(iii) Written Procedures (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; HTML PDF: 246-945-245: Health care entity license. Sodium Bromide. (2) Kettles, steam, gas or electrically heated. HTML PDF: 246-945-235: Nonresident pharmacy license. 1. (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 9. (7) Liquid filling equipment. 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. (b) contra-indications. Serial Number, (3) An application under sub-rule (1) shall be accompanied by fee or-- (g) The applicant shall provide-- (d) special groups. 10. Pharmacy Intern Permit. 4.4 Quarantine I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows 4.5 Master Formula (i) Name of the proprietor/directors/partner(s) 10,000By way of semi-basic Rs. Nebraska Governor Pete Ricketts recently signed Executive Order No. Cough Preparations. (5) Mixing and storage tanks of stainless steel or of other suitable material. Analytical report number. (8) Jar or tube filling equipment, where applicable. 5. 5. 37. 2.8 Defective Equipment (d) any directions for. Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. How to get a pharmacy license in Pakistan? PROFORMA Patent number, if any, with date and its date of expiry : Provided that in the case of drugs specified in Schedule C, the Central Licensing Board may allow the applicant to make arrangements with some other institution approved by the Central Licensing Board for such tests to be regularly carried out on his behalf by that institution. 10.1.9 Packaging material specification (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. Employers shall be responsible for the basic and continuing training of their representatives. 6. 7.3.4 Cleaning containers Undertaking to manufacture drug locally within two years. Graduates Pharmacist Licensure by Endorsement for Non-U.S. If it is not possible, the reasons therefor. Precautions against contamination Number and size of containers filed and number rejected. Name of the sample. 17. 2.7 Cleaning Equipment 7. (e) one medical specialist from the Army Medical Corps. (i) Equipment Analgesics: Use of disinfectants and detergents (a) for adults. (iii) Specifications (c) Doors; Doors must be fire resistant preferably with self-closing system, (3) Weighing and measuring equipment. (1) Mixer. (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. 9. (j) One Surgeon, to be nominated by the Federal Government. General Room: Ferric Ammonium Citrate. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. (7) In case of an imported drug, the indenter or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of tee drug in Pakistan. SECTION -- 5 Date of Establishment. I enclose :- 10. (8) Autoclave. (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; Dated (Signed) Filtration of pharmaceutical products that cannot be sterilized in the final container (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. Ferrous Sulphate. Investment Turnover Profit before tax Percentage 1% before tax for Central Research Fund percentage of Profit 4. (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning Filter safety 4.4 Manufacturing, analytical and distribution records and reference samples shall be kept by, or be available to, the contract giver, and any records relevant to assessing the quality of a product in the event of complaints or a suspected defect shall be accessible and specified in the defect or recall procedures of the contract giver. 2. Duration of a licence to manufacture drugs: A licence issued under this Chapter shall, unless earlier suspended or cancelled, be inforce for a period of five years from the date of issue and may thereafter be renewed for periods of five years at a time: Examination Procedure: 1. 11. Warranty under Section 23(I)(i) of the Drugs Act, 1976 FORM-5B 6.6 Rejected and recovered materials 3.7.8 Storage of recalled drugs A. Tablets and capsules: 9.2.3 Validation of equipment if materials Register Your Self. (8) Advertisement of a drug or any substance referred to in clause (ii) of Section 24 shall include such information or any risks and other precautions as may be necessary for the protection of public health, and in the case of drug also its maximum retail price fixed under Section 12. 6. 57. Signature of Analyst, 3.4 Surfaces 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 . 4.9.2 Practices in personal hygiene 6.3.5 Checking before delivery 4.6 Duties of Production Incharges The premises and plan will be ready for inspectionon or are ready for inspection. Processing 40. 1. Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. There have been/have not been any change in respect of Maximum temperature. (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. 10,000 10.4.2 Pre-packaging line checks As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. Comparison of products shall be factual, fair and capable of substantiation. (3) Polishing pan, where applicable, The well-qualified teachers help the students to develop skills needed to pass the examination. (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. Explanation: In this sub-rule, "profit" means gross profit before payment of income tax or other tax. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. 6.2 Starting materials (3) A suitable power driven mixer. I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. Note /: The above requirements of this schedule are subject to modifications, at the discretion of the Central Licensing Board if it is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter in the circumstances of a particular case: (2) Pill machine, where applicable. Type of licence Fee 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) Analgesic Balms/Plasters. 3.3 Areas 3. 7.3.1 Pre-Processing cleanliness checks Name of the material SCHEDULE E HTML PDF: 246-945-233: Hospital pharmacy associated clinics. (d) Floors: Floors should be impermeable to liquids, smooth and free from cracks. ---------------------- 16. (2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. (9) Miscellaneous. Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : (e) Disintegration test (time in minutes). Changes, if any, in information furnished at the time of initial registration or last renewal Equipment maintenance CRF due C R F paid as per Col. 41 2 3 4 5 10.1.1 Maintenance of documents (7) Advertisement material shall be presented with courtesy and good taste and words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as "the most potent", "the most rapid", "the most efficacious", or which make exaggerated claims or to general claims, such as "effective in all cases" or "effective against all complaints" or superlatives shall be avoided. 1. of Pack Total quantity in terms of individual units e.g., total No. 4.4 Specifications for Finished Products II. Practiced pharmaceutical profession for a period not less than two years (for foreigners) Fluent Arabic and foreign language. Sentonin. Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. (A) For the grant of Registration Rs. in case of proprietorship the names) of proprietors and their address (es), in the case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors). 18. The Ministry of Health and Family Affairs issued the Cosmetic Rules in December 2020, which states that a drug license is mandatory for importing cosmetics into India. (a) if that drug at any time, for safety reasons is withdrawn or banned or certain restrictions are imposed in any of the said countries, then it shall be the responsibility of the manufacturer in Pakistan or as the case may be, the indentor, to immediately withdraw the drug from the market in Pakistan or, as the case may be to impose similar restriction and to inform the registration Board within fourteen days of such an information having come to his knowledge and having taken the necessary action. 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. Remarks. 7.3.9 Repair or maintenance The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. (Signature of designated authority (Place and date) (3) Sealing equipment, SCHEDULE B-III (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; (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; 11. (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. (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug. (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: 10.1.3 Documentation system STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE 5. Note//: This Schedule gives equipment and space required for certain categories of drugs only. (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. Expenditure on advertisement: No person shall spend more than five per cent of his turnover on advertisement, sampling and other promotional activities in respect of drugs, Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; (4) Tube filling equipment. Serial Number. 12,500 SECTION--3 The Doctor of Pharmacy degree (often abbreviated Pharm.D. Type of licence Fee (i) one representative of the Central Board of Revenue, not below the status of an officer of B-20, to be nominated by the Federal Government; If you have an active intern registration in Kansas, you may only need to pay $100. 6.2 Changing Rooms Proviso: Added vide S.R.O. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. 2. Licence to Manufacture 3.7.2 Authorized procedures (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals 66. (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. Signature of the examiner. Actual production and packing particulars. 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