9. {4) Heater and exhaust system, where applicable. (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. 13. _________________________ APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG Medical representative shall not offer inducements to prescribers and dispensers. 6.9 Reference standards Ammonium Bicarbonate. (3) Employers shall be responsible for the statements and activities of their medical, representatives. (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. 7.1.7 Unauthorized entry prohibited 6.2.4 Damaged container 5.2 Hygiene 20. Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. 3. Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) 10.4.5 Analytical records (at) "returned product" means finished product sent back to the manufacturer or distributor; 8. (iv) Validation Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). Magnesium Sulphate. Monitoring of clean areas [See rule 30(6)] (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. Explanation: In this sub-rule, "profit" means gross profit before payment of income tax or other tax. (ii) A decrease of more than 40% in blood cholinesterase activity from the pre-exposure value indicates that the worker concerned should be removed from further exposure to organophosphates or carbamates. 8. 16. The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. 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. 6 wherever necessary. Proviso: Added vide S.R.O. Fumigation Prescribers and dispenses shall not solicit such inducements. 6.5.1 Quarantine 1.2 General.-- Contract production and analysis shall be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a drug or work or analysis of unsatisfactory quality. (8) Where it is necessary in the public interest so to do, the Registration Board may register a drug on its own motion without having received any application for registration. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS Phone - (717) 783-7156. Serial Number, Signature of the Analyst. (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- 2,500 10.4 Batch packaging records 17. This license is not granted until before inspecting the premises and consequently issuing of inspection report after which the licensing authority shall issue a license for Pharmacy or Medical Store. 4. of pharmacy degree is no longer offered in the U.S. Pharmacy Admissions (b) Shelf-life when stored under expected or directed storage conditions. 1993. [Omitted vide S.R.O. 4.4 Quarantine (Seal) Chairman, Central Licensing Board. 11. This room shall be air-conditioned. Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. 41. 3.1 The contract acceptor shall not pass to a third party any of the work entrusted to him or her under the contract without the written consent of the contract giver and prior evaluation and approval by the arrangements of the Central Licensing Board, and arrangements made between the contract acceptor and any third party shall ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor. Vaccines. 2.2 Layout FORM 6 (c) "authorized person" means a person responsible for the release of batches of product for sale; Care after final cleaning of materials Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. 10. 7.4.10 Discrepancies to be investigated 12,500 For the procedure to withdraw your application, contact the Pharmacy Unit at opunit1@nysed.gov or by calling 518-474-3817 ext. 190.00 Renewal Fee. Name of the Firm. 6.7 Recalled and returned products 66. 551(1)//93, dated 3. 9.2.3 Validation of equipment if materials (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. Quantity received. 1. 3.3 Control procedures To verify a wholesale drug distributor is licensed in the state (s) where it is. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. Pharmacists who have completed all of the elements listed above can then apply for a license for the 1,000 hour clinical training programme. 9. (4) Water still. 8. Sterilization by dry heat CERTIFICATE OF REGISTRATION 10. 4.3 Specifications for Starting and Packaging Materials Protocols of tests applied: Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. If withdrawn from the market anywhere Form-5 (Click to Download) 2) Fill an affidavit on Rs. The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. (7) The licensee shall comply with the provisions of the Ordinance and the rules and with such further requirements, if any, as may be specified in any rule subsequently made-in this behalf or any other condition that may be imposed at the time of grant of a licence in the special circumstances of each case. (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; (6) Hot air drying ovens. 8. Toxins. For the quarter ending. 4. 7.2.3 Cross contamination checks (b) Proprietory name, if any: 7.1 Processing operations 2. 1. Application fee for Advertisement. Countersigned by .. 5. Sulphur Precipitated. 8. pharmacy license requirements in pakistan pharmacy license requirements in pakistan Examination and course Description When submitting Continuing Education correspondence, it is necessary for you to send it via email to BPL-BoardSupport@michigan.gov.. (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; 7. 6.4 Animal House (Such observations should be utilized for appropriate labelled storage conditions or warning statements). Year Name and address of the manufacturer Hygiene and cleanliness Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. 6. B. Parenteral preparation: (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; 6.2.9 Correct dispensing Date and methods of filtration. Potassium Acetate. (b) The licensee shall record in Schedule B-Ill the particulars of manufacture of each batch of drugs manufactured by him 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. Local exhaust system must be effective,. (iii) licence to manufacture by way of formulation; Signature of the expert staff responsible for the manufacture, APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- 29. The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. GOVERNMENT OF PAKISTAN 6.4.1 Storage 2.3 Products sterilized by filtration 5 whenever necessary. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Safety instructions should be strategically displayed in local language. (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. (9) The following information shall be supplied to the Registration Board-- 25,000 12. 7. The tanks or containers shall be made of either glass or such material which will not react with the liquid Filtration of pharmaceutical products that cannot be sterilized in the final container 11. 19. SCHEDULE A General C.). Using double filter layer 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). criteria. Compound Effervescent Salts, [--] , Milk of Magnesia. (b) the Director, Health Services of, each Provincial Government; 38. (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. Sterilized non-sterilizer products differentiation 4.2 Specification & Testing Procedures WHICH IS PROHIBITED Tableting Section: (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. 10.4.3 Recording packaging operation (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. (1) Storage equipment for ampoules and vials [Omitted vide S.R.O. (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. Attested copies of the last two income tax assessment orders of the Income Tax Department attached. 9. 4. 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. Measurement of radiation 10.1.4 Status identification (8) Jar or tube filling equipment, where applicable. Provided that the Central Licensing Board may allow a portion of such contribution to be spent by the firm itself for research and development of new drugs or for establishing research laboratories when it is fully satisfied that such expenditure will be utilised for the said purpose effectively and properly. Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- Record maintenance 16. (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. 11. [See rule 16(c) (iii) and (e)] Calcium Lactate. Name of drugs with quantity to be manufactured. 3.7.1 System Air supply system Household remedies including-- The room shall be air-conditioned and also dehumidified wherever necessary. Opinion and signature of the approved Analyst. 8. 14. 37. Batch Size, (2) Graduated delivery equipment for measurement of the medicament. Washing of clothing Sodium Salicylate. 10. (b) the content of active ingredient(s) per dosage form or regimen; Use of disinfectants and detergents 6. (ii) the route of administration; (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); 4, Date of receipt of sample. 3.3 Areas (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 6.2.2 Purchase from producer or established supplier 10,000By way of semi-basic Rs. Quality control. Name of all ingredients, quantities required for the lot size, quantities actually used. Sufficient time allowed to reach required temperature The contract pharmacist registration renewal process in india. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, : SCHEDULE F Initial investment (and details of equity shares). (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and Universal Licensing Requirements. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. (ao) "reconciliation" means a comparison, making due allowance for normal variation between the amount of product or materials theoretically produced or used and the amount actually produced or used; (iii) Surfaces Gripe Waters. 5. 10.1.6 Reference standards identification Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. The drug(s) or class(es) of drugs intended to be manufactured :- Name and address of the manufacturer: For Foreign-trained Pharmacy Graduates / Pharmacists. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. 3.4.1 General Pharmacy Services Health Department KP. (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be whole time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry or a degree in medicine or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: (b) To check the presence of foreign particles. 4 5 6 7 6. (12} Filling and. PART-II 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. 9. (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; Name of the manufacturer/supplier. 7.3.6 Product pipelines 3.1 Quality Control Department Number of containers filled. 1.2 Surroundings (j) One Surgeon, to be nominated by the Federal Government. Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record, 28. 1. (2) Coating pan. An area of minimum of 200, square feet required far the basic installation, 2.1 Manufacturing operations C). (b) major indication(s) for use; (S.R.O. For assistance with licensing, please . ----------------------- To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. PRACTICE OF PHARMACY AS A PROFESSION. at least one person holding a degree in pharmacy, medicine, science with chemistry or chemical engineering from a university in Pakistan or any other institution, recognised by the Federal Government for the purposes of the Ordinance, and shall possess qualifications and experience which, in the opinion of the Central Licensing Board, is appropriate and adequate for the manufacture and handling of the drug to be, or being, manufactured. Register Lost your Password? Control reference numbers in respect of raw materials used in formulation. 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 :-- 6. 4. Undertaking to manufacture drug locally within two years. By way of formulation Rs. 4. 4.11 Labels PharmD Program Accreditation This professional degree program leading to the Doctor of Pharmacy degree is judged to meet established qualifications and education standards through initial and subsequent periodic evaluations. Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request. For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. 5. Conditions or registration of drug: (1) The relevant provisions of the Ordinance and the rules in respect of the registered drug, shall be complied with. Information on price to the consumer shall be accurately and honestly portrayed. 2. Yes, the physician must obtain from the Board of Pharmacy a license to dispense. 201 - 208, P.L. Storage Areas 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 . The invitation letter should accurately reflect the presentations and discussions to be held. (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. Opinion and signature of the approved Analyst. Name of drug. (7) Potassium Bromide. Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. Sec. The coating section shall be made dust-free and suitable exhaust provided to remove excess powder and the fumes resulting from solvent evaporation. (A) The following equipment is required for the manufacture of drugs for external appliances or suspense: Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. Results and remarks, Each state may have different individual . Retailer's discount: The retailers discount shall be 15% of the maximum retail price. (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. 3.4 Self inspection The Central Licensing Board may, however, direct the nature of records to be maintained by the licensee for such drugs as are not covered by the categories described in this Schedule. (1) Rolling machine. 8. Bismuth Subnitrate. 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. (ap) "recovery or blending" means the introduction of all or part of previous batches, or of redistilled solvents and similar products, of the required quality into another batch at a defined stage of manufacture; SECTION -- 5 3. 08.80.040 . Sena. 4. ], reject the application for registration and inform the applicant of the reasons for such rejection in writing. ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT (2) Pill machine, where applicable. Signature of Analyst, Records of readings taken to check weight variation in case of capsules, (9) Miscellaneous. Disciplinary and criminal history for owners and officers of the pharmacy. 15. (f) Any other tests. 31. 10.4.2 Pre-packaging line checks 2. 13. Place.. Name, designation and address (i) A decease of more than 20% in blood cholinesterase activity,. (i) 6, Results of tests applied. (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. 6.1 Material, general 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. . (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. Provided that an application for renewal shall not be entertained unless it has been made within sixty days after the expiry of the licence and when an application has been made as aforesaid the licence shall subject to the orders passed on the application for renewal continue in force for the next period of two years. (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned. use to be included in the labelling warnings and precautions in use: symptoms of overdosage should be given alongwith the treatment including antidotes where required. (c) Identification. E. Container, packing material, etc. 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. 3. 23. About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies 49. 6.2.5 Delivery from different batches 12. (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. 3.7.7 Evaluation 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. 22-04 to avoid a healthcare workforce shortage emergency. Potassium Citrate. Warranty under Section 23(I)(i) of the Drugs Act, 1976 By way of basic Rs. Methylene Blue. 7.1.5 Avoiding mix-ups 3.7.8 Storage of recalled drugs 7.4 Packaging operations GOOD PRACTICES IN MANUFACTURING PROCESSING 26. 43. (1) Hot air oven electrically heated with thermostatic control. The Registration Board after getting the said intimation shall take similar action for the same drug available from other sources within the shortest possible time; open lesions or skin infection shall be engaged in production areas. (c) major precautions, contra-indications and warnings, if any; and (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. (6) No advertisement under this rule shall contain any direct or indirect comparison in any way with any other drug or substance or remedy for any disease for the purpose of attracting customers or with a view to discredit other such product. 3.4 Facilities 10.4.7 Recording batch distribution Provided further that the Central Licensing Board, may, in the case of anufacture of disinfectant fluids, insecticides liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of paris, surgical dressing or chemicals for the manufacture of which the knowledge of pharmacy or pharmaceutical chemistry is not essential, permit manufacture of the drug under the active direction and personal supervision of competent staff who, [..] has in the opinion of the Central Licensing Board, adequate knowledge and experience in the manufacture of the drug (s) to be produced. 7. (d) Omitted by S.R.O. Prohibitions