[See rule (31)1] (c) the statement of all the representations to be made for the promotion of the drug in respect of-- (a) The generic name(s) of the active ingredient(s); This room shall be air-conditioned. (b) Disintegration time as often as practicable. Suitability of process Pack size (s) and proposed maximum retail price with the following details:- In order to apply for a license or submit a service request, you must first have a DELPROS user account. 5. 8. 20. Sufficient water must be available for fire-fighting. Granulating Section: (1) Disintegrator, where applicable. Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : 7. 6.2 Starting materials 5.1 Sanitation 2. Medical representative shall not offer inducements to prescribers and dispensers. Filling and Sealing Room: 1. 61. The contract 2.7 Cleaning Equipment I/we.of .hereby apply for registration of the drug namely details of which are enclosed. and detailed records must be kept. 2. Sanitation and hygiene (d). Fish Liver Oil and its equivalents. Gentian Violet. 10. Cetrimide Powder. 1. 13. 4. (7) Liquid filling equipment. 4. Name of all ingredients, quantities required for the batch size, quantities actually used. (6) The Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, require the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological, availability, and its safety and efficacy to be established under the local conditions: 6 wherever necessary. (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. 1. Maximum temperature. 10.1.4 Status identification 6.6.3 Batch recovers 1.1 Contract of manufacture shall be undertaken only by a manufacturer who hold a valid drug manufacturing license, and the contract acceptor shall/have adequate facilities, knowledge, experience and competent personnel to satisfactorily carry out the work ordered by the contract giver. 3.7.7 Evaluation approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: (b) contra-indications. Quantity received. Ammonium Chloride. (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health. Validation 3.2 Services 3.6.8 Review for Reviewing Problem Analgesics: Dated Signed 6.6.2 Reprocessing Prescribers and dispenses shall not solicit such inducements. 5. (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. 1. (b) major indication(s) for use; (S.R.O. 2.2 Terminally sterilized products (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. If withdrawn from the market anywhere The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. (All weighings and measurements shall be checked and initialled by the competent person in the section). 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. DRUG MANUFACTURING LICENCE FEE (2) Ampoule washing and drying equipment. Washing of clothing (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. 21. (b) the Director, Health Services of, each Provincial Government; Use of protective garments 7.2.2 Measures against contamination 3.4.6 Follow-up Action 10.1.8 Revision of specification 6.2 Changing Rooms In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. No. CONDITIONS OF FACTORY PREMISES Universal Licensing Requirements. Registration Board: (1) The Registration Board shall consist of such members, including the Sera. 66. Borax. Serial number. 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. 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. 16. 3. Captcha: 9 + 4 = Sign In. 1. 5,000 Pulv Gentian. Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- 10. 10.1.6 Reference standards identification 14. Finishing of sterile products Date Signed. 4. How to get a pharmacy license in Pakistan? (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination. Find funding 5. (2) If a person is conducting a part of the process of the manufacture on behalf of another manufacturer in accordance with the permission granted under sub-rule (1), and he is not responsible for the quality of the final product, the Central Licensing Board may not require him to establish an independent quality control laboratory for such products. (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. Under the Pharmacy Act-1948, now all registered pharmacists in Maharashtra state pharmacy council are required to renewal of the pharmacist certificate created for themselves as per the rules made by the MSPC.. 23. Countersigned by .. Quality control. (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. Equilibrium with humidity and temperature Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' degree from a college accredited by the Accreditation Council for Pharmacy Education (ACPE). General 10.4.4 Recording batch numbers (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". For Foreign-trained Pharmacy Graduates / Pharmacists. 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. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. 3. (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; (vii) Packaging Pharm.D. 4.6 Packaging Instructions Pharmacy Services Health Department KP. Protocols of tests applied: Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. Manufacture of sterile preparations 34. 1. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). Name of drugs with quantity to be manufactured. Bismuth Carbonate. 10.4.1 General (D) The following equipment is required for the manufacture of Powders :-- 3.5 Quality Audit Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : Address. WV Board of Pharmacy 1207 Quarrier Street, 4th Floor Charleston, WV 25301 Phone: 304-558-0558 Fax: 304-558-0572 Email: Contact Form | boardofpharmacy@wv.gov 2 Examinations. (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. The application fee is $147. 4.9 S.O.Ps for Sanitation 4.2 Written duties Sterility test as the last measures Batch number. Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. (aq) "repacking" means all operations involved in the transfer of a drug from a larger container or packing into smaller containers or packings including filling, packing and labeling with a view to make it ready for retail sale or wholesale, but does not includes any compounding, or processing with a view to formulate it in any dosage form; 4. [See rule 30(6)] Application fee $10.00: Pay by credit or debit card for applications submitted online. 46. 14. Pharmacists measure and sell prescription drugs. 8. (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. Changes, if any, in information furnished at the time of initial registration or last renewal Name of the drug. Summed response, Personnel 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. (2) Pill machine, where applicable. 7.3.7 Water pipes REQUIREMENTS OF PLANT AND EQUIPMENT Entry restricted 3.3.1 General 4. 201 - 208, P.L. 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 . Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). Note:-Strike off which is not applicable 5. 7.3.6 Product pipelines 10. SCHEDULE D-I 5. 3.4.2 Items for self inspection 2.8 Defective Equipment General The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. (16) Storage equipment including cold storage and refrigerators, if necessary Date of compression in case of tablets/date of filling in case of capsules. . 5. Name of the manufacturer/supplier. Sterilization Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). of USA. 7.1 Processing operations Toxins. 9.2 Process validation Phone - (717) 783-7156. Care after final cleaning of materials Proposed dosage : 6.2.6 Labelling APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS SCHEDULE B I-A. Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container. This registration shall be valid for a period of five years unless earlier suspended or cancelled. The more commonly issued license is the "practitioners of the healing . Signature of the Analyst, 3. (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. 2.4 Piping (b) "airlock" means an enclosed space with two or more doors, which is interposed between two or more rooms of differing classes of cleanliness for the purpose of controlling the airflow between those rooms when they need to be entered and an airlock is designed for and used by either people or goods; of Pack Total quantity in terms of individual units e.g., total No. Analytical report number. Select correct technology 9. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). (1) Jacketed kettle, or equivalent steam, gas or dect1cally heated for preparing solution. (b) PH wherever applicable, 8. (15) Labelling and packing benches, (i) Particulars regarding the legal status of the applicant (i.e. (iv) Validation MANUFACTURE BY WAY OF FORMULATION 7.3 Processing operations intermediate and bulk products For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. 58. 4.5 Sampling (i) licence to manufacture by way of basic manufacture. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. 7.4 Packaging operations 3.7.2 Authorized procedures (a) Clarity, If you want to do your own job as a pharmacist in the state of Maharashtra, then you . Please contact the Board at pharmacy@ks.gov for more information. Visa, Mastercard. Name(s) of Proprietor(s)/Director(s)/Partner(s). Zinc Oxide. Explanation: In this sub-rule, "profit" means gross profit before payment of income tax or other tax. 8. Pharmacists will have to arrange their own internship in either a hospital or community pharmacy setting. (at) "returned product" means finished product sent back to the manufacturer or distributor; An area of minimum of 300 square feet is required for the basic installations. Harrisburg, PA 17105-2649. Licence to Manufacture 7.3.8 Equipment calibration 5.1 General responsibility of licensee and SECTION--4 10.1.5 Product labelling 7.3.2 In-process controls Sterilization by radiation Pharmacological and clinical data : Name of the material [Omitted vide S.R.O. (i) A decease of more than 20% in blood cholinesterase activity,. 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. 7.4.2 Pre-packaging checks (b) Preparation of solution: This includes preparation and filteration of solution. Dates of coating wherever applicable. 1. (y) "manufacture" means all operations of production, quality control, release, storage and the related controls; Monitoring of clean areas FOR EXPERIMENTAL PURPOSES Drug Regulatory Authority of Pakistan. 3.7.1 System Eliminate fibers (5) The manufacture of any drug shall not, without the prior approval of the Registration Board, be discontinued for period which may result in its shortage: 4. (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- Magnesium Sulphate. (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). 25,000 How to get Category A pharmacy license in Pakistan? Invoice/Challan number and date. Personnel Potassium Permanganate. having been made, approve of the manufacture of such categories of drugs. 8. PH of the solution wherever applicable. (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record, Conditions of licence to manufacture drugs for experimental proposes: A licence issuing under rule 21 shall be subject to the following conditions, namely :-- 7.4.9 Product re-introduction on packaging line 4.8 Packaging Materials 4.1 General Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. I/We ..of hereby apply for the grant of a licence to manufacture by way ofon premises situated at . 15. 3.1 General (b) children by age group. (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. I/We of .. hereby apply for a licence to manufacture drug(s) specified below for experimental purposes at .. and I/We undertake to comply with the conditions applicable to the licence under rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976. , you must complete a 2-year pharmacy Technician b Category diploma the types. Fee $ 10.00: Pay by credit or debit card for applications submitted online which such shall. 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