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. Serial Number, (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and Aseptic Filling and sealing room: (bb) An applicant for registration of insecticides, pesticides and household disinfectants shall, in addition to the conditions specified in Schedule B and Schedule B-l, comply with the conditions specified in Schedule B-l, A. As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. 4.8.1 Written programme In order to avoid over-promotion, the main part of the volume of sales they generate. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and (iii) Coating Section. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. (ad) "new drug" means a drug that has not been commonly sold or distributed to the public in Pakistan and is introduced for the first time; (i) 4.11 Labels (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring; (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. 08.80.040 . (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. Validation 42. (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. (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. 6.10.1 Storage Sterilization Date of receipt of sample, 31. Sulphur Sublime. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. Stability studies : Chloral Hydrate. Date of Registration Secretary Registration Board (Seal) Chairman. Resorcin. (3} Granular Benzoic Acid. (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; (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. (12) The manufacturer or, as the case may be, the indentor shall supply the information in relation to safety, efficacy, production, quality, or availability of the drugs as and when required by the Registration Board with a view to ensure safety, efficacy or quality of the drug. Name of the Sample *The whole course must be done in the campus of the University/Country . 3. (i) Class(es) of drugs. (4) Water still. (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; 145 (I)/76 dated 12th February 1976:- In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government is pleased to make the following rules, namely :-- (a) Generic/international non-proprietary name: (1) Tablet machine, single punch or rotary. (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. HTML PDF: 246-945-245: Health care entity license. 3.6.7 Recording measures 2.6 Filters Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. (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. 8. 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; [See rule 21(I)] 6 wherever necessary. (i) Reference Books 2.3 Products sterilized by filtration 1 2 3 SECTION -- 4 14. 3, Batch Size, 6.5 Finished Pharmaceutical Products (2) Stainless steel scoops end vessels. The Tableting Section shall be free from dust and floating particles. (ag) "packaging material" means any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment and packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product; (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; The premises and plan will be ready for inspectionon or are ready for inspection. (iii) Name of the drug(s) registered/approved. (2) A drug or any substance referred to in clause (ii) of Sec. Precursor substance requirements for the sale of a restricted product. Find funding 5. (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate 4.8.3 Specific training Name and address of the manufacturer: 16. Conditions of licence to manufacture drugs for experimental proposes: A licence issuing under rule 21 shall be subject to the following conditions, namely :-- 11. There should be no drains at all in plants and in warehouse. 6, Results of tests applied. You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. (6) Finished products shall be stored in a suitable separate place. (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 (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution. (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: criteria. Bacteriophages. ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION 30. 5. (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. 4.7 Duties of Quality Control Incharges 7,500 5. ---------------- Number of containers filled. (e) one medical specialist from the Army Medical Corps. The License can be renewed as it is valid for up to five years. (k) Price of the drug, ; and 6. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; 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. 1. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. 2. 16. Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. 7. MANUFACTURE BY WAY OF FORMULATION Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). Checking integrity of filters (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. SECTION -- 5 (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; Signature of the Analyst, An area of minimum of 250 square feet is required for the basic installation. 15,000 10.1.10 Starting material re-assay The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. 5 whenever necessary. Sale at more than one place .- (1) If a person desires to sell, store, exhibit for sa le or distribute drugs at more than one place, he shall apply for a separate license in ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. 3. One must pass this exam to be registered as pharmacist. Potassium Bicarb. 20. 6.9.4 Storage 7.4.10 Discrepancies to be investigated 1.2 Surroundings Calamine. SCHEDULE B I-A. Gripe Waters. Activities in clean areas kept minimum Sentonin. 4.3 GMP awareness Advertisements in any form made to physicians and health-related professionals.-(1) The wording and illustrations in advertisements to physicians and related health professionals shall be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. Monitoring water supply of sources (b) the Director, Health Services of, each Provincial Government; 6.2.5 Delivery from different batches 1.1 Responsibility of licensee for drugs fitness for use. (i) adequate facilities for first aid; Name(s) of Proprietor(s)/Director(s)/Partner(s). FIHS is registered with Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician (Category-B) professional diploma. (i) the name and address of manufacturer or distributor; [--] Total. Dated Signed (3) Drier. Simulation of aseptic operations validation 7. (f) the applicant shall ensure that-- 2 Examinations. Potassium Acetate. wherever necessary 4.6 Packaging Instructions Justification : (Only in case of a new entity). 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