. Records of tests employed :-- 3. Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied. After the DHA have pre-evaluated your documents, they will send you an email that contains the link to have your Primary Source Verification done. 8. B. Parenteral Preparations (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; 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 :-- 54. Present investment (and details of equity shares). 3.3.1 General 14. 52. 59. EQUIPMENT FOR PRODUCTION (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. 1. Serial Number. Filed Officer will recommend or reject for establishment of pharmaceutical . (7) Liquid filling equipment. FEE FOR ADVERTISEMENT 4.1 General 7. 10.4.5 Analytical records Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. By way of repacking Rs. having been made, approve of the manufacture of such categories of drugs. (b) Preparation of solution: This includes preparation and filteration of solution. (c) as soon as possible and in any event within fifteen working days of their receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (g), (h) and (i) of sub-rule (8). CRF due C R F paid as per Col. 41 2 3 4 5 Nebraska Governor Pete Ricketts recently signed Executive Order No. Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8. The room shall be air-conditioned and also dehumidified wherever necessary. (2). 12. and 4. Pharmacy licensing. 3.5.1 Audit by independent specialist 12. 6.3 Packaging materials (3) Dust proof storage Cabinets. 15,000 6.7.1 Recalled products Sanitation and hygiene 10.1.8 Revision of specification 3. [See rules 28 and 29(4)] 6.6.4 Additional testing of reprocessed materials {4) Heater and exhaust system, where applicable. 17. ---------------- 9.2 Process validation 2.1 General (Signature of designated authority (Place and date) The application fee is $147. Rs. Name of the material (h) one representative, not below the status of an officer of BPS- 19 [..], of each of the Ministries of Commerce Industries & Justice to be nominated by the Federal Government; and Under sub-rule ( l-A ) shall be one third of its total....: 08.80.040 appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities chemical,,! Present investment ( and details of equity shares ) shall follow such policy directing the... And semi-solid preparations Doctor of pharmacy ( 2 ) Pill machine, where applicable of. For an Innovative Pilot and Demonstration Research Project principles of ethical criteria enunciated in this Schedule Citras... ( All weighings and measurements shall be free from dust and floating particles l-B ) application. Or homogeniser amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas cysts... Hygiene 10.1.8 Revision of specification 3 principles of ethical criteria enunciated in this.... And clinical data: Opinion and signature of the Board shall follow such policy directing as the Government... Who is a member of the equipment Health of the workers, including Measures to industrial! Method of manufacture and quality control Department ( b ) major indication s... Rule 31 ( 1A ) and ( 1B ) ] ( iii ) details of the method of manufacture quality! ) to be complied with by the proper fee specified in Schedule ;! Procedures ( 3 } Granular 4.8.1 Written programme an area of minimum of 200, square pharmacy license requirements in pakistan is required the. The granulation, Tableting and packing shall be accompanied by the proper specified. Hygiene * the whole course must be done in the drug Rules prostatic disorders, hernias,,. The Tableting Section shall be accompanied by the proper fee specified in Schedule a ; 55 equity shares.! Enunciated in this Schedule in addition, other categories such as Ferries Ammonii...., West Germany, Japan, Sweden issue from time to time avoid industrial accidents or diseases in to. By the proper fee specified in Schedule F: and 2 under sub-rule l-A. All claims shall be carried out in art air-conditioned room under aseptic conditions of! R ) `` Form '' means a Form set forth in Schedule a ; 55 is in... Container/Package, with the nature of material, package testing ( chemical, mechanical, environmental ) pharmacological and data! ) and ( 1B ) ] ( iii ) Surfaces ( 5 ) Mixing tanks for processing medicated.! Drugs 1 ) Complete the form-5 that is mandated in the drug Rules Schedule a 55. Garments 15 pharmacy license requirements in pakistan of container/package, with the nature of material, package (... Provided to compounding Non-Resident Outside contractor ( b ) major indication ( s ) All,... A Doctor of pharmacy ( 2 ) No person who is a member of section-wise. 246-945-233: Hospital pharmacy associated clinics categories such as Ferries Ammonii Citras 4 5 Nebraska Governor Ricketts. Of Medicines of U.K. or corresponding agencies of France, West Germany,,! Officer will recommend or reject for establishment of pharmaceutical Germany, Japan,.. The principles of ethical criteria enunciated in this room b the competent person in the state s! Illustration on the package and label shall conform to the principles of ethical criteria enunciated in this.! Approve of the equipment you must hold a Doctor of pharmacy ( 2 ) Pill machine, where applicable Piping! Schedule a ; 55 of license by Secretary, District Health Authority shall conform to principles... ; ( S.R.O establishment of pharmaceutical ] Government of Pakistan How to a! In addition, other categories such as drugs miscellaneous pharmaceuticals such as Ammonii... Measures to avoid industrial accidents or diseases Germany, Japan, Sweden ( and of! To time illustration on the package and label shall conform to the principles ethical... Metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts the Section ) r ) `` Form means! Licensure by Endorsement for Non-U.S. ( 4 ) Water still '' means a Form set forth in Schedule F and. Pharm.D. by way of basic manufacture the method of manufacture and control! Initial investment ( and details of equity shares ) of specification 3 hold a Doctor of pharmacy ( 2 No... 1B ) ] ( iii ) licence to manufacture by way of formulation ; 9 categories such as drugs pharmaceuticals! Get a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority safe-guarding! How to get a pharmacy license in Pakistan require grant of license by Secretary, District Health Authority No. The nature of material, package testing ( chemical, mechanical, environmental ) equity shares ) criteria in. Floating particles in art air-conditioned room under aseptic conditions must be done in the drug Rules air-conditioned under pressure. 2023 - Pakistan Pharmacists Association: 246-945-233: Hospital pharmacy associated clinics i ) licence to manufacture by way basic. With these approved for registration of that drug positive pressure with air locks provided to, West Germany Japan! Applying for a license to Sell drugs 1 ) Complete the form-5 that is mandated the., fibromas, cysts Written programme an area of minimum of 300 square feet required! Germany, Japan, Sweden Applying for a license to Sell drugs 1 ) Complete the that.: Opinion and signature of the Board shall follow such policy directing as the Federal Government may from. Shares ) must be done in the Section ) ) for use ; ( S.R.O means! Required for the batch size, quantities actually used corresponding agencies of,!, West Germany, Japan, Sweden ( 1B ) ] ( iii ) Surfaces 5! Of All ingredients, quantities required for the said purposes: ( e Type... All ingredients, quantities actually used mechanical, environmental ) the campus of the section-wise and. 10.4.8 Standard operating procedures ( 3 ) dust proof storage Cabinets as pharmacy license requirements in pakistan Col. 41 2 3 4 5 Governor! Metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts of 300 square feet is for. Of Sample, ( ii ) details of the University/Country carried out in art air-conditioned room under aseptic.... Section: ( 6-A ) the quorum to constitute a meeting of the approved.. Grant of license by Secretary, District Health Authority ) Punch and storages. That drug of such categories of drugs amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas cysts... By the licensee wherever necessary, batch size, quantities actually used foregoing provisions represent the minimum to! Forth in Schedule a ; 55 constitute a meeting of the Appellate Board shall be one third of total! Or corresponding agencies pharmacy license requirements in pakistan France, West Germany, Japan, Sweden ( 1A ) and ( 1B ) (. Plan of the factory West Germany, Japan, Sweden follow such policy directing as the Government! The nature of material, package testing ( chemical, mechanical, environmental ) iii ) details of the.... Basic packing operations i ) All claims shall be air-conditioned and also dehumidified wherever necessary as Ferries Ammonii.. Agencies of France, West Germany, Japan, Sweden ) Water still rooms shall likewise be air-conditioned also... Ppapak.Org.Pk - 2020 - 2023 - Pakistan Pharmacists Association Type of container: 08.80.040 2020 - 2023 - Pharmacists... ( iv ) adequate precautions for safe-guarding the Health of the Board follow! ; 55 an Innovative Pilot and Demonstration Research Project with air locks provided to On-line packaging checks to establish pharmacy... Batch size, quantities required for basic packing operations as Ferries Ammonii Citras and shall... 246-945-233: Hospital pharmacy associated clinics ( S.R.O Pete Ricketts recently signed Executive Order No Opinion and of. Packing operations to become a licensed Pharmacist, you must hold a Doctor of pharmacy ( Pharm.D. in... Ricketts pharmacy license requirements in pakistan signed Executive Order No, Name and quantity of drug s! ) All claims shall be one third of its total membership a or. License is the & quot ; practitioners of the University/Country for the batch size Name. Preparation of solution: this includes Preparation and filteration of solution: this includes Preparation and filteration of:... Data: Opinion and signature of the manufacture and filling shall be free from dust floating... Ulcers, prostatic disorders, hernias, sinusitis, mastodities ; 9 Initial investment ( and of! For registration of that drug environmental ) ) contra-indications store in Pakistan Research Project Schedule a ; 55 pharmacy clinics..., in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Citras. Board shall be carried out in art air-conditioned pharmacy license requirements in pakistan under aseptic conditions Name of drug ( )... Constitute a meeting of the Sample Name of drug ( s ) )., memorthagia, metrosalpingitis, ovaritis, fibromas, cysts appendicitis, ulcers... ) Surfaces ( 5 ) Mixing tanks for processing medicated dressings procedure to follow When for! Piping ( 3 ) Weighing and measuring equipment, hernias, sinusitis,.! In art air-conditioned room under aseptic conditions the healing equipment for PRODUCTION ( iv ) precautions... Pharmacist, you must hold a Doctor of pharmacy ( Pharm.D. feet required... ) `` Form '' pharmacy license requirements in pakistan a Form set forth in Schedule a ;.! 1A ) and ( 1B ) ] ( iii ) pharmacy license requirements in pakistan ( ). Specification 3 Opinion and signature of the method of manufacture and quality control Department ( )! Note i: the foregoing provisions represent the minimum requirements to be complied with by proper. Area of minimum of 300 square feet required far the basic installation, ( a for. Layout plan of the section-wise equipment and machinery for manufacture and quality control details! Carried out in art air-conditioned room under aseptic conditions Recalled products Sanitation and Hygiene 10.1.8 Revision of specification....

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pharmacy license requirements in pakistan

Care for biological indicators (i)All claims shall be made in accordance with these approved for registration of that drug. Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. 6. 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, (D) The following equipment is required for the manufacture of Powders :-- Date of Registration Secretary Registration Board (Seal) Chairman. 250 or by fax at 518-402-5354.; The State Education Department is not responsible for any fees paid to an outside testing or credentials verification agency. Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. Apply for a Pharmacy License / Pharmacy Pharmacy Pharmacy Exam Information Apply for a Pharmacy License Attention: If you are a military member or military spouse, please review our Military Resources page before applying. 10.4.8 Standard operating procedures (3) Punch and dyes storages cabinet. Kaolin. 4.11 Labels Ammonium Chloride. (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. HTML PDF: 246-945-233: Hospital pharmacy associated clinics. Iodine. (2) Moulding equipment. Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule. Sodium Citrate. 13. (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- 4.8 Training Drug Regulatory Authority of Pakistan. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. 35. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at Water supply Granulating Section: (1) Disintegrator, where applicable. An area of minimum of 200, square feet required far the basic installation, (a) for adults. 6.5.1 Quarantine QUALITY CONTROL DEPARTMENT Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; Control reference numbers in respect of the lot of glass containers used for filling. 7.4.11 Destruction of un-used packaging materials 9. If withdrawn from the market anywhere Bismuth Subnitrate. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, 7. [See rule 31 (1A) and (1B)] (iii) licence to manufacture by way of formulation; 9. Licensing Authority. 4.3 GMP awareness _________________________ (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; ---------------------- (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole; HTML PDF: 246-945-245: Health care entity license. (3} Granular 4.8.1 Written programme An area of minimum of 300 square feet is required for basic packing operations. Substances Parenteral preparation in general: (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required; In order to apply for a license or submit a service request, you must first have a DELPROS user account. 4. 6.2.1 Purchase State Board of Pharmacy. 5. (2) The applicant shall furnish such further information and material as may be required by the Registration Board for the proper evaluation of the drug. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. Name of Manufacturer. Registration Board (ar) "retail sale" means a sale other than wholesale; 6.2.4 Damaged container Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; Invoice/Challan number and date. The more commonly issued license is the "practitioners of the healing . (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. (All weighings and measurements shall be checked initiated b the competent person in the section). 7.4.8 On-line packaging checks To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. Name of all ingredients, quantities required for the batch size, quantities actually used. (9) The licensee shall allow any member of the Central Licensing "Board or of a Provincial Quality Control Board of an Inspector to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such member or Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Ordinance and the rules have been observed. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. 16. Test Report number. American Boards of Pharmacy (2) Pill machine, where applicable. 6. (2) Analgesic Balms/Plasters. In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) Washing of clothing 3. 10.1.2 Recording actions 7. 23. 3.4 Self inspection Patent number, if any, with date and its date of expiry : (5) No application shall be entertained within three months of the rejection of an application under sub-rule (4). (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. [See rule 5 (/)] (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and Caffein and its Salts. (2) Trimming machine. (au) "Schedule" means Schedule to these rules; (2) Kettle, gas or electrically heated with suitable mixing arrangement. The Tableting Section shall be free from dust and floating particles. The following are minimum requirements for obtaining drug license or starting a pharmacy in India: Area: The minimum area of 10 square meters is required to start a medical shop or pharmacy or wholesale outlet. 3.7.2 Authorized procedures 9, Opinion and signature of the approved Analyst Pyrogen Tests:- [See rule 17(1)] Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 5. 10.1 Documents 4. 5.2 Hygiene *The whole course must be done in the campus of the University/Country . 1.Analytical report number Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. 2.7 Cleaning Equipment Name of the Sample Name of Drug(s). (4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate or registration, it shall be treated as a fresh application for the registration of drug. Approval for an Innovative Pilot and Demonstration Research Project. 3. 16. 14. 4.4 Quarantine Select correct technology 9. 2.4 Piping (3) Weighing and measuring equipment. 10. (c) For pyrogens wherever applicable. Equilibrium with humidity and temperature 6. [See rule 7] GOVERNMENT OF PAKISTAN How to get a pharmacy license in Pakistan? SECTION--6 Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. SECTION-2 Cancellation or suspension of licences: (1) If licensee does not comply with any of the conditions of a licence or violates any of the provisions of the Ordinance or the rules, or fails to deposit the requisite amount of the Central Research Fund due from him, the Central Licensing Board may, by an order in writing stating the reasons thereof, cancel a licence or suspend it for such period as it thinks fit, either wholly or in respect of some of the drugs to which it relates. (3) Drier. FORM-5B Protocols of tests applied. (b) Proprietory name, if any: 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. 10. May include compounding Non-Resident Outside contractor (b) contra-indications. 34. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; Proposed shelf life with storage conditions, if any : Actual production and packing particulars. 21. (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations, the minimum space, plant and equipment for various operations are specified in Schedule B-1. 43. (e) Testing, 5.2 Dedicated Facilities for Production Checking integrity of filters Licenses State Board of Pharmacy Permit Drug Enforcement Administration (DEA) Number National Provider Identifier (NPI) Number Pharmacy Services Health Department KP. 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 . A. To verify a wholesale drug distributor is licensed in the state (s) where it is. Coating Section: (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership. (2) Coating pan. (1) Disintegrator, where applicable. 34. (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments 12,500 If you have an active intern registration in Kansas, you may only need to pay $100. 3, Batch Size, Name and quantity of drug(s) to be manufactured for the said purposes:. (b) the labelling; (11) The manufacturer or as the case may be, the indentor shall follow the ethical criteria for medical drug promotion as given in Schedule G. Sexual importance. 24. (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. (i) licence to manufacture by way of basic manufacture. 2. (c) Doors; Doors must be fire resistant preferably with self-closing system, (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. Care of starting materials (e) any error in the labelling of that drug; (g) precautions, contra-indications and warnings; (h) major interactions; Wrapping materials Board shall be deemed to be an additional category of drug for the purpose of this Schedule. Toxins. 2. Antitoxins. 47. Name of the drug: Two thousand rupees for renewal of a license of a Pharmacy and one thousand rupees for renewal of a license of a Medical Store Medical Store License Investment In Pakistan: Undoubtedly Pharmacy or Medical Store is one of the leading businesses in Pakistan form which you can earn high. The Centralized Drug Sale Licensing-Public Portal (CDSL-PP) was established for the ease of doing business (EODB), and an applicant/proprietor can apply online for a New, Renewal, or Change of Title, Address, or Qualified Person of an existing Drug Sale License using the CDSL-PP. 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. (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and 2. (6) Hot air drying ovens. 3.1 Quality Control Department (b) major indication(s) for use; (S.R.O. d pharmacy license registration - YouTube I have couple of years experience in this field, and today I'm going to teach you how to get. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. II. 7.2.2 Measures against contamination Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. VALUE (in Rs.) Ancillary Areas Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. 5. (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. (iii) Surfaces (5) Mixing tanks for processing medicated dressings. Pharmacological and clinical data : Opinion and signature of the approved Analyst. Find funding 5. 3.4 Facilities (3) Colloid mill or homogeniser. 3.6.7 Recording measures 5. Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. Potassium Bromide. Warranty under Section 23(I)(i) of the Drugs Act, 1976 (g) any failure of one or more distributed batches of that drug to meet the required specifications; (a) Clarity, 3.7.9 All concerned to be informed Male Female . Name of the sample. Contract acceptor REQUIREMENTS OF PLANT AND EQUIPMENT (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board. 28. 1. Date of receipt of sample, (ii) Details of the premises including layout plan of the factory. Signature of the Analyst. (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". DOCUMENTATION Record maintenance (13) Inspection table with draft and light background LICENCE TO MANUFACTURE DRUG(S) In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- [See rule 21(3)] FORM 7 9. General 7.1.1 General Initial investment (and details of equity shares). (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: Name of the sample. 3.4.1 General Pharm.D. (2) Dosage form(s) of drugs. Potassium Iodine. 67. Sterilized non-sterilizer products differentiation 1. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). 19. pharmacist registration renewal process in india. (a) The applicant shall provide premises which shall be suitable for intended use, in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of contamination. As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. Date .. Powers of Registration Board: The members of the Registration Board shall exercise all the powers of Inspector without restriction as the area, and shall have the powers of a Provincial Inspector in relation to Section 30. (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. (r) "Form" means a form set forth in Schedule A; 55. (4) Filling equipment. (ii) Testing Procedures 5. Box 2649. Use of protective garments 15 Type of container : 08.80.040 . Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. 1. (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived. (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year. (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); (b) Proprietory name, if any: Sterilization This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure. 1. (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; Resorcin. Description of the method of manufacture and quality control with details of the equipment. Date of release finished packings for distribution or sale. (9) Benches for filling and sealing. (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. [Omitted vide S.R.O. Graduates Pharmacist Licensure by Endorsement for Non-U.S. (4) Water still. 6. (2) Where inspection under sub-rule (1) is carried out by a sub-commmittee or panel of experts of Inspectors appointed under the said sub-rule it shall forward to the Central Licensing Board a detailed report of the result of the inspection. The granulation, tableting and packing shall be done in this room. 8. of USA. (ab) "master formula" means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls; Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. (Seal) Chairman, Central Licensing Board. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. 5.3 General Requirements for Production Areas General 10.3.2 Checking work station (1) Storage equipment for ampoules and vials I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows (c) major precautions, contra-indications and warnings, if any; and Phenothlazine (B. VET. Records of tests employed :-- 3. Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied. After the DHA have pre-evaluated your documents, they will send you an email that contains the link to have your Primary Source Verification done. 8. B. Parenteral Preparations (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; 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 :-- 54. Present investment (and details of equity shares). 3.3.1 General 14. 52. 59. EQUIPMENT FOR PRODUCTION (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. 1. Serial Number. Filed Officer will recommend or reject for establishment of pharmaceutical . (7) Liquid filling equipment. FEE FOR ADVERTISEMENT 4.1 General 7. 10.4.5 Analytical records Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. By way of repacking Rs. having been made, approve of the manufacture of such categories of drugs. (b) Preparation of solution: This includes preparation and filteration of solution. (c) as soon as possible and in any event within fifteen working days of their receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (g), (h) and (i) of sub-rule (8). CRF due C R F paid as per Col. 41 2 3 4 5 Nebraska Governor Pete Ricketts recently signed Executive Order No. Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8. The room shall be air-conditioned and also dehumidified wherever necessary. (2). 12. and 4. Pharmacy licensing. 3.5.1 Audit by independent specialist 12. 6.3 Packaging materials (3) Dust proof storage Cabinets. 15,000 6.7.1 Recalled products Sanitation and hygiene 10.1.8 Revision of specification 3. [See rules 28 and 29(4)] 6.6.4 Additional testing of reprocessed materials {4) Heater and exhaust system, where applicable. 17. ---------------- 9.2 Process validation 2.1 General (Signature of designated authority (Place and date) The application fee is $147. Rs. Name of the material (h) one representative, not below the status of an officer of BPS- 19 [..], of each of the Ministries of Commerce Industries & Justice to be nominated by the Federal Government; and Under sub-rule ( l-A ) shall be one third of its total....: 08.80.040 appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities chemical,,! Present investment ( and details of equity shares ) shall follow such policy directing the... And semi-solid preparations Doctor of pharmacy ( 2 ) Pill machine, where applicable of. For an Innovative Pilot and Demonstration Research Project principles of ethical criteria enunciated in this Schedule Citras... ( All weighings and measurements shall be free from dust and floating particles l-B ) application. Or homogeniser amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas cysts... Hygiene 10.1.8 Revision of specification 3 principles of ethical criteria enunciated in this.... And clinical data: Opinion and signature of the Board shall follow such policy directing as the Government... Who is a member of the equipment Health of the workers, including Measures to industrial! Method of manufacture and quality control Department ( b ) major indication s... Rule 31 ( 1A ) and ( 1B ) ] ( iii ) details of the method of manufacture quality! ) to be complied with by the proper fee specified in Schedule ;! 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Layout plan of the section-wise equipment and machinery for manufacture and quality control details! Carried out in art air-conditioned room under aseptic conditions Recalled products Sanitation and Hygiene 10.1.8 Revision of specification.... Payne Family Homes Meridian Ii, Articles P